FDA.reportPublic FDA data

NDC 64539-014-01 - Folrex Cream

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
64539-014
Requested NDC
64539-014-01
Package NDCs from labels
64539-014-01, 64539-014-02
Manufacturer
Catalysis, SL
Effective date
2018-03-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Folrex Cream - Catalysis, SLCatalysis, SL2018-03-09HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64539-014-022020-01-31C16284748780-19d75b9d0-069d-f424-e053-dadaa90a57ceFolrex Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64539-014-01Folrex Cream100 mL in 1 TUBECREAM1002
64539-014-02Folrex Cream1 in 1 BOXCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64539-014FOLREX CREAM (MENTHOL) CREAM [CATALYSIS, SL]2Legacy NDC, 2 package rows20180309_6689c713-3731-0760-e053-2a91aa0aca30.zip

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 48 of 391 · 7,818 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Icy Hot Pain Relieving BalmMENTHOL AND METHYL SALICYLATEChattem, Inc.40c8c02f-fa5f-4e80-81a0-48271fa6f94b2026-06-12WarningsExact identifier
unii: L7T10EIP3A
Lidocaine and MentholLIDOCAINE AND MENTHOLAdvanced Rx of Tennessee, LLC44840250-2112-6ef4-e063-6394a90acdcc2026-06-12WarningsExact identifier
unii: L7T10EIP3A
Bighero GENITAL WART REMOVERSALICYLIC ACID 17% GENITAL WART REMOVERJiangxi Yudexi Pharmaceutical Co., LTD496e178e-0172-21e6-e063-6394a90ae1ce2026-06-12WarningsExact identifier
unii: O414PZ4LPZ
Bighero Liquid Wart Corn Callus RemoverSALICYLIC ACID 17% LIQUID WART CORN CALLUS REMOVERJiangxi Yudexi Pharmaceutical Co., LTD496ef896-3c20-eec7-e063-6294a90a2ead2026-06-12WarningsExact identifier
unii: O414PZ4LPZ
BITANK Liquid WART CORN CALLUS REMOVERBITANK LIQUID WART CORN CALLUS REMOVERJiangxi Yudexi Pharmaceutical Co., LTD496f7a1e-05b4-d434-e063-6394a90afe542026-06-12WarningsExact identifier
unii: O414PZ4LPZ
Dhizhayo WART REMOVERSALICYLIC ACID 17% WART REMOVERJiangxi Yudexi Pharmaceutical Co., LTD496ff16d-a18b-c660-e063-6294a90ab8f42026-06-12WarningsExact identifier
unii: O414PZ4LPZ
CODECURE WART REMOVERSALICYLIC ACID 17% WART REMOVERJiangxi Yudexi Pharmaceutical Co., LTD4a462f8c-e49f-4d01-e063-6394a90a45442026-06-12WarningsExact identifier
unii: O414PZ4LPZ
HEALSURE WART REMOVERSALICYLIC ACID 17% WART REMOVERJiangxi Yudexi Pharmaceutical Co., LTD4a466b8e-5684-91e8-e063-6394a90a67132026-06-12WarningsExact identifier
unii: O414PZ4LPZ
HEALSURE WART MOLES REMOVERSALICYLIC ACID 17% WART MOLES REMOVERJiangxi Yudexi Pharmaceutical Co., LTD4a4693f9-37d5-b8da-e063-6394a90a4ef32026-06-12WarningsExact identifier
unii: O414PZ4LPZ
BM BM11 DROPSACIDUM SALICYLICUM, BELLADONNA, COFFEA CRUDA, GELSEMIUM, IRIS VERS, MELILOTUS OFF, SPIGELIA, USNEA BARBTotal Operations Management LLC DBA:Bestmade Natural Products Micro540ff544-b406-70e2-e063-6394a90ae4512026-06-12WarningsExact identifier
unii: O414PZ4LPZ
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBTotal Operations Management LLC DBA:Bestmade Natural Products Micro54113d1f-e8e7-6b4c-e063-6394a90a0edf2026-06-12WarningsExact identifier
unii: 059QF0KO0R
Prenate MiniASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, LEVOMEFOLATE CALCIUM, CYANOCOBALAMIN, BIOTIN, CALCIUM CARBONATE, FERROUS ASPARTO GLYCINATE, IRON, POTASSIUM IODIDE, MAGNESIUM OXIDE, DOCONEXENT AND LOWBUSH BLUEBERRYAvion Pharmaceuticals, LLC8ab766c2-d554-4141-92b2-fbe038e80c9f2026-06-12Boxed warning, Adverse reactionsExact identifier
unii: 935E97BOY8
Prenate EssentialASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, LEVOMEFOLATE CALCIUM, CYANOCOBALAMIN, BIOTIN, CALCIUM FORMATE, FERROUS ASPARTO GLYCINATE, POTASSIUM IODIDE, MAGNESIUM OXIDE, DOCONEXENT AND ICOSAPENTAvion Pharmaceuticals, LLCe5acfb2a-0959-4542-9b4c-790be194d5812026-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 935E97BOY8
Prenate Elite.BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, LEVOMEFOLATE CALCIUM, CALCIUM FORMATE, FERROUS ASPARTO GLYCINATE, CYANOCOBALAMIN, BIOTIN, POTASSIUM IODIDE, MAGNESIUM OXIDE, ZINC OXIDE AND CUPRIC OXIDEAvion Pharmaceuticals, LLC9b79c950-4312-4a53-9e36-fb8e00b053df2026-06-12Boxed warning, Adverse reactionsExact identifier
unii: 935E97BOY8
Butterflys tear MILIA REMOVERSALICYLIC ACID 1% MILIA REMOVERJiangxi Yudexi Pharmaceutical Co., LTD52226dfd-eafa-42d7-e063-6394a90a16ef2026-06-12WarningsExact identifier
unii: O414PZ4LPZ
Butterflys tear WART REMOVERSALICYLIC ACID 17% SKIN TAG REMOVERJiangxi Yudexi Pharmaceutical Co., LTD52230e87-2358-1126-e063-6394a90aef432026-06-12WarningsExact identifier
unii: O414PZ4LPZ
Butterflys tear WART REMOVER PatchesSALICYLIC ACID 1% WART REMOVER PATCHESJiangxi Yudexi Pharmaceutical Co., LTD52a1905e-c897-9dd1-e063-6294a90af10c2026-06-12WarningsExact identifier
unii: O414PZ4LPZ
Smart Care Hand Sanitizer Fall Scents-AppleALCOHOLShenzhen Lantern Scicence Co.,Ltd.541a09b6-2928-9fbf-e063-6394a90a3c4d2026-06-12WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer Holiday-Spiced CranberryALCOHOLShenzhen Lantern Scicence Co.,Ltd.541a41cf-5c63-c6fc-e063-6294a90abfcc2026-06-12WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer Holiday-MistletoeALCOHOLShenzhen Lantern Scicence Co.,Ltd.541a8aa9-1d4b-28ec-e063-6294a90aa34e2026-06-12WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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