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 17 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Triple Antibiotic plus pain relief	BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL	Kroger Company	e31c8d92-bf9f-4b7f-8f81-54199745cd20	2024-10-06	Warnings	Exact identifier application number: M004
careone triple antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE	American Sales Company	9df0c4c2-f045-4f25-878e-4d55a99b8df4	2024-10-06	Warnings	Exact identifier application number: M004
DG Health Antibiotic	BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL	Dolgencorp, LLC	0a04da51-d169-4eff-b70c-352913ce3966	2024-10-06	Warnings	Exact identifier application number: M004
Signature Care Triple Antibiotic	BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL	Safeway	8d5bac6b-98b6-4fc4-983a-ca5292b4c361	2024-10-06	Warnings	Exact identifier application number: M004
antibiotic plus pain relief	NEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDE	Kroger Company	91828614-d0d1-472f-802f-43f473860125	2024-09-26	Warnings	Exact identifier application number: M004
DG Health Antibiotic	NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL	Dolgencorp Inc	efaf3ea5-0a2f-414f-96eb-7e8cfba9e901	2024-09-26	Warnings	Exact identifier application number: M004
Good Sense First Aid Antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B	A-S Medication Solutions	29c223ff-3cb7-4578-a326-08516e89cd47	2024-09-26	Warnings	Exact identifier application number: M004
Signature Care First Aid Antibiotic	NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL	Safeway	78ecfb28-f4c4-4f70-90c9-d6d7bf920fb5	2024-09-26	Warnings	Exact identifier application number: M004
Good Neighbor Pharmacy Antibiotic and Pain Relief	NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL	Amerisource Bergen	3d1694ea-3f3e-45d5-8edf-8b31ac7d3a40	2024-09-26	Warnings	Exact identifier application number: M004
Rexall Antibiotic	BACITRACIN	Dolgencorp, LLC	7ad42602-6e42-47c8-91a8-e4785fa8d24b	2024-09-23	Warnings	Exact identifier application number: M004
bacitracin	BACITRACIN	H E B	0a5eeef0-309b-4edd-a664-3d9c1c74a6e9	2024-09-23	Warnings	Exact identifier application number: M004
signature care first aid antibiotic	BACITRACIN	Safeway	38fc0c5c-e0bc-44d2-acbd-d4d329fef1e1	2024-09-23	Warnings	Exact identifier application number: M004
Antibiotic	BACITRACIN	Topco Associates LLC	3267a695-9e53-42f2-b30a-022653a0b8bb	2024-09-23	Warnings	Exact identifier application number: M004
Bacitracin	BACITRACIN	Kroger Company	4490cece-0635-4ea7-91ab-324a971fef63	2024-09-23	Warnings	Exact identifier application number: M004
triple antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B	Padagis Israel Pharmaceuticals Ltd	28fff253-ddd4-4669-aa90-b4caf48c905f	2024-09-22	Warnings	Exact identifier application number: M004
Signature Care Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B	Safeway	044aff98-f398-40f5-8c18-2751b4ab4384	2024-09-18	Warnings	Exact identifier application number: M004
careone triple antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	American Sales Company	09a0b0b9-1806-4ff9-80fa-448dabbf2cc7	2024-09-18	Warnings	Exact identifier application number: M004
equaline first aid antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B	United Natural Foods, Inc. dba UNFI	022e009e-0192-4089-86f3-4d63448e0f88	2024-09-18	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B	Kroger Company	c531bac4-ab15-4fde-99a7-19e20ce10387	2024-09-17	Warnings	Exact identifier application number: M004
basic care first aid antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B	Amazon.com Services LLC	c159b18d-0d6e-409f-8b2b-e8f28cd85633	2024-09-17	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