Triple Antibiotic

Product NDC: 0168-0012
11-digit product format: 001680012
Labeler code: 0168
Product ID: 0168-0012_17785628-26c0-4498-aba8-c121fafb36d4
Type: HUMAN OTC DRUG
Nonproprietary name: Neomycin and Polymyxin B Sulfates and Bacitracin Zinc
Dosage form: OINTMENT
Route: TOPICAL
Labeler: E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
Application: part333B
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2010-01-06
Marketing end: 0000-00-00
Substance: BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength: 400 [USP'U]/g; mg/g; [USP'U]/g
NDC exclude flag: E
Listing certified through: 2018-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0168-0012		D	Discontinued by firm	2026-08-11
excluded package	package	0168-0012	0168-0012-09	D	Discontinued by firm	2026-08-11
excluded package	package	0168-0012	0168-0012-31	D	Discontinued by firm	2026-08-11
excluded package	package	0168-0012	0168-0012-35	D	Discontinued by firm	2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 52 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0168-0012-31	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0168-0012-09	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0168-0012-35	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0168-0012-31	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0168-0012-09	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0168-0012-35	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0168-0012-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0168-0012-09	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0168-0012-35	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0168-0012-31	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0168-0012-09	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0168-0012-35	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0168-0012-31	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0168-0012-09	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0168-0012-35	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0168-0012-31	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0168-0012-09	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0168-0012-35	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0168-0012-31	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0168-0012-09	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0168-0012-35	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0168-0012-31	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0168-0012-09	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0168-0012-35	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0168-0012-31	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0168-0012-09	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0168-0012-35	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0168-0012-31	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0168-0012-09	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0168-0012-35	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0168-0012-31	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0168-0012-09	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0168-0012-35	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0168-0012-31	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0168-0012-09	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0168-0012-35	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	0168-0012-35	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	0168-0012-31	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	0168-0012-09	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
99e684e6-f435-feb8-d2bb-3a546f1cb768	Product name	2	20161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0c	Product name	1	20160603
b045ad64-0f28-9a02-2f9b-b34d94fb2278	Product name	1	20140508
b6082387-f592-1148-0844-bd068fd213fb	Product name	1	20140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0168-0012-09	EA - Each	0168-0012	f955a9b2-cb31-4572-a5ec-c455dd57c71b	1	2012-07-24
0168-0012-31	GM - Gram	0168-0012	744c935d-272c-436f-8e28-39a21fb01c43	1	2012-07-24
0168-0012-35	GM - Gram	0168-0012	71a23c05-c781-467e-aca8-9c0a572a5724	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Bacitracin Zinc	ACTIVE INGREDIENT	89Y4M234ES	TRIPLE ANTIBIOTIC (NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC) OINTMENT [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	2
NEOMYCIN SULFATE	ACTIVE INGREDIENT	057Y626693	TRIPLE ANTIBIOTIC (NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC) OINTMENT [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	2
Polymyxin B Sulfate	ACTIVE INGREDIENT	19371312D4	TRIPLE ANTIBIOTIC (NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC) OINTMENT [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	2
BACITRACIN	ACTIVE MOIETY	58H6RWO52I	TRIPLE ANTIBIOTIC (NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC) OINTMENT [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	2
NEOMYCIN	ACTIVE MOIETY	I16QD7X297	TRIPLE ANTIBIOTIC (NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC) OINTMENT [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	2
Polymyxin B	ACTIVE MOIETY	J2VZ07J96K	TRIPLE ANTIBIOTIC (NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC) OINTMENT [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	2
petrolatum	INACTIVE INGREDIENT	4T6H12BN9U	TRIPLE ANTIBIOTIC (NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC) OINTMENT [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	2
Bacitracin Zinc	ACTIVE INGREDIENT	89Y4M234ES	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC OINTMENT [H.J. HARKINS COMPANY, INC.]	1
Bacitracin Zinc	ACTIVE INGREDIENT	89Y4M234ES	TRIPLE ANTIBIOTIC (NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC) OINTMENT [REBEL DISTRIBUTORS CORP]	1
Neomycin Sulfate	ACTIVE INGREDIENT	057Y626693	TRIPLE ANTIBIOTIC (NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC) OINTMENT [REBEL DISTRIBUTORS CORP]	1
Neomycin Sulfate	ACTIVE INGREDIENT	057Y626693	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC OINTMENT [H.J. HARKINS COMPANY, INC.]	1
Polymyxin B Sulfate	ACTIVE INGREDIENT	19371312D4	TRIPLE ANTIBIOTIC (NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC) OINTMENT [REBEL DISTRIBUTORS CORP]	1
Polymyxin B Sulfate	ACTIVE INGREDIENT	19371312D4	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC OINTMENT [H.J. HARKINS COMPANY, INC.]	1
Bacitracin Zinc	ACTIVE MOIETY	89Y4M234ES	TRIPLE ANTIBIOTIC (NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC) OINTMENT [REBEL DISTRIBUTORS CORP]	1
Bacitracin Zinc	ACTIVE MOIETY	89Y4M234ES	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC OINTMENT [H.J. HARKINS COMPANY, INC.]	1
Neomycin	ACTIVE MOIETY	I16QD7X297	TRIPLE ANTIBIOTIC (NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC) OINTMENT [REBEL DISTRIBUTORS CORP]	1
Neomycin	ACTIVE MOIETY	I16QD7X297	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC OINTMENT [H.J. HARKINS COMPANY, INC.]	1
Polymyxin B	ACTIVE MOIETY	J2VZ07J96K	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC OINTMENT [H.J. HARKINS COMPANY, INC.]	1
Polymyxin B	ACTIVE MOIETY	J2VZ07J96K	TRIPLE ANTIBIOTIC (NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC) OINTMENT [REBEL DISTRIBUTORS CORP]	1
petrolatum	INACTIVE INGREDIENT	4T6H12BN9U	TRIPLE ANTIBIOTIC (NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC) OINTMENT [REBEL DISTRIBUTORS CORP]	1
petrolatum	INACTIVE INGREDIENT	4T6H12BN9U	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC OINTMENT [H.J. HARKINS COMPANY, INC.]	1

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
89Y4M234ES	BACITRACIN ZINC	1405-89-6	BACITRACIN ZINC
057Y626693	NEOMYCIN SULFATE	1405-10-3	NEOMYCIN SULFATE
19371312D4	POLYMYXIN B SULFATE	1405-20-5	POLYMYXIN B SULFATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
204602	bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical Ointment	PSN	75ab9c13-3227-4f20-a8a1-891a4380c085	1
204602	bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical Ointment	PSN	dc8dbd0f-fe07-4308-b9a5-a031e8a41e74	1
204602	bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical Ointment	SCD	75ab9c13-3227-4f20-a8a1-891a4380c085	1
204602	bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical Ointment	SCD	dc8dbd0f-fe07-4308-b9a5-a031e8a41e74	1
204602	bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical Ointment	SY	75ab9c13-3227-4f20-a8a1-891a4380c085	1
204602	bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical Ointment	SY	dc8dbd0f-fe07-4308-b9a5-a031e8a41e74	1

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fougera ® Triple Antibiotic Ointment (Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ointment USP)	Proficient Rx LP	2019-11-01	HUMAN OTC DRUG LABEL	2
Fougera ® Triple Antibiotic Ointment (Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ointment USP)	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. \| Fougera Pharmaceuticals Inc.	2012-10-22	HUMAN OTC DRUG LABEL	2
Fougera ® Triple Antibiotic Ointment (Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ointment USP)	H.J. Harkins Company, Inc. \| Nycomed US Inc.	2011-08-30	HUMAN OTC DRUG LABEL	1
Fougera ® Triple Antibiotic Ointment (Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ointment USP)	Rebel Distributors Corp	2011-02-09	HUMAN OTC DRUG LABEL	1