SmileCare Mouth Ulcer Gel
- Product NDC
- 87512-004
- 11-digit product format
- 875120004
- Labeler code
- 87512
- Product ID
- 87512-004_4d6db039-5b98-8f3f-e063-6294a90a9d85
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Menthol
- Dosage form
- GEL
- Route
- ORAL
- Labeler
- Yantai Aien Biotechnology Co., Ltd.
- Application
- M022
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-03-20
- Substance
- MENTHOL
- Active strength
- .1 g/100g
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- SmileCare Mouth Ulcer Gel
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MENTHOL | .1 g/100g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| L7T10EIP3A | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4d6db039-5b97-8f3f-e063-6294a90a9d85 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 87512-004-01 | SmileCare Mouth Ulcer Gel | 10 g in 1 TUBE | GEL | 10 | 1 | |
| 87512-004-02 | SmileCare Mouth Ulcer Gel | 15 g in 1 TUBE | GEL | 15 | 1 | |
| 87512-004-03 | SmileCare Mouth Ulcer Gel | 20 g in 1 TUBE | GEL | 20 | 1 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Listerine Essential Care | SODIUM MONOFLUOROPHOSPHATE | Kenvue Brands LLC | 90b5c3d8-baa4-44ab-8f73-e177007f0219 | 2025-10-10 | Warnings | M022 |
| DuoCare Clinical Oral Rinse | CETYLPYRIDINIUM CHLORIDE | Medline Industries, LP | 98e61cd5-7e29-7066-e053-2a95a90afa21 | 2025-10-10 | Warnings | M022 |
| 4-in-1 Teeth Care Pens | 4-IN-1 TEETH CARE PENS | Jiangxi Dentalbright Technology Co., Ltd | 40b756b7-ce1b-6482-e063-6294a90a0425 | 2025-10-09 | Warnings | M022 |
| Giltuss Bucalsep | BENZOCAINE, MENTHOL, ZINC CHLORIDE | Gil Pharmaceutical Corp | 85053391-8d71-ab4f-e053-2991aa0a7e08 | 2025-10-09 | Warnings | M022 |
| Listerine Gum Therapy Mouthwash Glacier Mint | EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL | Kenvue Brands LLC | 40a0bdf3-1698-1449-e063-6394a90ab13d | 2025-10-08 | Warnings | M022 |
| Kalaya Breath Refresh | MOUTHWASH | Avaria Health and Beauty Corp | 750e99ff-72e4-3c2f-e053-2a91aa0ad5a0 | 2025-10-08 | Warnings | M022 |
| Trader Joes | SODIUM FLUORIDE 0.24% AND POTASSIUM NITRATE 5% | TRADER JOE'S COMPANY | 159abeba-6da2-2643-e063-6394a90a730d | 2025-10-08 | Warnings | M022 |
| Family Wellness Oral Pain Relief | BENZOCAINE 20% | FAMILY DOLLAR SERVICES INC | 105d87d6-9147-43d4-e063-6394a90a57ee | 2025-10-08 | Warnings | M022 |
| Equate Glistening Mint | SODIUM FLUORIDE | Walmart Inc. | 39ff21ee-a362-014e-e063-6294a90a0d91 | 2025-10-03 | Warnings | M022 |
| Mouth Sore Relief Professional Strength | BENZOCAINE | CVS Pharmacy | 1b7209f6-8368-47fa-8df2-b049613b8c1b | 2025-09-30 | Warnings | M022 |
| Hydrogen Peroxide | HYDROGEN PEROXIDE | Family Dollar (FAMILY WELLNESS) | 9db73da2-5b70-41e6-bcf9-caa7f1142024 | 2025-09-29 | Warnings | M022 |
| Esunix Oral Bacteriostatic Liquid | CETYLPYRIDINIUM CHLORIDE | Xiling (Zhenjiang) Medical Technology Co., Ltd. | 3f47d7e1-b6ae-efd1-e063-6394a90a4602 | 2025-09-27 | Warnings | M022 |
| Chloraseptic Sore Throat Cherry | PHENOL | Prestige Brands Holdings, Inc. | d5d62f7a-8f92-4d42-a2fb-691f896f72fc | 2025-09-26 | Warnings | M022 |
| Giltuss Bucalsep | BENZOCAINE, MENTHOL, ZINC CHLORIDE | Dextrum Laboratories Inc. | 3fa233dc-156c-1e95-e063-6294a90a8bbd | 2025-09-25 | Warnings | M022 |
| Finafta MultiOral | BENZOCAINE | Dextrum Laboratories Inc. | cb027ab8-4175-4cc0-a73e-991dfb113df9 | 2025-09-23 | Warnings | M022 |
| 4-in-1 Teeth Care Pens | 4-IN-1 TEETH CARE PENS | Jiangxi Dentalbright Technology Co., Ltd | 3f872924-0c44-267b-e063-6394a90a1a67 | 2025-09-23 | Warnings | M022 |
| Dental Relief | BENZOCAINE | Cintas Corporation | 0f40f775-797e-43cf-88c9-00eea666494f | 2025-09-23 | Warnings | M022 |
| Seavue Anti-caries Gel | SODIUM FLUORIDE | Xiling (Zhenjiang) Medical Technology Co., Ltd. | 3f4c6086-b96d-8fa4-e063-6294a90ad800 | 2025-09-21 | Warnings | M022 |
| Seavue Dental Desensitizer | POTASSIUM NITRATE AND SODIUM FLUORIDE DENTIFRICE | Xiling (Zhenjiang) Medical Technology Co., Ltd. | 3f47f399-1a14-5264-e063-6394a90aeb1c | 2025-09-20 | Warnings | M022 |
| Povi-One | POVIDONE-IODINE 10% TOPICAL | Elevate Oral Care | 27c29a33-d1cc-d72f-e063-6394a90a4d45 | 2025-09-19 | Warnings | M022 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 87512-004-01 | 87512000401 | 10 g in 1 TUBE (87512-004-01) | 10 g | 2026-03-20 | No | No | Current |
| 87512-004-02 | 87512000402 | 15 g in 1 TUBE (87512-004-02) | 15 g | 2026-03-20 | No | No | Current |
| 87512-004-03 | 87512000403 | 20 g in 1 TUBE (87512-004-03) | 20 g | 2026-03-20 | No | No | Current |