FDA.reportPublic FDA data

NDC 51672-1279-01 - 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
51672-1279
Requested NDC
51672-1279-01
Package NDCs from labels
51672-1279-1, 51672-1279-2, 51672-1279-3, 51672-1279-01
Manufacturer
Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.
Effective date
2025-12-23
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.2025-12-23HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-1279-1Fluocinonide1 in 1 CARTONGEL18
51672-1279-1Fluocinonide15 g in 1 TUBEGEL158
51672-1279-2Fluocinonide30 g in 1 TUBEGEL308
51672-1279-2Fluocinonide1 in 1 CARTONGEL18
51672-1279-3Fluocinonide1 in 1 CARTONGEL18
51672-1279-3Fluocinonide60 g in 1 TUBEGEL608

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1279FLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]5Current NDC, Legacy NDC, 6 package rows20240823_b0bc89a9-c9d5-4adb-9785-2d4487c4c656.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1279-1GM - Gram51672-12799fbfb81e-7840-4eb7-8fff-ef706dc3060e12012-07-24
51672-1279-2GM - Gram51672-127925cef57b-43c9-4315-94d5-ff490563a35712012-07-24
51672-1279-3GM - Gram51672-12792287d5cd-41a5-4955-8b57-c1cd2723231b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FluocinonideACTIVE INGREDIENT2W4A77YPANFLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
FluocinonideACTIVE MOIETY2W4A77YPANFLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
1,2,6-hexanetriolINACTIVE INGREDIENTW45XXM0XWEFLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLFLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
carbomer homopolymer type cINACTIVE INGREDIENT4Q93RCW27EFLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
cetyl alcoholINACTIVE INGREDIENT936JST6JCNFLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPFLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
edetate disodiumINACTIVE INGREDIENT7FLD91C86KFLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
glycerinINACTIVE INGREDIENTPDC6A3C0OXFLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE4FLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
mineral oilINACTIVE INGREDIENTT5L8T28FGPFLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
petrolatumINACTIVE INGREDIENT4T6H12BN9UFLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
polyethylene glycol 3350INACTIVE INGREDIENTG2M7P15E5PFLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
polyethylene glycol 8000INACTIVE INGREDIENTQ662QK8M3BFLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
polysorbate 60INACTIVE INGREDIENTCAL22UVI4MFLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
propyl gallateINACTIVE INGREDIENT8D4SNN7V92FLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
propylene carbonateINACTIVE INGREDIENT8D08K3S51EFLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
propylene glycolINACTIVE INGREDIENT6DC9Q167V3FLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
sodium hydroxideINACTIVE INGREDIENT55X04QC32IFLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58XFLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1YFLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
waterINACTIVE INGREDIENT059QF0KO0RFLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2
white waxINACTIVE INGREDIENT7G1J5DA97FFLUOCINONIDE CREAM FLUOCINONIDE GEL FLUOCINONIDE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]2

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 8 of 68 · 1,355 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GUNA-CELLACETYLCARNITINE, L-AMPC-ALPHA-LIPOIC AC-A-TOCOPHEROL-ASCORBIC ACID-CALC CARB-CITRIC AC-COBALAMIN-COLCHICUM-CONIUM-CUPRIC SULF-HERRING SPERM DNA-FERROUS FUMARATE-FOLIC ACID-FUMARIC ACID-KALI ASPARTATE-MANG PHOS-MANG GLUCONATE-MANG PHOS II-PYRUVALDEHYDE-NAT OXALACETICUM-SODIUM PYRUVATE-NIACIN-PANTOTHENIC ACID-PH-PODOPHYLLUM PELTATUM-PYRIDOXINE HYDROCHLORIDE-RIBOFLAVIN-SACCHAROMYCES CEREVISIAE RNA-SELENOMETHIONINE-SUCCINIC ACID-SULFUR-THIAMINE HYDROCHLORIDE-ZINCGuna spa90db80ed-c037-4e8f-a7f6-304a65f9fe222026-06-11WarningsExact identifier
unii: 2968PHW8QP
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBBM Private Limited53fa21d9-1f80-2e69-e063-6394a90ab9f32026-06-11WarningsExact identifier
unii: 059QF0KO0R
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350PIONEER LIFE SCIENCES, LLC478f104a-0e50-479c-8722-a3f1eab686912026-06-11WarningsExact identifier
unii: G2M7P15E5P
Equaline HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMUnited Natural Foods, Inc. dba UNFIbf87824a-522d-46da-81b6-e30ea11a22352026-06-11WarningsExact identifier
unii: 4T6H12BN9U
unii: PDC6A3C0OX
GUNA-FLAMACONITUM NAPELLUS - APIS MELLIFERA - ATROPA BELLADONNA - BASIC CUPRIC CARBONATE - BRYONIA ALBA ROOT - CALCIUM SULFIDE - CITRIC ACID MONOHYDRATE - FERRIC PHOSPHATE - INTERLEUKIN-10 - MELATONIN - METENKEFALIN - PHYTOLACCA AMERICANA ROOT - RANCID BEEF - SODIUM PYRUVATE - SUS SCROFA CONJUNCTIVA - SUS SCROFA PINEAL GLAND - SUS SCROFA PITUITARY GLAND - TRANSFORMING GROWTH FACTOR BETA-1 - ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT -Guna spa7bda7eb0-8fd5-42d9-b336-39920bfc964d2026-06-10WarningsExact identifier
unii: 2968PHW8QP
HEMORRHOIDALMINERAL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDECVS PHARMACY, INC93482a9b-145b-42d4-96db-599c281a39f12026-06-10WarningsExact identifier
unii: 4T6H12BN9U
unii: T5L8T28FGP
SUPRADERMWHITE PETROLATUM, LANOLINOlen Skin Care Corporation4e7199bd-52c6-48e9-9c78-c84e45412faf2026-06-10WarningsExact identifier
unii: 4T6H12BN9U
XIMONTH Fungi Free Bee Venom Nail Soothing SerumGLYCERINShantou Ximonth Biotechnology Co., Ltd.53bab969-8407-6334-e063-6294a90aa5d12026-06-08WarningsExact identifier
unii: 059QF0KO0R
Chloraseptic Sore Throat MaxPHENOL AND GLYCERINPrestige Brands Holdings, Inc.882c940c-b3c3-4aa4-8d64-e4260f066ff42026-06-08WarningsExact identifier
unii: PDC6A3C0OX
365 WHOLE FOODS MARKET Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350Whole Foods Market, Inc.b19f42a9-18ac-4d23-87b5-3c43e47c40542026-06-05WarningsExact identifier
unii: G2M7P15E5P
GAVILAXPOLYETHYLENE GLYCOL 3350Atlantic Biologicals Corp.4c207478-6f0f-c3cf-e063-6394a90aa4f22026-06-04WarningsExact identifier
unii: G2M7P15E5P
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMHyVee Incb867f691-7a13-4659-b664-06aa368993102026-06-03WarningsExact identifier
unii: 4T6H12BN9U
unii: PDC6A3C0OX
ADVANCED HEALINGPETROLATUMRejoice International Corp.532c7e5a-4d05-3bd0-e063-6294a90aee002026-06-01WarningsExact identifier
unii: 4T6H12BN9U
FluocinonideFLUOCINONIDEBryant Ranch Prepack9bad56f2-6070-44fc-a39d-bb00280057f02026-06-01Adverse reactionsExact identifier
unii: 2W4A77YPAN
C-More Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINPROFOUND NUTRITION LIMITED78f04ecb-da5e-468c-81fe-70f7c26b76c22026-06-01WarningsExact identifier
unii: PDC6A3C0OX
ADVANCED HEALING BALMPETROLATUMRejoice International Corp.53285d82-3755-ca78-e063-6394a90a50192026-05-31WarningsExact identifier
unii: 4T6H12BN9U
PURE PETROLATUMPETROLATUMVASA COSMETICS PRIVATE LIMITED52efd466-49bd-bbdf-e063-6394a90aa1082026-05-28WarningsExact identifier
unii: 4T6H12BN9U
TheraCare Vitamin A and D plus EPETROLATUMVeridian Healthcare52e0e248-6c04-feb9-e063-6394a90add462026-05-28WarningsExact identifier
unii: 4T6H12BN9U
Peep ClubGLYCERINPeep Club Eyecare Corp.513d1988-2827-28d8-e063-6294a90a8d1f2026-05-28WarningsExact identifier
unii: PDC6A3C0OX
Advanced HealingPETROLATUMCVS Pharamacy, Inc0bd3380e-2284-44a7-b2ef-68c9909627fd2026-05-26Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U

Reported adverse events (FAERS/openFDA)#

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