Zapotol Bacitracin

Product NDC
59428-135
11-digit product format
594280135
Labeler code
59428
Product ID
59428-135_41c89cd8-cf22-fc47-e063-6394a90a07de
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin
Dosage form
CREAM
Route
TOPICAL
Labeler
Zapatol Corp.
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-08-06
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN500 [USP'U]/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii58H6RWO52I

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
59428-135-14Zapotol Bacitracin14 g in 1 TUBECREAM145
59428-135-14Zapotol Bacitracin1 in 1 PACKAGECREAM15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BACITRACINACTIVE INGREDIENT58H6RWO52IZAPOTOL BACITRACIN (BACITRACIN) CREAM [ZAPATOL CORP.]1
BACITRACINACTIVE MOIETY58H6RWO52IZAPOTOL BACITRACIN (BACITRACIN) CREAM [ZAPATOL CORP.]1
ALOE VERA WHOLEINACTIVE INGREDIENTKIZ4X2EHYXZAPOTOL BACITRACIN (BACITRACIN) CREAM [ZAPATOL CORP.]1
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVPZAPOTOL BACITRACIN (BACITRACIN) CREAM [ZAPATOL CORP.]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UZAPOTOL BACITRACIN (BACITRACIN) CREAM [ZAPATOL CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59428-135ZAPOTOL BACITRACIN (BACITRACIN) CREAM [ZAPATOL CORP.]4Current NDC, Legacy NDC, 2 package rows20241226_c8704895-8819-49ac-8baa-5b97be1d00aa.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59428-135-14594280135141 TUBE in 1 PACKAGE (59428-135-14) / 14 g in 1 TUBE1 tube2016-10-130000-00-00NoNoCurrent