FDA.reportPublic FDA data

Bacitracin

Product NDC
68071-5253
11-digit product format
680715253
Labeler code
68071
Product ID
68071-5253_1d78bc6e-79b8-c6be-e063-6394a90a18f8
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin
Dosage form
OINTMENT
Route
TOPICAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
M014
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
a526ae4b-baae-5d50-e053-2a95a90ae293Available on FDA.report

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-5253-32022-02-07C16284748780-1d6a99b39-a5ab-a426-e053-dadaa90af4c2Bacitracin Ointment
68071-5253-32022-01-28C16284748780-1d6a99b39-a5ab-a426-e053-dadaa90af4c2Bacitracin Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-5253-3Bacitracin28.4 g in 1 BOXOINTMENT28.44

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-5253BACITRACIN OINTMENT [NUCARE PHARMACEUTICALS,INC.]4Current NDC, Legacy NDC, 1 package rows20240727_a526ae4b-baae-5d50-e053-2a95a90ae293.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 3 of 7 · 129 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HANCHOBIT Lemon Turmeric Kojic Acid BrighteningGLYCERINHANCHOYEANBIOTEC Co.,Ltd.2ded8f31-d72a-d123-e063-6294a90a28562025-11-27WarningsExact identifier
application number: M014
XIMONTH Wart RemoverGLYCERINShantou Ximonth Biotechnology Co., Ltd.337d4d37-c2d6-44d3-e063-6294a90a77ce2025-11-26WarningsExact identifier
application number: M014
Swimmers EarCLEARCANALNeilmed Pharmaceuticals Inc.43778b02-e90b-36b7-e063-6394a90ab62b2025-11-13WarningsExact identifier
application number: M014
Hand SanitizerALCOHOLCharlotte Products Ltd.1fbfe3f9-e0db-a3a2-e063-6294a90ab6aa2025-10-28WarningsExact identifier
application number: M014
Carbamide peroxide 6.5%EARWAX REMOVAL KITAllegiant Health54515e9d-2225-4875-a1cf-a24a823300dd2025-10-28WarningsExact identifier
application number: M014
OFTAL-MYCIN LUBRICANT OPHTHALMICLIGHT MINERAL, WHITE PETROLATUMGRANDALL DISTRIBUTING, LLC298db04a-21a9-e46e-e063-6294a90acee22025-10-27WarningsExact identifier
application number: M014
Debrox Swimmers EarISOPROPYL ALCOHOLMedtech Products Inc.b5d57c7b-8315-4260-967e-38fdd54e2a9c2025-10-23WarningsExact identifier
application number: M014
Family Care Earwax RemovalCARBAMIDE PEROXIDEUnited Exchange Corp.958741f5-47c1-339c-e053-2a95a90a3f5f2025-10-22WarningsExact identifier
application number: M014
GoodSense Ear Wax Removal KitCARBAMIDE PEROXIDEGeiss, Destin & Dunn, Inc31ea324f-a9a1-7865-e063-6294a90a92e82025-09-19WarningsExact identifier
application number: M014
blue goo NERVE EASE Pain RELIEF Topical AnalgesicLIDOCAINE HCL 4%, MENTHOL 1%Garcoa, Inc.619d5c87-636c-407d-909e-c38512dcd5532025-09-10WarningsExact identifier
application number: M014
DEBROXCARBAMIDE PEROXIDEA-S Medication Solutions8d6f1769-eb44-4bde-b3fa-3ff4658b7dd12025-09-03WarningsExact identifier
application number: M014
AuralytCARBAMIDE PEROXIDEMenper Distributors, Inc95920b87-941f-48cb-850c-40d2735596d42025-07-22WarningsExact identifier
application number: M014
hydrocortisoneHYDROCORTISONENuCare Pharmaceuticals,Inc.a0fde5c9-afb2-76a9-e053-2995a90af3e82025-07-21WarningsExact identifier
application number: M014
Healthy EarsCARBIDE PEROXIDEVitamex USA, Corp25953441-cd8e-5038-e063-6294a90ae4012025-06-23WarningsExact identifier
application number: M014
WaxRx Ear Wax Removal Aid DropsCARBAMIDE PEROXIDEDOCTOR EASY MEDICAL PRODUCTS, LLC7e08cd86-7ae4-7d12-e053-2991aa0a4cba2025-05-01WarningsExact identifier
application number: M014
Meijer Earwax Removal DropsCARBAMIDE PEROXIDEMeijer Distribution Inc900108c6-0324-644a-e053-2a95a90a3b2b2025-02-28WarningsExact identifier
application number: M014
Tech Care Earwax Removal KitCARBAMIDE PEROXIDEWarner Tech-care Products, LLC5851c1f6-c15b-447c-b495-3707e7a12bdb2025-02-28WarningsExact identifier
application number: M014
Tech Care Earwax Removal DropsCARBAMIDE PEROXIDEWarner Tech-care Products, LLC1c97783b-dcdf-4f95-8516-0d7f197cbc272025-02-28WarningsExact identifier
application number: M014
TopCare Earwax Removal KitCARBAMIDE PEROXIDETOPCO ASSOCIATES LLC890cc9b6-41a5-480a-bc94-45c8d4fdeef32025-02-28WarningsExact identifier
application number: M014
Audiologists Choice Earwax Removal Aid DropsCARBAMIDE PEROXIDEOaktree Products Inc2922dde2-d082-437b-8f51-4a91ced20a582025-02-28WarningsExact identifier
application number: M014

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648110bacitracin 500 UNT in GM Topical OintmentPSNa526ae4b-baae-5d50-e053-2a95a90ae2934
1648110bacitracin 0.5 UNT/MG Topical OintmentSCDa526ae4b-baae-5d50-e053-2a95a90ae2934
1648110bacitracin 500 UNT per GM Topical OintmentSYa526ae4b-baae-5d50-e053-2a95a90ae2934

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-5253-36807152530328.4 g in 1 BOX (68071-5253-3) 28.4 g2020-05-080000-00-00NoNoCurrent