FDA.reportPublic FDA data

Water-Jel Neomycin Antibiotic

Product NDC
59898-730
11-digit product format
598980730
Labeler code
59898
Product ID
59898-730_4749cc3b-6c22-f299-e063-6294a90ab902
Type
HUMAN OTC DRUG
Nonproprietary name
First Aid Ointment
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Water-Jel Technologies
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-03-31
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

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
Water-Jel Neomycin Antibiotic
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
abea91a2-4453-406d-a7ed-3ffc19ef521aAvailable 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
59898-730-01Water-Jel Neomycin Antibiotic0.9 g in 1 PACKETOINTMENT0.98
59898-730-01Water-Jel Neomycin Antibiotic1728 in 1 CARTONOINTMENT17288
59898-730-02Water-Jel Neomycin Antibiotic0.9 g in 1 PACKETOINTMENT0.98
59898-730-02Water-Jel Neomycin Antibiotic144 in 1 BOX, UNIT-DOSEOINTMENT1448
59898-730-03Water-Jel Neomycin Antibiotic0.9 g in 1 PACKETOINTMENT0.98
59898-730-03Water-Jel Neomycin Antibiotic25 in 1 BOX, UNIT-DOSEOINTMENT258
59898-730-04Water-Jel Neomycin Antibiotic10 in 1 BOX, UNIT-DOSEOINTMENT108
59898-730-04Water-Jel Neomycin Antibiotic0.9 g in 1 PACKETOINTMENT0.98
59898-730-36Water-Jel Neomycin Antibiotic0.9 g in 1 PACKETOINTMENT0.98

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Neomycin sulfateACTIVE INGREDIENT057Y626693WATER-JEL NEOMYCIN ANTIBIOTIC (FIRST AID OINTMENT) OINTMENT [WATER-JEL TECHNOLOGIES]4
NeomycinACTIVE MOIETYI16QD7X297WATER-JEL NEOMYCIN ANTIBIOTIC (FIRST AID OINTMENT) OINTMENT [WATER-JEL TECHNOLOGIES]4
PetrolatumINACTIVE INGREDIENT4T6H12BN9UWATER-JEL NEOMYCIN ANTIBIOTIC (FIRST AID OINTMENT) OINTMENT [WATER-JEL TECHNOLOGIES]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59898-730WATER-JEL NEOMYCIN ANTIBIOTIC (FIRST AID OINTMENT) OINTMENT [WATER-JEL TECHNOLOGIES]7Current NDC, Legacy NDC, 9 package rows20240216_abea91a2-4453-406d-a7ed-3ffc19ef521a.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 13 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Balma Septic Antiseptic Hand WashBENZALKONIUM CHLORIDERochester Midland Corporation1b8e0a27-dcdd-4d07-b0f2-55cf74a9b5282025-01-10WarningsExact identifier
application number: M004
LX0380 Lynx glacier fresh Antiseptic Hand and Body Wash 6380CHLOROXYLENOLABC Compounding Co., Inc.efa3938f-64de-77ba-e053-2a95a90ac8402025-01-10WarningsExact identifier
application number: M004
BacitracinBACITRACINA-S Medication Solutions64aa660d-2d69-48e8-bd0d-4876815d89ff2025-01-08WarningsExact identifier
application number: M004
BacitracinBACITRACINWater-Jel Technologies412928a1-3708-4fa8-99c5-aaa2b079cf6e2025-01-06WarningsExact identifier
application number: M004
AVON HeXashield Triple Antibiotic with Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HCLTai Guk Pharm. Co., Ltd.8e0cb861-d8aa-1f71-e053-2a95a90aaa882025-01-01WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATETrifecta Pharmaceuticals USA LLC087694c2-4b1b-e293-e063-6294a90a961f2024-12-31WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATETRIFECTA PHARMACEUTICALS USA LLC0c017b10-29b6-e30f-e063-6294a90a8a3c2024-12-31WarningsExact identifier
application number: M004
Triple Antibiotic and Pain ReliefBACITRACIN,NEOMYCIN,POLYMYXINB,PRAMOXINETrifecta Pharmaceutical USA LLC0bf08cf6-be3f-f9aa-e063-6294a90a43932024-12-31WarningsExact identifier
application number: M004
Single Antibiotic with BacitracinBACITRACIN ZINCRandob Labs Ltd.2a807f1b-986f-a9ea-e063-6394a90aed252024-12-30WarningsExact identifier
application number: M004
TripleantibioticapainscaritchFAMILY WELLNESS BACITRACIN,NEOMYCIN,POLYMYXINB,PRAMOXINEHCLTrifecta Pharmaceutical USA LLC935106c6-8a9e-07fa-e053-2a95a90a24842024-12-20WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.TRIFECTA PHARMACEUTICALS USA LLC00c52a31-9bfa-a8bf-e063-6294a90ac4d72024-12-20WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATETrifecta Pharmaceuticals Usa Llcd04b397c-1608-4fd9-be28-ef7285d6a9962024-12-20WarningsExact identifier
application number: M004
TripleantibioticointmentandpainreliefFAMILY WELLNESS BACITRACIN,NEOMYCIN,POLYMYXINB,PRAMOXINETrifecta Pharmaceutical USA LLC91575333-5268-5d8f-e053-2a95a90a7a892024-12-20WarningsExact identifier
application number: M004
Premier Value Max Strength Antibiotic plus pain reliefPREMIER VALUE NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HCLPharmacy Value Alliance LLC9767821e-054b-3bd3-e053-2a95a90a4b0e2024-12-20WarningsExact identifier
application number: M004
Premier Value Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEPremier Value Alliance LLC.ab843664-a1e0-6716-e053-2995a90a20632024-12-20WarningsExact identifier
application number: M004
Premier Value Bacitracin ZincBACITRACIN ZINCPharmacy Value Alliance LLC99d789be-aa85-0917-e053-2a95a90acd132024-12-20WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEPremier Value Alliance LLC.ab863d90-1a8f-3c1f-e053-2a95a90aa0a72024-12-20WarningsExact identifier
application number: M004
Family Wellness First Aid AntibioticFAMILY WELLNESS BACITRACIN ZINC, POLYMYXIN B SULFATETrifecta Pharmaceuticals USA, LLC9157681a-3ed1-096e-e053-2a95a90a05e32024-12-18WarningsExact identifier
application number: M004
Family Wellness OriginalFAMILY WELLNESS BACITRACIN, NEOMYCIN, POLYMYXIN BTrifecta Pharmaceuticals USA LLC.915759af-0d4f-6a87-e053-2a95a90acbd62024-12-18WarningsExact identifier
application number: M004
Family Wellness Pain Scar ItchBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCLTrifecta Pharmaceutical USA LLC9e507ec5-310d-3a21-e053-2a95a90a15a62024-12-18WarningsExact identifier
application number: M004

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311928neomycin 0.35 % Topical OintmentPSNabea91a2-4453-406d-a7ed-3ffc19ef521a8
311928neomycin 0.0035 MG/MG Topical OintmentSCDabea91a2-4453-406d-a7ed-3ffc19ef521a8
311928neomycin (as neomycin sulfate 5 MG per 1 GM) 3.5 MG per 1 GM Topical OintmentSYabea91a2-4453-406d-a7ed-3ffc19ef521a8
311928neomycin 0.35 % Topical OintmentSYabea91a2-4453-406d-a7ed-3ffc19ef521a8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59898-730-01598980730011728 PACKET in 1 CARTON (59898-730-01) / .9 g in 1 PACKET1728 packet2010-03-310000-00-00NoNoCurrent
59898-730-0259898073002144 PACKET in 1 BOX, UNIT-DOSE (59898-730-02) / .9 g in 1 PACKET144 packet2010-03-310000-00-00NoNoCurrent
59898-730-035989807300325 PACKET in 1 BOX, UNIT-DOSE (59898-730-03) / .9 g in 1 PACKET25 packet2010-03-310000-00-00NoNoCurrent
59898-730-045989807300410 PACKET in 1 BOX, UNIT-DOSE (59898-730-04) / .9 g in 1 PACKET10 packet2010-03-31NoNoCurrent
59898-730-3659898073036.9 g in 1 PACKET (59898-730-36) 2010-03-310000-00-00NoNoCurrent