FDA.reportPublic FDA data

POMADA SULFA FIRST AID ANTIBIOTIC

Product NDC
48201-104
11-digit product format
482010104
Labeler code
48201
Product ID
48201-104_42407f73-c1f3-9f81-e063-6294a90a502d
Type
HUMAN OTC DRUG
Nonproprietary name
NEOMYCIN SULFATE
Dosage form
OINTMENT
Route
TOPICAL
Labeler
GRANDALL DISTRIBUTING, LLC
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-07-18
Substance
NEOMYCIN SULFATE
Active strength
.5 g/100g
Pharmacologic classes
Aminoglycoside Antibacterial [EPC], Aminoglycosides [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
POMADA SULFA FIRST AID ANTIBIOTIC
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NEOMYCIN SULFATE.5 g/100g

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
1544556Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1d8e1fca-6864-7c08-e063-6394a90a08b6Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48201-104-40POMADA SULFA FIRST AID ANTIBIOTIC40 g in 1 JAROINTMENT402

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48201-104POMADA SULFA FIRST AID ANTIBIOTIC (NEOMYCIN SULFATE) OINTMENT [GRANDALL DISTRIBUTING, LLC]1Current NDC, 1 package rows20240720_1d8e1fca-6864-7c08-e063-6394a90a08b6.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 21 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Bacitracin ZincBACITRACIN ZINCCardinal Health 110 dba LEADERa353dce2-8ae5-23aa-e053-2a95a90a89c22024-01-02WarningsExact identifier
application number: M004
Triple AntibioticPOLYMYXIN B SULFATE, BACITRACIN ZINC AND NEOMYCIN SULFATENuCare Pharmaceuticals,Inc.0dfe5f6a-6968-68e6-e063-6294a90ae25b2024-01-02WarningsExact identifier
application number: M004
BacitracinBACITRACINProficient Rx LPe1166948-5d80-44c2-a20d-78be631647d92024-01-01WarningsExact identifier
application number: M004
TRIPLE ANTIBIOTICBACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATEProficient Rx LP949c5b44-ee52-4913-8872-39181d3199982024-01-01WarningsExact identifier
application number: M004
Triple Antibiotic PlusPOLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE, PRAMOXINE HCLCosette Pharmaceuticals, Inc.69d911c2-cb89-2241-35f8-c83acfe182492023-12-21WarningsExact identifier
application number: M004
BacitracinBACITRACINCosette Pharmaceuticals, Inc.630e0841-baf2-e9fa-b309-ad1a5f95da3b2023-12-20WarningsExact identifier
application number: M004
Triple AntibioticPOLYMYXIN B SULFATE, BACITRACIN ZINC AND NEOMYCIN SULFATECosette Pharmaceuticals, Inc.39893365-c94f-bc83-67f6-0005d5f2aa242023-12-20WarningsExact identifier
application number: M004
Triple AntibioticPOLYMYXIN B SULFATE, BACITRACIN ZINC AND NEOMYCIN SULFATEProficient Rx LP524d65e7-9dc6-47b0-a924-46a765fa18692023-12-01WarningsExact identifier
application number: M004
ViabeclineTETRACYCLINE HYDROCHLORIDEAccuria, LLC9fd7041a-6c23-4332-90fe-759bb4aea2ae2023-12-01WarningsExact identifier
application number: M004
BacitracinBACITRACINProficient Rx LP65f8fd49-1882-4eac-9c0e-d63968da33d42023-12-01WarningsExact identifier
application number: M004
Genuine First Aid AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEGFA Production(Xiamen) Co.,Ltd0aaee474-cf35-8b39-e063-6294a90a815c2023-11-21WarningsExact identifier
application number: M004
Sheffield Bacitracin ZincBACITRACIN ZINCSheffield Pharmaceuticals LLC0f446f48-f55d-4de7-b447-285d7a329c842023-11-20WarningsExact identifier
application number: M004
Sheffield Triple Antibiotic Plus Pain ReliefBACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, PRAMOXINE HYDROCHLORIDESheffield Pharmaceuticals LLC485a779c-017b-4064-a446-e5073c1bdb072023-11-20WarningsExact identifier
application number: M004
BacitracinBACITRACINBluePoint Laboratoriesb4d8ef06-6269-68f7-e053-2995a90ac8ea2023-11-17WarningsExact identifier
application number: M004
Bacitracin ZincFIRST AID ANTIBIOTICBluePoint Laboratoriesd914abe1-5e14-5673-e053-2a95a90ac91b2023-11-17WarningsExact identifier
application number: M004
EVERLIT CARE Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEEVERLIT GLOBAL INC.e9157891-fc05-41a1-8a86-761a9ae56f8a2023-11-14WarningsExact identifier
application number: M004
CR-371059 Tolnaftate 1%CR-371059 TOLNAFTATE 1%A-S Medication Solutionsbb4e4612-850c-4863-954d-7ad0500b9c052023-11-01WarningsExact identifier
application number: M004
Isopropyl AlcoholISOPROPYL ALCOHOLA-S Medication Solutionsb44b07a0-91ff-476a-ae0a-080fa01917772023-10-31WarningsExact identifier
application number: M004
Family wellnessBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEFRONT PHARMACEUTICAL PLCbd3b8146-6271-488d-bf79-0bb659123b312023-10-27WarningsExact identifier
application number: M004
Family WellnessBACITRACIN ZINCFRONT PHARMACEUTICAL PLCdfc148c1-d1bb-4230-b8cf-9457b99d4e8a2023-10-27WarningsExact identifier
application number: M004

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1544556neomycin sulfate 0.5 % Topical OintmentPSN1d8e1fca-6864-7c08-e063-6394a90a08b62
1544556neomycin sulfate 0.005 MG/MG Topical OintmentSCD1d8e1fca-6864-7c08-e063-6394a90a08b62
1544556neomycin sulfate 0.5 % Topical OintmentSY1d8e1fca-6864-7c08-e063-6394a90a08b62
1544556neomycin sulfate 5 MG/GM Topical OintmentSY1d8e1fca-6864-7c08-e063-6394a90a08b62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
48201-104-404820101044040 g in 1 JAR (48201-104-40) 40 g2024-07-18NoNoCurrent