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 16 of 35 · 696 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dukal Sterile Alcohol SwabstickISOPROPYL ALCOHOLDukal LLC8e47e9ad-cea4-76a4-e053-2a95a90ae7802025-11-19WarningsExact identifier
unii: ND2M416302
Alcohol Prep PadISOPROPYL ALCOHOLShandong Lianfa Medical Plastic Products CO.,LTD435fd382-d2f5-b07f-e063-6294a90a7d8a2025-11-14WarningsExact identifier
unii: ND2M416302
BodyMed Alcohol Prep PadALCOHOL PREP PADBoxout, LLCd30dce9c-8d12-4c71-e053-2995a90a12052025-11-14WarningsExact identifier
unii: ND2M416302
Alcohol Prep PadsISOPROPYL ALCOHOLShandong Lianfa Medical Plastic Products CO.,LTD43401653-b260-e86d-e063-6294a90abb3f2025-11-13WarningsExact identifier
unii: ND2M416302
Swimmers EarCLEARCANALNeilmed Pharmaceuticals Inc.43778b02-e90b-36b7-e063-6394a90ab62b2025-11-13WarningsExact identifier
unii: ND2M416302
CVS Health Isopropyl Rubbing Alcohol PadsISOPROPYL ALCOHOLCVS Healthc8d4f3b3-166c-2411-e053-2a95a90abb4a2025-11-12WarningsExact identifier
unii: ND2M416302
FLUOCINOLONE ACETONIDEFLUOCINOLONE ACETONIDEBryant Ranch Prepackf7861aba-f199-4fe4-90cc-bebea55b3b5f2025-11-11Adverse reactionsExact identifier
unii: 0CD5FD6S2M
Fluocinolone AcetonideFLUOCINOLONE ACETONIDEBryant Ranch Prepack1539d6ac-b527-4ff0-afe4-083ceac655f32025-11-11Adverse reactionsExact identifier
unii: 0CD5FD6S2M
Isopropyl Rubbing Alcohol 70%ISOPROPYL ALCOHOLJell Pharmaceuticals Pvt. Ltd.cd9884b7-6df3-5ece-e053-2a95a90ab20e2025-11-11WarningsExact identifier
unii: ND2M416302
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLJell Pharmaceuticals Pvt. Ltd.cd8643ef-dc83-8bc1-e053-2995a90a007b2025-11-11WarningsExact identifier
unii: ND2M416302
Fluocinolone AcetonideFLUOCINOLONE ACETONIDEBryant Ranch Prepack8b6cbb2e-9c9a-4bef-bf06-f62bdbed8c8b2025-11-10Warnings, Adverse reactionsExact identifier
unii: 0CD5FD6S2M
Pocket NurseISOPROPYL ALCOHOLPocket Nurse Enterprises, LLC42ded32e-15d9-8b03-e063-6394a90ad6bc2025-11-06WarningsExact identifier
unii: ND2M416302
ChloraPrep One-StepCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLCareFusion 213, LLC85291b2b-40b9-07fa-e053-2a91aa0a84e42025-11-04WarningsExact identifier
unii: ND2M416302
ChloraPrep One-StepCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLCareFusion 213, LLC85416361-90b5-3efa-e053-2a91aa0af4312025-11-03WarningsExact identifier
unii: ND2M416302
ChloraPrep One-StepCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLCareFusion 213, LLC8528a4f5-5ff4-45f3-e053-2991aa0a804c2025-11-03WarningsExact identifier
unii: ND2M416302
ChloraPrep One-StepCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLCareFusion 213, LLC8529596f-37e4-c44e-e053-2a91aa0ad0142025-10-30WarningsExact identifier
unii: ND2M416302
Fluocinolone acetonideFLUOCINOLONE ACETONIDEBryant Ranch Prepackf674a0c0-df04-47e8-8d3f-a370182a596a2025-10-29Adverse reactionsExact identifier
application number: ANDA202848
unii: 0CD5FD6S2M
ChloraPrep One-StepCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLCareFusion 213, LLC8578da30-a155-2505-e053-2991aa0a2c042025-10-29WarningsExact identifier
unii: ND2M416302
American Red Cross 70% Isopropyl AlcoholISOPROPYL ALCOHOL(70%CONC.)MY IMPORTS USA LLC421d7bd9-c893-ec97-e063-6394a90a4b282025-10-27WarningsExact identifier
unii: ND2M416302
OFTAL-MYCIN LUBRICANT OPHTHALMICLIGHT MINERAL, WHITE PETROLATUMGRANDALL DISTRIBUTING, LLC298db04a-21a9-e46e-e063-6294a90acee22025-10-27WarningsExact identifier
unii: N6K5787QVP

Reported adverse events (FAERS/openFDA)#

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