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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage11527-16211527-162-27DDiscontinued by firm2026-10-12
excluded packagepackage11527-16211527-162-30DDiscontinued by firm2026-10-12

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 1 · 12 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0511527-162-27d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0511527-162-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2611527-162-27f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2611527-162-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3111527-162-272ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3111527-162-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2811527-162-27a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2811527-162-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2111527-162-27cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2111527-162-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1011527-162-27cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1011527-162-30cdf11ea48f46…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
IngredientStrength
BACITRACIN ZINC400 [USP'U]/g
POLYMYXIN B SULFATE5000 [USP'U]/g
NEOMYCIN SULFATE3.5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
89Y4M234ESInternal UNII lookup
19371312D4Internal UNII lookup
057Y626693Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1aa95046-c1f7-4fc7-acac-839065d998f6Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11527-162-27Sheffield Triple Antibiotic144 in 1 CARTONOINTMENT1446
11527-162-27Sheffield Triple Antibiotic0.9 g in 1 PACKETOINTMENT0.96
11527-162-30Sheffield Triple Antibiotic30 g in 1 TUBEOINTMENT306
11527-162-30Sheffield Triple Antibiotic1 in 1 CARTONOINTMENT16
11527-162-47Sheffield Triple Antibiotic9.35 g in 1 TUBEOINTMENT9.356
11527-162-47Sheffield Triple Antibiotic1 in 1 CARTONOINTMENT16
11527-162-51Sheffield Triple Antibiotic1 in 1 CARTONOINTMENT16
11527-162-51Sheffield Triple Antibiotic14 g in 1 TUBEOINTMENT146
11527-162-55Sheffield Triple Antibiotic1 in 1 CARTONOINTMENT16
11527-162-55Sheffield Triple Antibiotic28 g in 1 TUBEOINTMENT286

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11527-162-47GM - Gram11527-1626c6c7bbc-a101-4ce7-bc52-1951b48d42d812021-06-02
11527-162-51GM - Gram11527-162ba250ba0-cb97-49dd-aae5-a6abb1e40fa212021-06-02
11527-162-55GM - Gram11527-162846db55e-4ed6-4258-805b-60b34cd648cf12021-06-02

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11527-162SHEFFIELD TRIPLE ANTIBIOTIC (BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE) OINTMENT [SHEFFIELD PHARMACEUTICALS LLC]6Current NDC, Legacy NDC, 10 package rows20250221_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 6 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Water-Jel Neomycin AntibioticFIRST AID OINTMENTWater-Jel Technologiesabea91a2-4453-406d-a7ed-3ffc19ef521a2025-12-31WarningsExact identifier
application number: M004
Caring Mill Triple Antibiotic and PainPRAMOXINE HYDROCHLORIDE, BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATEFSA Store Inc. (Caring Mills)3c5b6909-6b30-5256-e063-6294a90a90962025-12-29WarningsExact identifier
application number: M004
Caring Mills Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATEVeridian Healthcarefbd11419-4513-10d7-e053-6394a90ac82b2025-12-27WarningsExact identifier
application number: M004
Caring Mill Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEVeridian Healthcare8cd0cd64-fe62-4225-8986-5e8641dd6df22025-12-22WarningsExact identifier
application number: M004
PS-2261 Triple Antibiotic, 0.5gPS-2261 TRIPLE ANTIBIOTIC, 0.5GProStat First Aid LLC0072f8de-fc06-d529-e063-6294a90a08db2025-12-15WarningsExact identifier
application number: M004
PS - 2895 Triple Antibiotic , 0.5gPS - 2895 TRIPLE ANTIBIOTIC , 0.5GProstat First Aid LLC0050de33-914b-f76d-e063-6394a90a7fab2025-12-15WarningsExact identifier
application number: M004
Triple AntibioticTRIPLE ANTIBIOTICProStat First Aidf76d7d18-0fa1-d943-e053-6294a90ac20a2025-12-15WarningsExact identifier
application number: M004
Triple AntibioticTRIPLE ANTIBIOTICFront Line Safety0f509f96-a083-37d1-e063-6394a90a622c2025-12-15WarningsExact identifier
application number: M004
ElixirTripleGuard Triple AntibioticBACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN BELIXIR HEALTHCARE USA, LLC.43edfb80-4d50-9362-e063-6394a90a21992025-12-13WarningsExact identifier
application number: M004
El Valle Decolorized IodineALCOHOLPharmadel LLCfd7a227b-536c-b3f7-e053-6394a90a41582025-12-04WarningsExact identifier
application number: M004
Vitastem First Aid AntibioticTETRACYCLINE HYDROCHLORIDEVIADERMA DISTRIBUTION INC3970ac49-ab0f-4492-ba61-95a12faed5002025-12-02WarningsExact identifier
application number: M004
Thera Plus Original Strength Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEFourstar Group USA, Inc2f916502-4daf-4cb9-a638-f37bb96c80772025-12-02WarningsExact identifier
application number: M004
CAREALL BacitracinBACITRACIN ZINCNew World Imports, Incea16e1de-0100-456b-abe6-d33de78221da2025-12-02WarningsExact identifier
application number: M004
Triple Antibiotic Ointment, Circle KTRIPLE ANTIBIOTIC OINTMENTLil' Drug Store Products, Inc.44e5107e-832a-2ce6-e063-6294a90a711d2025-12-01WarningsExact identifier
application number: M004
Viaderma Care First Aid AntibioticBACITRACIN ZINCVIADERMA DISTRIBUTION INC0f36f396-e479-486c-b047-2760477609e22025-12-01WarningsExact identifier
application number: M004
CareALL Triple Antibiotic plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HCLNew World Imports, Inc1982b664-e8fd-4030-aa89-f7543e1b487b2025-12-01WarningsExact identifier
application number: M004
CareALL Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENew World Imports, Inc9c2d417e-6fec-42f4-9f0c-2ec79de9342d2025-12-01WarningsExact identifier
application number: M004
BacitracinBACITRACINBryant Ranch Prepack5b0249c0-c196-4d3c-973f-49bd2d3d4a752025-12-01WarningsExact identifier
application number: M004
Neosporin Plus LidocaineBACITRACIN, NEOMYCIN, POLYMYXIN B, LIDOCAINEKenvue Brands LLCe450b6a1-a8da-e5db-e053-2995a90a0ef02025-11-24WarningsExact identifier
application number: M004
ElixirZincoCareZINC OXIDE 20%ELIXIR HEALTHCARE USA, LLC.bac18496-3b76-4faf-abde-968d79b718d82025-11-22WarningsExact identifier
application number: M004

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204602bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical OintmentPSN1aa95046-c1f7-4fc7-acac-839065d998f66
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD1aa95046-c1f7-4fc7-acac-839065d998f66
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY1aa95046-c1f7-4fc7-acac-839065d998f66

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11527-162-2711527016227144 PACKET in 1 CARTON (11527-162-27) > .9 g in 1 PACKET144 packet2018-10-120000-00-00NoNoCurrent
11527-162-30115270162301 TUBE in 1 CARTON (11527-162-30) > 30 g in 1 TUBE1 tube2020-12-220000-00-00NoNoCurrent
11527-162-47115270162471 TUBE in 1 CARTON (11527-162-47) / 9.35 g in 1 TUBE1 tube2011-01-230000-00-00NoNoCurrent
11527-162-51115270162511 TUBE in 1 CARTON (11527-162-51) / 14 g in 1 TUBE1 tube2011-01-230000-00-00NoNoCurrent
11527-162-55115270162551 TUBE in 1 CARTON (11527-162-55) / 28 g in 1 TUBE1 tube2012-11-090000-00-00NoNoCurrent