Bacitracin

Product NDC: 67777-116
11-digit product format: 677770116
Labeler code: 67777
Product ID: 67777-116_5c2bc26d-07df-dec4-e063-6294a90ad482
Type: HUMAN OTC DRUG
Nonproprietary name: Bacitracin
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Dynarex Corporation
Application: M004
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2016-09-12
Substance: BACITRACIN
Active strength: 500 [USP'U]/1000mg
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: Bacitracin
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BACITRACIN	500 [USP'U]/1000mg

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	SPL version
67777-116-10	Bacitracin	1728 in 1 CASE	OINTMENT	1728	10
67777-116-11	Bacitracin	144 in 1 BOX	OINTMENT	144	10
67777-116-11	Bacitracin	900 mg in 1 PACKET	OINTMENT	900	10
67777-116-20	Bacitracin	72 in 1 CASE	OINTMENT	72	10
67777-116-21	Bacitracin	14000 mg in 1 TUBE	OINTMENT	14000	10
67777-116-30	Bacitracin	72 in 1 CASE	OINTMENT	72	10
67777-116-31	Bacitracin	28400 mg in 1 TUBE	OINTMENT	28400	10
67777-116-31	Bacitracin	1 in 1 BOX	OINTMENT	1	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67777-116-10	EA - Each	67777-116	81543e57-a59d-40dc-8dee-7b6749b6bcf4	1	2023-07-06
67777-116-11	EA - Each	67777-116	1fd8a2da-8c1f-4251-90e6-f8f313e36872	1	2023-07-06
67777-116-20	GM - Gram	67777-116	3b081bc4-8e96-4dc0-a6cd-6b8e76999f75	1	2023-07-06
67777-116-21	GM - Gram	67777-116	d872c710-0600-45d6-a69e-cbd24ac0b2f5	1	2023-07-06
67777-116-30	GM - Gram	67777-116	be7113ed-2faa-4520-b558-009c856210dc	1	2023-07-06
67777-116-31	GM - Gram	67777-116	e1d78b49-c513-4871-9bfe-252a4b32455d	1	2023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67777-116	BACITRACIN OINTMENT [DYNAREX CORPORATION]	10	Current NDC, Legacy NDC, 8 package rows	20241122_7f8752c7-6839-261d-e053-2991aa0a0c30.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 22 of 22 · 422 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
EVERLIT CARE Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Nantong Health & Beyond Hygienic Products Inc.	f4921508-c32f-426f-a2f0-16c3acbd4713	2023-10-14	Warnings	Exact identifier application number: M004
Cuadriderma	BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDE	ProMex LLC	4fa99b96-ab4b-4523-82bc-343dbaf39fb6	2022-01-25	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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1648110	bacitracin 500 UNT in GM Topical Ointment	PSN	7f8752c7-6839-261d-e053-2991aa0a0c30	10
1648110	bacitracin 0.5 UNT/MG Topical Ointment	SCD	7f8752c7-6839-261d-e053-2991aa0a0c30	10
1648110	bacitracin 500 UNT per GM Topical Ointment	SY	7f8752c7-6839-261d-e053-2991aa0a0c30	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67777-116-10	67777011610	1728 BOX in 1 CASE (67777-116-10) / 144 PACKET in 1 BOX (67777-116-11) / 900 mg in 1 PACKET	1728 box	2016-09-12	0000-00-00	No	No	Current
67777-116-11	67777011611	144 in 1 BOX						Historical
67777-116-20	67777011620	72 TUBE in 1 CASE (67777-116-20) / 14000 mg in 1 TUBE (67777-116-21)	72 tube	2016-09-12	0000-00-00	No	No	Current
67777-116-21	67777011621	14000 mg in 1 TUBE	14000 mg					Historical
67777-116-30	67777011630	72 BOX in 1 CASE (67777-116-30) / 1 TUBE in 1 BOX (67777-116-31) / 28400 mg in 1 TUBE	72 box	2016-09-12	0000-00-00	No	No	Current
67777-116-31	67777011631	28400 mg in 1 TUBE	28400 mg					Historical