FDA.reportPublic FDA data

NDC 63629-9584-01 - Fluocinolone Acetonide Topical Solution USP, 0.01%

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
63629-9584
Requested NDC
63629-9584-01
Package NDCs from labels
63629-9584-1, 63629-9584-01
Manufacturer
Bryant Ranch Prepack
Effective date
2024-08-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Fluocinolone Acetonide Topical Solution USP, 0.01% - Bryant Ranch PrepackBryant Ranch Prepack2024-08-20HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-9584-1Fluocinolone Acetonide Topical Solution USP, 0.01%60 mL in 1 BOTTLESOLUTION60104
63629-9584-1Fluocinolone Acetonide Topical Solution USP, 0.01%1 in 1 CARTONSOLUTION1104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-9584FLUOCINOLONE ACETONIDE TOPICAL SOLUTION USP, 0.01% SOLUTION [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 2 package rows20240821_ce89966d-d7ea-4986-936e-6d46aee497cd.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-9584-1ML - Milliliter63629-95842b794636-6647-4316-8e52-a9484ed7ef6912023-02-06

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 13 · 245 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DERMA-SMOOTHE/FSFLUOCINOLONE ACETONIDERoyal Pharmaceuticals113e167a-a9fe-440e-9446-d6d87963ef462026-06-09Warnings, Adverse reactionsExact identifier
unii: 0CD5FD6S2M
fluocinolone acetonideFLUOCINOLONE ACETONIDEBryant Ranch Prepack4790bdfa-c964-4c3e-9d01-c2fb23a0172e2026-05-26Warnings, Adverse reactionsExact identifier
unii: 0CD5FD6S2M
Alka-Seltzer OriginalANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATESelect Consumer Group3ca80d74-1e8b-49d9-e063-6394a90a43122026-05-24WarningsExact identifier
unii: XF417D3PSL
Systane Pro PFPROPYLENE GLYCOLAlcon Laboratories, Inc.a12baf3d-f22b-4c9f-a4c8-4e0d09f6d6f12026-05-12WarningsExact identifier
unii: 6DC9Q167V3
Market Basket Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEDemoulas Super Markets, Inc.e15439c7-0e3c-7752-e053-2995a90a1a402026-05-11WarningsExact identifier
unii: XF417D3PSL
Meijer Effervescent Antacid and Pain ReliefASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATEMeijer Distribution Inc7305972b-aa0f-4daa-e053-2991aa0adfd72026-05-11WarningsExact identifier
unii: XF417D3PSL
Fluocinolone acetonideFLUOCINOLONE ACETONIDEA-S Medication Solutions09284ede-6be9-4192-b178-567b3c6265bb2026-05-08Warnings, Adverse reactionsExact identifier
unii: 0CD5FD6S2M
CLENPIQSODIUM PICOSULFATE, MAGNESIUM OXIDE, AND ANHYDROUS CITRIC ACIDFerring Pharmaceuticals Inc.e95fff66-4ec0-4001-a727-33e66a5ec7d52026-04-15Warnings, Adverse reactionsExact identifier
unii: XF417D3PSL
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
Fluocinolone Acetonide Topical Solution USP, 0.01%FLUOCINOLONE ACETONIDE TOPICAL SOLUTION USP, 0.01%Encube Ethicals, Inc.3fb00d90-6a5b-4e95-ab6b-f5b102ff0f362026-03-18Adverse reactionsExact identifier
application number: ANDA209913
ndc (product): 21922-003
rxcui: 1191310
spl id: 2a5cbd76-85fe-4c9c-89b9-7c5924c82c6f
spl set id: 3fb00d90-6a5b-4e95-ab6b-f5b102ff0f36
unii: 0CD5FD6S2M
Neo-SynalarNEOMYCIN SULFATE AND FLUOCINOLONE ACETONIDEEurofarma, Inc.1141956e-8a4c-4f80-95d1-f15bdb57fdf62026-03-18Warnings, Adverse reactionsExact identifier
unii: 0CD5FD6S2M
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
Fluocinolone Acetonide OilFLUOCINOLONE ACETONIDERising Pharma Holdings, Inc.79591576-1eab-48c5-b0a6-e205b3cc097e2026-03-09Warnings, Adverse reactionsExact identifier
unii: 0CD5FD6S2M
Fluocinolone Acetonide OilFLUOCINOLONE ACETONIDERising Pharma Holdings, Inc.f45b0ef2-1702-4d21-8ac8-7747693045952026-03-09Warnings, Adverse reactionsExact identifier
unii: 0CD5FD6S2M
Kidnex IVGINKGO BILOBA, ALPHA-KETOGLUTARICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MALICUM ACIDUM, PYRUVIC ACID, SUCCINICUM ACIDUM, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, GERMANIUM SESQUIOXIDE, MERCURIUS VIVUS, NUX VOMICA, KIDNEY (SUIS), LYMPH NODE (SUIS), NAPHTHOCHINONUM, NATRUM OXALACETICUM, PHOSPHORUS, URINARY BLADDER (SUIS), ACONITICUM ACIDUM, CIS-Energique, Inc.23de6b8e-7622-4ba6-89f7-37bd151687e22026-02-26WarningsExact identifier
unii: XF417D3PSL
Leader Extra Strength Effervescent Antacid and Pain RelieverASPIRIN, CITRIC ACID, SODIUM BICARBONATECardinal Healthc5d7bf5f-3e59-52f2-e053-2a95a90a4a002026-02-25WarningsExact identifier
unii: XF417D3PSL
fluocinolone acetonideFLUOCINOLONE ACETONIDEANI Pharmaceuticals, Inc.50e7006d-a51b-49aa-8e1c-330340e7bf822026-02-23Adverse reactionsExact identifier
unii: 0CD5FD6S2M
Fluocinolone AcetonideFLUOCINOLONE ACETONIDEANI Pharmaceuticals, Inc.622c9804-0be0-4dec-a6ba-5cf4b5578a842026-02-23Adverse reactionsExact identifier
unii: 0CD5FD6S2M

Reported adverse events (FAERS/openFDA)#

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