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 11 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
First Aid AntibioticBACITRACIN ZINCTARGET Corporation4d8e7146-9215-417e-93be-af706502cfee2025-07-07WarningsExact identifier
application number: M004
TRIPLE ANTIBIOTIC PLUS PAIN RELIEFBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEGENOMMA LAB USA, INC.506fcda5-df44-49c8-8dbd-cab7434b06b22025-07-02WarningsExact identifier
application number: M004
DG Poly Antibiotic First Aid AntibioticBACITRACIN AND POLYMYXIN B SULFATEDollar General4d710928-5a7d-4f1a-aea0-be7fe599ae0c2025-07-02WarningsExact identifier
application number: M004
Curad Maximum Strength Triple AntibioticBACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDEMedline Industries, LP99e9c394-ebf1-7a27-e053-2a95a90ab1572025-07-01WarningsExact identifier
application number: M004
Double AntibioticBACITRACIN ZINC AND POLYMYXIN B SULFATESun Pharmaceutical Industries, Inc.7e8af528-eb25-4f93-9b35-8fff635932cc2025-07-01WarningsExact identifier
application number: M004
Triple Antibiotic plus Pain Relief Maximum StrengthBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND PRAMOXINE HYDROCHLORIDEChain Drug Consortium, LLC55ef2205-aaf1-4aa4-917f-2b4cfa43b77e2025-07-01WarningsExact identifier
application number: M004
BacitracinBACITRACINRUGBY LABORATORIESaa9f414e-d8de-417d-9ccd-027d5a5f54992025-06-27WarningsExact identifier
application number: M004
Meret Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.385d8642-9eae-a750-e063-6394a90a79312025-06-24WarningsExact identifier
application number: M004
ProCure Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATETwin Med LLC37a3916f-cc1a-41a0-e063-6394a90a35ed2025-06-16WarningsExact identifier
application number: M004
Bacitracin ZincFIRST AID ANTIBIOTICDynarex Corporation82cf8dd0-eef6-5871-e053-2991aa0a38cf2025-06-16WarningsExact identifier
application number: M004
Sion Biotext Bacitracin ZincBACITRACIN ZINCSion Biotext Medical Ltd35056345-f325-99e8-e063-6294a90a2d7e2025-06-12WarningsExact identifier
application number: M004
ProCure Bacitracin ZincBACITRACIN ZINCTwin Med LLC36da7993-7c65-7430-e063-6294a90a06262025-06-05WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, POLYMYXIN BJ&A Digital Inc.9b8f2046-5886-440d-a7fc-a71138d7f34b2025-06-02WarningsExact identifier
application number: M004
Lights Povidone Iodine ScrubPOVIDONE-IODINELights Medical Manufacture Co., Ltd.5e1eef53-c2c7-477e-9ee4-19c01c1881e52025-05-20WarningsExact identifier
application number: M004
BacitracinBACITRACIN ZINCTrifecta Pharmaceuticals USA, LLC.4a9fe0fa-5549-4e06-e054-00144ff8d46c2025-05-15WarningsExact identifier
application number: M004
SionBiotext Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATESion Biotext Medical Ltd35083d42-5823-eeb1-e063-6294a90acafa2025-05-13WarningsExact identifier
application number: M004
Multi ActionBACITRACINZINC,NEOMYCINSULFATE,POLYMYXINBSULFATE,PRAMOXINEHCLTrifecta Pharmaceutical USA LLCb98082f3-be95-49fb-e053-2a95a90a37b82025-05-13WarningsExact identifier
application number: M004
Leader Triple antibiotic and pain reliefBACITRACIN,NEOMYCIN,POLYMXIN, PRAMOXINECardinal Health 110 dba LEADERf4c521d9-dd05-1c23-e053-2995a90a6e2c2025-05-13WarningsExact identifier
application number: M004
TripleantibioticointmentandpainreliefBACITRACIN,NEOMYCIN,POLYMXIN, PRAMOXINETrifecta Pharmaceuticals USA34f1db74-6506-d53d-e063-6394a90ac4002025-05-12WarningsExact identifier
application number: M004
Triple Antibiotic plus LidocaineBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE, LIDOCAINETRIFECTA PHARMACEUTICALS USA LLC14fda967-54ba-c964-e063-6294a90a21ee2025-04-24WarningsExact 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