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 7 of 22 · 434 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bacitracin ZincBACITRACIN ZINCHenry Scheineaf1555d-7a3d-7ccb-e053-2995a90af62e2025-11-25WarningsExact identifier
application number: M004
Bacitracin Zinc, Polymyxin B Sulfate, and Neomycin SulfateBACITRACIN ZINC, POLYMYXIN B SULFATE, AND NEOMYCIN SULFATEHenry Scheineadb847e-aefe-41cf-e053-2995a90af2cd2025-11-25WarningsExact identifier
application number: M004
Neosporin Plus LidocaineBACITRACIN, NEOMYCIN, POLYMYXIN B, LIDOCAINEKenvue Brands LLCe450b6a1-a8da-e5db-e053-2995a90a0ef02025-11-24WarningsExact identifier
application number: M004
ElixirZincoCareZINC OXIDE 20%ELIXIR HEALTHCARE USA, LLC.bac18496-3b76-4faf-abde-968d79b718d82025-11-22WarningsExact identifier
application number: M004
Hand-AidALCOHOLABC Compounding Co., Inc.788d7584-bc33-49e8-90fd-767045ea29142025-11-19WarningsExact identifier
application number: M004
VITACILINA NEOMYCIN SULFATE FIRST AID ANTIBIOTICNEOMYCIN SULFATECompania Internacional de Comercio, S.A.P.I de C.V.ba7a3331-466e-496f-bebd-9ee7067bcdb22025-11-19WarningsExact identifier
application number: M004
dabur First AidBACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATEDabur India Limited229170a3-ef9e-597d-e063-6394a90acf8b2025-11-18WarningsExact identifier
application number: M004
QS Plus Instant Hand SanitizerBENZEALKONIUM CHLORIDERomaine Companies5e16f52d-3bf3-4897-bd3a-cf4e117583c92025-11-18WarningsExact identifier
application number: M004
Hand Guard Foaming Instant Hand SanitizerALCOHOLWechem, Inc.d9b89f90-aece-48a2-862a-c524d3c908412025-11-18WarningsExact identifier
application number: M004
Puri-San Plus Instant Hand SanitizerBENZEALKONIUM CHLORIDEPeople's Janitorial Supplyf0726bdd-9d2b-4383-af10-e2e0c5460e1e2025-11-18WarningsExact identifier
application number: M004
Lynx san a foamALCOHOLABC Compounding Co., Inc.2b987ebc-c73b-edbd-e063-6394a90a1d2d2025-11-18WarningsExact identifier
application number: M004
Instant Hand SanitizerALCOHOLABC Compounding Co., Inc.ee46cb57-c79c-4edf-bc88-4a4f8a95bfc82025-11-18WarningsExact identifier
application number: M004
Rapidol Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEPharmadel LLC1ad22205-f8c3-b142-e063-6394a90a00442025-11-17WarningsExact identifier
application number: M004
BacitracinBACITRACINKroger3f860e7f-487b-d706-e063-6394a90a73ad2025-11-13WarningsExact identifier
application number: M004
ElixirBaciShield First AidBACITRACIN ZINCELIXIR HEALTHCARE USA, LLC.15e31a2a-01b5-4598-850f-4d0348086b4b2025-11-12WarningsExact identifier
application number: M004
Bacitracin ZincBACITRACIN ZINCTrifecta Pharmaceuticals USA LLC4352c453-a89c-a2b9-e063-6294a90a61f32025-11-11WarningsExact identifier
application number: M004
Bacitracin ZincBACITRACIN ZINCUniversal Distribution Center LLC186b2750-5bf6-1702-e063-6294a90a62b32025-10-30WarningsExact identifier
application number: M004
POMADA SULFA FIRST AID ANTIBIOTICNEOMYCIN SULFATEGRANDALL DISTRIBUTING, LLC1d8e1fca-6864-7c08-e063-6394a90a08b62025-10-28WarningsExact identifier
application number: M004
POLVO DE SULFA FIRST AID ANTIBIOTICBACITRACIN ZINC, POLYMYXIN B SULFATEGRANDALL DISTRIBUTING, LLC1d8e3a03-a39f-a99e-e063-6394a90a31db2025-10-28WarningsExact identifier
application number: M004
EasyTouch Alcohol Prep Pads SterileISOPROPYL ALCOHOLMHC Medical Products, LLCfd60ad34-5fd9-4440-9f3f-23beffc19dd92025-10-24WarningsExact 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