FDA.reportPublic FDA data

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
IngredientStrength
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
VIF565UC2GInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3227bdc9-9323-68eb-e063-6294a90a29d2Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82953-045-01burn gel010.85 g in 1 POUCHGEL0.851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82953-045BURN GEL 01 (MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL) GEL [COSMUSES COSMETICS (NINGBO) CO., LTD.]1Current NDC, 1 package rows20250408_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 19 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Triple Antibiotic First Aid AntibioticBACITRACIN ZINC, NEOMYCIN AND POLYMYXIN B SULFATEUniversal Distribution Center LLC78f00296-267b-44c3-a9e3-c40f122e905e2024-05-14WarningsExact identifier
application number: M004
TRIPLE ANTIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATEJHK Inc dba American Safety & First Aid26e66025-9457-42b3-9319-51302c17506e2024-04-26WarningsExact identifier
application number: M004
Hydrogen PeroxideHYDROGEN PEROXIDEJHK Inc1472c854-09c8-4ad8-b8a6-0235440ac26b2024-04-26WarningsExact identifier
application number: M004
Isopropyl AlcoholISOPROPYL ALCOHOLJHK Incabae6a80-e859-47b5-8e34-d391eb8545832024-04-26WarningsExact identifier
application number: M004
AntisepticBENZALKONIUM CHLORIDE, BENZOCAINEJHK Inc0ac5d890-c262-4a30-9fd8-2de6cb0f76012024-04-25WarningsExact identifier
application number: M004
First Aid Antibiotic Bacitracin Zinc Neomycin Sulfate Polymyxin B SulfateBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEM-star (Hubei) Health&Care Products Co., Ltd.c6f2656e-b822-4d61-b557-dd2046dd51f52024-04-01WarningsExact identifier
application number: M004
AntibioticBACITRACIN ZINC, POLYMYXIN B SULFATECVS PHARMACY, INC32e92acf-2e48-4933-8e08-e1df650e7d192024-03-15WarningsExact identifier
application number: M004
Major BacitracinBACITRACINMajor Pharmaceuticals13288efb-e282-68f8-e063-6294a90ae7122024-03-08WarningsExact identifier
application number: M004
UniShield TRIPLE ANTIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEUnishield00b85d3a-322b-43c1-b022-5f6ed50c66092024-03-02WarningsExact identifier
application number: M004
Triple Antibiotic Plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEChain Drug Marketing Association Inc.1277942d-753f-ab69-e063-6394a90a496a2024-02-28WarningsExact identifier
application number: M004
Triple Antibiotic with Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDESafetec of America, Inc.ca1df4a0-844d-4b1d-b972-f2704a8ebbab2024-02-16WarningsExact identifier
application number: M004
Single AntibioticBACITRACIN ZINCSafetec of America, Inc.9993c204-6e61-4da3-90ef-2b7dfa09c9202024-02-14WarningsExact identifier
application number: M004
Single Antibiotic with NeomycinNEOMYCIN SULFATESafetec of Americae989cf7e-f3d1-42d2-af45-fc80095b97cb2024-02-08WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATESafetec of America, Inc.96c41fc1-81f9-4757-abc6-867b5383ed5d2024-02-07WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATESafetec of America, Inc.2c2aa8af-2adb-4f59-ac20-15818d0e28e72024-02-07WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATESafetec of America, Inc.03c05028-5a5f-4690-a836-cc1b1044ab392024-02-05WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATESafetec of America, Inc.59494d5c-dd8a-431c-8e6a-4e1151ba74602024-02-05WarningsExact identifier
application number: M004
Triple AntibioticFIRST AID ANTIBIOTICBluePoint Laboratoriesc47e15bd-1062-4cca-e053-2995a90a90752024-01-31WarningsExact identifier
application number: M004
NeomycinNEOMYCIN OINTMENTDynarex Corporation0f9e087b-6e86-a3c7-e063-6394a90ac8d42024-01-23WarningsExact identifier
application number: M004
Antibiotic and Pain ReliefNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDETarget Corporation050be94c-1fbb-4d84-82c6-841aac8f318e2024-01-18WarningsExact identifier
application number: M004

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82953-045-0182953004501.85 g in 1 POUCH (82953-045-01) 2025-04-06NoNoCurrent