Bacitracin

Product NDC: 63187-299
11-digit product format: 631870299
Labeler code: 63187
Product ID: 63187-299_41cd2973-b1b3-4201-bbdb-f5a113cdb59d
Type: HUMAN OTC DRUG
Nonproprietary name: Bacitracin
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Proficient Rx LP
Application: M004
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2009-12-01
Substance: BACITRACIN
Active strength: 500 [iU]/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: Bacitracin
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BACITRACIN	500 [iU]/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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1648110	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
e1166948-5d80-44c2-a20d-78be631647d9	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
63187-299-01	Bacitracin	28.35 g in 1 TUBE	OINTMENT	28.35		5

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BACITRACIN	ACTIVE INGREDIENT	58H6RWO52I	BACITRACIN OINTMENT [PROFICIENT RX LP]	1
BACITRACIN	ACTIVE MOIETY	58H6RWO52I	BACITRACIN OINTMENT [PROFICIENT RX LP]	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	BACITRACIN OINTMENT [PROFICIENT RX LP]	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	BACITRACIN OINTMENT [PROFICIENT RX LP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-299	BACITRACIN OINTMENT [PROFICIENT RX LP]	5	Current NDC, Legacy NDC, 1 package rows	20240123_e1166948-5d80-44c2-a20d-78be631647d9.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 18 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Major Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B SULFAT	Major Pharmaceuticals	a6cc3fbc-6302-4033-e053-2a95a90a19f0	2024-09-11	Warnings	Exact identifier application number: M004
Leader Triple antibiotic	BACITRACIN,NEOMYCIN,POLYMXIN	Cardinal Health 110 dba LEADER	2175e00a-bf85-3377-e063-6394a90a916f	2024-09-06	Warnings	Exact identifier application number: M004
Members Mark Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B	Sam's West Inc	200f4020-7699-4a9e-8fab-2d3df9e76836	2024-09-05	Warnings	Exact identifier application number: M004
Leader Poly Bacitracin	BACITRACIN ZINC POLYMIXIN B SULFATE	Cardinal Health 110 dba LEADER	20d7624f-cafa-25e1-e063-6394a90a4439	2024-08-29	Warnings	Exact identifier application number: M004
triple antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B	Meijer Distribution Inc	edcb423e-b5c2-4e26-8f7f-9b9ee575042c	2024-08-19	Warnings	Exact identifier application number: M004
Major Clotrimazole	CLOTRIMAZOLE	NuCare Pharmaceuticals,Inc.	562dfc9f-1897-330a-e054-00144ff8d46c	2024-08-14	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Wildeman Business Group	1f96450a-3bda-1f0a-e063-6294a90a514f	2024-08-13	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Provision Medical	bbf4b99c-9738-4855-82a6-f4e213924ec9	2024-08-09	Warnings	Exact identifier application number: M004
Tetracyte Topical Tetracycline Hydrochloride	TETRACYCLINE HYDROCHLORIDE	VIADERMA DISTRIBUTION INC	4ac5177d-bb67-45e6-adcf-44f0821746bd	2024-08-01	Warnings	Exact identifier application number: M004
Bacitracin	BACITRACIN	Padagis Israel Pharmaceuticals Ltd	bebbedf6-dd65-47a4-aa3e-ad197b3e05a1	2024-07-31	Warnings	Exact identifier application number: M004
Bacitracin Zinc	BACITRACIN ZINC	Chain Drug Marketing Association Inc.	1cd9ded3-068c-496e-e063-6394a90a6a0b	2024-07-09	Warnings	Exact identifier application number: M004
Anti-Itch with Aloe	HYDROCORTISONE 1%	Chain Drug Marketing Association Inc.	1cbea7cd-03a0-1469-e063-6294a90a7cc1	2024-07-08	Warnings	Exact identifier application number: M004
astonea First Aid	BACITRACIN ZINC	ASTONEA LABS PRIVATE LIMITED	de0b2e06-64bc-78f0-e053-2995a90a39a0	2024-06-25	Warnings	Exact identifier application number: M004
Publix Bacitracin Zinc	BACITRACIN ZINC	PUBLIX SUPER MARKETS, INC.	51f21123-7826-40c9-b2aa-b202125085e2	2024-06-17	Warnings	Exact identifier application number: M004
Publix Triple Antibiotic	BACITRACIN ZINC 400 U, POLYMXYIN B SULFATE 5,000 U, NEOMYCIN SULFATE 3.5MG/G	PUBLIX SUPER MARKETS, INC.	871fa43c-a1be-4c15-bbfa-a998a2d89d2e	2024-06-17	Warnings	Exact identifier application number: M004
Biofreeze Professional	MENTHOL, UNSPECIFIED FORM	NuCare Pharmaceuticals,Inc.	66ff9726-20da-688a-e053-2a91aa0a59ac	2024-06-06	Warnings	Exact identifier application number: M004
QC Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.	Chain Drug Marketing Association	1a1501a4-75b0-5900-e063-6394a90ad77a	2024-06-04	Warnings	Exact identifier application number: M004
Always Save Bacitracin Zinc	BACITRACIN ZINC	Trifecta Pharmaceuticals USA LLC	1a00df31-a38a-fc82-e063-6394a90abbf3	2024-06-03	Warnings	Exact identifier application number: M004
PENTREXCILINA TRIPLE ANTIBIOTIC PLUS PAIN RELIEF	BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE	OPMX LLC	7c0d3cdf-af50-4a65-a01b-a33510feeb94	2024-05-17	Warnings	Exact identifier application number: M004
PENIMIXCINA	BACITRACIN, NEOMYCIN SULFATE, POLYMIXIN B SULFATE, PRAMOXINE HYDROCHLORIDE	OPMX LLC	92bcbc02-9683-4117-af2b-6d4687796f1f	2024-05-17	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	e1166948-5d80-44c2-a20d-78be631647d9	5
1648110	bacitracin 0.5 UNT/MG Topical Ointment	SCD	e1166948-5d80-44c2-a20d-78be631647d9	5
1648110	bacitracin 500 UNT per GM Topical Ointment	SY	e1166948-5d80-44c2-a20d-78be631647d9	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63187-299-01	63187029901	28.35 g in 1 TUBE (63187-299-01)	28.35 g	2019-01-01	0000-00-00	No	No	Current