Sheffield Triple Antibiotic

Product NDC: 11527-162
11-digit product format: 115270162
Labeler code: 11527
Product ID: 11527-162_e78cd65b-8aeb-4fc5-8551-2deceb5d01e2
Type: HUMAN OTC DRUG
Nonproprietary name: Bacitracin Zinc, Polymyxin B Sulfate, Neomycin Sulfate
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Sheffield Pharmaceuticals LLC
Application: M004
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2011-01-23
Substance: BACITRACIN ZINC; POLYMYXIN B SULFATE; NEOMYCIN SULFATE
Active strength: 400; 5000; 3.5 [USP'U]/g; [USP'U]/g; mg/g
Pharmacologic classes: Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], 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 package	package	11527-162	11527-162-27	D	Discontinued by firm		2026-10-15
excluded package	package	11527-162	11527-162-30	D	Discontinued by firm		2026-10-15

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 · 12 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	11527-162-27	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	11527-162-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	11527-162-27	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	11527-162-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	11527-162-27	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	11527-162-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	11527-162-27	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	11527-162-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	11527-162-27	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	11527-162-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	11527-162-27	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	11527-162-30	`cdf11ea48f46…`	`ba0047e9e063…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Sheffield Triple Antibiotic
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BACITRACIN ZINC	400 [USP'U]/g
POLYMYXIN B SULFATE	5000 [USP'U]/g
NEOMYCIN SULFATE	3.5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
89Y4M234ES	Internal UNII lookup
19371312D4	Internal UNII lookup
057Y626693	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
204602	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1aa95046-c1f7-4fc7-acac-839065d998f6	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
11527-162-27	Sheffield Triple Antibiotic	144 in 1 CARTON	OINTMENT	144	6
11527-162-27	Sheffield Triple Antibiotic	0.9 g in 1 PACKET	OINTMENT	0.9	6
11527-162-30	Sheffield Triple Antibiotic	30 g in 1 TUBE	OINTMENT	30	6
11527-162-30	Sheffield Triple Antibiotic	1 in 1 CARTON	OINTMENT	1	6
11527-162-47	Sheffield Triple Antibiotic	9.35 g in 1 TUBE	OINTMENT	9.35	6
11527-162-47	Sheffield Triple Antibiotic	1 in 1 CARTON	OINTMENT	1	6
11527-162-51	Sheffield Triple Antibiotic	1 in 1 CARTON	OINTMENT	1	6
11527-162-51	Sheffield Triple Antibiotic	14 g in 1 TUBE	OINTMENT	14	6
11527-162-55	Sheffield Triple Antibiotic	1 in 1 CARTON	OINTMENT	1	6
11527-162-55	Sheffield Triple Antibiotic	28 g in 1 TUBE	OINTMENT	28	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
11527-162-47	GM - Gram	11527-162	6c6c7bbc-a101-4ce7-bc52-1951b48d42d8	1	2021-06-02
11527-162-51	GM - Gram	11527-162	ba250ba0-cb97-49dd-aae5-a6abb1e40fa2	1	2021-06-02
11527-162-55	GM - Gram	11527-162	846db55e-4ed6-4258-805b-60b34cd648cf	1	2021-06-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Bacitracin Zinc	ACTIVE INGREDIENT	89Y4M234ES	SHEFFIELD TRIPLE ANTIBIOTIC (BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE) OINTMENT [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]	2
Neomycin Sulfate	ACTIVE INGREDIENT	057Y626693	SHEFFIELD TRIPLE ANTIBIOTIC (BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE) OINTMENT [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]	2
Polymyxin B Sulfate	ACTIVE INGREDIENT	19371312D4	SHEFFIELD TRIPLE ANTIBIOTIC (BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE) OINTMENT [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]	2
Bacitracin	ACTIVE MOIETY	58H6RWO52I	SHEFFIELD TRIPLE ANTIBIOTIC (BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE) OINTMENT [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]	2
Neomycin	ACTIVE MOIETY	I16QD7X297	SHEFFIELD TRIPLE ANTIBIOTIC (BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE) OINTMENT [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]	2
Polymyxin B	ACTIVE MOIETY	J2VZ07J96K	SHEFFIELD TRIPLE ANTIBIOTIC (BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE) OINTMENT [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]	2
Petrolatum	INACTIVE INGREDIENT	4T6H12BN9U	SHEFFIELD TRIPLE ANTIBIOTIC (BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE) OINTMENT [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11527-162	SHEFFIELD TRIPLE ANTIBIOTIC (BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE) OINTMENT [SHEFFIELD PHARMACEUTICALS LLC]	6	Current NDC, Legacy NDC, 10 package rows	20250221_1aa95046-c1f7-4fc7-acac-839065d998f6.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 21 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Leader Bacitracin Zinc	BACITRACIN ZINC	Cardinal Health 110 dba LEADER	a353dce2-8ae5-23aa-e053-2a95a90a89c2	2024-01-02	Warnings	Exact identifier application number: M004
Triple Antibiotic	POLYMYXIN B SULFATE, BACITRACIN ZINC AND NEOMYCIN SULFATE	NuCare Pharmaceuticals,Inc.	0dfe5f6a-6968-68e6-e063-6294a90ae25b	2024-01-02	Warnings	Exact identifier application number: M004
Bacitracin	BACITRACIN	Proficient Rx LP	e1166948-5d80-44c2-a20d-78be631647d9	2024-01-01	Warnings	Exact identifier application number: M004
TRIPLE ANTIBIOTIC	BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE	Proficient Rx LP	949c5b44-ee52-4913-8872-39181d319998	2024-01-01	Warnings	Exact identifier application number: M004
Triple Antibiotic Plus	POLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE, PRAMOXINE HCL	Cosette Pharmaceuticals, Inc.	69d911c2-cb89-2241-35f8-c83acfe18249	2023-12-21	Warnings	Exact identifier application number: M004
Bacitracin	BACITRACIN	Cosette Pharmaceuticals, Inc.	630e0841-baf2-e9fa-b309-ad1a5f95da3b	2023-12-20	Warnings	Exact identifier application number: M004
Triple Antibiotic	POLYMYXIN B SULFATE, BACITRACIN ZINC AND NEOMYCIN SULFATE	Cosette Pharmaceuticals, Inc.	39893365-c94f-bc83-67f6-0005d5f2aa24	2023-12-20	Warnings	Exact identifier application number: M004
Triple Antibiotic	POLYMYXIN B SULFATE, BACITRACIN ZINC AND NEOMYCIN SULFATE	Proficient Rx LP	524d65e7-9dc6-47b0-a924-46a765fa1869	2023-12-01	Warnings	Exact identifier application number: M004
Viabecline	TETRACYCLINE HYDROCHLORIDE	Accuria, LLC	9fd7041a-6c23-4332-90fe-759bb4aea2ae	2023-12-01	Warnings	Exact identifier application number: M004
Bacitracin	BACITRACIN	Proficient Rx LP	65f8fd49-1882-4eac-9c0e-d63968da33d4	2023-12-01	Warnings	Exact identifier application number: M004
Genuine First Aid Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	GFA Production(Xiamen) Co.,Ltd	0aaee474-cf35-8b39-e063-6294a90a815c	2023-11-21	Warnings	Exact identifier application number: M004
Sheffield Bacitracin Zinc	BACITRACIN ZINC	Sheffield Pharmaceuticals LLC	0f446f48-f55d-4de7-b447-285d7a329c84	2023-11-20	Warnings	Exact identifier application number: M004
Sheffield Triple Antibiotic Plus Pain Relief	BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, PRAMOXINE HYDROCHLORIDE	Sheffield Pharmaceuticals LLC	485a779c-017b-4064-a446-e5073c1bdb07	2023-11-20	Warnings	Exact identifier application number: M004
Bacitracin	BACITRACIN	BluePoint Laboratories	b4d8ef06-6269-68f7-e053-2995a90ac8ea	2023-11-17	Warnings	Exact identifier application number: M004
Bacitracin Zinc	FIRST AID ANTIBIOTIC	BluePoint Laboratories	d914abe1-5e14-5673-e053-2a95a90ac91b	2023-11-17	Warnings	Exact identifier application number: M004
EVERLIT CARE Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	EVERLIT GLOBAL INC.	e9157891-fc05-41a1-8a86-761a9ae56f8a	2023-11-14	Warnings	Exact identifier application number: M004
CR-371059 Tolnaftate 1%	CR-371059 TOLNAFTATE 1%	A-S Medication Solutions	bb4e4612-850c-4863-954d-7ad0500b9c05	2023-11-01	Warnings	Exact identifier application number: M004
Isopropyl Alcohol	ISOPROPYL ALCOHOL	A-S Medication Solutions	b44b07a0-91ff-476a-ae0a-080fa0191777	2023-10-31	Warnings	Exact identifier application number: M004
Family wellness	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	FRONT PHARMACEUTICAL PLC	bd3b8146-6271-488d-bf79-0bb659123b31	2023-10-27	Warnings	Exact identifier application number: M004
Family Wellness	BACITRACIN ZINC	FRONT PHARMACEUTICAL PLC	dfc148c1-d1bb-4230-b8cf-9457b99d4e8a	2023-10-27	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
057Y626693	NEOMYCIN SULFATE	1405-10-3	NEOMYCIN 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	1aa95046-c1f7-4fc7-acac-839065d998f6	6
204602	bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical Ointment	SCD	1aa95046-c1f7-4fc7-acac-839065d998f6	6
204602	bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical Ointment	SY	1aa95046-c1f7-4fc7-acac-839065d998f6	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
11527-162-27	11527016227	144 PACKET in 1 CARTON (11527-162-27) > .9 g in 1 PACKET	144 packet	2018-10-12	0000-00-00	No	No	Current
11527-162-30	11527016230	1 TUBE in 1 CARTON (11527-162-30) > 30 g in 1 TUBE	1 tube	2020-12-22	0000-00-00	No	No	Current
11527-162-47	11527016247	1 TUBE in 1 CARTON (11527-162-47) / 9.35 g in 1 TUBE	1 tube	2011-01-23	0000-00-00	No	No	Current
11527-162-51	11527016251	1 TUBE in 1 CARTON (11527-162-51) / 14 g in 1 TUBE	1 tube	2011-01-23	0000-00-00	No	No	Current
11527-162-55	11527016255	1 TUBE in 1 CARTON (11527-162-55) / 28 g in 1 TUBE	1 tube	2012-11-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sheffield Triple Antibiotic Ointment	Sheffield Pharmaceuticals LLC	2025-02-17	HUMAN OTC DRUG LABEL	6
Triple Antibiotic - NuCare Pharmaceuticals,Inc.	NuCare Pharmaceuticals,Inc.	2021-01-11	HUMAN OTC DRUG LABEL	2