FDA.reportPublic FDA data

NDC 0065-0526 - Isopto Cetamide

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0065-0526
Package NDCs from labels
0065-0526-35
Manufacturer
Alcon
Effective date
2006-11-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Isopto Cetamide - AlconAlcon2006-11-20Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0065-0526-35Cetamide3.5 g in 1 TUBEOINTMENT3.51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0065-0526ISOPTO CETAMIDE (SULFACETAMIDE SODIUM) SOLUTION/ DROPS CETAMIDE (SULFACETAMIDE SODIUM) OINTMENT [ALCON]11 package rows20080313_5a5d8fee-b42a-4f0c-a508-75c7c71bedb4.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
sulfacetamide sodiumACTIVE INGREDIENT4NRT660KJQISOPTO CETAMIDE (SULFACETAMIDE SODIUM) SOLUTION/ DROPS CETAMIDE (SULFACETAMIDE SODIUM) OINTMENT [ALCON]1
sulfacetamideACTIVE MOIETY4965G3J0F5ISOPTO CETAMIDE (SULFACETAMIDE SODIUM) SOLUTION/ DROPS CETAMIDE (SULFACETAMIDE SODIUM) OINTMENT [ALCON]1
anhydrous liquid lanolinINACTIVE INGREDIENTISOPTO CETAMIDE (SULFACETAMIDE SODIUM) SOLUTION/ DROPS CETAMIDE (SULFACETAMIDE SODIUM) OINTMENT [ALCON]1
dibasic sodium phosphateINACTIVE INGREDIENTGR686LBA74ISOPTO CETAMIDE (SULFACETAMIDE SODIUM) SOLUTION/ DROPS CETAMIDE (SULFACETAMIDE SODIUM) OINTMENT [ALCON]1
hydroxypropyl methylcellulose 2910INACTIVE INGREDIENTISOPTO CETAMIDE (SULFACETAMIDE SODIUM) SOLUTION/ DROPS CETAMIDE (SULFACETAMIDE SODIUM) OINTMENT [ALCON]1
methylparabenINACTIVE INGREDIENTA2I8C7HI9TISOPTO CETAMIDE (SULFACETAMIDE SODIUM) SOLUTION/ DROPS CETAMIDE (SULFACETAMIDE SODIUM) OINTMENT [ALCON]1
mineral oilINACTIVE INGREDIENTISOPTO CETAMIDE (SULFACETAMIDE SODIUM) SOLUTION/ DROPS CETAMIDE (SULFACETAMIDE SODIUM) OINTMENT [ALCON]1
monobasic sodium phosphateINACTIVE INGREDIENT3980JIH2SWISOPTO CETAMIDE (SULFACETAMIDE SODIUM) SOLUTION/ DROPS CETAMIDE (SULFACETAMIDE SODIUM) OINTMENT [ALCON]1
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHISOPTO CETAMIDE (SULFACETAMIDE SODIUM) SOLUTION/ DROPS CETAMIDE (SULFACETAMIDE SODIUM) OINTMENT [ALCON]1
sodium thiosulfateINACTIVE INGREDIENTHX1032V43MISOPTO CETAMIDE (SULFACETAMIDE SODIUM) SOLUTION/ DROPS CETAMIDE (SULFACETAMIDE SODIUM) OINTMENT [ALCON]1
waterINACTIVE INGREDIENT059QF0KO0RISOPTO CETAMIDE (SULFACETAMIDE SODIUM) SOLUTION/ DROPS CETAMIDE (SULFACETAMIDE SODIUM) OINTMENT [ALCON]1
white petrolatumINACTIVE INGREDIENT4T6H12BN9UISOPTO CETAMIDE (SULFACETAMIDE SODIUM) SOLUTION/ DROPS CETAMIDE (SULFACETAMIDE SODIUM) OINTMENT [ALCON]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 2 of 3 · 43 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineral OilMINERAL OILRetail Business Services, LLCb0abcdf9-c226-424f-8970-c2135708c6c82026-02-06Warnings, Adverse reactionsName fallback
brand name: Mineral Oil
Mineral OilMINERAL OILCARDINAL HEALTH 110, LLC. DBA LEADER803f444f-d136-4f06-9842-24a71a3d7d6b2026-01-29Warnings, Adverse reactionsName fallback
brand name: Mineral Oil
SULFACETAMIDE SODIUMSULFACETAMIDE SODIUMBioComp Pharma, Inc.f79c8287-a832-4f39-ad4d-3a12d64618ab2025-12-17Warnings, Adverse reactionsName fallback
brand name: SULFACETAMIDE SODIUM
Mineral OilMINERAL OILATLANTIC BIOLOGICALS CORP.960502ae-2468-406e-8799-cacb01f2727e2025-05-23WarningsName fallback
brand name: Mineral Oil
Mineral OilMINERAL OILAmerisourceBergen (Good Neighbor Pharmacy) 46122581f81a0-7488-4c90-b33e-06c6301a4fd22025-04-17WarningsName fallback
brand name: Mineral Oil
Mineral OilMINERAL OILKesin Pharma Corporation30a11cc9-e407-23b7-e063-6294a90a7d6e2025-03-18WarningsName fallback
brand name: Mineral Oil
Mineral oilMINERAL OILP & L Development, LLC68e88119-1468-4ab7-a5fa-242d960d25df2025-02-21WarningsName fallback
brand name: Mineral oil
Mineral oilMINERAL OILBest Choice (Valu Merchandisers Company)3ec8a716-60e0-4dfb-adae-ddc53c6139352025-02-04WarningsName fallback
brand name: Mineral oil
Mineral OilMINERAL OILSafecor Health, LLCef182484-692e-4eb3-bcf1-3c990ec0d08e2025-01-08WarningsName fallback
brand name: Mineral Oil
White PetrolatumPETROLATUMTrifecta Pharmaceuticals USA LLCf1eb0ec2-98e7-13a2-e053-2a95a90a29382024-12-20WarningsName fallback
brand name: White Petrolatum
White PetrolatumPETROLATUMGeri-Care Pharmaceuticals, Corpf40a29c2-65ea-91f9-e053-2a95a90ac4392024-12-17WarningsName fallback
brand name: White Petrolatum
SULFACETAMIDE SODIUMSULFACETAMIDE SODIUMCintex Services, LLC214ff8a6-179f-b907-e063-6394a90adcb12024-09-04Warnings, Adverse reactionsName fallback
brand name: SULFACETAMIDE SODIUM
Sulfacetamide SodiumSULFACETAMIDE SODIUMNuCare Pharmaceuticals,Inc.9910ec80-e37c-6a83-e053-2995a90a82372024-06-20Warnings, Adverse reactionsName fallback
brand name: Sulfacetamide Sodium
SULFACETAMIDE SODIUMSULFACETAMIDE SODIUMCintex Services, LLC0fa3302e-b2b4-6b9b-e063-6394a90abc2c2024-01-23Warnings, Adverse reactionsName fallback
brand name: SULFACETAMIDE SODIUM
White PetrolatumWHITE PETROLATUMNantong Health & Beyond Hygienic Products Inc.0f0d6ff0-ff30-aaf8-e063-6394a90a27162024-01-16WarningsName fallback
brand name: White Petrolatum
White PetrolatumWHITE PETROLATUMSled Distribution, LLCe73a4b7a-7b27-abfc-e053-2995a90a35c22024-01-15WarningsName fallback
brand name: White Petrolatum
Sulfacetamide SodiumSULFACETAMIDE SODIUMBausch & Lomb Incorporated6c1b2658-e756-4f31-9bc8-f99a0baa46372023-08-31Warnings, Adverse reactionsName fallback
brand name: Sulfacetamide Sodium
Sulfacetamide SodiumSULFACETAMIDE SODIUMPadagis Israel Pharmaceuticals Ltd4fb4d39a-330e-4c84-abbc-3b33b36b206f2023-04-01Warnings, Adverse reactionsName fallback
brand name: Sulfacetamide Sodium
Sulfacetamide SodiumSULFACETAMIDE SODIUMAsclemed USA, Inc.c4c29e13-8303-4a9a-bb47-d7413eaf2f262022-10-12Warnings, Adverse reactionsName fallback
brand name: Sulfacetamide Sodium
Sulfacetamide SodiumSULFACETAMIDE SODIUMProficient Rx LP2b4f125c-338e-479f-8feb-b82324230c652022-08-01Warnings, Adverse reactionsName fallback
brand name: Sulfacetamide Sodium

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.