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 10 of 391 · 7,818 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Careland Lidocaine Plus Menthol Pain RelievingLIDOCAINE, MENTHOLPlanet (Anhui) Pharmaceutical Co., Ltd0f928b5b-60f5-4a45-a409-c601eb3304872026-08-26WarningsExact identifier
unii: L7T10EIP3A
PARCHE CALIENTECAPSAICINA AND MENTOLDW SUPPORT LLC59f2708e-295a-ccb3-e063-6394a90ad3952026-08-26WarningsExact identifier
unii: L7T10EIP3A
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
REGULAR STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEKROGER COMPANYb9e61a03-e008-50ab-e053-2a95a90a32102026-08-26WarningsExact identifier
unii: 92RU3N3Y1O
MAXIMUM STRENGTH ANTACIDALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONECVS PHARMACYaf71e02d-e7c7-f925-e053-2995a90a08612026-08-26WarningsExact identifier
unii: 92RU3N3Y1O
Scentsational Square Hand SanitizerHAND SANITIZERRaining Rose, Inc.59f9bacf-80dc-3468-e063-6294a90a0ae12026-08-26WarningsExact identifier
unii: 3K9958V90M
AntacidALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEPreferred Pharmaceuticals Inc.a96496ff-4b35-4ebe-a6e4-bcfa48fb13412026-08-26WarningsExact identifier
unii: 92RU3N3Y1O
IMODIUM Multi-Symptom ReliefLOPERAMIDE HYDROCHLORIDE AND DIMETHICONEKenvue Brands LLCecb91e47-2b0c-47c8-9256-4623d8bc825e2026-08-25WarningsExact identifier
unii: 92RU3N3Y1O
Acne ReliefSALICYLIC ACID,NIACINAMIDE,PANTHENOL.Guangzhou Senmai Biotechnology Co.,Ltd.59db0143-de57-59d2-e063-6294a90a32a82026-08-25WarningsExact identifier
unii: O414PZ4LPZ
WART REMOVER PATCHSSALICYLIC ACID 17%Guangxi Keyun E-commerce Co., Ltd.572b71cc-6af0-4a49-e063-6394a90afed22026-08-25WarningsExact identifier
unii: O414PZ4LPZ
WART REMOVERSALICYLIC ACIDGuangzhou Hechuang Commercial Service Co.,Ltd.59df0688-5d06-1da4-e063-6394a90a799b2026-08-25WarningsExact identifier
unii: O414PZ4LPZ
Kreain Nature Soothing CoolingKREAIN NATURE SOOTHING COOLINGWANWANG INC59e046de-2be7-26bd-e063-6394a90a4b312026-08-25WarningsExact identifier
unii: L7T10EIP3A
SpectrumETHYL ALCOHOLMedline Industries, LP428b1cb9-7db8-3141-e054-00144ff8d46c2026-08-25WarningsExact identifier
unii: 3K9958V90M
Salicylic Acid Acne Gel CleanserSALICYLIC ACID,PANTHENOLGuangzhou Senmai Biotechnology Co.,Ltd.59eb395b-493b-efc9-e063-6294a90aa8912026-08-25WarningsExact identifier
unii: O414PZ4LPZ
Mirexa MiniMIREXA MINIOncora Pharma, LLCea48f64a-9a70-40df-ba25-0983532730892026-08-25Warnings, Adverse reactionsExact identifier
unii: 935E97BOY8
TOTCLEAR SKIN WART CORN REMOVERSALICYLIC ACIDGOOD BRIDGE LLC4270e1c0-5a8a-40b6-b93e-2f95e70e34eb2026-08-25WarningsExact identifier
unii: O414PZ4LPZ
Gas ReliefSIMETHICONERugby Laboratories9353633b-5718-4366-a943-d49b8076256c2026-08-24WarningsExact identifier
unii: 92RU3N3Y1O
WART REMOVERSALICYLIC ACIDGuangzhou Hechuang Commercial Service Co.,Ltd.59c32b2b-5be0-74a8-e063-6394a90ab71f2026-08-24WarningsExact identifier
unii: O414PZ4LPZ
WISH HAND SANITIZER pink dragon blossomALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA593b3fbe-a8de-1c09-e063-6294a90adc692026-08-24WarningsExact identifier
unii: 3K9958V90M
ClaravieDIMETHICONEGentell LLC59c6da39-b5f1-8253-e063-6394a90a0e8f2026-08-24WarningsExact identifier
unii: 92RU3N3Y1O

Reported adverse events (FAERS/openFDA)#

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