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 70 of 389 · 7,761 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Salicylic Acid 0.5% Body SerumSALICYLIC ACIDDeciem5036dc50-e95c-ea8d-e063-6394a90a6cfe2026-04-24WarningsExact identifier
unii: O414PZ4LPZ
SALICYLIC ACIDSALICYLIC ACIDAcella Pharmaceuticals, LLC572171f7-832f-4710-b888-eef5638fc9d42026-04-24Adverse reactionsExact identifier
unii: O414PZ4LPZ
Foaming Sanitizing HandALCOHOLKutol Products Companyb2e22e51-88f5-4391-8705-3855c1645d802026-04-24WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer Amber Breeze ScentedALCOHOLFourstar Group USA, Inc.eb39678d-7576-4147-be02-b7779a5758282026-04-24WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer Kick Off ScentedALCOHOLFourstar Group USA, Inc.860f25c3-54b0-4438-ba97-0fc81cf350442026-04-24WarningsExact identifier
unii: 3K9958V90M
SOMBRA WARM THERAPYMENTHOL CAMPHORSOMBRA COSMETICS INC.de78dba9-53b3-4dbd-9dd2-6a692378da342026-04-24WarningsExact identifier
unii: L7T10EIP3A
Prenatal Plus VitaminsPRENATAL WITH FERROUS FUMARATE AND FOLIC ACIDREMEDYREPACK INC.1b8ef3ea-5563-48ef-ba5e-27e0b454efb92026-04-23Boxed warningExact identifier
unii: 935E97BOY8
Wart removerSALICYLIC ACIDDr.Ramay Beauty Science Inc502ca820-2f62-dfda-e063-6394a90a35572026-04-23WarningsExact identifier
unii: O414PZ4LPZ
ProBliva Folliculitis .shampoo.SELENIUMDISULFIDE 1%CAVTECH HOLDING LLC502caa29-f817-cc12-e063-6394a90a22402026-04-23WarningsExact identifier
unii: O414PZ4LPZ
SOUR LEMON HAND SANITIZER Island Coco ScentETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO9e4d9add-0a02-4cce-91e0-7c3ce3ad5cb22026-04-23WarningsExact identifier
unii: 3K9958V90M
SOUR LEMON HAND SANITIZER Sugar Lemon ScentETHYL ALCOHOLDiamond Life Cosmetics Trading FZCObaa5166d-e41f-46aa-adae-038f444bb54e2026-04-23WarningsExact identifier
unii: 3K9958V90M
Childrens Emetrol Multi Symptom Upset Stomach ReliefCHILDRENS EMETROL MULTI-SYMPTOM UPSET STOMACH RELIEFWellSpring Pharmaceutical Corporationfe9ccc29-3cca-4666-9bb5-abb41816b3f52026-04-23WarningsExact identifier
unii: 92RU3N3Y1O
Folic AcidFOLIC ACIDBryant Ranch Prepacka1b71c5d-c842-43fd-9557-2bb4e934b9142026-04-23Warnings, Adverse reactionsExact identifier
unii: 935E97BOY8
Little Remedies Gas Relief DropsSIMTHICONEMedtech Products Inc.874d3f1d-1e4a-49ab-8285-4d6bf2601d5e2026-04-23WarningsExact identifier
unii: 92RU3N3Y1O
FRESH FEELS HAND SANITIZER MIST LAVENDER SCENTETHYL ALCOHOLAmber Glow Cosmetics Limited8efafedf-a66e-44a3-b2af-700292f1d0012026-04-23WarningsExact identifier
unii: 3K9958V90M
MISTIFY WHIPPED STRAWBERRY HYDRATING HAND SANITISERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5006097e-16e6-d180-e063-6394a90ae0c22026-04-22WarningsExact identifier
unii: 3K9958V90M
BYNISEP 5% MINOXIDIL HAIR GROWTH SERUMHAIR GROWTH SERUMPutian Licheng District Zhijiancheng Trading Co., Ltd.409de2af-f6f6-8181-e063-6294a90a0b4b2026-04-22WarningsExact identifier
unii: 3K9958V90M
BYNISEP 5% MINOXIDIL HAIR GROWTH SERUMMINOXIDILPutian Licheng District Zhijiancheng Trading Co., Ltd.5009b231-23c3-7356-e063-6394a90a569f2026-04-22WarningsExact identifier
unii: 3K9958V90M
Zitsticka Killa Acne Extra StrengthSALICYLIC ACIDBrndxl LLC463db517-be07-8c90-e063-6394a90a4c8c2026-04-22WarningsExact identifier
unii: O414PZ4LPZ
ZO Skin Health Oil Control Pads Acne TreatmentSALICYLIC ACIDZO Skin Health, Inc.84283a64-8f31-4e98-ad04-948dbe94887d2026-04-22WarningsExact identifier
unii: O414PZ4LPZ

Reported adverse events (FAERS/openFDA)#

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