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 17 of 30 · 593 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Systane UltraPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.0537c23a-15f7-be64-1231-a6c93468e9a82025-07-30WarningsExact identifier
unii: 6DC9Q167V3
SystanePOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.1d679d0f-cec2-a644-79cd-079607254bb92025-07-30WarningsExact identifier
unii: 6DC9Q167V3
Systane Ultra Preservative FreePOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.751fb85f-6683-4b0a-a650-324d4a74c5de2025-07-30WarningsExact identifier
unii: 6DC9Q167V3
Systane COMPLETE PFPROPYLENE GLYCOLAlcon Laboratories, Inc.99b63d62-1cf0-4f28-8760-773917c2538a2025-07-29WarningsExact identifier
unii: 6DC9Q167V3
Doctor Butler Hemorrhoid and Fissure Advanced FormulaGLYCERIN 37.5%, LANOLIN 12.5%, LIDOCAINE 4%, ZINC OXIDE 5%Beyond Health, PAd2a769e2-afd0-aed2-e053-2995a90ad4292025-07-23WarningsExact identifier
unii: PDC6A3C0OX
GAVILAXPOLYETHYLENE GLYCOL 3350ATLANTIC BIOLOGICALS CORP.c9688f06-b6db-4afb-b8ff-ef5fb8bf99462025-07-22WarningsExact identifier
unii: G2M7P15E5P
Cold Sore Fast-Acting Pain ReliefGLYCERIN AND LIDOCAINEBlistex Inc.c7511322-dd6c-441c-bf7d-ad4f0c14956a2025-07-22WarningsExact identifier
unii: PDC6A3C0OX
Cureforte Breath ResetMOUTH SPRAYSTEEL CITY HEALTH PRIVATE LIMITED38ddf1a7-29ab-cb8d-e063-6294a90ad34c2025-07-21WarningsExact identifier
unii: PDC6A3C0OX
GoodSense Hemorrhoidal Pain ReliefGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLPerrigo Direct, Inc2e5f699d-45e8-6451-e063-6394a90a8ad82025-07-20WarningsExact identifier
unii: PDC6A3C0OX
SilkTearsGLYCERIN OPHTHALMIC SOLUTIONSilkTears3866e2c1-051b-0b01-e063-6394a90af5cf2025-07-16WarningsExact identifier
unii: PDC6A3C0OX
Nikzon HemorrhoidalGLYCERIN, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE, AND PRAMOXINE HYDROCHLORIDEGenomma Lab USA8f9a9939-2c99-489f-b597-9a51ec2684f92025-07-14WarningsExact identifier
unii: PDC6A3C0OX
Maximum Strength Hemorrhoidal Cream with AloeGLYCERIN, PHENYLEPHINE HCI, PRAMOXINE HCI, PETROLATUMChain Drug Marketing Association396ea654-8be1-591a-e063-6294a90a11e22025-07-08WarningsExact identifier
unii: PDC6A3C0OX
FluocinonideFLUOCINONIDESun Pharmaceutical Industries, Inc.5782d791-48fd-4cee-853d-235eb4d04a402025-07-08Adverse reactionsExact identifier
application number: ANDA071500
ndc (package): 51672-1386-1
ndc (package): 51672-1386-4
ndc (package): 51672-1386-2
ndc (package): 51672-1386-3
ndc (product): 51672-1386
ndc11 (package): 51672138601
rxcui: 103456
spl id: 3972605f-b081-0289-e063-6294a90ab0e3
spl set id: 5782d791-48fd-4cee-853d-235eb4d04a40
unii: 2W4A77YPAN
FluocinonideFLUOCINONIDENorthStar RxLLC6ae5147c-84c8-4fc8-9bfe-5489e856e8902025-07-03Adverse reactionsExact identifier
unii: 2W4A77YPAN
FluocinonideFLUOCINONIDESun Pharmaceutical Industries, Inc.16c7d142-e695-4e33-986f-78cb37f7b3872025-07-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 2W4A77YPAN
Hemorrhoidal CreamGLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUMTrifecta Pharmaceuticals Usa Llc38cf4e43-280b-eb96-e063-6294a90a59492025-07-02WarningsExact identifier
unii: PDC6A3C0OX
SEFUDUN FUNGAL NAIL PATCHESGLYCERINShenzhen Shandian Jingling Technology Co., Ltd.38db97d6-27c8-da99-e063-6294a90aac662025-07-01WarningsExact identifier
unii: PDC6A3C0OX
FluocinonideFLUOCINONIDESun Pharmaceutical Industries, Inc.6fe14034-7703-4aa1-a029-e97c84e024302025-07-01Adverse reactionsExact identifier
unii: 2W4A77YPAN
Glycerin LaxativeGLYCERIN LAXATIVE SUPPOSITORIESNeilmed Pharmaceuticals Inc.35cc266a-196f-16ce-e063-6394a90a24af2025-06-20WarningsExact identifier
unii: PDC6A3C0OX
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350Kesin Pharma Corporation3729a1d2-4c98-dfdf-e063-6394a90a5a872025-06-12WarningsExact identifier
unii: G2M7P15E5P

Reported adverse events (FAERS/openFDA)#

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