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

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: Zapotol Bacitracin
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BACITRACIN	500 [USP'U]/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
58H6RWO52I	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
c8704895-8819-49ac-8baa-5b97be1d00aa	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
2d352c73-a357-4193-a4de-dfdf9a2ac8e4	Product name	1	20150819

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59428-135-14	Zapotol Bacitracin	14 g in 1 TUBE	CREAM	14		5
59428-135-14	Zapotol Bacitracin	1 in 1 PACKAGE	CREAM	1		5

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BACITRACIN	ACTIVE INGREDIENT	58H6RWO52I	ZAPOTOL BACITRACIN (BACITRACIN) CREAM [ZAPATOL CORP.]	1
BACITRACIN	ACTIVE MOIETY	58H6RWO52I	ZAPOTOL BACITRACIN (BACITRACIN) CREAM [ZAPATOL CORP.]	1
ALOE VERA WHOLE	INACTIVE INGREDIENT	KIZ4X2EHYX	ZAPOTOL BACITRACIN (BACITRACIN) CREAM [ZAPATOL CORP.]	1
LIGHT MINERAL OIL	INACTIVE INGREDIENT	N6K5787QVP	ZAPOTOL BACITRACIN (BACITRACIN) CREAM [ZAPATOL CORP.]	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	ZAPOTOL BACITRACIN (BACITRACIN) CREAM [ZAPATOL CORP.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59428-135	ZAPOTOL BACITRACIN (BACITRACIN) CREAM [ZAPATOL CORP.]	4	Current NDC, Legacy NDC, 2 package rows	20241226_c8704895-8819-49ac-8baa-5b97be1d00aa.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 20 of 22 · 422 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Leader Poly Bacitracin	FIRST AID ANTIBIOTIC	Cardinal Health 110, Inc.	442e11aa-7d14-44f9-bf14-446018f1de0d	2024-01-18	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Unifirst First Aid Corporation	7b16cb9b-5847-4360-9974-2118f4a2c70f	2024-01-17	Warnings	Exact identifier application number: M004
Green Guard Triple Antibiotic	BACITRACIN ZIN, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Unifirst First Aid Corporation	bd456e2f-e6d7-d2ad-e053-2995a90a5c12	2024-01-17	Warnings	Exact identifier application number: M004
Medi-First Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Unifirst First Aid Corporation	bd432abc-fefb-1b4b-e053-2995a90acb18	2024-01-17	Warnings	Exact identifier application number: M004
Crane Safety Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Crane Safety LLC	96dbc282-4b3f-aaf3-e053-2995a90a5694	2024-01-17	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE	Target Corporation	10c4a1b5-bb91-48da-b0ae-303e4adf793a	2024-01-17	Warnings	Exact identifier application number: M004
First Aid Antibiotic	BACITRACIN ZINC	Target Corporation	6020956d-2f58-4be8-97da-3f6b7e0f34aa	2024-01-17	Warnings	Exact identifier application number: M004
Triple Antibiotic and Pain Relief	TRIPLE ANTIBIOTIC	Target Corporation	8fda7b8a-72f3-4b92-a229-ac5be0e3b3eb	2024-01-17	Warnings	Exact identifier application number: M004
Travel Savvy First Aid Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Bellegrove Medical Supply, Inc.	69fa1c9d-5e6d-4593-e053-2a91aa0a7690	2024-01-16	Warnings	Exact identifier application number: M004
American Safety First Aid Antispetic	ISOPROPYL ALCOHOL	Orazen Inc	ea302ba4-a63d-e713-e053-2995a90a3fc4	2024-01-15	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Sled Distribution, LLC	e7398df8-8e23-5439-e053-2a95a90ac3aa	2024-01-15	Warnings	Exact identifier application number: M004
ER Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	EVER READY FIRST AID	20f97e1c-584f-4844-afd8-8641ffe2f466	2024-01-11	Warnings	Exact identifier application number: M004
Lightning X Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Nantong Health & Beyond Hygienic Products Inc.	0e66af91-e0b4-827f-e063-6294a90a9847	2024-01-07	Warnings	Exact identifier application number: M004
triple antibiotic 01	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	0e1b23f3-fa1e-f42b-e063-6394a90a3bec	2024-01-04	Warnings	Exact identifier application number: M004
Triple Antibiotic Ointment, Circle K	TRIPLE ANTIBIOTIC	Lil' Drug Store products, Inc.	0d98477b-aa33-ebb7-e063-6294a90a597f	2024-01-03	Warnings	Exact identifier application number: M004
Bacitracin Zinc	BACITRACIN ZINC	Trifecta Pharmaceuticals USA LLC	d9f2702c-a514-cb69-e053-2a95a90a29a9	2024-01-02	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.	Geri-Care Pharmaceuticals, Corp	ef309620-1cf9-d007-e053-2995a90ad46f	2024-01-02	Warnings	Exact identifier application number: M004
Bacitracin Zinc	BACITRACIN ZINC	Geri-Care Pharmaceuticals, Corp.	eec90f72-fd13-05c9-e053-2995a90a642a	2024-01-02	Warnings	Exact identifier application number: M004
Leader Bacitracin Zinc	BACITRACIN ZINC	Cardinal Health 110 dba LEADER	a353dce2-8ae5-23aa-e053-2a95a90a89c2	2024-01-02	Warnings	Exact identifier application number: M004
Triple Antibiotic	POLYMYXIN B SULFATE, BACITRACIN ZINC AND NEOMYCIN SULFATE	NuCare Pharmaceuticals,Inc.	0dfe5f6a-6968-68e6-e063-6294a90ae25b	2024-01-02	Warnings	Exact identifier application number: M004

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
58H6RWO52I	BACITRACIN	1405-87-4	BACITRACIN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59428-135-14	59428013514	1 TUBE in 1 PACKAGE (59428-135-14) / 14 g in 1 TUBE	1 tube	2016-10-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Zapotol Termicina Antibiotic Ointment 0.5oz 1350A ZDP	Zapatol Corp.	2025-10-22	HUMAN OTC DRUG LABEL	5