FDA.reportPublic FDA data

Bacitracin Zinc

Product NDC
49035-510
11-digit product format
490350510
Labeler code
49035
Product ID
49035-510_f7e8a5a9-b5e2-452b-adf4-0b5a5e025e56
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin Zinc
Dosage form
OINTMENT
Route
TOPICAL
Labeler
EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)
Application
part333B
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2017-08-07
Marketing end
0000-00-00
Substance
BACITRACIN ZINC
Active strength
500 [USP'U]/g
Pharmacologic classes
Decreased Cell Wall Synthesis & Repair [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct49035-510DDiscontinued by firm2026-10-02
excluded packagepackage49035-51049035-510-26DDiscontinued by firm2026-10-02

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
49035-510-26Bacitracin Zinc28 g in 1 TUBEOINTMENT287
49035-510-26Bacitracin Zinc1 in 1 CARTONOINTMENT17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-510-26GM - Gram49035-510aa6b94b6-bc41-493d-80aa-58ab014eda2412019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-510BACITRACIN ZINC OINTMENT [EQUATE (WAL-MART STORES, INC.) (SEE ALSO WAL-MART INC)]7Legacy NDC, 2 package rows20240321_9f30d731-9aab-4e3c-a0c2-669c15677e03.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1366116bacitracin zinc 500 UNT/GM Topical OintmentPSN9f30d731-9aab-4e3c-a0c2-669c15677e037
1366116bacitracin zinc 0.5 UNT/MG Topical OintmentSCD9f30d731-9aab-4e3c-a0c2-669c15677e037
1366116bacitracin zinc 500 UNT per GM Topical OintmentSY9f30d731-9aab-4e3c-a0c2-669c15677e037

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-510-26490350510261 TUBE in 1 CARTON (49035-510-26) > 28 g in 1 TUBE1 tube2017-08-070000-00-00NoNoCurrent