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 12 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.Front Pharmaceutical PLC3244d91e-6c6b-a351-e063-6294a90aa02d2025-04-08WarningsExact identifier
application number: M004
Walgreens Advanced Wound HydrogelALLANTOIN, BENZETHONIUM CHLORIDEWALGREEN COMPANY25c6ada8-4a16-0896-e063-6294a90a0fdb2025-04-08WarningsExact identifier
application number: M004
Honestly Battleborn First Aid for Real ManTETRACYCLINE HYDROCHLORIDEHONESTLY LLC13c1f2df-ba52-45e0-8868-a7518e9cdb552025-04-07WarningsExact identifier
application number: M004
Honestly Battleborn First Aid for Real ManTETRACYCLINE HYDROCHLORIDEHONESTLY LLC93a6e02e-9f4b-4821-afa2-2029769f30882025-04-07WarningsExact identifier
application number: M004
burn gel 01MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OILCosmuses Cosmetics (Ningbo) Co., Ltd.3227bdc9-9323-68eb-e063-6294a90a29d22025-04-06WarningsExact identifier
application number: M004
Vitastem ULTRABACITRACIN ZINCViaDerma Distribution, Incfd96cc09-8522-44a5-b034-0d30e532410d2025-04-03WarningsExact identifier
application number: M004
Vitastem Ultra First Aid AntibioticBACITRACIN ZINCViaderma Distribution Ince6986bf9-22ea-4484-a709-27bc91c9058d2025-03-18WarningsExact identifier
application number: M004
Redicare Triple Antibiotic First AidTRIPLE ANTIBIOTIC FIRST AID OINTMENTRedicare LLC9468979d-446e-e4be-e053-2995a90a3f212025-03-05WarningsExact identifier
application number: M004
Neosporin OriginalBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATEKenvue Brands LLC0ad21575-0e2d-24c2-e063-6394a90a616e2025-02-21WarningsExact identifier
application number: M004
The Life Safety Pro Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.64a7331f-98a6-4052-85b9-695c83b3bd162025-02-19WarningsExact identifier
application number: M004
VitastemTETRACYCLINE HYDROCHLORIDEViaDerma Distribution, Inc.a6630858-7038-425f-8a75-bb25f36a0dbe2025-02-18WarningsExact identifier
application number: M004
Sheffield Triple AntibioticBACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATESheffield Pharmaceuticals LLC1aa95046-c1f7-4fc7-acac-839065d998f62025-02-17WarningsExact identifier
application number: M004
EquateBACITRACIN ZINC ANTIBIOTIC OINTMENTWalmart Inc.20908780-8803-4e19-e063-6394a90aab872025-02-01WarningsExact identifier
application number: M004
Tetracyte Topical Tetracycline HydrochlorideTETRACYCLINE HYDROCHLORIDEVIADERMA DISTRIBUTION INC0961b097-ba41-40c2-aaec-dd291841bf092025-01-30WarningsExact identifier
application number: M004
AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEWelly Health PBC9446375d-4bb4-4bb1-bdc2-c18e995bfe262025-01-29WarningsExact identifier
application number: M004
FAK Care4 Bus and School Yellow ORM DBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE, ISOPROPYL ALCOHOL, BENZOCAINE, ALCOHOLGFA Production (Xiamen) Co., Ltd.3b5d07c6-bda2-4bc7-89b8-88280d11ed742025-01-22WarningsExact identifier
application number: M004
Members Mark Alcohol Prep Pads, SterileISOPROPYL ALCOHOLSam's Club West Inc.13001877-ae90-40be-899d-fb38f3a38b122025-01-22WarningsExact identifier
application number: M004
Equate Antibiotic Plus Pain, Itch, Scar ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEWalMart2b743271-4f58-4ba1-a04c-560f7f8a547e2025-01-16WarningsExact identifier
application number: M004
Equate Antibiotic Plus Pain ReliefNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEWalMarte08b427f-d070-4521-ad3c-faf2955317912025-01-16WarningsExact identifier
application number: M004
NATUREPLEX ANTIBIOTICBACITRACIN ZINC AND POLYMYXIN B SULFATENatureplex LLC86ea3452-c810-4c9a-9f52-bcb0688020f92025-01-15WarningsExact 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