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 |
|---|---|---|---|---|---|---|
| First Aid Antibiotic plus Burn Relief | BACITRACINZINC,NEOMYCINSULFATE,POLYMXINBSULFATE,PRAMOXINEHCI | Trifecta Pharmaceuticals USA LLC | 048871e2-c917-292d-e063-6394a90af130 | 2024-12-18 | Warnings | M004 |
| TheraCare Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE | Veridian Healthcare | 0c3fc798-9a97-5316-e063-6394a90a6830 | 2024-12-18 | Warnings | M004 |
| Bacitracin Zinc | BACITRACIN ZINC | Rugby Laboratories | ac3c9897-c812-1360-e053-2a95a90ad591 | 2024-12-17 | Warnings | M004 |
| Major Bacitracin | BACITRACIN ZINC | Major Pharmaceuticals | a23ce772-7078-0a4b-e053-2995a90aff0d | 2024-12-17 | Warnings | M004 |
| Bacitracin Zinc | BACITRACIN ZINC | Trifecta Pharmaceuticals USA LLC | eea0d90c-914b-2624-e053-2a95a90a34c9 | 2024-12-13 | Warnings | M004 |
| OP First Aid Series TRIPLE ANTIBIOTIC | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | Nantong Health & Beyond Hygienic Products Inc. | cadebf07-dd48-4855-8296-7a91e28d7123 | 2024-12-05 | Warnings | M004 |
| triple antibiotic and pain relief | BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDE | CVS Pharmacy | f0864d78-23e6-4e6c-bc67-7ba3e6dd862c | 2024-12-03 | Warnings | M004 |
| triple antibiotic | BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDE | Publix Super Markets Inc | 330c7b7a-d0d1-42dc-b8f7-9c96aeaf69f9 | 2024-11-25 | Warnings | M004 |
| WinCo Maximum Strength Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, POYMYXIN B SULFATE, AND PRAMOXINE HYDROCHRLORIDE | WinCo Foods, LLC | 01b03c7e-6c4e-43aa-8480-aff1c2688f7f | 2024-11-21 | Warnings | M004 |
| WinCo Original Strength Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE | WinCo Foods, LLC | e364b623-6e20-4894-8d4c-5c739be78f86 | 2024-11-21 | Warnings | M004 |
| Winco Bacitracin Zinc | BACITRACIN ZINC | WinCo Foods, LLC | dcdf647f-fa32-4b72-b714-a77e8e332358 | 2024-11-21 | Warnings | M004 |
| Walgreens Multi-Antibiotic with Pain Relief Cream | POLYMYXIN B SULFATE, NEOMYCIN SULFATE, PRAMOXINE HYDROCHLORIDE | Walgreens Company | f4feccc3-ac25-4d8a-9b68-9a24f755524a | 2024-11-20 | Warnings | M004 |
| Walgreens Kids Multi-Antibiotic with Pain Relief Cream | POLYMYXIN B SULFATE, NEOMYCIN SULFATE, PRAMOXINE HYDROCHLORIDE | Walgreens Company | fbc364d7-d8b8-43f5-99cc-290438f3982b | 2024-11-20 | Warnings | M004 |
| Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | Acme United Corporation | f9a48f73-aa12-cf68-e053-6294a90a8e53 | 2024-11-19 | Warnings | M004 |
| Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE | Acme United Corporation | e55cbf7e-c955-7f1a-e053-2a95a90a3f28 | 2024-11-19 | Warnings | M004 |
| First Aid Only Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | Acme United Corporation | f4eba34c-ce31-3004-e053-2995a90a245b | 2024-11-19 | Warnings | M004 |
| First Aid Only Neomycin Antibiotic | NEOMYCIN SULFATE | Acme United Corporation | c651e98e-aabe-de46-e053-2a95a90a6307 | 2024-11-19 | Warnings | M004 |
| Neosporin Original | BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE | Kenvue Brands LLC | f07d3bca-4312-46ed-b0c4-f886c01bd095 | 2024-11-14 | Warnings | M004 |
| Polysporin First Aid Antibiotic | BACITRACIN ZINC AND POLYMYXIN B SULFATE | Kenvue Brands LLC | e0fcf83e-a374-4fc0-a629-873033054392 | 2024-11-14 | Warnings | M004 |
| Neosporin Pain Itch Scar | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE | Kenvue Brands LLC | 55392c48-b5d8-44cd-8c10-6d8668349848 | 2024-11-13 | 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 |