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 16 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BACITRACINBACITRACINMeijer Distribution Inc029e7150-1b9a-47c9-90bd-5f8bcd21365c2024-10-29WarningsExact identifier
application number: M004
SUNMARK TRIPLE ANTIBIOTIC PLUS PAIN RELIEFPOLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDEA-S Medication Solutions01131ba6-6d5b-4710-bec3-ba1769c08c792024-10-22WarningsExact identifier
application number: M004
BACITRACINBACITRACINCVS Pharmacy15ea4415-943a-4d0a-ac23-5f37cd2cf2062024-10-22WarningsExact identifier
application number: M004
Tetracyte First Aid and Antibiotic TopicalTETRACYCLINE HYDROCHLORIDEVIADERMA DISTRIBUTION INCdcb3d96a-41a5-40d8-a47e-56d419bbe6e22024-10-21WarningsExact identifier
application number: M004
AntibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BCVS Pharmacy3ba24e32-7078-45fb-85d1-2ab252fa9cb52024-10-16WarningsExact identifier
application number: M004
triple antibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCLMeijer Distribution Inc43486da5-6e8b-45c0-bd7e-cc2d8b28c5102024-10-16WarningsExact identifier
application number: M004
Genuine First Aid First Aid Antibiotic Bacitracin ZincBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEGFA Production (Xiamen) Co., Ltd.af08c1fe-fb1a-56d2-e053-2a95a90a67c42024-10-15WarningsExact identifier
application number: M004
Exchange Select First Aid Triple Anitbiotic Pain RelievingBACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCLArmy & Air Force Exchange Service1c7f1700-69c0-4a71-8bb0-a71e3082efeb2024-10-14WarningsExact identifier
application number: M004
antibioticNEOMYCIN, POLYMYXIN B, PRAMOXINE HCLH E B55fa94cb-7e1c-41bc-879a-5618a828f14a2024-10-14WarningsExact identifier
application number: M004
first aid antibiotic and pain reliefNEOMYCIN, POLYMYXIN B, PRAMOXINE HCLMeijer, Inc.f0892a30-8a88-44e8-ab04-0e87c12f9c442024-10-14WarningsExact identifier
application number: M004
triple antibiotic plus pain reliefBACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCLMeijer Distribution Incd97a69e8-4058-4c77-b628-ad3e2b97a6202024-10-14WarningsExact identifier
application number: M004
Antibiotic and Pain ReliefNEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDECVS Pharmacyb541f1a9-7e40-4c35-840f-ea1e357b580e2024-10-14WarningsExact identifier
application number: M004
Exchange Select triple antibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BArmy & Air Force Exchange Serviceb7bf899c-44e5-48d6-bf8e-d843fd4424322024-10-12WarningsExact identifier
application number: M004
topcare triple antibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BTopco Associates LLC675665ee-bd0d-4168-81b8-341b1258c1022024-10-12WarningsExact identifier
application number: M004
First Aid AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEHubei Changjian Medical Products Co., Ltd.34e8776c-1f36-4e1b-9d71-727591ac904d2024-10-11WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BH E B58a4d263-e234-43cd-a3bd-b19a492174d92024-10-11WarningsExact identifier
application number: M004
topcare triple antibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDETopco Associates LLC5e0fc39b-e6d4-4543-8afc-2881e2f85f9b2024-10-06WarningsExact identifier
application number: M004
Good Sense Triple Antibiotic and Pain ReliefBACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCLL. Perrigo Companyc3e9215f-fcef-4938-8208-df40996522892024-10-06WarningsExact identifier
application number: M004
triple antibiotic plus maximum strengthBACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCLH E Bc428b0a3-e80a-493c-ac67-807ebca3ce012024-10-06WarningsExact identifier
application number: M004
Basic Care First Aid AntibioticBACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCLAmazon.com Services LLCa9247f69-0366-42dd-ae0d-39a2a6976cdc2024-10-06WarningsExact 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