Single Antibiotic with bacitracin

Product NDC: 61010-5601
11-digit product format: 610105601
Labeler code: 61010
Product ID: 61010-5601_55135000-91eb-c54b-e063-6394a90afdcd
Type: HUMAN OTC DRUG
Nonproprietary name: bacitracin zinc
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Safetec of America
Application: M004
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2008-11-13
Substance: BACITRACIN ZINC
Active strength: 400 [USP'U]/g
Pharmacologic classes: Decreased Cell Wall Synthesis & Repair [PE]
NDC exclude flag: No
Listing certified through: 2027-12-31
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: Single Antibiotic with bacitracin
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BACITRACIN ZINC	400 [USP'U]/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
89Y4M234ES	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
4ae9a105-e3f9-4015-8844-085e0b34cdb6	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
61010-5601-2	2024-02-13	61010-5601, Single antibiotic with Bacitracin
61010-5601-2	2024-02-13	61010-5601, Single antibiotic with Bacitracin
61010-5601-3	2024-02-13	61010-5601, Single antibiotic with Bacitracin
61010-5601-3	2024-02-13	61010-5601, Single antibiotic with Bacitracin
61010-5601-2	2024-01-30	61010-5601, Single antibiotic with Bacitracin
61010-5601-2	2024-01-30	61010-5601, Single antibiotic with Bacitracin
61010-5601-3	2024-01-30	61010-5601, Single antibiotic with Bacitracin
61010-5601-3	2024-01-30	61010-5601, Single antibiotic with Bacitracin

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61010-5601-1	Single Antibiotic with bacitracin	0.9 g in 1 POUCH	OINTMENT	0.9	5
61010-5601-2	Single Antibiotic with bacitracin	144 in 1 BOX	OINTMENT	144	5
61010-5601-3	Single Antibiotic with bacitracin	25 in 1 BOX	OINTMENT	25	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61010-5601	SINGLE ANTIBIOTIC WITH BACITRACIN (BACITRACIN ZINC) OINTMENT [SAFETEC OF AMERICA]	5	Current NDC, Legacy NDC, 3 package rows	20240215_4ae9a105-e3f9-4015-8844-085e0b34cdb6.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 · 424 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Leader Triple Antibiotic	FIRST AID TRIPLE ANTIBIOTIC	Cardinal Health 110,Inc.	844cd9a1-b68e-47d8-a5eb-c9e880ba019e	2024-01-18	Warnings	Exact identifier application number: M004
Multi-Action Antibiotic and Pain Relief	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE OINTMENT	Target Corporation	8fecff32-bd67-4351-90f7-0c28cb335ea3	2024-01-18	Warnings	Exact identifier application number: M004
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
89Y4M234ES	BACITRACIN ZINC	1405-89-6	BACITRACIN ZINC

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61010-5601-1	61010560101	0.9 g in 1 POUCH	0.9 g					Historical
61010-5601-2	61010560102	144 POUCH in 1 BOX (61010-5601-2) / .9 g in 1 POUCH (61010-5601-1)	144 pouch	2008-11-13	0000-00-00	No	No	Current
61010-5601-3	61010560103	25 POUCH in 1 BOX (61010-5601-3) / .9 g in 1 POUCH (61010-5601-1)	25 pouch	2008-11-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
61010-5601, Single antibiotic with Bacitracin	Safetec of America \| Safetec of America, Inc.	2026-06-25	HUMAN OTC DRUG LABEL	6