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 |
|---|---|---|---|---|---|---|
| Medi First Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | Unifirst First Aid Corporation | 545fa5b6-781c-18ae-e063-6294a90a2f0d | 2026-06-16 | Warnings | M004 |
| Triple Antibiotic | FIRST AID ANTIBIOTIC ORIGINAL STRENGTH | Aldermed Inc. | 19eace87-b505-4be6-93b3-db5323e34216 | 2026-06-12 | Warnings | M004 |
| Bacitracin | BACITRACIN | AlderMed Inc. | 3f0eb4a0-f7bf-45f7-8885-92c65a4bd899 | 2026-06-08 | Warnings | M004 |
| Bacitracin Zinc | FIRST AID ANTIBIOTIC | Aldermed Inc. | 7f4bff4f-588d-4e45-8aa3-f95b4d746f25 | 2026-06-08 | Warnings | M004 |
| Triple Antibiotic First Aid Antibiotic plus Pain Relief | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HCL | Aldermed Inc. | 5bfc7776-1030-48ba-9df4-897c4984c9e6 | 2026-06-08 | Warnings | M004 |
| Triple Antibiotic Plus Pain Relief | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | 4545c043-8e8e-4288-b4d8-e6ec9d72f979 | 2026-06-04 | Warnings | M004 |
| First Aid Kit, Orazen Inc | 5 ADHESIVE BANDAGES, 2 ANTIBIOTIC OINTMENTS | Orazen Inc | 525bcb89-af5b-8652-e063-6294a90a41a6 | 2026-06-03 | Warnings | M004 |
| Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE | Sun Pharmaceutical Industries, Inc. | d77239e6-5e81-439a-b0cd-f8be59169442 | 2026-06-02 | Warnings | M004 |
| First Aid Antibiotic | BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B | HyVee Inc | 3ac9f0fc-e08c-49d9-9079-3ba0393c612b | 2026-06-02 | Warnings | M004 |
| Triple Antibiotic Plus Pain Relief | BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL | HyVee Inc | 69a4b642-b7ec-43cc-aa57-6858da0b3d63 | 2026-06-02 | Warnings | M004 |
| Careland Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | Planet (Anhui) Pharmaceutical Co., Ltd. | 0e64179d-fce2-48fc-833e-ce43a54b987c | 2026-05-31 | Warnings | M004 |
| First Aid Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | Hubei Fanjian Medical Product Co.,Ltd | f44ab989-c618-1831-e053-2995a90adc8e | 2026-05-28 | Warnings | M004 |
| Vitastem-tetracycline hydrochloride | TETRACYCLINE HYDROCHLORIDE | ViaDerma Distribution, Inc. | 7ffe82a4-864b-48c7-9307-d262f20ca01e | 2026-05-26 | Warnings | M004 |
| Viaderma Vitastem First Aid Topical Antibiotic | TETRACYCLINE HYDROCHLORIDE | VIADERMA DISTRIBUTION INC | 6eb04a76-7995-4df6-9c9b-dd450537e538 | 2026-05-26 | Warnings | M004 |
| Medi-First Bacitracin Zinc | BACITRACIN | Unifirst First Aid Corporation | 54609a4f-0fe9-b750-e063-6394a90ae9ce | 2026-05-26 | Warnings | M004 |
| Hand San | ALCOHOL | Rochester Midland Corporation | 2d89982d-d1fd-4a98-8b44-c2ae3545be58 | 2026-05-14 | Warnings | M004 |
| first aid antibiotic | BACITRACIN | HyVee Inc | 97c87111-260a-48d0-92cd-e22f55a48c7d | 2026-05-12 | Warnings | M004 |
| triple antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | Walgreens Co. | 32df5cca-77bc-45d2-b1f6-2cfdfc371ea9 | 2026-05-12 | Warnings | M004 |
| ANTIBIOTIC Maximum Strength | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | Walgreens Co. | 653c88bf-5b7d-45be-a131-d59990573e9c | 2026-05-12 | Warnings | M004 |
| Fresh Start | CHLOROXYLENOL | Pro Chem, Inc. | dd1708d8-0bb2-c96a-e053-2995a90a5b86 | 2026-05-11 | 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 |