Home NDC 11980-422 NDC 11980-422 - FML-S 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 11980-422
Package NDCs from labels 11980-422-05, 11980-422-10
Manufacturer Allergan, Inc.
Effective date 2007-02-20
Current FDA listing Not matched in FDA.report NDC product tables DailyMed Labels# Label, Manufacturer, Effective date table Label Manufacturer Effective date Type FML-S - Allergan, Inc. Allergan, Inc. 2007-02-20 HUMAN PRESCRIPTION DRUG LABELING
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 11980-422-05 FML-S 5 mL in 1 BOTTLE, DROPPER SUSPENSION 5 1 11980-422-10 FML-S 10 mL in 1 BOTTLE, DROPPER SUSPENSION 10 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11980-422 FML-S (FLUOROMETHOLONE AND SULFACETAMIDE SODIUM) SUSPENSION [ALLERGAN, INC.] 1 2 package rows 20070223_9d71d7fd-2b25-4163-922f-018ed8c5171f.zip
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded fluorometholone ACTIVE INGREDIENT SV0CSG527L FML-S (FLUOROMETHOLONE AND SULFACETAMIDE SODIUM) SUSPENSION [ALLERGAN, INC.] 1 sulfacetamide sodium ACTIVE INGREDIENT 4NRT660KJQ FML-S (FLUOROMETHOLONE AND SULFACETAMIDE SODIUM) SUSPENSION [ALLERGAN, INC.] 1 fluorometholone ACTIVE MOIETY SV0CSG527L FML-S (FLUOROMETHOLONE AND SULFACETAMIDE SODIUM) SUSPENSION [ALLERGAN, INC.] 1 sulfacetamide ACTIVE MOIETY 4965G3J0F5 FML-S (FLUOROMETHOLONE AND SULFACETAMIDE SODIUM) SUSPENSION [ALLERGAN, INC.] 1 benzalkonium chloride INACTIVE INGREDIENT FML-S (FLUOROMETHOLONE AND SULFACETAMIDE SODIUM) SUSPENSION [ALLERGAN, INC.] 1 edetate disodium INACTIVE INGREDIENT 7FLD91C86K FML-S (FLUOROMETHOLONE AND SULFACETAMIDE SODIUM) SUSPENSION [ALLERGAN, INC.] 1 hydrochloric acid INACTIVE INGREDIENT QTT17582CB FML-S (FLUOROMETHOLONE AND SULFACETAMIDE SODIUM) SUSPENSION [ALLERGAN, INC.] 1 polysorbate 80 INACTIVE INGREDIENT FML-S (FLUOROMETHOLONE AND SULFACETAMIDE SODIUM) SUSPENSION [ALLERGAN, INC.] 1 polyvinyl alcohol INACTIVE INGREDIENT FML-S (FLUOROMETHOLONE AND SULFACETAMIDE SODIUM) SUSPENSION [ALLERGAN, INC.] 1 povidone INACTIVE INGREDIENT FML-S (FLUOROMETHOLONE AND SULFACETAMIDE SODIUM) SUSPENSION [ALLERGAN, INC.] 1 sodium chloride INACTIVE INGREDIENT 451W47IQ8X FML-S (FLUOROMETHOLONE AND SULFACETAMIDE SODIUM) SUSPENSION [ALLERGAN, INC.] 1 sodium hydroxide INACTIVE INGREDIENT 55X04QC32I FML-S (FLUOROMETHOLONE AND SULFACETAMIDE SODIUM) SUSPENSION [ALLERGAN, INC.] 1 sodium phosphate, dibasic INACTIVE INGREDIENT GR686LBA74 FML-S (FLUOROMETHOLONE AND SULFACETAMIDE SODIUM) SUSPENSION [ALLERGAN, INC.] 1 sodium phosphate, monobasic INACTIVE INGREDIENT 3980JIH2SW FML-S (FLUOROMETHOLONE AND SULFACETAMIDE SODIUM) SUSPENSION [ALLERGAN, INC.] 1 sodium thiosulfate INACTIVE INGREDIENT HX1032V43M FML-S (FLUOROMETHOLONE AND SULFACETAMIDE SODIUM) SUSPENSION [ALLERGAN, INC.] 1 water INACTIVE INGREDIENT 059QF0KO0R FML-S (FLUOROMETHOLONE AND SULFACETAMIDE SODIUM) SUSPENSION [ALLERGAN, INC.] 1
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Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.