Bacitracin Zinc

Product NDC
69396-163
11-digit product format
693960163
Labeler code
69396
Product ID
69396-163_4352c463-e65e-55a7-e063-6394a90a4b11
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin Zinc
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Trifecta Pharmaceuticals USA LLC
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-06-05
Substance
BACITRACIN ZINC
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

Additional Listing Data#

Finished product
Yes
Brand name base
Bacitracin Zinc
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC500 [USP'U]/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii89Y4M234ES
Rxcui1366116

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
69396-163-09Bacitracin Zinc144 in 1 CARTONOINTMENT1441
69396-163-09Bacitracin Zinc0.9 g in 1 PACKETOINTMENT0.91

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1366116bacitracin zinc 500 UNT/GM Topical OintmentPSN4352c453-a89c-a2b9-e063-6294a90a61f31
1366116bacitracin zinc 0.5 UNT/MG Topical OintmentSCD4352c453-a89c-a2b9-e063-6294a90a61f31
1366116bacitracin zinc 500 UNT per GM Topical OintmentSY4352c453-a89c-a2b9-e063-6294a90a61f31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69396-163-0969396016309144 PACKET in 1 CARTON (69396-163-09) / .9 g in 1 PACKET144 packet2025-06-05NoNoCurrent