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 table
Ingredient	Strength
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL	1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
VIF565UC2G	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3227bdc9-9323-68eb-e063-6294a90a29d2	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
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#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82953-045	BURN GEL 01 (MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL) GEL [COSMUSES COSMETICS (NINGBO) CO., LTD.]	1	Current NDC, 1 package rows	20250408_3227bdc9-9323-68eb-e063-6294a90a29d2.zip

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.

Matched openFDA labels page 21 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Leader Bacitracin Zinc	BACITRACIN ZINC	Cardinal Health 110 dba LEADER	a353dce2-8ae5-23aa-e053-2a95a90a89c2	2024-01-02	Warnings	Exact identifier application number: M004
Triple Antibiotic	POLYMYXIN B SULFATE, BACITRACIN ZINC AND NEOMYCIN SULFATE	NuCare Pharmaceuticals,Inc.	0dfe5f6a-6968-68e6-e063-6294a90ae25b	2024-01-02	Warnings	Exact identifier application number: M004
Bacitracin	BACITRACIN	Proficient Rx LP	e1166948-5d80-44c2-a20d-78be631647d9	2024-01-01	Warnings	Exact identifier application number: M004
TRIPLE ANTIBIOTIC	BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE	Proficient Rx LP	949c5b44-ee52-4913-8872-39181d319998	2024-01-01	Warnings	Exact identifier application number: M004
Triple Antibiotic Plus	POLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE, PRAMOXINE HCL	Cosette Pharmaceuticals, Inc.	69d911c2-cb89-2241-35f8-c83acfe18249	2023-12-21	Warnings	Exact identifier application number: M004
Bacitracin	BACITRACIN	Cosette Pharmaceuticals, Inc.	630e0841-baf2-e9fa-b309-ad1a5f95da3b	2023-12-20	Warnings	Exact identifier application number: M004
Triple Antibiotic	POLYMYXIN B SULFATE, BACITRACIN ZINC AND NEOMYCIN SULFATE	Cosette Pharmaceuticals, Inc.	39893365-c94f-bc83-67f6-0005d5f2aa24	2023-12-20	Warnings	Exact identifier application number: M004
Triple Antibiotic	POLYMYXIN B SULFATE, BACITRACIN ZINC AND NEOMYCIN SULFATE	Proficient Rx LP	524d65e7-9dc6-47b0-a924-46a765fa1869	2023-12-01	Warnings	Exact identifier application number: M004
Viabecline	TETRACYCLINE HYDROCHLORIDE	Accuria, LLC	9fd7041a-6c23-4332-90fe-759bb4aea2ae	2023-12-01	Warnings	Exact identifier application number: M004
Bacitracin	BACITRACIN	Proficient Rx LP	65f8fd49-1882-4eac-9c0e-d63968da33d4	2023-12-01	Warnings	Exact identifier application number: M004
Genuine First Aid Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	GFA Production(Xiamen) Co.,Ltd	0aaee474-cf35-8b39-e063-6294a90a815c	2023-11-21	Warnings	Exact identifier application number: M004
Sheffield Bacitracin Zinc	BACITRACIN ZINC	Sheffield Pharmaceuticals LLC	0f446f48-f55d-4de7-b447-285d7a329c84	2023-11-20	Warnings	Exact identifier application number: M004
Sheffield Triple Antibiotic Plus Pain Relief	BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, PRAMOXINE HYDROCHLORIDE	Sheffield Pharmaceuticals LLC	485a779c-017b-4064-a446-e5073c1bdb07	2023-11-20	Warnings	Exact identifier application number: M004
Bacitracin	BACITRACIN	BluePoint Laboratories	b4d8ef06-6269-68f7-e053-2995a90ac8ea	2023-11-17	Warnings	Exact identifier application number: M004
Bacitracin Zinc	FIRST AID ANTIBIOTIC	BluePoint Laboratories	d914abe1-5e14-5673-e053-2a95a90ac91b	2023-11-17	Warnings	Exact identifier application number: M004
EVERLIT CARE Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	EVERLIT GLOBAL INC.	e9157891-fc05-41a1-8a86-761a9ae56f8a	2023-11-14	Warnings	Exact identifier application number: M004
CR-371059 Tolnaftate 1%	CR-371059 TOLNAFTATE 1%	A-S Medication Solutions	bb4e4612-850c-4863-954d-7ad0500b9c05	2023-11-01	Warnings	Exact identifier application number: M004
Isopropyl Alcohol	ISOPROPYL ALCOHOL	A-S Medication Solutions	b44b07a0-91ff-476a-ae0a-080fa0191777	2023-10-31	Warnings	Exact identifier application number: M004
Family wellness	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	FRONT PHARMACEUTICAL PLC	bd3b8146-6271-488d-bf79-0bb659123b31	2023-10-27	Warnings	Exact identifier application number: M004
Family Wellness	BACITRACIN ZINC	FRONT PHARMACEUTICAL PLC	dfc148c1-d1bb-4230-b8cf-9457b99d4e8a	2023-10-27	Warnings	Exact identifier application number: M004

Packages#

Package NDC, 11-digit format, Description table
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