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 1 of 3 · 43 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sulfacetamide SodiumSULFACETAMIDE SODIUMPreferred Pharmaceuticals, Inccf0cc763-49b5-435d-852b-e7617c8d32862026-09-02Warnings, Adverse reactionsName fallback
brand name: Sulfacetamide Sodium
Mineral OilMINERAL OILYour Military Exchanges6025dce6-02e8-418c-a248-0b5c33ff60672026-08-28Warnings, Adverse reactionsName fallback
brand name: Mineral Oil
Mineral oilMINERAL OILEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)92f2147d-b52d-4282-b217-28f6095dca0e2026-08-12WarningsName fallback
brand name: Mineral oil
Mineral OilMINERAL OILOld East Main Co.4bae831d-caba-40c9-bdb5-2611eac35dd52026-08-05Warnings, Adverse reactionsName fallback
brand name: Mineral Oil
Mineral oilMINERAL OILCVS Pharmacy, Inc.1183bcbc-51ec-e53a-e063-6394a90af0f22026-06-26Warnings, Adverse reactionsName fallback
brand name: Mineral oil
Sodium ThiosulfateSODIUM THIOSULFATEHope Pharmaceuticals82f55408-2de9-463d-85e8-b39c3b259f0b2026-05-26Warnings, Adverse reactionsName fallback
brand name: Sodium Thiosulfate
Mineral OilMINERAL OILPublix Supermarkets, Inc.382a57d1-85bf-480f-9967-f85da29044102026-04-23WarningsName fallback
brand name: Mineral Oil
White PetrolatumPETROLATUMDynarex Corporation81f5092d-0632-bf47-e053-2991aa0ac5632026-03-25WarningsName fallback
brand name: White Petrolatum
Sulfacetamide SodiumSULFACETAMIDE SODIUMA-S Medication Solutionsf212af23-be3d-4e82-9f6f-5ddce12a89da2026-03-23Warnings, Adverse reactionsName fallback
brand name: Sulfacetamide Sodium
Mineral OilMINERAL OILChain Drug Marketing Association3bfdad9c-ac58-4e92-b952-555e8a8351cd2026-02-27Warnings, Adverse reactionsName fallback
brand name: Mineral Oil
White PetrolatumWHITE PETROLATUMWalmart Inc.176d7711-7c4f-4319-91af-0aba1260c4122026-02-27Warnings, Adverse reactionsName fallback
brand name: White Petrolatum
Mineral OilMINERAL OILBetter Living Brands, LLC7f2f1b30-497a-4c53-accc-8455169b17b32026-02-24Warnings, Adverse reactionsName fallback
brand name: Mineral Oil
WHITE PETROLATUMPETROLATUMSion Biotext Medical Ltd53ca3aeb-1d5d-4964-adb5-1cfa901642da2026-02-23WarningsName fallback
brand name: WHITE PETROLATUM
Mineral OilMINERAL OILPerrigo Direct, Incf1656280-fad9-4922-9d5c-be774a8b14222026-02-19Warnings, Adverse reactionsName fallback
brand name: Mineral Oil
Mineral OilMINERAL OILMeijer, Inc.652d1da9-a71f-4113-9ef3-da09167246252026-02-19Warnings, Adverse reactionsName fallback
brand name: Mineral Oil
Mineral OilMINERAL OILTarget Corporation526508f0-e908-4e3d-88f5-404a95f6de762026-02-18Warnings, Adverse reactionsName fallback
brand name: Mineral Oil
Mineral OilMINERAL OILUnited Natural Foods, Inc. dba UNFIcb7bc571-295f-47c2-ae93-18cba194752c2026-02-17Warnings, Adverse reactionsName fallback
brand name: Mineral Oil
Mineral OilMINERAL OILStrategic Sourcing Services LLCe4965086-dcc0-4b34-bb30-81facf7139f32026-02-17Warnings, Adverse reactionsName fallback
brand name: Mineral Oil
Mineral OilMINERAL OILTopco Associates LLCe9b1fd61-c229-4529-82c2-d6ac5b0760822026-02-13WarningsName fallback
brand name: Mineral Oil
Mineral OilMINERAL OILWalgreen Co.822fd02a-92b0-4010-8bfb-737dba331d542026-02-12Warnings, Adverse reactionsName fallback
brand name: Mineral Oil

Reported adverse events (FAERS/openFDA)#

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