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 58 of 389 · 7,761 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 059QF0KO0R
Phazyme UltimateSIMETHICONEC.B. Fleet Company, Inc.c8e9f6ac-2db2-4d21-a4b1-5ca6c31056622026-05-20WarningsExact identifier
unii: 92RU3N3Y1O
good sense anti diarrheal anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONEL. Perrigo Company2cda08a8-3f5e-430c-84a3-d29b97d647af2026-05-20WarningsExact identifier
unii: 92RU3N3Y1O
AFTER CAREDIMETHICONEMerz North Americac19c5ffe-3b62-43e1-83c2-d89c7b9aa2ae2026-05-20WarningsExact identifier
unii: 92RU3N3Y1O
Smart Care Hand Sanitizer with Beaded Wristlet Vanilla BlossomALCOHOLShenzhen Lantern Scicence Co.,Ltd.5227736d-c13b-652b-e063-6394a90adc6b2026-05-19WarningsExact identifier
unii: 3K9958V90M
Biofreeze Triple Target Roll-OnCAMPHOR, CAPSAICIN, MENTHOLReckitt Benckiser LLC5089c088-3026-233a-e063-6394a90a93b62026-05-19WarningsExact identifier
unii: L7T10EIP3A
CeraVe Developed with Dermatologists BHA Exfoliating Toner Acne TreatmentSALICYLIC ACIDL'Oreal USA Products Inc434ab915-faa3-40a7-8f8d-ff0eeef95e1f2026-05-19WarningsExact identifier
unii: O414PZ4LPZ
Smart Care Hand Sanitizer with Beaded Wristlet Lily WaterALCOHOLShenzhen Lantern Scicence Co.,Ltd.523a8084-a67b-77da-e063-6394a90a4ff92026-05-19WarningsExact identifier
unii: 3K9958V90M
TobaccotoxAVENA SATIVA, KALI PHOSPHORICUM, CACTUS GRANDIFLORUS, EUCALYPTUS GLOBULUS, LOBELIA INFLATA, DAPHNE INDICA, MENTHOLUM, IGNATIA AMARA, NUX VOMICA, STAPHYSAGRIA, TABACUM, BENZINUM, NAPHTHALINUMBioActive Nutritional, Inc.b286c7fd-e456-49bf-bb82-0fd32eeb37232026-05-18WarningsExact identifier
unii: L7T10EIP3A
Berry Bougie Hand SanitizerETHYL ALCOHOLPEACH LAYNE, LLC51d843af-dad3-75fd-e063-6394a90a6b572026-05-18WarningsExact identifier
unii: 3K9958V90M
MORKORIA BEE VENOM WART REMOVERSALICYLIC ACID 17% BEE VENOM 1% BEE VENOM WART REMOVERJiangxi Yudexi Pharmaceutical Co., LTD4a1e3a7a-0570-a95f-e063-6394a90adbc72026-05-18WarningsExact identifier
unii: O414PZ4LPZ
Meijer Hand Sanitizer Fall Harvest AppleALCOHOLShenzhen Lantern Scicence Co.,Ltd.5213f632-33a0-aa45-e063-6294a90a71a02026-05-18WarningsExact identifier
unii: 3K9958V90M
Salicylic acidCALLUS REMOVERSPremier Brands of America Inc.0b637f58-5604-454d-99ba-24115113ac3d2026-05-18WarningsExact identifier
unii: O414PZ4LPZ
Meijer Hand Sanitizer Fall Harvest Pumpkin SpiceALCOHOLShenzhen Lantern Scicence Co.,Ltd.522413eb-d7e3-65ea-e063-6394a90a942b2026-05-18WarningsExact identifier
unii: 3K9958V90M
Skin Tag RemoveSKIN TAG REMOVEShenzhen Earth Surface Trading Co., Ltd.5224362c-967e-9b98-e063-6294a90a98672026-05-18WarningsExact identifier
unii: O414PZ4LPZ
Smart Care Hand Sanitizer with Beaded Wristlet RosewateALCOHOLShenzhen Lantern Scicence Co.,Ltd.52245438-751b-b52e-e063-6394a90aeb472026-05-18WarningsExact identifier
unii: 3K9958V90M
Blistex Maximum Hydration LipCAMPHOR (SYNTHETIC), DIMETHICONE, UNSPECIFIED, MENTHOL, UNSPECIFIED FORM, AND PHENOLBlistex Inc.fed223bc-edf3-46eb-b678-acb906f9ef112026-05-18WarningsExact identifier
unii: L7T10EIP3A
unii: 92RU3N3Y1O
Tiger BalmCAMPHOR (SYNTHETIC), MENTHOL, AND CAPSICUMHaw Par Healthcare Ltd.5066dc10-e4d5-49e9-9a5f-0ac220cfbf282026-05-18WarningsExact identifier
unii: L7T10EIP3A
KOOL AID HAND SANITIZER TROPICAL PUNCHALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5208adea-27d8-81a3-e063-6294a90afc802026-05-17WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLGuangdong Yanze Biotechnology Co., Ltd.520e7b2b-e24e-5ce7-e063-6294a90a986d2026-05-17WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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