FDA.reportPublic FDA data

NDC 51672-1279-03 - 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
51672-1279-03
Package NDCs from labels
51672-1279-1, 51672-1279-2, 51672-1279-3, 51672-1279-03
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 1 of 69 · 1,380 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
leader clearlaxPOLYETHYLENE GLYCOL 3350Cardinal Health 110, LLC. dba Leader812c59b0-e7ce-4c7a-91ed-e74b7b1b84be2026-09-22WarningsExact identifier
unii: G2M7P15E5P
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350L.N.K. International, Inc.bbc11078-73f7-4d27-b0d3-4d4ae5dae2402026-09-10WarningsExact identifier
unii: G2M7P15E5P
Lanolin, PetrolatumLANOLIN, PETROLATUMCVS Pharmacy, Inc.606f65a8-08fd-4ab6-9d68-03ddf662bdf02026-09-09Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
Advanced HealingPETROLATUMWalgreen Co.22bd8e87-965c-466b-bb9b-7d4753e500bc2026-09-09Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
Leader Eye Drops Redness ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDECardinal Healthaee4bbe2-4f11-4c54-be8b-df48b3ba4f3a2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
Drs. Pharmacy baby healingPETROLATUMOL PHARMA TECH, LLC Drs PHARMACY5b14ffa0-9486-a7fe-e063-6394a90ab3ed2026-09-09WarningsExact identifier
unii: 4T6H12BN9U
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMRite Aid Corporation407c78ca-6fee-4ed6-b61b-711ec049c86e2026-09-09WarningsExact identifier
unii: 4T6H12BN9U
unii: PDC6A3C0OX
CLEARLAXPOLYETHYLENE GLYCOL 3350Amazon.com Services LLC7ed915ec-7e99-4e0e-aca0-20718987a88c2026-09-08WarningsExact identifier
unii: G2M7P15E5P
Intense Therapy Lip Balm Pineapple MintSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLC0862534c-5f48-4f67-a3b8-0876a667556f2026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Intense Therapy Lip Balm SPF25, Shea Butter and Vitamin ELIP BALM SPF25Jack Black, LLC88e8752d-1fbf-4e28-b79d-7c05ecdce8422026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Jack Black Intense Lip Therapy SPF25, Natural Mint and Shea ButterLIP BALM SUNSCREENJack Black, LLCe8730127-2d8d-4b80-ab90-d2f136d9e5162026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Jack Black Intense Therapy Lip Balm SPF25, Grapefruit and GingerLIP BALM SUNSCREENJack Black, LLCd961d22a-2125-41e9-94a3-5b53d12b320f2026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Jack Black Intense Lip Therapy SPF25, Black Tea and BlackberryLIP BALM SUNSCREENJack Black, LLC172a70bc-8a09-4258-b9bf-cf3c67ff76132026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Clear Eyes NighttimeGLYCERINPrestige Brands Holdings, Inc.af75e2f7-81dd-43e0-a390-b52bbfbebf622026-09-08WarningsExact identifier
unii: PDC6A3C0OX
Intense Therapy Lip Balm Asian PearSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLCacace707-6671-4818-86f2-d9813792157a2026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Intense Therapy Lip Balm Basil LemonSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLC277cb44d-608a-4ffc-a2a5-ac57d33d214c2026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Intense Therapy Lip Balm Black CherrySUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLC8f413bd6-258c-4c3c-89d1-369938c857202026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Intense Therapy Lip Balm Cucumber LimeSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLC5f15bee9-9bf4-4f27-a6b5-4205deb625f62026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Intense Therapy Lip Balm Winter MelonSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLCe7792b4e-a6d2-487e-ba28-27b68e6d7e272026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Jack Black Intense Therapy Lip Balm Vanilla BourbonAVOBENZONE, OCTINOXATE LIP BALM SUNSCREENJack Black, LLC517040d1-e6ed-40ca-a46f-2f75403dbc3c2026-09-08WarningsExact identifier
unii: 4T6H12BN9U

Reported adverse events (FAERS/openFDA)#

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