bacitracin zinc, neomycin sulfate and polymyxin b sulfate

Product NDC: 50382-008
11-digit product format: 503820008
Labeler code: 50382
Product ID: 50382-008_cae22cb8-66e4-4702-80c2-89428b37f1cc
Type: HUMAN OTC DRUG
Nonproprietary name: bacitracin zinc, neomycin sulfate and polymyxin b sulfate
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Galentic Pharma (India) Private Limited
Application: part333B
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2013-08-07
Marketing end: 0000-00-00
Substance: BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength: 400 [iU]/g; mg/g; [iU]/g
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	50382-008		I	Inactivated by FDA	2026-10-12
excluded package	package	50382-008	50382-008-01	I	Inactivated by FDA	2026-10-12
excluded package	package	50382-008	50382-008-02	I	Inactivated by FDA	2026-10-12
excluded package	package	50382-008	50382-008-03	I	Inactivated by FDA	2026-10-12
excluded package	package	50382-008	50382-008-04	I	Inactivated by FDA	2026-10-12

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 2 · 110 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50382-008-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50382-008-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50382-008-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50382-008-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50382-008-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50382-008-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50382-008-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50382-008-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50382-008-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50382-008-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50382-008-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50382-008-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50382-008-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50382-008-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50382-008-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50382-008-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50382-008-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50382-008-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50382-008-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50382-008-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50382-008-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50382-008-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50382-008-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50382-008-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50382-008-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50382-008-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50382-008-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50382-008-02	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50382-008-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50382-008-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50382-008-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50382-008-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50382-008-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50382-008-04	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50382-008-03	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50382-008-02	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50382-008-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50382-008-04	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50382-008-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50382-008-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50382-008-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50382-008-04	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50382-008-03	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50382-008-02	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50382-008-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50382-008-04	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50382-008-03	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50382-008-02	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
99e684e6-f435-feb8-d2bb-3a546f1cb768	Product name	2	20161117
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
b6082387-f592-1148-0844-bd068fd213fb	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
50382-008-01	Galentic Triple Antibiotic Ointment
50382-008-02	Galentic Triple Antibiotic Ointment
50382-008-03	Galentic Triple Antibiotic Ointment
50382-008-04	Galentic Triple Antibiotic Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50382-008-01	bacitracin zinc, neomycin sulfate and polymyxin b sulfate	28.35 g in 1 TUBE	OINTMENT	28.35	1
50382-008-02	bacitracin zinc, neomycin sulfate and polymyxin b sulfate	14.17 g in 1 TUBE	OINTMENT	14.17	1
50382-008-03	bacitracin zinc, neomycin sulfate and polymyxin b sulfate	56.7 g in 1 TUBE	OINTMENT	56.7	1
50382-008-04	bacitracin zinc, neomycin sulfate and polymyxin b sulfate	113.4 g in 1 TUBE	OINTMENT	113.4	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BACITRACIN ZINC	ACTIVE INGREDIENT	89Y4M234ES	BACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE OINTMENT [GALENTIC PHARMA (INDIA) PRIVATE LIMITED]	1
NEOMYCIN SULFATE	ACTIVE INGREDIENT	057Y626693	BACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE OINTMENT [GALENTIC PHARMA (INDIA) PRIVATE LIMITED]	1
POLYMYXIN B SULFATE	ACTIVE INGREDIENT	19371312D4	BACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE OINTMENT [GALENTIC PHARMA (INDIA) PRIVATE LIMITED]	1
BACITRACIN	ACTIVE MOIETY	58H6RWO52I	BACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE OINTMENT [GALENTIC PHARMA (INDIA) PRIVATE LIMITED]	1
NEOMYCIN	ACTIVE MOIETY	I16QD7X297	BACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE OINTMENT [GALENTIC PHARMA (INDIA) PRIVATE LIMITED]	1
POLYMYXIN B	ACTIVE MOIETY	J2VZ07J96K	BACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE OINTMENT [GALENTIC PHARMA (INDIA) PRIVATE LIMITED]	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	BACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE OINTMENT [GALENTIC PHARMA (INDIA) PRIVATE LIMITED]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50382-008	BACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE OINTMENT [GALENTIC PHARMA (INDIA) PRIVATE LIMITED]	1	Legacy NDC, 4 package rows	20130808_f562f46c-a764-44f5-b8f4-2d4e97489691.zip

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	f562f46c-a764-44f5-b8f4-2d4e97489691	1
204602	bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical Ointment	SCD	f562f46c-a764-44f5-b8f4-2d4e97489691	1
204602	bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical Ointment	SY	f562f46c-a764-44f5-b8f4-2d4e97489691	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
50382-008-01	50382000801	28.35 g in 1 TUBE	28.35 g	Historical
50382-008-02	50382000802	14.17 g in 1 TUBE	14.17 g	Historical
50382-008-03	50382000803	56.7 g in 1 TUBE	56.7 g	Historical
50382-008-04	50382000804	113.4 g in 1 TUBE	113.4 g	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Galentic Triple Antibiotic Ointment	Galentic Pharma (India) Private Limited	2013-08-07	HUMAN OTC DRUG LABEL	1