FDA.reportPublic FDA data

Pomada de Sulfa

Product NDC
53145-056
11-digit product format
531450056
Labeler code
53145
Product ID
53145-056_3a8a3022-d082-1ccf-e063-6394a90a90ed
Type
HUMAN OTC DRUG
Nonproprietary name
Neomycin sulfate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Menper Distributors, Inc.
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-02-21
Substance
NEOMYCIN SULFATE
Active strength
3.5 mg/g
Pharmacologic classes
Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage53145-056-02IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage53145-056-02IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage53145-056-02EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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
Pomada de Sulfa
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NEOMYCIN SULFATE3.5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
057Y626693Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
311928Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
216f4d22-e5e8-46c8-a4ef-8d1532792b56Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53145-056-022023-07-28C16284748780-19d75b9d0-1e04-f424-e053-dadaa90a57cePomada de Sulfa
53145-056-022021-08-14C16284748780-19d75b9d0-1e04-f424-e053-dadaa90a57cePomada de Sulfa
53145-056-022020-01-31C16284748780-19d75b9d0-1e04-f424-e053-dadaa90a57cePomada de Sulfa

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53145-056-02Pomada de Sulfa57 g in 1 JAROINTMENT575
53145-056-02Pomada de Sulfa1 in 1 PACKAGEOINTMENT15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NEOMYCIN SULFATEACTIVE INGREDIENT057Y626693POMADA DE SULFA (NEOMYCIN SULFATE) OINTMENT [MENPER DISTRIBUTORS, INC.]1
NEOMYCINACTIVE MOIETYI16QD7X297POMADA DE SULFA (NEOMYCIN SULFATE) OINTMENT [MENPER DISTRIBUTORS, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPOMADA DE SULFA (NEOMYCIN SULFATE) OINTMENT [MENPER DISTRIBUTORS, INC.]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UPOMADA DE SULFA (NEOMYCIN SULFATE) OINTMENT [MENPER DISTRIBUTORS, INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHPOMADA DE SULFA (NEOMYCIN SULFATE) OINTMENT [MENPER DISTRIBUTORS, INC.]1

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 20 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Triple AntibioticFIRST AID TRIPLE ANTIBIOTICCardinal Health 110,Inc.844cd9a1-b68e-47d8-a5eb-c9e880ba019e2024-01-18WarningsExact identifier
application number: M004
Multi-Action Antibiotic and Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE OINTMENTTarget Corporation8fecff32-bd67-4351-90f7-0c28cb335ea32024-01-18WarningsExact identifier
application number: M004
Leader Poly BacitracinFIRST AID ANTIBIOTICCardinal Health 110, Inc.442e11aa-7d14-44f9-bf14-446018f1de0d2024-01-18WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEUnifirst First Aid Corporation7b16cb9b-5847-4360-9974-2118f4a2c70f2024-01-17WarningsExact identifier
application number: M004
Green Guard Triple AntibioticBACITRACIN ZIN, NEOMYCIN SULFATE, POLYMYXIN B SULFATEUnifirst First Aid Corporationbd456e2f-e6d7-d2ad-e053-2995a90a5c122024-01-17WarningsExact identifier
application number: M004
Medi-First Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEUnifirst First Aid Corporationbd432abc-fefb-1b4b-e053-2995a90acb182024-01-17WarningsExact identifier
application number: M004
Crane Safety Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATECrane Safety LLC96dbc282-4b3f-aaf3-e053-2995a90a56942024-01-17WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATETarget Corporation10c4a1b5-bb91-48da-b0ae-303e4adf793a2024-01-17WarningsExact identifier
application number: M004
First Aid AntibioticBACITRACIN ZINCTarget Corporation6020956d-2f58-4be8-97da-3f6b7e0f34aa2024-01-17WarningsExact identifier
application number: M004
Triple Antibiotic and Pain ReliefTRIPLE ANTIBIOTICTarget Corporation8fda7b8a-72f3-4b92-a229-ac5be0e3b3eb2024-01-17WarningsExact identifier
application number: M004
Travel Savvy First Aid Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEBellegrove Medical Supply, Inc.69fa1c9d-5e6d-4593-e053-2a91aa0a76902024-01-16WarningsExact identifier
application number: M004
American Safety First Aid AntispeticISOPROPYL ALCOHOLOrazen Incea302ba4-a63d-e713-e053-2995a90a3fc42024-01-15WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATESled Distribution, LLCe7398df8-8e23-5439-e053-2a95a90ac3aa2024-01-15WarningsExact identifier
application number: M004
ER Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEEVER READY FIRST AID20f97e1c-584f-4844-afd8-8641ffe2f4662024-01-11WarningsExact identifier
application number: M004
Lightning X Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.0e66af91-e0b4-827f-e063-6294a90a98472024-01-07WarningsExact identifier
application number: M004
triple antibiotic 01BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATECosmuses Cosmetics (Ningbo) Co., Ltd.0e1b23f3-fa1e-f42b-e063-6394a90a3bec2024-01-04WarningsExact identifier
application number: M004
Triple Antibiotic Ointment, Circle KTRIPLE ANTIBIOTICLil' Drug Store products, Inc.0d98477b-aa33-ebb7-e063-6294a90a597f2024-01-03WarningsExact identifier
application number: M004
Bacitracin ZincBACITRACIN ZINCTrifecta Pharmaceuticals USA LLCd9f2702c-a514-cb69-e053-2a95a90a29a92024-01-02WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.Geri-Care Pharmaceuticals, Corpef309620-1cf9-d007-e053-2995a90ad46f2024-01-02WarningsExact identifier
application number: M004
Bacitracin ZincBACITRACIN ZINCGeri-Care Pharmaceuticals, Corp.eec90f72-fd13-05c9-e053-2995a90a642a2024-01-02WarningsExact identifier
application number: M004

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311928neomycin 0.35 % Topical OintmentPSN216f4d22-e5e8-46c8-a4ef-8d1532792b565
311928neomycin 0.0035 MG/MG Topical OintmentSCD216f4d22-e5e8-46c8-a4ef-8d1532792b565
311928neomycin (as neomycin sulfate 5 MG per 1 GM) 3.5 MG per 1 GM Topical OintmentSY216f4d22-e5e8-46c8-a4ef-8d1532792b565
311928neomycin 0.35 % Topical OintmentSY216f4d22-e5e8-46c8-a4ef-8d1532792b565

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53145-056-02531450056021 JAR in 1 PACKAGE (53145-056-02) / 57 g in 1 JAR1 jar2012-02-210000-00-00NoNoCurrent