FDA.reportPublic FDA data

Bacitracin Zinc

Product NDC
51672-2075
11-digit product format
516722075
Labeler code
51672
Product ID
51672-2075_4f1daf7d-bd63-8325-e063-6394a90ac878
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin Zinc
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2006-05-11
Substance
BACITRACIN ZINC
Active strength
500 [USP'U]/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 [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
4afdeedf-9cdf-47d6-919f-ea907fda0290Available 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
51672-2075-1Bacitracin Zinc15 g in 1 TUBEOINTMENT156
51672-2075-1Bacitracin Zinc1 in 1 CARTONOINTMENT16
51672-2075-2Bacitracin Zinc1 in 1 CARTONOINTMENT16
51672-2075-2Bacitracin Zinc30 g in 1 TUBEOINTMENT306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-2075-1GM - Gram51672-2075e945b097-4fbc-49ee-be04-cda62ddd0a1b12013-02-13
51672-2075-2GM - Gram51672-20759d1461f6-ec4f-41a4-abbd-699c44ef8cb812013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Bacitracin ZincACTIVE INGREDIENT89Y4M234ESBACITRACIN ZINC OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
BacitracinACTIVE MOIETY58H6RWO52IBACITRACIN ZINC OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
mineral oilINACTIVE INGREDIENTT5L8T28FGPBACITRACIN ZINC OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
petrolatumINACTIVE INGREDIENT4T6H12BN9UBACITRACIN ZINC OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-2075BACITRACIN ZINC OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]4Current NDC, Legacy NDC, 4 package rows20241105_4afdeedf-9cdf-47d6-919f-ea907fda0290.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 9 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Antibiotic Maximum StrengthBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEWalgreens9a092f24-65b2-4b57-8103-265ea3e033112025-09-02WarningsExact identifier
application number: M004
AerosootheTRIPLE ANTIBIOTIC OINTMENTAero Healthcare US LLC2287a31c-750c-728d-e054-00144ff88e882025-08-29WarningsExact identifier
application number: M004
Triple Antibiotic Plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEChain Drug Marketing Association Inc.3d4b3d73-171a-bc6a-e063-6394a90a69c12025-08-26WarningsExact identifier
application number: M004
Dual Action CreamNEOMYCINSULFATE,POLYMYXINBSULFATE,PRAMOXINEHCLTrifecta Pharmaceutical USA LLCb84015ae-9c76-b1d7-e053-2a95a90a2cc82025-08-23WarningsExact identifier
application number: M004
Natureplex Antibiotic Plus Pain, Itch, Scar ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDENatureplex LLCf0af8829-72fb-46b1-9328-6f4920710bb12025-08-15WarningsExact identifier
application number: M004
PROHEAL TRIPLE ANTIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.6c61d88e-4ced-4468-8f99-91652f7a03e42025-08-13WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEJ&A Digital Inc.9f006f16-083d-4e95-aec2-6ef83405f3932025-08-07WarningsExact identifier
application number: M004
Vitacilina First Aid AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATETaisho Pharmaceutical California Inc.93fb9e05-f78c-4d37-b6f1-926cbcb2e7a72025-08-07WarningsExact identifier
application number: M004
SurviveX Triple AntibioticTRIPLE ANTIBIOTIC OINTMENTNantong Health & Beyond Hygienic Products Inc.3bd25bb6-6486-8a0a-e063-6394a90a085c2025-08-07WarningsExact identifier
application number: M004
Thera Plus Original Strength Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEFOURSTAR GROUP USA, INC.09e8bdb7-dc14-4f28-8306-c0e2bf73f0812025-07-31WarningsExact identifier
application number: M004
BacitracinBACITRACINBryant Ranch Prepack0c081802-429f-468f-9650-293cb7a1ad342025-07-29WarningsExact identifier
application number: M004
health and .beyond Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.0070ea5f-434d-53a7-e063-6294a90abf182025-07-27WarningsExact identifier
application number: M004
health and beyond TRIPLE ANTIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.13cbe416-a146-447d-be36-8b3af9b3c8952025-07-27WarningsExact identifier
application number: M004
AOSI HEALTHCARE TRIPLE ANTIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.70c53369-7cf6-4352-a19f-c85a55c5a4bd2025-07-27WarningsExact identifier
application number: M004
Pomada de SulfaNEOMYCIN SULFATEMenper Distributors, Inc.216f4d22-e5e8-46c8-a4ef-8d1532792b562025-07-22WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATESTRATEGIC SOURCING SERVICES LLC1bda9c30-8fc8-4814-b211-94550672b22f2025-07-21WarningsExact identifier
application number: M004
Triple Antibiotic plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDESTRATEGIC SOURCING SERVICES LLC6a61c900-2dfc-4c07-8ae5-32ffbd89d2b62025-07-21WarningsExact identifier
application number: M004
FifthPulse Bacitracin Zinc 1ozBACITRACIN ZINCFront Pharmaceutical PLC39f994d4-5f41-fb34-e063-6294a90a45ea2025-07-15WarningsExact identifier
application number: M004
FifthPulse Bacitracin Zinc 4ozBACITRACIN ZINCFront Pharmaceutical PLC39fa0e5f-b794-e1e3-e063-6394a90a4ce32025-07-15WarningsExact identifier
application number: M004
FifthPulse Hydrocortisone 1ozHYDROCORTISONEFront Pharmaceutical PLC39fae2a4-902e-3c88-e063-6394a90acbd52025-07-15WarningsExact identifier
application number: M004

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1366116bacitracin zinc 500 UNT/GM Topical OintmentPSN9fcda25b-3940-4028-a8ee-6e6c6e4b2a538
1366116bacitracin zinc 0.5 UNT/MG Topical OintmentSCD9fcda25b-3940-4028-a8ee-6e6c6e4b2a538
1366116bacitracin zinc 500 UNT per GM Topical OintmentSY9fcda25b-3940-4028-a8ee-6e6c6e4b2a538
1366116bacitracin zinc 500 UNT/GM Topical OintmentPSN4afdeedf-9cdf-47d6-919f-ea907fda02906
1366116bacitracin zinc 0.5 UNT/MG Topical OintmentSCD4afdeedf-9cdf-47d6-919f-ea907fda02906
1366116bacitracin zinc 500 UNT per GM Topical OintmentSY4afdeedf-9cdf-47d6-919f-ea907fda02906

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-2075-1516722075011 TUBE in 1 CARTON (51672-2075-1) / 15 g in 1 TUBE1 tube2006-05-110000-00-00NoNoCurrent
51672-2075-2516722075021 TUBE in 1 CARTON (51672-2075-2) / 30 g in 1 TUBE1 tube2006-05-110000-00-00NoNoCurrent