Bacitracin

Product NDC: 68001-477
Requested package NDC: 68001-477-48
11-digit product format: 680010477
Labeler code: 68001
Product ID: 68001-477_097d4e93-7f8a-53f8-e063-6294a90a4e40
Type: HUMAN OTC DRUG
Nonproprietary name: Bacitracin
Dosage form: OINTMENT
Route: TOPICAL
Labeler: BluePoint Laboratories
Application: M004
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-11-24
Substance: BACITRACIN
Active strength: 500 [iU]/g
Pharmacologic classes: Decreased Cell Wall Synthesis & Repair [PE]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TRIPLE ANTIBIOTIC	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Vive Health LLC	236c62bf-3de0-0b3e-e063-6394a90ad6c6	2026-07-21	Warnings	Exact identifier application number: M004
TRIPLE ANTIBIOTIC	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Vive Health LLC	21b38b00-1e64-83d8-e063-6294a90a07bd	2026-07-21	Warnings	Exact identifier application number: M004
DERMFREE Triple Antibiotic	TRIPLE ANTIBIOTIC	Jiangxi Yudexi Pharmaceutical Co., LTD	4a5a5603-3478-5f7a-e063-6294a90acc40	2026-07-21	Warnings	Exact identifier application number: M004
Bacitracin	BACITRACIN ZINC	Preferred Pharmaceuticals Inc.	e094566b-3b80-45ac-be73-54c798bbb763	2026-07-15	Warnings	Exact identifier application number: M004
Good Sense First Aid Antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B	L. Perrigo Company	3eadd35c-3df2-4e46-b76d-a6e537895917	2026-07-10	Warnings	Exact identifier application number: M004
Ever Ready First Aid Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	EVER READY FIRST AID	ee1ad6d7-e9c1-2b20-e053-2995a90a3366	2026-07-03	Warnings	Exact identifier application number: M004
Single Antibiotic with bacitracin	BACITRACIN ZINC	Safetec of America	4ae9a105-e3f9-4015-8844-085e0b34cdb6	2026-06-25	Warnings	Exact identifier application number: M004
Antibacterial Hand Wipes (0.13% Benzalkonium Chloride)	BENZALKONIUM CHLORIDE	Eleeo Brands LLC	551baf59-39b9-e994-e063-6294a90a65e6	2026-06-25	Warnings	Exact identifier application number: M004
Medi First Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Unifirst First Aid Corporation	545fa5b6-781c-18ae-e063-6294a90a2f0d	2026-06-16	Warnings	Exact identifier application number: M004
Triple Antibiotic	FIRST AID ANTIBIOTIC ORIGINAL STRENGTH	Aldermed Inc.	19eace87-b505-4be6-93b3-db5323e34216	2026-06-12	Warnings	Exact identifier application number: M004
Bacitracin	BACITRACIN	AlderMed Inc.	3f0eb4a0-f7bf-45f7-8885-92c65a4bd899	2026-06-08	Warnings	Exact identifier application number: M004
Bacitracin Zinc	FIRST AID ANTIBIOTIC	Aldermed Inc.	7f4bff4f-588d-4e45-8aa3-f95b4d746f25	2026-06-08	Warnings	Exact identifier application number: M004
Triple Antibiotic First Aid Antibiotic plus Pain Relief	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HCL	Aldermed Inc.	5bfc7776-1030-48ba-9df4-897c4984c9e6	2026-06-08	Warnings	Exact identifier application number: M004
Triple Antibiotic Plus Pain Relief	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	4545c043-8e8e-4288-b4d8-e6ec9d72f979	2026-06-04	Warnings	Exact identifier application number: M004
First Aid Kit, Orazen Inc	5 ADHESIVE BANDAGES, 2 ANTIBIOTIC OINTMENTS	Orazen Inc	525bcb89-af5b-8652-e063-6294a90a41a6	2026-06-03	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE	Sun Pharmaceutical Industries, Inc.	d77239e6-5e81-439a-b0cd-f8be59169442	2026-06-02	Warnings	Exact identifier application number: M004
First Aid Antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B	HyVee Inc	3ac9f0fc-e08c-49d9-9079-3ba0393c612b	2026-06-02	Warnings	Exact identifier application number: M004
Triple Antibiotic Plus Pain Relief	BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL	HyVee Inc	69a4b642-b7ec-43cc-aa57-6858da0b3d63	2026-06-02	Warnings	Exact identifier application number: M004
Careland Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Planet (Anhui) Pharmaceutical Co., Ltd.	0e64179d-fce2-48fc-833e-ce43a54b987c	2026-05-31	Warnings	Exact identifier application number: M004
First Aid Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Hubei Fanjian Medical Product Co.,Ltd	f44ab989-c618-1831-e053-2995a90adc8e	2026-05-28	Warnings	Exact identifier application number: M004

Additional Listing Data#

Finished product: Yes
Brand name base: Bacitracin
Listing expiration: 2026-12-31

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
b4d8ef06-6269-68f7-e053-2995a90ac8ea	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	SPL version
68001-477-45	Bacitracin	0.9 g in 1 PACKET	OINTMENT	0.9	5
68001-477-46	Bacitracin	14.2 g in 1 TUBE	OINTMENT	14.2	5
68001-477-46	Bacitracin	1 in 1 CARTON	OINTMENT	1	5
68001-477-47	Bacitracin	28.4 g in 1 TUBE	OINTMENT	28.4	5
68001-477-47	Bacitracin	1 in 1 CARTON	OINTMENT	1	5
68001-477-48	Bacitracin	1 in 1 CARTON	OINTMENT	1	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68001-477-45	EA - Each	68001-477	a69106f1-a39c-4977-a894-9da4520bae89	1	2021-09-07
68001-477-46	GM - Gram	68001-477	c4b4d076-130c-4dd7-b3e0-86c9ee078adf	1	2021-08-05
68001-477-47	GM - Gram	68001-477	cda38210-f644-4f31-abb3-a21b836896c3	1	2021-08-05
68001-477-48	EA - Each	68001-477	f328fd23-9156-449e-b2b0-7f7472bfd121	1	2021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68001-477	BACITRACIN OINTMENT [BLUEPOINT LABORATORIES]	5	Current NDC, Legacy NDC, 6 package rows	20231118_b4d8ef06-6269-68f7-e053-2995a90ac8ea.zip

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	b4d8ef06-6269-68f7-e053-2995a90ac8ea	5
1648110	bacitracin 0.5 UNT/MG Topical Ointment	SCD	b4d8ef06-6269-68f7-e053-2995a90ac8ea	5
1648110	bacitracin 500 UNT per GM Topical Ointment	SY	b4d8ef06-6269-68f7-e053-2995a90ac8ea	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68001-477-48	68001047748	1 PACKET in 1 CARTON (68001-477-48) / .9 g in 1 PACKET (68001-477-45)	1 packet	2020-11-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Bacitracin_Ointment	BluePoint Laboratories \| Gopaldas Visram & Co., Ltd	2023-11-17	HUMAN OTC DRUG LABEL	5