Triple Antibiotic

Product NDC: 63941-831
Requested package NDC: 63941-831-01
11-digit product format: 639410831
Labeler code: 63941
Product ID: 63941-831_b11f1994-9753-1bff-e053-2a95a90ab2c6
Type: HUMAN OTC DRUG
Nonproprietary name: Bacitracin Zinc, Neomycin Sulfate, Polymyxin B
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Valu Merchandisers, Co.
Application: part333B
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2012-07-16
Marketing end: 0000-00-00
Substance: POLYMYXIN B SULFATE; NEOMYCIN SULFATE; BACITRACIN ZINC
Active strength: 5000 [USP'U]/g; mg/g; [USP'U]/g
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	63941-831	63941-831-01	I	Inactivated by FDA		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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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#

Effective, Related label table
Effective	Related label
2025-01-30	Best Choice Triple Antibiotic Ointment
2023-02-10	Best Choice Triple Antibiotic Ointment
2023-01-30	Best Choice Triple Antibiotic Ointment
2020-10-07	Best Choice Triple Antibiotic Ointment
2020-09-27	Best Choice Triple Antibiotic Ointment
2020-09-25	Best Choice Triple Antibiotic Ointment
2020-07-22	Best Choice Triple Antibiotic Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63941-831-01	Triple Antibiotic	1 in 1 BOX	OINTMENT	1		4
63941-831-01	Triple Antibiotic	28 g in 1 TUBE	OINTMENT	28		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63941-831	TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B) OINTMENT [VALU MERCHANDISERS, CO.]	4	Legacy NDC, 2 package rows	20230212_49376b4d-d2fc-6472-e054-00144ff88e88.zip

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

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	49376b4d-d2fc-6472-e054-00144ff88e88	4
204602	bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical Ointment	SCD	49376b4d-d2fc-6472-e054-00144ff88e88	4
204602	bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical Ointment	SY	49376b4d-d2fc-6472-e054-00144ff88e88	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63941-831-01	63941083101	1 TUBE in 1 BOX (63941-831-01) > 28 g in 1 TUBE	1 tube	2017-02-22	0000-00-00	No	No	Current