FDA.reportPublic FDA data

NDC 51672-1386-01 - 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
51672-1386
Requested NDC
51672-1386-01
Package NDCs from labels
51672-1386-1, 51672-1386-2, 51672-1386-3, 51672-1386-4, 51672-1386-01
Manufacturer
A-S Medication Solutions
Effective date
2025-12-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Fluocinonide - A-S Medication SolutionsA-S Medication Solutions2025-12-06HUMAN PRESCRIPTION DRUG LABEL
Fluocinonide Cream USP, 0.05%Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.2025-07-08HUMAN PRESCRIPTION DRUG LABEL
Fluocinonide - RedPharm DrugRedPharm Drug2024-08-07HUMAN PRESCRIPTION DRUG LABEL
Fluocinonide Cream USP, 0.05%NuCare Pharmaceuticals,Inc.2024-06-14HUMAN PRESCRIPTION DRUG LABEL
Fluocinonide Cream USP, 0.05%NuCare Pharmaceuticals Inc.2024-06-06HUMAN PRESCRIPTION DRUG LABEL
Fluocinonide Cream USP, 0.05%RPK Pharmaceuticals, Inc.2022-03-30HUMAN PRESCRIPTION DRUG LABEL
Fluocinonide - A-S Medication SolutionsA-S Medication Solutions2021-03-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-1386-1Fluocinonide15 g in 1 TUBECREAM153
51672-1386-1Fluocinonide1 in 1 CARTONCREAM13
51672-1386-2Fluocinonide30 g in 1 TUBECREAM303
51672-1386-2Fluocinonide1 in 1 CARTONCREAM13
51672-1386-3Fluocinonide60 g in 1 TUBECREAM603
51672-1386-3Fluocinonide1 in 1 CARTONCREAM13
51672-1386-4Fluocinonide120 g in 1 TUBECREAM1203
51672-1386-4Fluocinonide1 in 1 CARTONCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1386FLUOCINONIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1Current NDC, Legacy NDC, 8 package rows20161118_5782d791-48fd-4cee-853d-235eb4d04a40.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1386-1GM - Gram51672-138694eaa54a-220f-4e16-a8cb-eb3c6fd2a84e12017-04-05
51672-1386-2GM - Gram51672-1386e709049c-b525-42c0-9c77-65fd58599d8f12017-04-05
51672-1386-3GM - Gram51672-138656fc2100-c2f3-4fc5-9602-8739f611c56812017-04-05
51672-1386-4GM - Gram51672-138673d0a0da-2a64-4d2b-be5a-dfdfa3e5a4a212017-04-05

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 4 of 30 · 598 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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: PDC6A3C0OX
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
Peep ClubGLYCERINPeep Club Eyecare Corp.513d1988-2827-28d8-e063-6294a90a8d1f2026-05-28WarningsExact identifier
unii: PDC6A3C0OX
RippleGLYCERIN, POVIDONECorneaCare Inc3b5ba197-d501-681e-e063-6294a90aefb52026-05-24WarningsExact identifier
unii: PDC6A3C0OX
Walgreens Adult Glycerin LaxativeGLYCERIN SUPPOSITORYWalgreens5285403b-ab44-21a1-e063-6394a90a9fd02026-05-23WarningsExact identifier
unii: PDC6A3C0OX
ACD ACITRIC ACID MONOHYDRATE, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATETerumo BCT, Ltd8e255bc7-a120-460a-a32d-43931f8115de2026-05-21Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
HEMORRHOIDAL WITH LIDOCAINEGLYCERIN, LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE, WHITE PETROLATUMCVS PHARMACY, INC4d870c68-9e72-464e-b0b8-900d0d661e432026-05-14WarningsExact identifier
unii: PDC6A3C0OX
FluocinonideFLUOCINONIDE TOPICAL SOLUTION USP, 0.05%Bryant Ranch Prepack38a36184-22b4-4e97-83e1-fdd984ef6ccb2026-05-14Adverse reactionsExact identifier
unii: 2W4A77YPAN
Systane Pro PFPROPYLENE GLYCOLAlcon Laboratories, Inc.a12baf3d-f22b-4c9f-a4c8-4e0d09f6d6f12026-05-12WarningsExact identifier
unii: 6DC9Q167V3
Polyethylene glycol 3350POLYETHYLENE GLYCOL 3350Major Pharmaceuticalsddc9d2b1-87d8-44fa-bac6-0a7261f335642026-05-12WarningsExact identifier
unii: G2M7P15E5P
FluocinonideFLUOCINONIDESaptalis Pharmaceuticals, LLC.20f8e9a2-a63d-4bee-bc14-b9f04087d87b2026-05-11Adverse reactionsExact identifier
unii: 2W4A77YPAN
smooth laxPOLYETHYLENE GLYCOL 3350Walgreen Company3027af65-2f7f-472d-83f5-254d5d75013c2026-05-08WarningsExact identifier
unii: G2M7P15E5P
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM, POTASSIUM SORBATE, RESORCINUM, SALICYLICUM ACIDUM,Energique, Inc.2831d28e-9cf1-4a72-9c6c-bb014d0595582026-05-06WarningsExact identifier
unii: PDC6A3C0OX
unii: 2KR89I4H1Y
GlycerinGLYCERIN SUPPOSITORIESNeilmed Pharmaceuticals Inc.374a2ca3-ee04-09a7-e063-6394a90ab7602026-05-05WarningsExact identifier
unii: PDC6A3C0OX
MiraLAXPOLYETHYLENE GLYCOL 3350Bayer HealthCare LLC.d69ce3d4-7ca4-4fe3-b49e-6655e48d69632026-05-04WarningsExact identifier
unii: G2M7P15E5P
GAVILAXPOLYETHYLENE GLYCOL 3350Preferred Pharmaceuticals, Inc.21654def-5ae0-422d-961b-1fe2456af00a2026-05-04WarningsExact identifier
unii: G2M7P15E5P
REFRESH TEARS PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINAllergan, Inc.9e1cba7b-84ed-47f3-b19a-1219928343502026-04-24WarningsExact identifier
unii: PDC6A3C0OX
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350CARDINAL HEALTH 110, LLC. DBA LEADER04cc4f2e-1725-4710-8cfb-73a6bdf52e4f2026-04-23WarningsExact identifier
unii: G2M7P15E5P

Reported adverse events (FAERS/openFDA)#

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