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 |
|---|---|---|---|---|---|---|
| Lemon Glycerin | GLYCERIN | Dynarex Corporation | 99fc00ea-9d55-0380-e053-2995a90a2c0b | 2026-03-24 | Warnings | M022 |
| Dual-FormulaToothpaste for sensitive teeth | DUAL-FORMULA TOOTHPASTE FOR SENSITIVE TEETH | Hangzhou Namei Zhikang Technology Co., Ltd. | 4d735f91-8abc-3a30-e063-6394a90a7639 | 2026-03-20 | Warnings | M022 |
| SmileCare Mouth Ulcer Gel | MENTHOL | Yantai Aien Biotechnology Co., Ltd. | 4d6db039-5b97-8f3f-e063-6294a90a9d85 | 2026-03-19 | Warnings | M022 87512-004 |
| Quala Topical Anesthetic Gel | BENZOCAINE | National Distribution & Contracting, Inc | 9f91e609-8ca5-0492-e053-2a95a90a85d0 | 2026-03-17 | Warnings | M022 |
| Quala Topical Anesthetic Gel | BENZOCAINE | National Distribution & Contracting, Inc | 9f81ffa5-05fd-4eef-e053-2995a90aac3e | 2026-03-17 | Warnings | M022 |
| Quala Topical Anesthetic Gel | BENZOCAINE | National Distribution & Contracting, Inc | 9f947366-9380-3fa9-e053-2a95a90ad49c | 2026-03-17 | Warnings | M022 |
| Quala Topical Anesthetic Gel | BENZOCAINE | National Distribution & Contracting, Inc | 9f947672-4873-5546-e053-2a95a90a3c4b | 2026-03-17 | Warnings | M022 |
| Quala Topical Anesthetic Gel | BENZOCAINE | National Distribution & Contracting, Inc | 9f9490c1-8bfe-3166-e053-2a95a90a7175 | 2026-03-17 | Warnings | M022 |
| Quala Topical Anesthetic Gel | BENZOCAINE | National Distribution & Contracting, Inc | 9f94b65d-47e3-9c6b-e053-2a95a90aa1f8 | 2026-03-17 | Warnings | M022 |
| BencoCaine Topical Anesthetic | BENZOCAINE | Benco Dental | 4d3e03ee-6e0f-c9ae-e063-6394a90a6f5b | 2026-03-17 | Warnings | M022 |
| HurriCaine Topical Anesthetic | BENZOCAINE | Beutlich Pharmaceuticals, LLC | 043c00a6-1346-7780-e063-6294a90a3d5a | 2026-03-12 | Warnings | M022 |
| ORAL PAIN RELIEF | BENZOCAINE | Nantong Health & Beyond Hygienic Products Inc. | a5f0be98-d47e-4307-8044-304a64db774b | 2026-03-11 | Warnings | M022 |
| SENSODYNE PRONAMEL Intensive Enamel Repair Whitening | POTASSIUM NITRATE AND SODIUM FLUORIDE | Haleon US Holdings LLC | a2f9d58b-671b-4427-a971-1fceff5f2323 | 2026-03-09 | Warnings | M022 |
| Sore Mouth Cleanser | HYDROGEN PEROXIDE | CVS Pharmacy, Inc. | a5dbaadf-76a8-4c48-af2d-f4455e9411f0 | 2026-03-09 | Warnings, Adverse reactions | M022 |
| Hydrogen Peroxide 3 Percent | HYDROGEN PEROXIDE | Sam's West, Inc | 78a3e024-73da-40b7-9d9c-099fd6ca9b9e | 2026-03-03 | Warnings | M022 |
| Sore Throat | PHENOL GLYCERIN | CVS PHARMACY, INC | 9683bcfb-2f7e-48a4-aa79-500ee8df099a | 2026-03-02 | Warnings | M022 |
| Spring Gene Oil Pulling Sensitivity | POTASSIUM NITRATE | Health and Natural Beauty USA Corp | 294051e3-69ec-4190-8b03-fa34988376b7 | 2026-02-26 | Warnings | M022 |
| Lolleez Watermelon | PECTIN | BFY LLC | 4ba8af8b-5a17-8b8c-e063-6394a90a63f3 | 2026-02-25 | Warnings | M022 |
| Oral Sore Antiseptic | HYDROGEN PEROXIDE, MENTHOL | H E B | f1450866-1be4-46d9-9fe4-52d699636b4f | 2026-02-24 | Warnings, Adverse reactions | M022 |
| SIGNATURE CARE SORE THROAT CHERRY FLAVOR | PHENOL | SAFEWAY | 94a2c1b9-f462-4489-b84a-825a82835d30 | 2026-02-23 | 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 |