FDA.reportPublic FDA data

NDC 51672-1353-04 - Fluocinonide

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
51672-1353
Requested NDC
51672-1353-04
Package NDCs from labels
51672-1353-2, 51672-1353-3, 51672-1353-4, 51672-1353-04
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
Fluocinonide - Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.2025-07-03HUMAN PRESCRIPTION DRUG LABEL
Fluocinonide - Asclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEMAsclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM2023-12-16HUMAN PRESCRIPTION DRUG LABEL
Fluocinonide - Preferred Pharmaceuticals, Inc.Preferred Pharmaceuticals, Inc.2020-05-27HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-1353-2Fluocinonide30 g in 1 TUBECREAM306
51672-1353-2Fluocinonide1 in 1 CARTONCREAM16
51672-1353-3Fluocinonide1 in 1 CARTONCREAM16
51672-1353-3Fluocinonide60 g in 1 TUBECREAM606
51672-1353-4Fluocinonide120 g in 1 TUBECREAM1206
51672-1353-4Fluocinonide1 in 1 CARTONCREAM16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1353FLUOCINONIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]5Current NDC, Legacy NDC, 6 package rows20241222_16c7d142-e695-4e33-986f-78cb37f7b387.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1353-2GM - Gram51672-13535b23c884-1697-4a4e-95bb-f2038ad8541012014-08-01
51672-1353-3GM - Gram51672-13532f7e90bc-8374-481e-b8fa-d6769ca070a612014-08-01
51672-1353-4GM - Gram51672-1353cd8e6294-5b40-4ce0-9ee8-e15d2a8a1e1f12014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FluocinonideACTIVE INGREDIENT2W4A77YPANFLUOCINONIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
FluocinonideACTIVE MOIETY2W4A77YPANFLUOCINONIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
carbomer homopolymer type c (allyl pentaerythritol crosslinked)INACTIVE INGREDIENT4Q93RCW27EFLUOCINONIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPFLUOCINONIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
diethylene glycol monoethyl etherINACTIVE INGREDIENTA1A1I8X02BFLUOCINONIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1AFLUOCINONIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
polyoxyl 20 cetostearyl etherINACTIVE INGREDIENTYRC528SWUYFLUOCINONIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
propylene glycolINACTIVE INGREDIENT6DC9Q167V3FLUOCINONIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58XFLUOCINONIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
trolamineINACTIVE INGREDIENT9O3K93S3TKFLUOCINONIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3

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 · 196 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Systane Pro PFPROPYLENE GLYCOLAlcon Laboratories, Inc.a12baf3d-f22b-4c9f-a4c8-4e0d09f6d6f12026-05-12WarningsExact identifier
unii: 6DC9Q167V3
FluocinonideFLUOCINONIDESaptalis Pharmaceuticals, LLC.20f8e9a2-a63d-4bee-bc14-b9f04087d87b2026-05-11Adverse reactionsExact identifier
unii: 2W4A77YPAN
FluocinonideFLUOCINONIDEPreferred Pharmaceuticals Inc.80b72854-3fae-4cc7-bc41-2bdeb3e2cbe12026-04-17Adverse reactionsExact identifier
unii: 2W4A77YPAN
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
FluocinonideFLUOCINONIDE TOPICAL SOLUTION USP, 0.05%Bryant Ranch Prepack628bda7e-b670-4f71-bcc4-0290d67655a02026-04-07Adverse reactionsExact identifier
unii: 2W4A77YPAN
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACIDChartwell Governmental & Specialty RX, LLC58c24504-47de-487a-ab8d-18add155ea952026-04-07Adverse reactionsExact identifier
unii: 2968PHW8QP
fluocinonideFLUOCINONIDEBryant Ranch Prepackf20e4aa4-11f3-4f9d-9c29-43f7fb9c549d2026-03-20Adverse reactionsExact identifier
unii: 2W4A77YPAN
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
FluocinonideFLUOCINONIDEA-S Medication Solutionsab79df76-192b-422e-8d2c-dd5a46ffb2162026-03-06Adverse reactionsExact identifier
unii: 2W4A77YPAN
DUAL ANESTHETIC NUMBINGDUAL ANESTHETIC NUMBINGLEIBOVICH EDWARD PERSOANA FIZICA AUTORIZATA4c1de25d-2586-f0cd-e063-6294a90aff362026-03-03WarningsExact identifier
unii: 9O3K93S3TK
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
Droptics Performance Eye DropsNAPHAZOLINE HYDROCHLORIDE, PROPYLENE GLYCOLDroptics LLC20fd6822-a7fd-4593-92bb-0a07260893e22026-02-09WarningsExact identifier
unii: 6DC9Q167V3
FluocinonideFLUOCINONIDEA-S Medication Solutionsb1b4a6e9-814e-41e9-9f35-8bed7595265b2026-02-08Adverse reactionsExact identifier
unii: 2W4A77YPAN
Additive Formula 3DEXTROSE MONOHYDRATE, TRISODIUM CITRATE DIHYDRATE, SODIUM CHLORIDE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, CITRIC ACID MONOHYDRATE, AND ADENINETerumo BCT, Ltd9a5247a1-cc05-442d-b2d0-950f887f03c22026-01-30Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
fluocinonideFLUOCINONIDEE. Fougera & Co. a division of Fougera Pharmaceuticals, LLCebca0c66-06f6-438a-a01a-634c53debc062026-01-28Adverse reactionsExact identifier
unii: 2W4A77YPAN
SWISS BLEU Relief-Calm Antimicrobial Skin CreamLACTOBACILLUS FERMENT LYSATE, LEONTOPODIUM ALPINUM, CALENDULA OFFICINALIS FLOWER EXTRACT, EVENING PRIMROSE FLOWER EXTRACT, CITRIC ACIDNanjing Hongruixing Biological Technology Co., Ltd487d3c2c-ce28-f7a1-e063-6294a90a5ec62026-01-16WarningsExact identifier
unii: 2968PHW8QP
FluocinonideFLUOCINONIDE TOPICAL SOLUTION USP, 0.05%Encube Ethicals, Inc.4b1f775e-a7ad-4151-975e-6026296b5cea2026-01-09Adverse reactionsExact identifier
unii: 2W4A77YPAN

Reported adverse events (FAERS/openFDA)#

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