FDA.reportPublic FDA data

Bacitracin Zinc

Product NDC
67777-008
11-digit product format
677770008
Labeler code
67777
Product ID
67777-008_37b6c5f2-0e91-5ec0-e063-6394a90a6499
Type
HUMAN OTC DRUG
Nonproprietary name
First Aid Antibiotic
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Dynarex Corporation
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-02-16
Substance
BACITRACIN ZINC
Active strength
500 [USP'U]/g
Pharmacologic classes
Decreased Cell Wall Synthesis & Repair [PE]
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
Bacitracin Zinc
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC500 [USP'U]/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
89Y4M234ESInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1366116Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
82cf8dd0-eef6-5871-e053-2991aa0a38cfAvailable on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67777-008-10Bacitracin Zinc12 in 1 CASEOINTMENT1212
67777-008-11Bacitracin Zinc144 in 1 BOXOINTMENT14412
67777-008-11Bacitracin Zinc0.9 g in 1 PACKETOINTMENT0.912
67777-008-20Bacitracin Zinc72 in 1 CASEOINTMENT7212
67777-008-21Bacitracin Zinc14.2 g in 1 TUBEOINTMENT14.212
67777-008-21Bacitracin Zinc1 in 1 BOXOINTMENT112
67777-008-30Bacitracin Zinc72 in 1 CASEOINTMENT7212
67777-008-31Bacitracin Zinc28.4 g in 1 TUBEOINTMENT28.412
67777-008-31Bacitracin Zinc1 in 1 BOXOINTMENT112
67777-008-50Bacitracin Zinc72 in 1 CASEOINTMENT7212
67777-008-51Bacitracin Zinc113 g in 1 TUBEOINTMENT11312
67777-008-51Bacitracin Zinc1 in 1 BOXOINTMENT112
67777-008-60Bacitracin Zinc12 in 1 CASEOINTMENT1212
67777-008-61Bacitracin Zinc425 g in 1 JAROINTMENT42512

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67777-008-10EA - Each67777-008a0ebd4b4-6e19-4673-8336-e7131686c9a012023-07-06
67777-008-20GM - Gram67777-0083646dc3b-b675-4692-9fc8-2f7265d7194512025-08-11
67777-008-21GM - Gram67777-008d7370a1a-0491-4c44-8e87-7fa37edec76612025-08-11
67777-008-30GM - Gram67777-0083eef27f2-71ce-48f9-ba7e-79751dbd20b512025-08-11
67777-008-31GM - Gram67777-008155a75c8-03fd-4601-b559-a6d1e5e10a6712025-08-11
67777-008-50GM - Gram67777-0082b28ccca-a563-4229-893a-1dab240c50fd12025-08-11
67777-008-51GM - Gram67777-008f3dce390-fe60-4d34-80d5-d9f93ad2256912025-08-11
67777-008-60GM - Gram67777-008b43c4c61-88a2-464b-ac1d-7e9530a8a8ad12023-02-06
67777-008-61GM - Gram67777-0088759180c-b4b8-43ae-a6ae-f02b563741f512023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67777-008BACITRACIN ZINC (FIRST AID ANTIBIOTIC) OINTMENT [DYNAREX CORPORATION]11Current NDC, Legacy NDC, 14 package rows20241122_82cf8dd0-eef6-5871-e053-2991aa0a38cf.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 19 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Triple Antibiotic First Aid AntibioticBACITRACIN ZINC, NEOMYCIN AND POLYMYXIN B SULFATEUniversal Distribution Center LLC78f00296-267b-44c3-a9e3-c40f122e905e2024-05-14WarningsExact identifier
application number: M004
TRIPLE ANTIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATEJHK Inc dba American Safety & First Aid26e66025-9457-42b3-9319-51302c17506e2024-04-26WarningsExact identifier
application number: M004
Hydrogen PeroxideHYDROGEN PEROXIDEJHK Inc1472c854-09c8-4ad8-b8a6-0235440ac26b2024-04-26WarningsExact identifier
application number: M004
Isopropyl AlcoholISOPROPYL ALCOHOLJHK Incabae6a80-e859-47b5-8e34-d391eb8545832024-04-26WarningsExact identifier
application number: M004
AntisepticBENZALKONIUM CHLORIDE, BENZOCAINEJHK Inc0ac5d890-c262-4a30-9fd8-2de6cb0f76012024-04-25WarningsExact identifier
application number: M004
First Aid Antibiotic Bacitracin Zinc Neomycin Sulfate Polymyxin B SulfateBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEM-star (Hubei) Health&Care Products Co., Ltd.c6f2656e-b822-4d61-b557-dd2046dd51f52024-04-01WarningsExact identifier
application number: M004
AntibioticBACITRACIN ZINC, POLYMYXIN B SULFATECVS PHARMACY, INC32e92acf-2e48-4933-8e08-e1df650e7d192024-03-15WarningsExact identifier
application number: M004
Major BacitracinBACITRACINMajor Pharmaceuticals13288efb-e282-68f8-e063-6294a90ae7122024-03-08WarningsExact identifier
application number: M004
UniShield TRIPLE ANTIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEUnishield00b85d3a-322b-43c1-b022-5f6ed50c66092024-03-02WarningsExact identifier
application number: M004
Triple Antibiotic Plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEChain Drug Marketing Association Inc.1277942d-753f-ab69-e063-6394a90a496a2024-02-28WarningsExact identifier
application number: M004
Triple Antibiotic with Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDESafetec of America, Inc.ca1df4a0-844d-4b1d-b972-f2704a8ebbab2024-02-16WarningsExact identifier
application number: M004
Single AntibioticBACITRACIN ZINCSafetec of America, Inc.9993c204-6e61-4da3-90ef-2b7dfa09c9202024-02-14WarningsExact identifier
application number: M004
Single Antibiotic with NeomycinNEOMYCIN SULFATESafetec of Americae989cf7e-f3d1-42d2-af45-fc80095b97cb2024-02-08WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATESafetec of America, Inc.96c41fc1-81f9-4757-abc6-867b5383ed5d2024-02-07WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATESafetec of America, Inc.2c2aa8af-2adb-4f59-ac20-15818d0e28e72024-02-07WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATESafetec of America, Inc.03c05028-5a5f-4690-a836-cc1b1044ab392024-02-05WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATESafetec of America, Inc.59494d5c-dd8a-431c-8e6a-4e1151ba74602024-02-05WarningsExact identifier
application number: M004
Triple AntibioticFIRST AID ANTIBIOTICBluePoint Laboratoriesc47e15bd-1062-4cca-e053-2995a90a90752024-01-31WarningsExact identifier
application number: M004
NeomycinNEOMYCIN OINTMENTDynarex Corporation0f9e087b-6e86-a3c7-e063-6394a90ac8d42024-01-23WarningsExact identifier
application number: M004
Antibiotic and Pain ReliefNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDETarget Corporation050be94c-1fbb-4d84-82c6-841aac8f318e2024-01-18WarningsExact identifier
application number: M004

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1366116bacitracin zinc 500 UNT/GM Topical OintmentPSN82cf8dd0-eef6-5871-e053-2991aa0a38cf12
1366116bacitracin zinc 0.5 UNT/MG Topical OintmentSCD82cf8dd0-eef6-5871-e053-2991aa0a38cf12
1366116bacitracin zinc 500 UNT per GM Topical OintmentSY82cf8dd0-eef6-5871-e053-2991aa0a38cf12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67777-008-106777700081012 BOX in 1 CASE (67777-008-10) / 144 PACKET in 1 BOX (67777-008-11) / .9 g in 1 PACKET12 box2018-02-160000-00-00NoNoCurrent
67777-008-1167777000811144 in 1 BOXHistorical
67777-008-206777700082072 BOX in 1 CASE (67777-008-20) / 1 TUBE in 1 BOX (67777-008-21) / 14.2 g in 1 TUBE72 box2018-02-160000-00-00NoNoCurrent
67777-008-216777700082114.2 g in 1 TUBE14.2 gHistorical
67777-008-306777700083072 BOX in 1 CASE (67777-008-30) / 1 TUBE in 1 BOX (67777-008-31) / 28.4 g in 1 TUBE72 box2018-02-160000-00-00NoNoCurrent
67777-008-316777700083128.4 g in 1 TUBE28.4 gHistorical
67777-008-506777700085072 BOX in 1 CASE (67777-008-50) / 1 TUBE in 1 BOX (67777-008-51) / 113 g in 1 TUBE72 box2018-02-160000-00-00NoNoCurrent
67777-008-5167777000851113 g in 1 TUBE113 gHistorical
67777-008-606777700086012 JAR in 1 CASE (67777-008-60) / 425 g in 1 JAR (67777-008-61) 12 jar2018-02-160000-00-00NoNoCurrent
67777-008-6167777000861425 g in 1 JAR425 gHistorical