FDA.reportPublic FDA data

antibiotic

Product NDC
49348-154
Requested package NDC
49348-154-72
11-digit product format
493480154
Labeler code
49348
Product ID
49348-154_99776353-c820-4fce-a9d0-ad13892d6617
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin Zinc
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Strategic Sourcing Services LLC
Application
part333B
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2006-05-11
Marketing end
0000-00-00
Substance
BACITRACIN ZINC
Active strength
500 [iU]/g
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage49348-15449348-154-72DDiscontinued by firm2026-10-16

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
49348-154-72antibioticBacitracin Zinc28.4 g in 1 TUBEOINTMENT28.44
49348-154-72antibioticBacitracin Zinc1 in 1 CARTONOINTMENT14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-154-72GM - Gram49348-15425943803-8b16-496b-a163-1cf4648d916212013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Bacitracin ZincACTIVE INGREDIENT89Y4M234ESANTIBIOTIC BACITRACIN ZINC (BACITRACIN ZINC) OINTMENT [MCKESSON]1
BacitracinACTIVE MOIETY58H6RWO52IANTIBIOTIC BACITRACIN ZINC (BACITRACIN ZINC) OINTMENT [MCKESSON]1
mineral oilINACTIVE INGREDIENTT5L8T28FGPANTIBIOTIC BACITRACIN ZINC (BACITRACIN ZINC) OINTMENT [MCKESSON]1
petrolatumINACTIVE INGREDIENT4T6H12BN9UANTIBIOTIC BACITRACIN ZINC (BACITRACIN ZINC) OINTMENT [MCKESSON]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49348-154ANTIBIOTIC BACITRACIN ZINC (BACITRACIN ZINC) OINTMENT [STRATEGIC SOURCING SERVICES LLC]3Legacy NDC, 2 package rows20241006_73cbb154-d543-4b63-ad72-5b580123d5d6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1366116bacitracin zinc 500 UNT/GM Topical OintmentPSN73cbb154-d543-4b63-ad72-5b580123d5d64
1366116bacitracin zinc 0.5 UNT/MG Topical OintmentSCD73cbb154-d543-4b63-ad72-5b580123d5d64
1366116bacitracin zinc 500 UNT per GM Topical OintmentSY73cbb154-d543-4b63-ad72-5b580123d5d64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49348-154-72493480154721 TUBE in 1 CARTON (49348-154-72) > 28.4 g in 1 TUBE1 tube2013-02-060000-00-00NoNoCurrent