FDA.reportPublic FDA data

Bacitracin Zinc

Product NDC
0404-0170
11-digit product format
004040170
Labeler code
0404
Product ID
0404-0170_5d41fdc3-7ecc-9da7-e063-6394a90a62db
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin Zinc
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Henry Schein
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-11-07
Substance
BACITRACIN ZINC
Active strength
500 [iU]/g
Pharmacologic classes
Decreased Cell Wall Synthesis & Repair [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
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
Bacitracin Zinc
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC500 [iU]/g

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0404-0170-502024-01-31C16284748780-11030e365-5074-111a-e063-dadaa90a10e2Bacitracin Zinc 28.4 g NDC 0404-0170-50
0404-0170-502024-01-31C16284748780-11030e365-5074-111a-e063-dadaa90a10e2570-3129 Bacitracin Zinc 28.4 g NDC 0404-0170-50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0404-0170-50Bacitracin Zinc1 in 1 BOXOINTMENT14
0404-0170-50Bacitracin Zinc72 in 1 CASEOINTMENT724

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0404-0170BACITRACIN ZINC OINTMENT [HENRY SCHEIN]3Current NDC, Legacy NDC, 2 package rows20241129_eaf1555d-7a3d-7ccb-e053-2995a90af62e.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 10 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FifthPulse Hydrocortisone 4ozHYDROCORTISONEFront Pharmaceutical PLC39fb29c8-6a28-e87e-e063-6294a90a78da2025-07-15WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATEFred's, Inc.41ee7a50-d36b-4214-b6f8-44f47ab44a842025-07-15WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATELidl US, LLC98389314-c2cf-4510-ab3d-41c4c47200192025-07-15WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN BPublix Super Markets Inc72bdb96c-af93-4a9b-93d9-81a94b6ff7562025-07-15WarningsExact identifier
application number: M004
Live Better Triple Antibiotic plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEThe Great Atlantic & Pacific Tea Company7e7a0b4c-67a9-42f3-aacd-2606fde250902025-07-15WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATETopco Associates LLC55a8a52c-4d03-417d-9283-406f6879bcb52025-07-15WarningsExact identifier
application number: M004
Triple Antibiotic Plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEFRED'S, INC.a44db5d1-7a74-44aa-9aa7-6247e771aaf22025-07-15WarningsExact identifier
application number: M004
Shopko Triple Antibiotic plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEShopko Stores Operating Co., LLC5a9b2ea4-9b9d-4147-8aa0-7313d6be2cfa2025-07-15WarningsExact identifier
application number: M004
sunmark triple antibiotic plus pain reliefPOLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDEStrategic Sourcing Services LLC941a6a71-e898-4af3-989a-6d3aa32243382025-07-15WarningsExact identifier
application number: M004
TopCare Triple Antibiotic Plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDETopco Associates LLC0fc0dbc6-ca1d-42be-8016-68e64f1197062025-07-15WarningsExact identifier
application number: M004
Triple Antibiotic Plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEWalgreen Companye2b7fc5b-c796-4ed1-aea7-4c810df250d52025-07-15WarningsExact identifier
application number: M004
Publix antibiotic plus Pain ReliefNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEPublix Super Markets Incd0193bf1-a257-490e-a058-5e6a514981da2025-07-15WarningsExact identifier
application number: M004
Live Better Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATEThe Great Atlantic & Pacific Tea Company7d3435ad-7d73-4db6-8019-3040b3dadfa92025-07-14WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATEWal-Mart Stores, Inc.f5199476-1ce2-4a82-9685-40d78b7a89352025-07-14WarningsExact identifier
application number: M004
Double AntibioticBACITRACIN ZINC AND POLYMYXIN B SULFATESTRATEGIC SOURCING SERVICES LLC38414fff-8dad-44d0-9dfa-f89a63ef9b442025-07-14WarningsExact identifier
application number: M004
sunmark double antibioticBACITRACIN ZINC AND POLYMYXIN B SULFATEStrategic Sourcing Services LLC2868de5c-4894-45ee-9647-9acd3bde7cfc2025-07-14WarningsExact identifier
application number: M004
Live Better Bacitracin ZincBACITRACIN ZINCThe Great Atlantic & Pacific Tea Company6915940c-2eae-445c-ba58-e39d221e9d3d2025-07-11WarningsExact identifier
application number: M004
Bacitracin ZincBACITRACIN ZINCSTRATEGIC SOURCING SERVICES LLC4594948d-1f25-4d3c-a615-9e6edda05a102025-07-11WarningsExact identifier
application number: M004
Good Neighbor Pharmacy Bacitracin ZincBACITRACIN ZINCAmerisourceBergen3fb302b5-7273-412c-a2ba-b76183e3f1792025-07-11WarningsExact identifier
application number: M004
TopCare Bacitracin ZincBACITRACIN ZINCTopco Associates LLC5b59e26d-cc25-49a6-ac8b-f79398e18f2d2025-07-07WarningsExact identifier
application number: M004

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1366116bacitracin zinc 500 UNT/GM Topical OintmentPSNeaf1555d-7a3d-7ccb-e053-2995a90af62e4
1366116bacitracin zinc 0.5 UNT/MG Topical OintmentSCDeaf1555d-7a3d-7ccb-e053-2995a90af62e4
1366116bacitracin zinc 500 UNT per GM Topical OintmentSYeaf1555d-7a3d-7ccb-e053-2995a90af62e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0404-0170-500040401705072 BOX in 1 CASE (0404-0170-50) / 1 TUBE in 1 BOX / 28.4 g in 1 TUBE72 box2022-11-070000-00-00NoNoCurrent