NDC 64539-014

Folrex Cream

Menthol

Folrex Cream is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Catalysis, Sl. The primary component is Menthol.

Product ID64539-014_6700222a-35e6-0ce2-e053-2a91aa0ab91f
NDC64539-014
Product TypeHuman Otc Drug
Proprietary NameFolrex Cream
Generic NameMenthol
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2018-03-03
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart348
Labeler NameCatalysis, SL
Substance NameMENTHOL
Active Ingredient Strength1 mg/mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 64539-014-02

1 TUBE in 1 BOX (64539-014-02) > 100 mL in 1 TUBE (64539-014-01)
Marketing Start Date2018-03-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 64539-014-01 [64539001401]

Folrex Cream CREAM
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-03-03

NDC 64539-014-02 [64539001402]

Folrex Cream CREAM
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-03-03
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
MENTHOL1.25 mg/mL

OpenFDA Data

SPL SET ID:6689c713-3731-0760-e053-2a91aa0aca30
Manufacturer
UNII
UPC Code
  • 8470000004650
  • NDC Crossover Matching brand name "Folrex Cream" or generic name "Menthol"

    NDCBrand NameGeneric Name
    64539-014Folrex CreamFolrex Cream
    0363-1071Cherry Cough DropMenthol
    0363-1086Cherry Cough DropsMenthol
    0363-0150Cool n Heat Patch for Arm, Neck and LegMenthol
    0363-0152Cool n Heat Patch for BackMenthol
    0363-1072Honey Lemon Cough DropMenthol
    0363-1087Honey Lemon Cough DropMenthol
    0219-0203Humphreys Bendito Alcoholadomenthol
    0363-1070Menthol Cough Dropmenthol
    0363-1084Menthol Cough Dropmenthol
    0067-2067Mineral IceMenthol
    0316-0226Mineral IceMenthol
    0316-0290Mineral Ice Quick Dry FoamMenthol
    0363-0151Pain Relieving PatchMenthol
    0363-1077SF Honey Lemon Cough DropMenthol
    0363-1085SF Menthol Cough DropMenthol
    0363-0043Studio 35 Medicated BodyMenthol
    0363-0864Walgreens Cold Pain ReliefMENTHOL
    0363-0874Walgreens Cold Pain ReliefMENTHOL
    0363-0966Walgreens Sunburn ReliefMenthol

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