FDA.reportPublic FDA data

NDC 51672-1365-04 - Fluocinolone Acetonide

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
51672-1365
Requested NDC
51672-1365-04
Package NDCs from labels
51672-1365-2, 51672-1365-4, 51672-1365-04
Manufacturer
Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.
Effective date
2025-07-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Fluocinolone Acetonide Topical Solution USP, 0.01%Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.2025-07-03HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-1365-2Fluocinolone Acetonide1 in 1 CARTONSOLUTION13
51672-1365-2Fluocinolone Acetonide20 mL in 1 BOTTLESOLUTION203
51672-1365-4Fluocinolone Acetonide1 in 1 CARTONSOLUTION13
51672-1365-4Fluocinolone Acetonide60 mL in 1 BOTTLESOLUTION603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1365FLUOCINOLONE ACETONIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]2Current NDC, Legacy NDC, 4 package rows20170421_02352ed1-3568-441f-add8-45201351a11c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1365-4ML - Milliliter51672-1365bf5c5a2c-bf1b-450d-94e6-4e47bbabbbe912015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
fluocinolone acetonideACTIVE INGREDIENT0CD5FD6S2MFLUOCINOLONE ACETONIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]1
fluocinolone acetonideACTIVE MOIETY0CD5FD6S2MFLUOCINOLONE ACETONIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]1
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPFLUOCINOLONE ACETONIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3FLUOCINOLONE ACETONIDE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]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 10 · 191 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
fluocinolone acetonideFLUOCINOLONE ACETONIDEBryant Ranch Prepack4790bdfa-c964-4c3e-9d01-c2fb23a0172e2026-05-26Warnings, Adverse reactionsExact identifier
unii: 0CD5FD6S2M
ACD ACITRIC ACID MONOHYDRATE, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATETerumo BCT, Ltd8e255bc7-a120-460a-a32d-43931f8115de2026-05-21Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Systane Pro PFPROPYLENE GLYCOLAlcon Laboratories, Inc.a12baf3d-f22b-4c9f-a4c8-4e0d09f6d6f12026-05-12WarningsExact identifier
unii: 6DC9Q167V3
Fluocinolone acetonideFLUOCINOLONE ACETONIDEA-S Medication Solutions09284ede-6be9-4192-b178-567b3c6265bb2026-05-08Warnings, Adverse reactionsExact identifier
unii: 0CD5FD6S2M
Artificial Tears Lubricant Eye DropsGLYCERIN, PROPYLENE GLYCOLCVS Pharmacy28297fee-8185-4869-8f39-5bfbf8bf8bfd2026-04-13WarningsExact identifier
unii: 6DC9Q167V3
Retaine Ultra PFPOLYETHYLENE GLYCOLOCuSOFT LLCa5aaaf06-772d-44d3-8601-f978ddc48ad72026-04-13WarningsExact identifier
unii: 6DC9Q167V3
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACIDChartwell Governmental & Specialty RX, LLC58c24504-47de-487a-ab8d-18add155ea952026-04-07Adverse reactionsExact identifier
unii: 2968PHW8QP
Fluocinolone Acetonide Topical Solution USP, 0.01%FLUOCINOLONE ACETONIDE TOPICAL SOLUTION USP, 0.01%Encube Ethicals, Inc.3fb00d90-6a5b-4e95-ab6b-f5b102ff0f362026-03-18Adverse reactionsExact identifier
rxcui: 1191310
unii: 0CD5FD6S2M
Neo-SynalarNEOMYCIN SULFATE AND FLUOCINOLONE ACETONIDEEurofarma, Inc.1141956e-8a4c-4f80-95d1-f15bdb57fdf62026-03-18Warnings, Adverse reactionsExact identifier
unii: 0CD5FD6S2M
Leader Ultra Lubricating Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCardinal Healthd7f011a2-05ba-47c3-9519-d31602e105c72026-03-12WarningsExact identifier
unii: 6DC9Q167V3
Leader Restorative Formula Lubricant Eye DropsPROPYLENE GLYCOLCardinal Health87fef7e4-e5a8-4aad-94d2-f80f34826d972026-03-12WarningsExact identifier
unii: 6DC9Q167V3
Fluocinolone Acetonide OilFLUOCINOLONE ACETONIDERising Pharma Holdings, Inc.79591576-1eab-48c5-b0a6-e205b3cc097e2026-03-09Warnings, Adverse reactionsExact identifier
unii: 0CD5FD6S2M
Fluocinolone Acetonide OilFLUOCINOLONE ACETONIDERising Pharma Holdings, Inc.f45b0ef2-1702-4d21-8ac8-7747693045952026-03-09Warnings, Adverse reactionsExact identifier
unii: 0CD5FD6S2M
TricitratesTRICITRATESChartwell Governmental & Specialty RX, LLC.c4ff0407-3930-4c48-afd4-d2cb3e1b18f42026-02-25Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Potassium Citrate and Citric AcidPOTASSIUM CITRATE AND CITRIC ACIDChartwell Governmental & Specialty RX, LLC.fd57a176-7faf-4053-b348-6ba5f192f05a2026-02-25Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
fluocinolone acetonideFLUOCINOLONE ACETONIDEANI Pharmaceuticals, Inc.50e7006d-a51b-49aa-8e1c-330340e7bf822026-02-23Adverse reactionsExact identifier
unii: 0CD5FD6S2M
Fluocinolone AcetonideFLUOCINOLONE ACETONIDEANI Pharmaceuticals, Inc.622c9804-0be0-4dec-a6ba-5cf4b5578a842026-02-23Adverse reactionsExact identifier
unii: 0CD5FD6S2M
YUTIQFLUOCINOLONE ACETONIDEANI Pharmaceuticals, Inc.f270cad8-ed82-4969-b785-831a1910bfa62026-02-19Warnings, Adverse reactionsExact identifier
unii: 0CD5FD6S2M
Fluocinolone Acetonide Topical Solution USP, 0.01%FLUOCINOLONE ACETONIDE TOPICAL SOLUTION USP, 0.01%Bryant Ranch Prepack3fa4d5db-b17f-44dc-aa6a-50934d42c68d2026-02-18Adverse reactionsExact identifier
rxcui: 1191310
unii: 0CD5FD6S2M
Droptics Performance Eye DropsNAPHAZOLINE HYDROCHLORIDE, PROPYLENE GLYCOLDroptics LLC20fd6822-a7fd-4593-92bb-0a07260893e22026-02-09WarningsExact identifier
unii: 6DC9Q167V3

Reported adverse events (FAERS/openFDA)#

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