FDA.reportPublic FDA data

First Aid Antibiotic plus Burn Relief

Product NDC
69396-138
11-digit product format
693960138
Labeler code
69396
Product ID
69396-138_298dae2b-f42d-53a1-e063-6394a90a223b
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracinzinc,NeomycinSulfate,PolymxinBSulfate,PramoxineHCI
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Trifecta Pharmaceuticals USA LLC
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-09-04
Substance
PRAMOXINE HYDROCHLORIDE; POLYMYXIN B SULFATE; BACITRACIN ZINC; NEOMYCIN SULFATE
Active strength
10; 10000; 500; 3.5 mg/g; [USP'U]/g; [USP'U]/g; mg/g
Pharmacologic classes
Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
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
First Aid Antibiotic plus Burn Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAMOXINE HYDROCHLORIDE10 mg/g
POLYMYXIN B SULFATE10000 [USP'U]/g
BACITRACIN ZINC500 [USP'U]/g
NEOMYCIN SULFATE3.5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
88AYB867L5Internal UNII lookup
19371312D4Internal UNII lookup
89Y4M234ESInternal UNII lookup
057Y626693Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1359350Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
048871e2-c917-292d-e063-6394a90af130Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69396-138-02First Aid Antibiotic plus Burn Relief57 g in 1 TUBEOINTMENT572
69396-138-02First Aid Antibiotic plus Burn Relief1 in 1 BOXOINTMENT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69396-138FIRST AID ANTIBIOTIC PLUS BURN RELIEF (BACITRACINZINC,NEOMYCINSULFATE,POLYMXINBSULFATE,PRAMOXINEHCI) OINTMENT [TRIFECTA PHARMACEUTICALS USA LLC]2Current NDC, 2 package rows20241220_048871e2-c917-292d-e063-6394a90af130.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 8 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GASCO ANTIBACTERIALBENZALKONIUM CHLORIDEGASCO INDUSTRIAL CORP411ffefe-16e5-a2e0-e063-6394a90a0cd42025-10-14WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.TRIFECTA PHARMACEUTICALS USA LLC4124e9e2-397f-8921-e063-6394a90a5ffe2025-10-14WarningsExact identifier
application number: M004
AntibioticNEOMYCIN SULFATETotal Resources International0725364b-b243-4891-af2f-a6049366d0382025-10-10WarningsExact identifier
application number: M004
MediChoice BacitracinBACITRACINO&M HALYARD, INC.78079b94-c6fc-4529-aaad-8186924ecba52025-10-09WarningsExact identifier
application number: M004
MediChoice Triple AntibioticBACITRACINO&M HALYARD, INC.8369f399-6f64-4441-be72-1f16c7306c0a2025-10-09WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEMedline Industries, LP301ebb9a-033b-4f04-99ff-571e921924ca2025-10-09WarningsExact identifier
application number: M004
First Aid AntibioticBACITRACIN ZINCMedline Industries, LPf8282204-f9b9-486f-b18b-dc5ba85cce102025-10-09WarningsExact identifier
application number: M004
TheraCare Triple Antibiotic Pain ReliefBACITRACIN,NEOMYCIN,POLYMXIN, PRAMOXINEVeridian Healthcarefaf73908-324f-27f5-e053-6394a90aa06e2025-10-02WarningsExact identifier
application number: M004
Viaderma Care First AidBACITRACIN ZINCViaDerma Distribution, Inc.dabb7ce8-3284-4dfc-bc6e-38a691be43c12025-10-02WarningsExact identifier
application number: M004
Double AntibioticBACITRACIN ZINC POLYMYXIN B SULFATEEncube Ethicals, Inc.8f00b059-6729-4fae-8e8c-e14fe8838c592025-09-30WarningsExact identifier
application number: M004
Xpect Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATECintas Corporation39355db3-24d7-485f-9ce0-f0e466e965932025-09-26WarningsExact identifier
application number: M004
TRIPLE ANTIBIOTICBACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE PRAMOXINE HCLEncube Ethicals, Inc.dfea6b2e-cd76-439d-a3da-64e2d87171632025-09-25WarningsExact identifier
application number: M004
TRIPLE ANTIBIOTICBACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATEEncube Ethicals, Inc.2e985ad0-aa50-4c6b-b0af-1d61489a9fda2025-09-25WarningsExact identifier
application number: M004
Medi-First Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEUnifirst First Aid Corporationf2f0a1da-3e33-3c1a-e053-2a95a90a12b12025-09-09WarningsExact identifier
application number: M004
Ecolab Triple AntibioticBACITRACIN, NEOMYCIN SULFATE, POLYMYXIN B SULFATEEcolabs Food Safety Specialties, Inc.4aef8f98-db76-07f2-e054-00144ff8d46c2025-09-09WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEUnifirst First Aid Corporationd265f094-e654-4c68-9215-b5d061af885d2025-09-08WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEUnifirst First Aid Corporationd7c1a10e-c38d-4ae8-9a27-c07c2208ca842025-09-08WarningsExact identifier
application number: M004
Thompson Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEThompsonf883c4cb-c32c-76e3-e053-6294a90aa4fc2025-09-08WarningsExact identifier
application number: M004
Thompson Triple AntibioticBACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATEThompsonde9489de-e677-2bd3-e053-2a95a90acfb42025-09-08WarningsExact identifier
application number: M004
BACITRACIN ZINCFIRST AID ANTIBIOTICEncube Ethicals, Inc.613cbed4-9790-4e6b-a61b-b7b7a8ee59c92025-09-04WarningsExact identifier
application number: M004

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1359350bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG in GM Topical OintmentPSN048871e2-c917-292d-e063-6394a90af1302
1359350bacitracin 0.5 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG / pramoxine hydrochloride 0.01 MG/MG Topical OintmentSCD048871e2-c917-292d-e063-6394a90af1302
1359350bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical OintmentSY048871e2-c917-292d-e063-6394a90af1302

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69396-138-02693960138021 TUBE in 1 BOX (69396-138-02) / 57 g in 1 TUBE1 tube2023-09-04NoNoCurrent