Double Antibiotic

Product NDC: 0168-0021
11-digit product format: 001680021
Labeler code: 0168
Product ID: 0168-0021_443a7f87-7fdc-4c44-aad9-f7d8441e7f2a
Type: HUMAN OTC DRUG
Nonproprietary name: Bacitracin Zinc and Polymyxin B Sulfate
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; POLYMYXIN B SULFATE
Active strength: 500 [USP'U]/g; [USP'U]/g
NDC exclude flag: No
Listing certified through: 2019-12-31
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	0168-0021		D	Discontinued by firm	2026-10-05
excluded package	package	0168-0021	0168-0021-09	D	Discontinued by firm	2026-10-05
excluded package	package	0168-0021	0168-0021-31	D	Discontinued by firm	2026-10-05
excluded package	package	0168-0021	0168-0021-35	D	Discontinued by firm	2026-10-05

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 · 56 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	0168-0021-09	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0168-0021-35	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0168-0021-31	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	0168-0021-09	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0168-0021-35	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0168-0021-31	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	0168-0021-09	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0168-0021-35	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0168-0021-31	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	0168-0021-09	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0168-0021-35	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0168-0021-31	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	0168-0021-09	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0168-0021-35	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0168-0021-31	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	0168-0021-09	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0168-0021-35	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0168-0021-31	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	0168-0021-09	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0168-0021-35	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0168-0021-31	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	0168-0021-09	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0168-0021-35	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0168-0021-31	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	0168-0021-09	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0168-0021-35	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0168-0021-31	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	0168-0021-09	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0168-0021-35	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0168-0021-31	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	0168-0021-09	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0168-0021-35	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0168-0021-31	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	0168-0021-09	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0168-0021-35	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0168-0021-31	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	0168-0021-31	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	0168-0021-35	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	0168-0021-09	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	0168-0021-31	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	0168-0021-35	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	0168-0021-09	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0c	Product name	1	20160603
2d352c73-a357-4193-a4de-dfdf9a2ac8e4	Product name	1	20150819
b045ad64-0f28-9a02-2f9b-b34d94fb2278	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
0168-0021-09	2021-12-17	Fougera ® Double Antibiotic Ointment (Bacitracin Zinc and Polymyxin B Sulfate Ointment USP)
0168-0021-31	2021-12-17	Fougera ® Double Antibiotic Ointment (Bacitracin Zinc and Polymyxin B Sulfate Ointment USP)
0168-0021-35	2021-12-17	Fougera ® Double Antibiotic Ointment (Bacitracin Zinc and Polymyxin B Sulfate Ointment USP)
0168-0021-09	2020-01-31	Fougera ® Double Antibiotic Ointment (Bacitracin Zinc and Polymyxin B Sulfate Ointment USP)
0168-0021-31	2020-01-31	Fougera ® Double Antibiotic Ointment (Bacitracin Zinc and Polymyxin B Sulfate Ointment USP)
0168-0021-35	2020-01-31	Fougera ® Double Antibiotic Ointment (Bacitracin Zinc and Polymyxin B Sulfate Ointment USP)

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0168-0021-09	EA - Each	0168-0021	53fd61b0-6893-4b1f-ae10-61d1bb422c98	1	2012-07-24
0168-0021-31	GM - Gram	0168-0021	76f30bd5-b2a6-474d-a05e-824eda21c0e1	1	2012-07-24
0168-0021-35	GM - Gram	0168-0021	ff516210-b74f-4ed5-8d43-a37d6e6164f1	1	2012-07-24

DailyMed Socrata Ingredients#

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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
89Y4M234ES	BACITRACIN ZINC	1405-89-6	BACITRACIN ZINC
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
308512	bacitracin 500 UNT / polymyxin B 10,000 UNT per GM Topical Ointment	PSN	6b5d9180-ea2f-4bb7-9e88-b596b638cb1d	1
308512	bacitracin 500 UNT / polymyxin B 10,000 UNT per GM Topical Ointment	PSN	715b4b25-5341-491f-98dc-dc4eb249d67b	1
308512	bacitracin 0.5 UNT/MG / polymyxin B 10 UNT/MG Topical Ointment	SCD	6b5d9180-ea2f-4bb7-9e88-b596b638cb1d	1
308512	bacitracin 0.5 UNT/MG / polymyxin B 10 UNT/MG Topical Ointment	SCD	715b4b25-5341-491f-98dc-dc4eb249d67b	1
308512	bacitracin 500 UNT / polymyxin B 10,000 UNT per GM Topical Ointment	SY	6b5d9180-ea2f-4bb7-9e88-b596b638cb1d	1
308512	bacitracin 500 UNT / polymyxin B 10,000 UNT per GM Topical Ointment	SY	715b4b25-5341-491f-98dc-dc4eb249d67b	1

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fougera ® Double Antibiotic Ointment (Bacitracin Zinc and Polymyxin B Sulfate Ointment USP)	A-S Medication Solutions	2017-10-04	HUMAN OTC DRUG LABEL	5
Fougera ® Double Antibiotic Ointment (Bacitracin Zinc and Polymyxin B Sulfate Ointment USP)	Preferred Pharmaceuticals, Inc.	2014-05-22	HUMAN OTC DRUG LABEL	1
Fougera ® Double Antibiotic Ointment (Bacitracin Zinc and Polymyxin B Sulfate Ointment USP)	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.	2013-02-12	HUMAN OTC DRUG LABEL	2
Fougera ® Double Antibiotic Ointment (Bacitracin Zinc and Polymyxin B Sulfate Ointment USP)	H.J. Harkins Company, Inc. \| Nycomed US Inc.	2011-08-29	HUMAN OTC DRUG LABEL	1
Fougera ® Double Antibiotic Ointment (Bacitracin Zinc and Polymyxin B Sulfate Ointment USP)	Rebel Distributors Corp	2011-02-09	HUMAN OTC DRUG LABEL	1