MOUTH ULCER
- Product NDC
- 87714-002
- 11-digit product format
- 877140002
- Labeler code
- 87714
- Product ID
- 87714-002_5264f81c-bfff-4f6d-e063-6394a90ae3bf
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- panthenol
- Dosage form
- LIQUID
- Route
- BUCCAL
- Labeler
- Guangzhou Shengli Shidai Cosmetics Co., Ltd.
- Application
- M022
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-05-22
- Substance
- PANTHENOL
- Active strength
- 1.2 g/100mL
- 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
- MOUTH ULCER
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PANTHENOL | 1.2 g/100mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| WV9CM0O67Z | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 5264f81c-bffe-4f6d-e063-6394a90ae3bf | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 87714-002-01 | MOUTH ULCER | 20 mL in 1 BOTTLE | LIQUID | 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 |
|---|---|---|---|---|---|---|
| Iolite | BENZOCAINE | Dharma Research, Inc. | e4b2d22b-00b3-45a6-9b7d-8ee719587059 | 2023-10-09 | Warnings | M022 |
| Iolite | BENZOCAINE | Dharma Research, Inc. | a0e284f6-292f-4231-8596-f7cee4e0a12f | 2023-10-09 | Warnings | M022 |
| HurriCaine Topical Anesthetic | BENZOCAINE | Beutlich Pharmaceuticals, LLC | fe92637a-c88a-f9dd-e053-6294a90a7fa3 | 2023-07-01 | Warnings | M022 |
| HurriCaine Topical Anesthetic | BENZOCAINE | Beutlich Pharmaceuticals, LLC | c979e958-2042-471a-bf03-e84e68620106 | 2023-06-20 | Warnings | M022 |
| Orajel Gum Pain 3X Medicated | BENZOCAINE, MENTHOL, ZINC CHLORIDE | Church & Dwight Co., Inc. | 9a1632ad-2b47-5653-e053-2995a90ae0d9 | 2023-01-20 | Warnings | M022 |
| KOLORZ TOPICAL ANESTHETIC TRIPLE MINT | BENZOCAINE | DMG AMERICA, LLC | 0f90b227-f938-4e1a-a79e-1967b1a0477e | 2021-10-01 | Warnings | M022 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 87714-002-01 | 87714000201 | 20 mL in 1 BOTTLE (87714-002-01) | 20 ml | 2026-05-22 | No | No | Current |