NDC 71798-006

PS

Menthol

PS is a Topical Gel in the Human Otc Drug category. It is labeled and distributed by New Leaf Pharmaceutical, Llc. The primary component is Menthol, Unspecified Form.

Product ID71798-006_9ce98dc6-3354-52a5-e053-2995a90a9a9c
NDC71798-006
Product TypeHuman Otc Drug
Proprietary NamePS
Generic NameMenthol
Dosage FormGel
Route of AdministrationTOPICAL
Marketing Start Date2020-04-01
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart348
Labeler NameNew Leaf Pharmaceutical, LLC
Substance NameMENTHOL, UNSPECIFIED FORM
Active Ingredient Strength11 g/10.5mL
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 71798-006-03

88.7 mL in 1 TUBE (71798-006-03)
Marketing Start Date2020-04-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71798-006-03 [71798000603]

PS GEL
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2020-04-01

Drug Details

Active Ingredients

IngredientStrength
MENTHOL, UNSPECIFIED FORM10.5 g/10.5mL

OpenFDA Data

SPL SET ID:9ce98dc6-3353-52a5-e053-2995a90a9a9c
Manufacturer
UNII
UPC Code
  • 0860340001811
  • NDC Crossover Matching brand name "PS" or generic name "Menthol"

    NDCBrand NameGeneric Name
    71798-005PSPS
    71798-006PSPS
    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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