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 98 of 387 · 7,740 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medicated Apricot ScrubSALICYLIC ACIDTopco Associates LLC66ccfcb7-6217-4bfb-ac11-4bcbdecb27d82026-03-03Warnings, Adverse reactionsExact identifier
unii: O414PZ4LPZ
Advanced Hand SanitizerETHYL ALCOHOLAmazon.Com Services LLC85421e9a-f1c9-4793-9479-8a072a610ed72026-03-03Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Antiseptic MouthrinseEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLAmazon.com Services LLCf13fd052-33dd-42b2-96ed-b3c4b5e869f22026-03-03Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLAmazon.com Services LLC7e628443-81b5-4728-b4c3-c02abecbdaa82026-03-03Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Aloe Vera GelLIDOCAINE HCL, MENTHOLAmazon.com Services LLC2acb1a6a-57e6-4915-b03a-89d1d2db3baf2026-03-03Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
FOOTSPA PEDIALCOHOLCHEMCO CORPORATION3886a958-d035-ed15-e063-6294a90af1b52026-03-03WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Moisturizing Hand Sanitizer Starfruit SangriaALCOHOLBath & Body Works, Inc.387caf6b-fda0-a63f-e063-6294a90a041a2026-03-03WarningsExact identifier
unii: 3K9958V90M
Gas Relief Extra StrengthSIMETHICONETOP CARE (Topco Associates LLC)ed8a723a-7dac-4670-8f02-f4154e0a36c92026-03-02WarningsExact identifier
unii: 92RU3N3Y1O
anti diarrheal anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONEHyVee Inc396ea4f5-5c3d-4cbc-acd5-09eb64c806e02026-03-02WarningsExact identifier
unii: 92RU3N3Y1O
Neutrogena Evenly Clear Acne Gel MoisturizerSALICYLIC ACIDKenvue Brands LLC3f8f344d-a468-8eb3-e063-6394a90a7dd72026-03-02WarningsExact identifier
unii: O414PZ4LPZ
HEEL PAIN RELIEF ROLL-ONLIDOCAINE AND MENTHOLGuangzhou Liuquanmiao Import & Export Trade Co., Ltd.4c06c4a4-557b-8bb1-e063-6294a90a91252026-03-02WarningsExact identifier
unii: L7T10EIP3A
Medicated Apricot ScrubSALICYLIC ACIDOld East Main Co.7c9c430b-30d8-4642-85bd-d028a9aa748a2026-03-02Warnings, Adverse reactionsExact identifier
unii: O414PZ4LPZ
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLOld East Main Co.468c9f98-b98a-4a82-a9e0-7333c4ae372f2026-03-02Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Still StandingMENTHOL, UNSPECIFIED FORMNatural Essentials Inc.66974aaf-c82f-4fe9-bfb3-3430b80ac9f22026-03-02WarningsExact identifier
unii: L7T10EIP3A
Mouth RinseEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLOld East Main Co.76554d61-ed96-4631-9140-135f1a2e282b2026-03-02Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLOld East Main Co.4ad54821-03fe-4f81-a2da-0cdab48441eb2026-03-02Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLOld East Main Co.1cfd85f3-ef19-46f6-8225-287a8a0a32fd2026-03-02Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Acne ScrubSALICYLIC ACIDOld East Main Co.f63d4184-44a2-484f-ae51-ce37e19374a22026-03-02Warnings, Adverse reactionsExact identifier
unii: O414PZ4LPZ
AlcoholALCOHOLOld East Main Co.31a38e0e-41de-4638-9e86-df1923b64d522026-03-02Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Anti-BacterialHandSpray Lavender and VanillaALCOHOLBath & Body Works, Inc.29a37aad-c6d3-b174-e063-6394a90abc3e2026-03-02WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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