burn gel
- Product NDC
- 82953-045
- 11-digit product format
- 829530045
- Labeler code
- 82953
- Product ID
- 82953-045_3227b643-a99e-6716-e063-6294a90a73b7
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- melaleuca alternifolia (tea tree) leaf oil
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Cosmuses Cosmetics (Ningbo) Co., Ltd.
- Application
- M004
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-04-06
- Substance
- MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL
- Active strength
- 1 g/100g
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- 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
- burn gel
- Brand name suffix
- 01
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL | 1 g/100g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| VIF565UC2G | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3227bdc9-9323-68eb-e063-6294a90a29d2 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 82953-045-01 | burn gel01 | 0.85 g in 1 POUCH | GEL | 0.85 | 1 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| FifthPulse Hydrocortisone 4oz | HYDROCORTISONE | Front Pharmaceutical PLC | 39fb29c8-6a28-e87e-e063-6294a90a78da | 2025-07-15 | Warnings | M004 |
| Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE | Fred's, Inc. | 41ee7a50-d36b-4214-b6f8-44f47ab44a84 | 2025-07-15 | Warnings | M004 |
| Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE | Lidl US, LLC | 98389314-c2cf-4510-ab3d-41c4c4720019 | 2025-07-15 | Warnings | M004 |
| Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B | Publix Super Markets Inc | 72bdb96c-af93-4a9b-93d9-81a94b6ff756 | 2025-07-15 | Warnings | M004 |
| Live Better Triple Antibiotic plus Pain Relief | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE | The Great Atlantic & Pacific Tea Company | 7e7a0b4c-67a9-42f3-aacd-2606fde25090 | 2025-07-15 | Warnings | M004 |
| Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE | Topco Associates LLC | 55a8a52c-4d03-417d-9283-406f6879bcb5 | 2025-07-15 | Warnings | M004 |
| Triple Antibiotic Plus Pain Relief | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE | FRED'S, INC. | a44db5d1-7a74-44aa-9aa7-6247e771aaf2 | 2025-07-15 | Warnings | M004 |
| Shopko Triple Antibiotic plus Pain Relief | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE | Shopko Stores Operating Co., LLC | 5a9b2ea4-9b9d-4147-8aa0-7313d6be2cfa | 2025-07-15 | Warnings | M004 |
| sunmark triple antibiotic plus pain relief | POLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDE | Strategic Sourcing Services LLC | 941a6a71-e898-4af3-989a-6d3aa3224338 | 2025-07-15 | Warnings | M004 |
| TopCare Triple Antibiotic Plus Pain Relief | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE | Topco Associates LLC | 0fc0dbc6-ca1d-42be-8016-68e64f119706 | 2025-07-15 | Warnings | M004 |
| Triple Antibiotic Plus Pain Relief | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE | Walgreen Company | e2b7fc5b-c796-4ed1-aea7-4c810df250d5 | 2025-07-15 | Warnings | M004 |
| Publix antibiotic plus Pain Relief | NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE | Publix Super Markets Inc | d0193bf1-a257-490e-a058-5e6a514981da | 2025-07-15 | Warnings | M004 |
| Live Better Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE | The Great Atlantic & Pacific Tea Company | 7d3435ad-7d73-4db6-8019-3040b3dadfa9 | 2025-07-14 | Warnings | M004 |
| Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE | Wal-Mart Stores, Inc. | f5199476-1ce2-4a82-9685-40d78b7a8935 | 2025-07-14 | Warnings | M004 |
| Double Antibiotic | BACITRACIN ZINC AND POLYMYXIN B SULFATE | STRATEGIC SOURCING SERVICES LLC | 38414fff-8dad-44d0-9dfa-f89a63ef9b44 | 2025-07-14 | Warnings | M004 |
| sunmark double antibiotic | BACITRACIN ZINC AND POLYMYXIN B SULFATE | Strategic Sourcing Services LLC | 2868de5c-4894-45ee-9647-9acd3bde7cfc | 2025-07-14 | Warnings | M004 |
| Live Better Bacitracin Zinc | BACITRACIN ZINC | The Great Atlantic & Pacific Tea Company | 6915940c-2eae-445c-ba58-e39d221e9d3d | 2025-07-11 | Warnings | M004 |
| Bacitracin Zinc | BACITRACIN ZINC | STRATEGIC SOURCING SERVICES LLC | 4594948d-1f25-4d3c-a615-9e6edda05a10 | 2025-07-11 | Warnings | M004 |
| Good Neighbor Pharmacy Bacitracin Zinc | BACITRACIN ZINC | AmerisourceBergen | 3fb302b5-7273-412c-a2ba-b76183e3f179 | 2025-07-11 | Warnings | M004 |
| TopCare Bacitracin Zinc | BACITRACIN ZINC | Topco Associates LLC | 5b59e26d-cc25-49a6-ac8b-f79398e18f2d | 2025-07-07 | Warnings | M004 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 82953-045-01 | 82953004501 | .85 g in 1 POUCH (82953-045-01) | 2025-04-06 | No | No | Current |