FDA.reportPublic FDA data

Bacitracin

Product NDC
0713-0280
11-digit product format
007130280
Labeler code
0713
Product ID
0713-0280_0cee4d1f-c118-adbd-e063-6294a90a74d8
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Cosette Pharmaceuticals, Inc.
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1995-01-10
Substance
BACITRACIN
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN500 [USP'U]/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
58H6RWO52IInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1648110Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
630e0841-baf2-e9fa-b309-ad1a5f95da3bAvailable 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
0713-0280-31Bacitracin28.4 g in 1 TUBEOINTMENT28.47

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0713-0280-31GM - Gram0713-0280d632d1a2-6347-44c8-b3d7-1e112ee42b9e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BacitracinACTIVE INGREDIENT58H6RWO52IBACITRACIN OINTMENT [PREFERRED PHARMACEUTICALS, INC]2
BacitracinACTIVE MOIETY58H6RWO52IBACITRACIN OINTMENT [PREFERRED PHARMACEUTICALS, INC]2
Light Mineral OilINACTIVE INGREDIENTN6K5787QVPBACITRACIN OINTMENT [PREFERRED PHARMACEUTICALS, INC]2
PetrolatumINACTIVE INGREDIENT4T6H12BN9UBACITRACIN OINTMENT [PREFERRED PHARMACEUTICALS, INC]2
BacitracinACTIVE INGREDIENT58H6RWO52IBACITRACIN (BACITRACIN) OINTMENT [G&W LABORATORIES, INC.]1
BacitracinACTIVE MOIETY58H6RWO52IBACITRACIN (BACITRACIN) OINTMENT [G&W LABORATORIES, INC.]1
Light Mineral OilINACTIVE INGREDIENTN6K5787QVPBACITRACIN (BACITRACIN) OINTMENT [G&W LABORATORIES, INC.]1
PetrolatumINACTIVE INGREDIENT4T6H12BN9UBACITRACIN (BACITRACIN) OINTMENT [G&W LABORATORIES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0713-0280BACITRACIN OINTMENT [COSETTE PHARMACEUTICALS, INC.]7Current NDC, Legacy NDC, 1 package rows20231221_630e0841-baf2-e9fa-b309-ad1a5f95da3b.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 13 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Balma Septic Antiseptic Hand WashBENZALKONIUM CHLORIDERochester Midland Corporation1b8e0a27-dcdd-4d07-b0f2-55cf74a9b5282025-01-10WarningsExact identifier
application number: M004
LX0380 Lynx glacier fresh Antiseptic Hand and Body Wash 6380CHLOROXYLENOLABC Compounding Co., Inc.efa3938f-64de-77ba-e053-2a95a90ac8402025-01-10WarningsExact identifier
application number: M004
BacitracinBACITRACINA-S Medication Solutions64aa660d-2d69-48e8-bd0d-4876815d89ff2025-01-08WarningsExact identifier
application number: M004
BacitracinBACITRACINWater-Jel Technologies412928a1-3708-4fa8-99c5-aaa2b079cf6e2025-01-06WarningsExact identifier
application number: M004
AVON HeXashield Triple Antibiotic with Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HCLTai Guk Pharm. Co., Ltd.8e0cb861-d8aa-1f71-e053-2a95a90aaa882025-01-01WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATETrifecta Pharmaceuticals USA LLC087694c2-4b1b-e293-e063-6294a90a961f2024-12-31WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATETRIFECTA PHARMACEUTICALS USA LLC0c017b10-29b6-e30f-e063-6294a90a8a3c2024-12-31WarningsExact identifier
application number: M004
Triple Antibiotic and Pain ReliefBACITRACIN,NEOMYCIN,POLYMYXINB,PRAMOXINETrifecta Pharmaceutical USA LLC0bf08cf6-be3f-f9aa-e063-6294a90a43932024-12-31WarningsExact identifier
application number: M004
Single Antibiotic with BacitracinBACITRACIN ZINCRandob Labs Ltd.2a807f1b-986f-a9ea-e063-6394a90aed252024-12-30WarningsExact identifier
application number: M004
TripleantibioticapainscaritchFAMILY WELLNESS BACITRACIN,NEOMYCIN,POLYMYXINB,PRAMOXINEHCLTrifecta Pharmaceutical USA LLC935106c6-8a9e-07fa-e053-2a95a90a24842024-12-20WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.TRIFECTA PHARMACEUTICALS USA LLC00c52a31-9bfa-a8bf-e063-6294a90ac4d72024-12-20WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATETrifecta Pharmaceuticals Usa Llcd04b397c-1608-4fd9-be28-ef7285d6a9962024-12-20WarningsExact identifier
application number: M004
TripleantibioticointmentandpainreliefFAMILY WELLNESS BACITRACIN,NEOMYCIN,POLYMYXINB,PRAMOXINETrifecta Pharmaceutical USA LLC91575333-5268-5d8f-e053-2a95a90a7a892024-12-20WarningsExact identifier
application number: M004
Premier Value Max Strength Antibiotic plus pain reliefPREMIER VALUE NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HCLPharmacy Value Alliance LLC9767821e-054b-3bd3-e053-2a95a90a4b0e2024-12-20WarningsExact identifier
application number: M004
Premier Value Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEPremier Value Alliance LLC.ab843664-a1e0-6716-e053-2995a90a20632024-12-20WarningsExact identifier
application number: M004
Premier Value Bacitracin ZincBACITRACIN ZINCPharmacy Value Alliance LLC99d789be-aa85-0917-e053-2a95a90acd132024-12-20WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEPremier Value Alliance LLC.ab863d90-1a8f-3c1f-e053-2a95a90aa0a72024-12-20WarningsExact identifier
application number: M004
Family Wellness First Aid AntibioticFAMILY WELLNESS BACITRACIN ZINC, POLYMYXIN B SULFATETrifecta Pharmaceuticals USA, LLC9157681a-3ed1-096e-e053-2a95a90a05e32024-12-18WarningsExact identifier
application number: M004
Family Wellness OriginalFAMILY WELLNESS BACITRACIN, NEOMYCIN, POLYMYXIN BTrifecta Pharmaceuticals USA LLC.915759af-0d4f-6a87-e053-2a95a90acbd62024-12-18WarningsExact identifier
application number: M004
Family Wellness Pain Scar ItchBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCLTrifecta Pharmaceutical USA LLC9e507ec5-310d-3a21-e053-2a95a90a15a62024-12-18WarningsExact identifier
application number: M004

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648110bacitracin 500 UNT in GM Topical OintmentPSN5b75944b-f0cb-4ba6-b1b2-bb8dd0114cd912
1648110bacitracin 0.5 UNT/MG Topical OintmentSCD5b75944b-f0cb-4ba6-b1b2-bb8dd0114cd912
1648110bacitracin 500 UNT per GM Topical OintmentSY5b75944b-f0cb-4ba6-b1b2-bb8dd0114cd912
1648110bacitracin 500 UNT in GM Topical OintmentPSN19007db7-fc17-4e31-9ce9-c9e7d35849617
1648110bacitracin 500 UNT in GM Topical OintmentPSN630e0841-baf2-e9fa-b309-ad1a5f95da3b7
1648110bacitracin 0.5 UNT/MG Topical OintmentSCD630e0841-baf2-e9fa-b309-ad1a5f95da3b7
1648110bacitracin 0.5 UNT/MG Topical OintmentSCD19007db7-fc17-4e31-9ce9-c9e7d35849617
1648110bacitracin 500 UNT per GM Topical OintmentSY19007db7-fc17-4e31-9ce9-c9e7d35849617
1648110bacitracin 500 UNT per GM Topical OintmentSY630e0841-baf2-e9fa-b309-ad1a5f95da3b7
1648110bacitracin 500 UNT in GM Topical OintmentPSN65f8fd49-1882-4eac-9c0e-d63968da33d46
1648110bacitracin 0.5 UNT/MG Topical OintmentSCD65f8fd49-1882-4eac-9c0e-d63968da33d46
1648110bacitracin 500 UNT per GM Topical OintmentSY65f8fd49-1882-4eac-9c0e-d63968da33d46
1648110bacitracin 500 UNT in GM Topical OintmentPSN549dcd7e-c958-07a7-e054-00144ff88e884
1648110bacitracin 500 UNT in GM Topical OintmentPSNa526ae4b-baae-5d50-e053-2a95a90ae2934
1648110bacitracin 0.5 UNT/MG Topical OintmentSCD549dcd7e-c958-07a7-e054-00144ff88e884
1648110bacitracin 0.5 UNT/MG Topical OintmentSCDa526ae4b-baae-5d50-e053-2a95a90ae2934
1648110bacitracin 500 UNT per GM Topical OintmentSY549dcd7e-c958-07a7-e054-00144ff88e884
1648110bacitracin 500 UNT per GM Topical OintmentSYa526ae4b-baae-5d50-e053-2a95a90ae2934
1648110bacitracin 500 UNT in GM Topical OintmentPSN2f115e22-10f5-47fe-85df-f59e4387a3733
1648110bacitracin 0.5 UNT/MG Topical OintmentSCD2f115e22-10f5-47fe-85df-f59e4387a3733
1648110bacitracin 500 UNT per GM Topical OintmentSY2f115e22-10f5-47fe-85df-f59e4387a3733

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0713-0280-310071302803128.4 g in 1 TUBE (0713-0280-31) 28.4 g1995-01-100000-00-00NoNoCurrent