Polvos de Sulpha

Product NDC: 53145-304
11-digit product format: 531450304
Labeler code: 53145
Product ID: 53145-304_2b362c67-d115-fb81-e063-6394a90aeb65
Type: HUMAN OTC DRUG
Nonproprietary name: Bacitracin Zinc, Polymyxin B Sulfate
Dosage form: POWDER
Route: TOPICAL
Labeler: Menper Distributors Inc.
Application: M004
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2006-12-11
Substance: BACITRACIN ZINC; POLYMYXIN B SULFATE
Active strength: 500; 10000 [USP'U]/g; [USP'U]/g
Pharmacologic classes: Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	53145-304		I	Inactivated by FDA		2026-09-14
excluded package	package	53145-304	53145-304-04	I	Inactivated by FDA		2026-09-14

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 · 4 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
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53145-304-04	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
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	53145-304-04	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
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#

Effective, Related label table
Effective	Related label
2023-10-19	Polvos de Sulpha
2023-07-28	Polvos de Sulpha
2022-02-18	Polvos de Sulpha
2022-01-28	Polvos de Sulpha
2020-02-07	Polvos de Sulpha
2020-01-31	Polvos de Sulpha

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53145-304-04	Polvos de SulphaFirst Aid Antibiotic	7.5 g in 1 BOTTLE, PLASTIC	POWDER	7.5		12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BACITRACIN ZINC	ACTIVE INGREDIENT	89Y4M234ES	POLVOS DE SULPHA FIRST AID ANTIBIOTIC (BACITRACIN ZINC, POLYMYXIN B SULFATE) POWDER [MENPER DISTRIBUTORS INC.]	4
POLYMYXIN B SULFATE	ACTIVE INGREDIENT	19371312D4	POLVOS DE SULPHA FIRST AID ANTIBIOTIC (BACITRACIN ZINC, POLYMYXIN B SULFATE) POWDER [MENPER DISTRIBUTORS INC.]	4
BACITRACIN ZINC	ACTIVE MOIETY	89Y4M234ES	POLVOS DE SULPHA FIRST AID ANTIBIOTIC (BACITRACIN ZINC, POLYMYXIN B SULFATE) POWDER [MENPER DISTRIBUTORS INC.]	4
POLYMYXIN B	ACTIVE MOIETY	J2VZ07J96K	POLVOS DE SULPHA FIRST AID ANTIBIOTIC (BACITRACIN ZINC, POLYMYXIN B SULFATE) POWDER [MENPER DISTRIBUTORS INC.]	4
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	POLVOS DE SULPHA FIRST AID ANTIBIOTIC (BACITRACIN ZINC, POLYMYXIN B SULFATE) POWDER [MENPER DISTRIBUTORS INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53145-304	POLVOS DE SULPHA FIRST AID ANTIBIOTIC (BACITRACIN ZINC, POLYMYXIN B SULFATE) POWDER [MENPER DISTRIBUTORS INC.]	12	Current NDC, Legacy NDC, 1 package rows	20250116_511b52e9-c112-4519-a567-dc9f433c4f37.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE	NuCare Pharmaceutical, Inc.	5b14499e-e45c-7c05-e063-6294a90a1cc2	2026-09-09	Warnings	Exact identifier application number: M004
American Safety and First Aid Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Orazen Inc	eb0df2da-1688-c477-e053-2995a90a74a2	2026-09-07	Warnings	Exact identifier application number: M004
American Safety and First Aid Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Orazen Inc	eb0d108f-42bf-3364-e053-2a95a90a4542	2026-09-07	Warnings	Exact identifier application number: M004
MEDI-FIRST	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Orazen Inc	f4e4d0a4-b90c-99b0-e053-2995a90ab423	2026-09-04	Warnings	Exact identifier application number: M004
Lil Drug Store Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	ORAZEN INC	e6e5263b-328f-4775-9fac-34302f050ce0	2026-09-04	Warnings	Exact identifier application number: M004
MEDI-FIRST	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Orazen Inc	f4e42c5c-e080-4efb-e053-2a95a90af52e	2026-09-04	Warnings	Exact identifier application number: M004
MEDI-FIRST	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Orazen Inc	f4e4854a-ee01-df72-e053-2995a90aa8ea	2026-09-04	Warnings	Exact identifier application number: M004
Circle K Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	ORAZEN INC	84c3f7e4-b28b-40bb-8d9d-7c8d679e3a3a	2026-09-04	Warnings	Exact identifier application number: M004
First Aid Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCL	Walgreen Company	b982091a-5aa0-4bbc-bb1d-08016f6d0a70	2026-09-03	Warnings	Exact identifier application number: M004
SurviveX Triple Antibiotic	TRIPLE ANTIBIOTIC	Nantong Health & Beyond Hygienic Products Inc.	5a7cb52d-a60c-b947-e063-6394a90afb0d	2026-09-02	Warnings	Exact identifier application number: M004
triple antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B	Walgreen Company	4f3cfe39-2df8-48b4-954d-5997217c92ba	2026-08-31	Warnings	Exact identifier application number: M004
First Aid Antibiotic	BACITRACIN ZINC	NINGBO TIANBO FIRST AID PRODUCT CO., LTD.	217aa2b8-94f5-468a-99b4-52824a77b573	2026-08-28	Warnings	Exact identifier application number: M004
OP Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Yiwu Ori-Power Medtech Co., Ltd.	03f3cce9-7e9f-90a6-e063-6294a90a660b	2026-08-28	Warnings	Exact identifier application number: M004
Alcare Extra Hand Sanitizer	ALCOHOL	SC Johnson Professional USA Inc.	5dc007a2-61fa-4115-a82c-1aa489a6bd39	2026-08-27	Warnings	Exact identifier application number: M004
InstantFoam Complete PURE	ALCOHOL	SC Johnson Professional USA Inc.	398ca23c-7202-4670-be14-9829675f7174	2026-08-27	Warnings	Exact identifier application number: M004
Be Smart Get Prepared Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Total Resources International, Inc	57ed1a03-7e1b-4eb4-8001-dfd118805edc	2026-08-24	Warnings	Exact identifier application number: M004
Claravie	BACITRACIN ZINC	Gentell LLC	59c5a363-6d79-d07e-e063-6294a90a8753	2026-08-24	Warnings	Exact identifier application number: M004
Claravie	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B	Gentell LLC	597cb2f0-ff05-a1ab-e063-6294a90acda9	2026-08-20	Warnings	Exact identifier application number: M004
Medpride First Aid	BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE	Shield Line LLC	5ba3e703-7873-4724-a0bf-bb22d8a25748	2026-08-18	Warnings	Exact identifier application number: M004
Medpride First Aid	BACITRACIN ZINC	Shield Line LLC	e6a6fb0f-5ab7-4647-84a0-7b9948eed303	2026-08-18	Warnings	Exact identifier application number: M004

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
308513	bacitracin 500 UNT / polymyxin B 10,000 UNT per GM Topical Powder	PSN	511b52e9-c112-4519-a567-dc9f433c4f37	12
308513	bacitracin 0.5 UNT/MG / polymyxin B 10 UNT/MG Topical Powder	SCD	511b52e9-c112-4519-a567-dc9f433c4f37	12
308513	bacitracin 500 UNT/GM / polymyxin B 10,000 UNT/GM Topical Powder	SY	511b52e9-c112-4519-a567-dc9f433c4f37	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53145-304-04	53145030404	7.5 g in 1 BOTTLE, PLASTIC (53145-304-04)	7.5 g	2006-12-11	0000-00-00	No	No	Current