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 66 of 389 · 7,761 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WalgreensSALICYLIC ACIDWalgreensec1a09dc-7fb6-6d89-e053-2a95a90a48412026-05-05WarningsExact identifier
unii: O414PZ4LPZ
MouthwashEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLDISCOUNT DRUG MARTd00e472f-78f2-3d36-e053-2995a90ac2672026-05-05WarningsExact identifier
unii: L7T10EIP3A
DISCOUNT DRUG MART Original Flavor MouthwashEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLDISCOUNT DRUG MART73e1b1f3-01dd-4609-9825-b598c6745c732026-05-05WarningsExact identifier
unii: L7T10EIP3A
Life is healed Daily MoisturizingDIMETHICONEApollo Health and Beauty Caree31f3fcf-cab7-4e25-8ab2-0d0a4d526faf2026-05-05WarningsExact identifier
unii: 92RU3N3Y1O
GuardALCOHOLApollo Health and Beauty Carefdc99948-1bd0-cdf2-e053-6394a90aaf972026-05-05WarningsExact identifier
unii: 3K9958V90M
MoxieETHYL ALCOHOLApollo Health and Beauty Care3752d034-d4b4-47ab-b1bb-066cef7fde752026-05-05WarningsExact identifier
unii: 3K9958V90M
Follence MedicatedSALICYLIC ACIDGuangzhou Pallas Cosmetics Co.,Ltd.51178cb9-f83f-2459-e063-6394a90a3f1e2026-05-05WarningsExact identifier
unii: O414PZ4LPZ
AlcoholETHYL ALCOHOLSam's West Inc16625ecb-11c3-a097-e063-6294a90af3d52026-05-05WarningsExact identifier
unii: 3K9958V90M
Biofreeze Triple Target GelCAMPHOR, CAPSAICIN, MENTHOLReckitt Benckiser LLC511852c8-7428-3234-e063-6394a90a5bc22026-05-05WarningsExact identifier
unii: L7T10EIP3A
PEGO Acne Buster Salicylic Acid Drying SerumZINC OXIDE,NIACINAMIDE,COLLOIDAL SULFUR,AZELAIC ACID,SALICYLIC ACID.Guangzhou Senmai Biotechnology Co.,Ltd.511eaced-c4d8-ae94-e063-6394a90a320e2026-05-05WarningsExact identifier
unii: O414PZ4LPZ
Scott Moisturizing Foam Hand SanitizerALCOHOLKimberly-Clark25900e62-c8fd-4942-ad38-4b99243084602026-05-05WarningsExact identifier
unii: 3K9958V90M
Loperamide Hydrochloride and SimethiconeLOPERAMIDE HYDROCHLORIDE AND SIMETHICONEAurohealth LLCd388f536-704a-4d6e-ab27-c1a96e9394132026-05-05WarningsExact identifier
unii: 92RU3N3Y1O
Rugby Gas reliefSIMETHICONERugby Laboratories9b84f74f-8609-489d-b411-3103afa1b5c22026-05-04WarningsExact identifier
unii: 92RU3N3Y1O
Recuren Plus Balanced ScalpSALICYLIC ACIDREGENEREN PLUS LTD50c27b0f-9bf5-de9c-e063-6394a90af41a2026-05-04WarningsExact identifier
unii: O414PZ4LPZ
Equate BeautySALICYLIC ACIDWALMART INCe4e3226e-61f3-2264-e053-2a95a90a8e782026-05-04WarningsExact identifier
unii: O414PZ4LPZ
Lidothol ESMENTHOL 5%, LIDOCAINE 4%Clinic Pharmab456b63b-cead-4bed-aa2e-881fe88a77dc2026-05-04Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Zinc Oxide with Menthol and White PetrolatumMENTHOL, ZINC OXIDE, WHITE PETROLATUMAldermed Inc.f993fc0a-bd80-4345-a948-65ac03f910e22026-05-04WarningsExact identifier
unii: L7T10EIP3A
Hand Sanitizer Lemon ScentedALCOHOLTaizhou Juheng Biotechnology Co., Ltd.21387234-0ac9-499d-97bf-90bccc4782ad2026-05-04WarningsExact identifier
unii: 3K9958V90M
Daily MoisturizerLOTIONWalgreensfc65f673-b23d-1ffa-e053-6394a90a09662026-05-03WarningsExact identifier
unii: 92RU3N3Y1O
WalgreensETHYL ALCOHOLWalgreensf1dca9c5-ef6a-2239-e053-2995a90a50e72026-05-03WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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