FDA.reportPublic FDA data

Sheffield Triple Antibiotic Plus Pain Relief

Product NDC
11527-161
11-digit product format
115270161
Labeler code
11527
Product ID
11527-161_d91f9d30-8d50-4e41-8ba5-38989db9180b
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin Zinc, Polymyxin B Sulfate, Neomycin Sulfate, Pramoxine Hydrochloride
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; PRAMOXINE HYDROCHLORIDE
Active strength
500; 10000; 3.5; 10 [USP'U]/g; [USP'U]/g; mg/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

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 Plus Pain Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC500 [USP'U]/g
POLYMYXIN B SULFATE10000 [USP'U]/g
NEOMYCIN SULFATE3.5 mg/g
PRAMOXINE HYDROCHLORIDE10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
89Y4M234ESInternal UNII lookup
19371312D4Internal UNII lookup
057Y626693Internal UNII lookup
88AYB867L5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1359350Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
485a779c-017b-4064-a446-e5073c1bdb07Available 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
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11527-161-55Sheffield Triple Antibiotic Plus Pain Relief28 g in 1 TUBEOINTMENT284
11527-161-55Sheffield Triple Antibiotic Plus Pain Relief1 in 1 CARTONOINTMENT14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Bacitracin ZincACTIVE INGREDIENT89Y4M234ESSHEFFIELD TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, PRAMOXINE HYDROCHLORIDE ) OINTMENT [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]1
Neomycin SulfateACTIVE INGREDIENT057Y626693SHEFFIELD TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, PRAMOXINE HYDROCHLORIDE ) OINTMENT [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]1
Polymyxin B SulfateACTIVE INGREDIENT19371312D4SHEFFIELD TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, PRAMOXINE HYDROCHLORIDE ) OINTMENT [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]1
PRAMOXINE HYDROCHLORIDEACTIVE INGREDIENT88AYB867L5SHEFFIELD TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, PRAMOXINE HYDROCHLORIDE ) OINTMENT [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]1
BacitracinACTIVE MOIETY58H6RWO52ISHEFFIELD TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, PRAMOXINE HYDROCHLORIDE ) OINTMENT [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]1
NeomycinACTIVE MOIETYI16QD7X297SHEFFIELD TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, PRAMOXINE HYDROCHLORIDE ) OINTMENT [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]1
Polymyxin BACTIVE MOIETYJ2VZ07J96KSHEFFIELD TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, PRAMOXINE HYDROCHLORIDE ) OINTMENT [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]1
PRAMOXINEACTIVE MOIETY068X84E056SHEFFIELD TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, PRAMOXINE HYDROCHLORIDE ) OINTMENT [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]1
PetrolatumINACTIVE INGREDIENT4T6H12BN9USHEFFIELD TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, PRAMOXINE HYDROCHLORIDE ) OINTMENT [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11527-161SHEFFIELD TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, PRAMOXINE HYDROCHLORIDE ) OINTMENT [SHEFFIELD PHARMACEUTICALS LLC]4Current NDC, Legacy NDC, 2 package rows20231121_485a779c-017b-4064-a446-e5073c1bdb07.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 22 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Family Wellness Antiseptic and Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDEFRONT PHARMACEUTICAL PLCcb7fdcde-2bd8-4834-ba4e-4d6fd15125992023-10-26WarningsExact identifier
application number: M004
GENUINE FIRST AID AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.23abfe12-5b50-4b49-878e-4fcdb6c341fd2023-10-19WarningsExact identifier
application number: M004
EVERLIT CARE Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.f4921508-c32f-426f-a2f0-16c3acbd47132023-10-14WarningsExact identifier
application number: M004
CuadridermaBACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDEProMex LLC4fa99b96-ab4b-4523-82bc-343dbaf39fb62022-01-25WarningsExact identifier
application number: M004

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1359350bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG in GM Topical OintmentPSN485a779c-017b-4064-a446-e5073c1bdb074
1359350bacitracin 0.5 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG / pramoxine hydrochloride 0.01 MG/MG Topical OintmentSCD485a779c-017b-4064-a446-e5073c1bdb074
1359350bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical OintmentSY485a779c-017b-4064-a446-e5073c1bdb074

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11527-161-55115270161551 TUBE in 1 CARTON (11527-161-55) / 28 g in 1 TUBE1 tube2011-01-230000-00-00NoNoCurrent