FDA.reportPublic FDA data

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; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/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

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
NEOMYCIN SULFATE3.5 mg/g
POLYMYXIN B SULFATE5000 [USP'U]/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii89Y4M234ES, 057Y626693, 19371312D4
Rxcui204602

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#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Bacitracin ZincACTIVE INGREDIENT89Y4M234ESSHEFFIELD TRIPLE ANTIBIOTIC (BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE) OINTMENT [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]2
Neomycin SulfateACTIVE INGREDIENT057Y626693SHEFFIELD TRIPLE ANTIBIOTIC (BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE) OINTMENT [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]2
Polymyxin B SulfateACTIVE INGREDIENT19371312D4SHEFFIELD TRIPLE ANTIBIOTIC (BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE) OINTMENT [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]2
BacitracinACTIVE MOIETY58H6RWO52ISHEFFIELD TRIPLE ANTIBIOTIC (BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE) OINTMENT [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]2
NeomycinACTIVE MOIETYI16QD7X297SHEFFIELD TRIPLE ANTIBIOTIC (BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE) OINTMENT [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]2
Polymyxin BACTIVE MOIETYJ2VZ07J96KSHEFFIELD TRIPLE ANTIBIOTIC (BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE) OINTMENT [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]2
PetrolatumINACTIVE INGREDIENT4T6H12BN9USHEFFIELD 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
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

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