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 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
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