Based on the provided FDA and EMA datasets, the following summarizes the types of mouthwashes approved and the regulatory pathways they have taken:

---

1. Mouthwashes Approved as Medical Devices (FDA 510(k) Pathway)

These products are typically classified as medical devices and are cleared via the FDA's 510(k) premarket notification process. They are often "substantially equivalent" to predicate devices already on the market.

A. Dry Mouth Relief / Artificial Saliva Mouthwashes

• Examples:
  • Biotene Dry Mouth Oral Rinse ^2241939
  • Oral-B Dry Mouth Oral Rinse ^59505672
  • SmartMouth DryMouth Oral Rinse ⁷³⁴⁵⁴
  • TheraBreath Dry Mouth Oral Rinse ^11123361
  • Oral7 Moisturizing Mouthwash ^6465962
  • GuruNanda Dry Mouth Oral Rinse ³¹
  • Hydris Oral Rinse ^28294078
  • GUM HYDRAL Dry Mouth Oral Rinse ¹⁴
  • Moisyn Dry Mouth Oral Rinse ¹⁵⁵⁸
  • Dr. Fresh Dry Mouth Mouthwash ¹¹⁷³⁰
• Regulatory Pathway: FDA 510(k) clearance as "saliva, artificial" (Product Code: LFD), typically unclassified or Class II medical devices. These products are reviewed for substantial equivalence to predicate devices and are subject to general controls (registration, labeling, GMP, etc.) ^{22457111415283134465056586272}.

B. Desensitizing Mouthwashes

• Examples:
  • Colgate Desensitizing Mouthwash / Sensitive Pro-Relief ⁸²³⁴¹
  • LISTERINE Sensitivity Defense Mouthrinse ³³⁶⁵¹
• Regulatory Pathway: FDA 510(k) clearance, typically as "cavity varnish" (21 CFR 872.3260, Product Code: LBH), Class II devices. These are cleared based on substantial equivalence to predicate devices for the management of sensitive teeth ^3823364151.

C. Oral Wound and Mucositis/Stomatitis Rinses

• Examples:
  • Aftamed Mouthwash ^4162126
  • MuGard Mucoadhesive Oral Wound Rinse ⁴²
  • OraMagicRx Oral Wound Rinse ²⁷
  • OraMagic Plus Oral Wound Rinse ⁷⁴
• Regulatory Pathway: FDA 510(k) clearance, often as "hydrogel wound dressing" or "mucositis/stomatitis oral rinse" (Product Code: MGQ), unclassified or Class II devices ^{4162126274274}.

D. Plaque/Gingivitis Reduction Rinses (Non-drug)

• Examples:
  • Decapinol Oral Rinse ²⁵³⁵
• Regulatory Pathway: FDA 510(k) clearance as "oral rinse to reduce adhesion of dental plaque" (21 CFR 872.5580, Product Code: NTO), Class II devices with special controls ²⁵³⁵.

---

2. Mouthwashes Approved as Drugs (FDA NDA/ANDA Pathway)

Some mouthwashes, especially those with active pharmaceutical ingredients (APIs) like chlorhexidine gluconate or sodium fluoride, are regulated as drugs and require New Drug Applications (NDA) or Abbreviated New Drug Applications (ANDA).

A. Antimicrobial Mouthwashes (Chlorhexidine Gluconate)

• Examples:
  • Peridex (chlorhexidine gluconate 0.12%) ^4455606375
  • ********* (chlorhexidine gluconate 0.12%)* ^{22475564656668697077}
• Regulatory Pathway: FDA NDA or ANDA approval. These are prescription (Rx) drugs. ANDA approvals require the generic product to be qualitatively and quantitatively (Q1/Q2) the same as the reference listed drug, and bioequivalence waivers are often granted due to the topical (oral cavity) use ^{224455606365667075}.

B. Anticaries/Antiplaque/Antigingivitis Mouthwashes (Fluoride, Triclosan)

• Examples:
  • Colgate Total (sodium fluoride 0.24%, triclosan 0.30%) ^203848577173
• Regulatory Pathway: FDA NDA approval (505(b)(1)), as these are considered new drugs due to their active ingredients and claims. The review includes efficacy and safety data for anti-caries and anti-gingivitis indications ^203848577173.

---

3. EMA (European Medicines Agency) Approvals

• The provided sources do not contain direct evidence of EMA approvals for mouthwashes. Some products are manufactured by European companies (e.g., Sinclair Pharmaceuticals, Bioplax Limited), but the regulatory pathway described is for FDA clearance, not EMA approval ^18253552.
• Note: In the EU, many mouthwashes are regulated as medical devices under the Medical Device Regulation (MDR) or as medicinal products, depending on their ingredients and claims. However, no EMA-specific approval data is present in the provided sources.

---

Summary Table

Type of Mouthwash	Example Products	FDA Regulatory Pathway	Class/Status
Dry Mouth/Artificial Saliva	Biotene, Oral-B, SmartMouth, Oral7	510(k)	Unclassified/Class II
Desensitizing	Colgate Sensitive, Listerine Defense	510(k)	Class II
Oral Wound/Mucositis	Aftamed, MuGard, OraMagic	510(k)	Unclassified/Class II
Plaque/Gingivitis (Non-drug)	Decapinol	510(k)	Class II
Antimicrobial (Chlorhexidine)	Peridex, ********	NDA/ANDA	Rx Drug
Anticaries/Antiplaque (Fluoride)	Colgate Total	NDA	OTC/Rx Drug

---

Key Points

• Most dry mouth, desensitizing, and wound care mouthwashes are regulated as medical devices and cleared via the FDA 510(k) pathway.
• Antimicrobial and anticaries mouthwashes with active drug ingredients (e.g., chlorhexidine, fluoride) are regulated as drugs and require NDA or ANDA approval.
• Bioequivalence waivers are commonly granted for generic chlorhexidine gluconate rinses due to their topical use and identical formulation to reference products ^{224455606365667075}.
• No direct EMA approval data is present in the provided sources.

Here are a few recalls from May 2025, based on public FDA datasets:

1. Yellowstone Baked Beans (Vietti Food Group)

   • Recall Date: Company Announcement Date: May 2, 2025; FDA Publish Date: May 5, 2025
   • Reason: Presence of undeclared soy allergen. Individuals with a soy allergy risk serious or life-threatening reactions if they consume this product.
   • Product: Yellowstone Brown Sugar Molasses Baked Beans (15 oz.)
   • Distribution: Retailers in multiple states including Arizona, Colorado, Delaware, Florida, Georgia, Illinois, Iowa, Kansas, Kentucky, Louisiana, Michigan, Mississippi, Missouri, New Hampshire, New York, North Carolina, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, and Virginia.
   • Action: Consumers urged to return the product for a full refund.
   • ¹⁷

2. President Brand Licorice Plum (Eats CL Trading, Inc.)

   • Recall Date: Company Announcement Date: May 1, 2025; FDA Publish Date: May 5, 2025
   • Reason: Undeclared allergen (sulfites) and use of unapproved color (Amaranth/E123). Sulfites can cause severe reactions in sensitive individuals.
   • Product: Licorice Plum, 8-ounce packages
   • Distribution: Nationwide in retail stores and mail orders.
   • Action: Consumers urged to return the product for a full refund.
   • ²¹

3. H&C Farms Label Tomatoes (Williams Farms Repack LLC)

   • Recall Date: Company Announcement Date: May 2, 2025; FDA Publish Date: May 2, 2025
   • Reason: Potential contamination with Salmonella, which can cause serious and sometimes fatal infections.
   • Product: Tomatoes (various sizes and packaging)
   • Distribution: Georgia, North Carolina, and South Carolina.
   • Action: Consumers urged not to consume and to return for a full refund.
   • ²⁵

4. New England Village Snacks 19th Hole Snack Mix (New England Village Foods)

   • Recall Date: Company Announcement Date: May 6, 2025; FDA Publish Date: May 6, 2025
   • Reason: Undeclared almonds and sesame allergens.
   • Product: 19th Hole Snack Mix
   • Action: Consumers urged to return the product for a full refund.
   • ²⁷

5. Nature Mills Rice Mixes, Soups, Spice Mixes, Porridge Mix, Papads and Vadam Products (Nature Mills US)

   • Recall Date: Company Announcement Date: May 13, 2025; FDA Publish Date: May 13, 2025
   • Reason: Undeclared allergens – wheat, milk, sesame.
   • Product: Various Nature Mills products (see source for full list)
   • Distribution: Nationwide via the Nature Mills website.
   • Action: Consumers with allergies should not consume and may contact the company for a refund or replacement.
   • ⁴¹

6. New Grain Gluten Free Bakery Breads, Bagels, Cookies, and Croutons (New Grains Gluten Free Bakery)

   • Recall Date: Company Announcement Date: May 8, 2025; FDA Publish Date: May 9, 2025
   • Reason: Products may contain undeclared eggs, soy, and milk.
   • Product: Various breads, bagels, cookies, and croutons.
   • Distribution: Utah, through retail stores.
   • Action: Consumers urged not to consume and to return for a full refund.
   • ⁶⁵

7. Bengal King Family Pack Vegetable Singara (South Asian Foods Inc.)

   • Recall Date: Company Announcement Date: May 16, 2025; FDA Publish Date: May 16, 2025
   • Reason: Undeclared peanut allergen.
   • Product: Family Pack Vegetable Singara, 1875g packages.
   • Distribution: Nationwide in retail stores and mail orders.
   • Action: Consumers urged not to consume and to return for a full refund.
   • ⁶⁶

These are a selection of recalls from May 2025. For more details or additional recalls, please refer to the FDA recall database.

Regulatory History of Enhertu:

United States (FDA)

1. Initial Approval (Accelerated) – December 20, 2019

   • Enhertu was first approved by the FDA under accelerated approval for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting ^546532381113.
   • The approval was based on tumor response rate and duration of response, with continued approval contingent upon confirmatory trials ⁶⁵⁵⁴.

2. Label Expansion – Gastric Cancer (January 15, 2021)

   • The FDA granted regular approval for Enhertu for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior Enhertu-based regimen ³⁸⁹⁴⁶.

3. Label Expansion – HER2-Positive Breast Cancer (May 4, 2022)

   • The FDA granted traditional approval for Enhertu for adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within 6 months of completing therapy. This satisfied the requirements for confirmatory evidence for the initial accelerated approval ³⁸⁵¹.

4. Label Expansion – HER2-Low Breast Cancer (2022)

   • Enhertu was approved for adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer, as determined by an FDA-approved test, who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy ³⁸³².

5. Label Expansion – Non-Small Cell Lung Cancer (NSCLC) (2022/2023)

   • The FDA granted accelerated approval for Enhertu for adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy ^946446334.

6. Label Expansion – HER2-Positive Solid Tumors (April 5, 2024)

   • The FDA granted accelerated approval for Enhertu for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options ^2447833235.
   • This approval is also under the accelerated approval pathway, contingent on confirmatory trials ²⁴⁴⁷.

Europe (EMA)

1. Initial Conditional Marketing Authorisation – December 10, 2020

   • The EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a conditional marketing authorisation for Enhertu for the treatment of metastatic HER2-positive breast cancer in adults who have received two or more prior anti-HER2-based regimens ⁷¹⁸²²⁵.
   • The approval was granted under the accelerated assessment program and as a conditional marketing authorisation, requiring further confirmatory data ⁷⁵⁵.

2. Label Expansion – Gastric Cancer (November 10, 2022)

   • The CHMP adopted a positive opinion for Enhertu as monotherapy for the treatment of adult patients with advanced HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior Enhertu-based regimen ^2639282942.

3. Label Expansion – HER2-Positive Breast Cancer (2022/2023)

   • The indication was expanded to include adult patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens ^26284362.

4. Ongoing and Further Developments (2023–2024)

   • The EMA has continued to assess further extensions of indication, including for HER2-low breast cancer and other solid tumors, with ongoing confirmatory studies and updates to the summary of product characteristics (SmPC) ^19275762.

Key Points

• Both FDA and EMA approvals began with HER2-positive breast cancer in heavily pretreated patients, followed by expansions to gastric cancer, HER2-low breast cancer, NSCLC, and other HER2-positive solid tumors.
• Initial approvals were under accelerated (FDA) or conditional (EMA) pathways, requiring confirmatory trials.
• Subsequent approvals have expanded the eligible patient populations and tumor types, reflecting ongoing clinical development and regulatory review.

References:
FDA: ^{3891113243234353844464751546365}
EMA: ^{2718192526272829394243555762}