FDA.reportPublic FDA data

Bacitracin

Product NDC
71205-057
11-digit product format
712050057
Labeler code
71205
Product ID
71205-057_6df0a5e7-318f-4554-895c-0a452db9bc79
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Proficient Rx LP
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
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
Listing expiration
2027-12-31

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
65f8fd49-1882-4eac-9c0e-d63968da33d4Available 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
71205-057-01Bacitracin28.4 g in 1 TUBEOINTMENT28.46

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-057-01GM - Gram71205-0576d27cd94-ae14-40c7-9422-b9c09705e0ec12018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-057BACITRACIN OINTMENT [PROFICIENT RX LP]6Current NDC, Legacy NDC, 1 package rows20231223_65f8fd49-1882-4eac-9c0e-d63968da33d4.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 6 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Water-Jel Neomycin AntibioticFIRST AID OINTMENTWater-Jel Technologiesabea91a2-4453-406d-a7ed-3ffc19ef521a2025-12-31WarningsExact identifier
application number: M004
Caring Mill Triple Antibiotic and PainPRAMOXINE HYDROCHLORIDE, BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATEFSA Store Inc. (Caring Mills)3c5b6909-6b30-5256-e063-6294a90a90962025-12-29WarningsExact identifier
application number: M004
Caring Mills Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATEVeridian Healthcarefbd11419-4513-10d7-e053-6394a90ac82b2025-12-27WarningsExact identifier
application number: M004
Caring Mill Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEVeridian Healthcare8cd0cd64-fe62-4225-8986-5e8641dd6df22025-12-22WarningsExact identifier
application number: M004
PS-2261 Triple Antibiotic, 0.5gPS-2261 TRIPLE ANTIBIOTIC, 0.5GProStat First Aid LLC0072f8de-fc06-d529-e063-6294a90a08db2025-12-15WarningsExact identifier
application number: M004
PS - 2895 Triple Antibiotic , 0.5gPS - 2895 TRIPLE ANTIBIOTIC , 0.5GProstat First Aid LLC0050de33-914b-f76d-e063-6394a90a7fab2025-12-15WarningsExact identifier
application number: M004
Triple AntibioticTRIPLE ANTIBIOTICProStat First Aidf76d7d18-0fa1-d943-e053-6294a90ac20a2025-12-15WarningsExact identifier
application number: M004
Triple AntibioticTRIPLE ANTIBIOTICFront Line Safety0f509f96-a083-37d1-e063-6394a90a622c2025-12-15WarningsExact identifier
application number: M004
ElixirTripleGuard Triple AntibioticBACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN BELIXIR HEALTHCARE USA, LLC.43edfb80-4d50-9362-e063-6394a90a21992025-12-13WarningsExact identifier
application number: M004
El Valle Decolorized IodineALCOHOLPharmadel LLCfd7a227b-536c-b3f7-e053-6394a90a41582025-12-04WarningsExact identifier
application number: M004
Vitastem First Aid AntibioticTETRACYCLINE HYDROCHLORIDEVIADERMA DISTRIBUTION INC3970ac49-ab0f-4492-ba61-95a12faed5002025-12-02WarningsExact identifier
application number: M004
Thera Plus Original Strength Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEFourstar Group USA, Inc2f916502-4daf-4cb9-a638-f37bb96c80772025-12-02WarningsExact identifier
application number: M004
CAREALL BacitracinBACITRACIN ZINCNew World Imports, Incea16e1de-0100-456b-abe6-d33de78221da2025-12-02WarningsExact identifier
application number: M004
Triple Antibiotic Ointment, Circle KTRIPLE ANTIBIOTIC OINTMENTLil' Drug Store Products, Inc.44e5107e-832a-2ce6-e063-6294a90a711d2025-12-01WarningsExact identifier
application number: M004
Viaderma Care First Aid AntibioticBACITRACIN ZINCVIADERMA DISTRIBUTION INC0f36f396-e479-486c-b047-2760477609e22025-12-01WarningsExact identifier
application number: M004
CareALL Triple Antibiotic plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HCLNew World Imports, Inc1982b664-e8fd-4030-aa89-f7543e1b487b2025-12-01WarningsExact identifier
application number: M004
CareALL Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENew World Imports, Inc9c2d417e-6fec-42f4-9f0c-2ec79de9342d2025-12-01WarningsExact identifier
application number: M004
BacitracinBACITRACINBryant Ranch Prepack5b0249c0-c196-4d3c-973f-49bd2d3d4a752025-12-01WarningsExact identifier
application number: M004
Neosporin Plus LidocaineBACITRACIN, NEOMYCIN, POLYMYXIN B, LIDOCAINEKenvue Brands LLCe450b6a1-a8da-e5db-e053-2995a90a0ef02025-11-24WarningsExact identifier
application number: M004
ElixirZincoCareZINC OXIDE 20%ELIXIR HEALTHCARE USA, LLC.bac18496-3b76-4faf-abde-968d79b718d82025-11-22WarningsExact identifier
application number: M004

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-057-017120500570128.4 g in 1 TUBE (71205-057-01) 28.4 g2018-06-010000-00-00NoNoCurrent