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 4 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lynx LX0864 peachy-foam antiseptic handsoapCHLOROXYLENOLABC Compounding Co., Inc.dd8025cb-d160-83a4-e053-2a95a90a51ac2026-05-11WarningsExact identifier
application number: M004
Satin Foam High Foaming Antiseptic Hand WashCHLOROXYLENOLCertus Medical, Inc.ea49da65-ae5e-bfde-e053-2a95a90adef22026-05-11WarningsExact identifier
application number: M004
Freshands Premium Foamy Antibacterial Handsoap 6876CHLOROXYLENOLConsolidated Chemicals, LLCf17299a4-28d6-e65b-e053-2a95a90a05e72026-05-11WarningsExact identifier
application number: M004
Harris Teeter Triple Antibiotic and Pain ReliefNEOMYCIN SULFATE, POLYMYXIN B SULFATE, BACITRACIN ZINC, PRAMOXINE HCLHARRIS TEETER LLC4b0c0a3c-7145-97ca-e063-6394a90a1a962026-05-07WarningsExact identifier
application number: M004
Harris Teeter Triple AntibioticNEOMYCIN SULFATE, POLYMYXIN B SULFATE, BACITRACIN ZINCHARRIS TEETER LLC4e81590c-32d3-f8aa-e063-6294a90ab3412026-05-06WarningsExact identifier
application number: M004
FIRSTAR TRIPLE ANTIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.5b9434ad-83d7-4df3-bfef-3db152e6c6cc2026-05-04WarningsExact identifier
application number: M004
oopsie First AidBACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE4 Visions LLC50b21f0a-1e87-51ae-e063-6294a90a8a3c2026-04-30WarningsExact identifier
application number: M004
First Aid Kit, Lil Drug Store5 ADHESIVE BANDAGES, 2 ANTIBIOTIC OINTMENTSLil' Drug Store Products, Inc.503c6c0e-3e1a-71ed-e063-6394a90abfa22026-04-24WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.TRIFECTA PHARMACEUTICALS USA LLC23a35ba8-ebc6-4252-bb88-ec237425056c2026-04-15WarningsExact identifier
application number: M004
El Valle Gentian VioletGENTIAN VIOLET 1%Pharmadel LLCfc75aa2b-0e6e-e2f7-e053-6294a90ac01f2026-04-13WarningsExact identifier
application number: M004
Bacitracin ZincBACITRACIN ZINCSun Pharmaceutical Industries, Inc.4afdeedf-9cdf-47d6-919f-ea907fda02902026-04-10WarningsExact identifier
application number: M004
Family Care Triple Antibiotic Original Formula 0.33ozTRIPLE ANTIBIOTIC ORIGINAL FORMULAUnited Exchange Corp4f1ef127-a67e-ca60-e063-6394a90a3a3d2026-04-10WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HYDROCHLORIDEH E B2a143950-13b4-457e-91a4-c61a88aad84b2026-04-02WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.ProStat First Aid, LLC.4e54f479-ad87-e86b-e063-6394a90aa6d22026-03-31WarningsExact identifier
application number: M004
El Valle MerthiolateBENZALKONIUM CHLORIDEPharmadel LLCfd7b28ca-9f71-0ff6-e053-6394a90a48222026-03-26WarningsExact identifier
application number: M004
sojo Triple AntibioticTRIPLE ANTIBIOTICJiangxi Yudexi Pharmaceutical Co., LTD4d8429bd-24b9-ad3c-e063-6294a90aeba02026-03-21WarningsExact identifier
application number: M004
Neosporin Plus Pain Relief ClubtrayBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEKenvue Brands LLCf4545718-8643-a340-e053-2995a90a00792026-03-18WarningsExact identifier
application number: M004
BacitracinBACITRACINPreferred Pharmaceuticals Inc.2f115e22-10f5-47fe-85df-f59e4387a3732026-03-16WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.ProStat First Aid, LLC.4cd49c65-e347-7589-e063-6394a90a53bd2026-03-12WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.ProStat First Aid, LLC.4cc6d822-f383-2ceb-e063-6294a90aecc72026-03-11WarningsExact 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