FDA.reportPublic FDA data

NDC 63629-8656-01 - Fluocinolone acetonide

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
63629-8656
Requested NDC
63629-8656-01
Package NDCs from labels
63629-8656-1, 63629-8656-01
Manufacturer
Bryant Ranch Prepack
Effective date
2024-05-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Fluocinolone acetonide - Bryant Ranch PrepackBryant Ranch Prepack2024-05-24HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-8656-1Fluocinolone acetonide1 in 1 CARTONOIL1109
63629-8656-1Fluocinolone acetonide118.28 mL in 1 BOTTLEOIL118.28109

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8656FLUOCINOLONE ACETONIDE OIL [BRYANT RANCH PREPACK]109Current NDC, Legacy NDC, 2 package rows20240807_c9e2b99e-1f64-4c21-99a7-a18963be2237.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8656-1ML - Milliliter63629-86566171836c-0fae-4bdf-88e6-de2f2985862e12023-08-08

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 30 of 35 · 695 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fluocinolone AcetonideFLUOCINOLONE ACETONIDEBryant Ranch Prepack8ca4528d-7afa-451e-97ae-9c1c21c07a6e2024-10-18Warnings, Adverse reactionsExact identifier
unii: 0CD5FD6S2M
Genuine First Aid Alcohol Cleansing PadISOPROPYL ALCOHOLGFA Production (Xiamen) Co., Ltd.af090168-f9b3-c2fa-e053-2a95a90a1b762024-10-15WarningsExact identifier
unii: ND2M416302
Isopropyl Alcohol Cleansing PadISOPROPYL ALCOHOLHubei Changjian Medical Products Co., Ltd.e6f9a23b-ae6e-4fce-b66d-b602038dc7462024-10-11WarningsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLBecton Dickinson and Company7ae72375-ffed-42c8-9506-051861ea68fc2024-10-03WarningsExact identifier
unii: ND2M416302
Soothe XP Preservative FreeLIGHT MINERAL OIL AND MINERAL OILBausch & Lomb Incorporatedb254d885-6d49-4c95-b6be-cfdad49c85e62024-09-20WarningsExact identifier
unii: N6K5787QVP
Soothe XPLIGHT MINERAL OIL AND MINERAL OILBausch & Lomb Incorporatedc0f053da-8d22-433e-a36e-79cf15ad387f2024-09-20WarningsExact identifier
unii: N6K5787QVP
WalmartISOPROPYL ALCOHOLWalmart Inc.d2b9f182-c341-c3b0-e053-2a95a90ac5a72024-09-18WarningsExact identifier
unii: ND2M416302
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLStrategic Sourcing Services LLC2216a551-9fbe-3721-e063-6294a90af13d2024-09-14WarningsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLembecta Medical II, LLCe9576c62-6b6e-4c51-a162-0f93f7ffd7dd2024-09-13WarningsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLWildman Business Group1fd15c0f-7119-0712-e063-6294a90a96252024-09-01WarningsExact identifier
unii: ND2M416302
Fluocinolone Acetonide Topical Solution USP, 0.01%FLUOCINOLONE ACETONIDE TOPICAL SOLUTION USP, 0.01%Bryant Ranch Prepackce89966d-d7ea-4986-936e-6d46aee497cd2024-08-20Adverse reactionsExact identifier
unii: 0CD5FD6S2M
Keep Going Sting Relief PadBENZOCAINE AND ISOPROPYL ALCOHOLJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.36c11178-b70f-4355-8823-c2b72598dae52024-08-08WarningsExact identifier
unii: ND2M416302
Keep Going Alcohol Prep PadISOPROPYL ALCOHOLJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.f67dd10c-746f-4c21-92f1-741f86218a692024-08-08WarningsExact identifier
unii: ND2M416302
SynalarFLUOCINOLONE ACETONIDEMedimetriks Pharmaceuticals, Inc.5af2e4c1-082b-48a0-aae7-72d4a68cbb2d2024-07-18Adverse reactionsExact identifier
unii: 0CD5FD6S2M
Ultra Prep Alcohol Prep PadsISOPROPYL ALCOHOLQuality Medical Products USA, Inc.f81a63dd-a699-459f-ab52-f63a6550b6802024-07-16WarningsExact identifier
unii: ND2M416302
Quality ChoiceISOPROPYL ALCOHOLChain Drug Marketing Association Inc1262c5d7-63ef-f1c1-e063-6294a90a1f0f2024-07-02WarningsExact identifier
unii: ND2M416302
Genuine First Aid Alcohol Cleansing PadISOPROPYL ALCOHOLGFA Production(Xiamen) Co.,Ltdd8842561-f61e-4cac-80d6-001e5369f0d12024-06-25WarningsExact identifier
unii: ND2M416302
SwabsISOPROPYL ALCOHOLMcKesson4650c945-8e38-5ad9-e054-00144ff8d46c2024-06-07WarningsExact identifier
unii: ND2M416302
Fluocinolone acetonideFLUOCINOLONE ACETONIDEBryant Ranch Prepackc9e2b99e-1f64-4c21-99a7-a18963be22372024-05-24Adverse reactionsExact identifier
application number: ANDA202848
ndc (package): 63629-8656-1
ndc (product): 63629-8656
ndc11 (package): 63629865601
spl id: fc6d4410-b1a1-4a02-a893-2448c8c215a0
spl set id: c9e2b99e-1f64-4c21-99a7-a18963be2237
unii: 0CD5FD6S2M
Debrox KidsISOPROPYL ALCOHOLMedtech Products Inc.f42eee70-c4ee-44ad-85d5-a06d98ecb8b02024-05-09WarningsExact identifier
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

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