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 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
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