NDC 65121-828

PainKoolers

Menthol, Capsaicin

PainKoolers is a Topical Patch in the Human Otc Drug category. It is labeled and distributed by Pure Source, Llc. The primary component is Menthol; Capsaicin.

Product ID65121-828_4830e546-7dda-3fb5-e054-00144ff8d46c
NDC65121-828
Product TypeHuman Otc Drug
Proprietary NamePainKoolers
Generic NameMenthol, Capsaicin
Dosage FormPatch
Route of AdministrationTOPICAL
Marketing Start Date2014-12-30
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart348
Labeler NamePure Source, LLC
Substance NameMENTHOL; CAPSAICIN
Active Ingredient Strength5 g/100g; g/100g
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 65121-828-05

5 PATCH in 1 BOX (65121-828-05) > 8 g in 1 PATCH
Marketing Start Date2017-02-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65121-828-05 [65121082805]

PainKoolers PATCH
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-02-10

Drug Details

Active Ingredients

IngredientStrength
MENTHOL5 g/100g

OpenFDA Data

SPL SET ID:f8f8d9b6-0781-4a42-ab03-3fd2e8ea59ba
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1300889
  • NDC Crossover Matching brand name "PainKoolers" or generic name "Menthol, Capsaicin"

    NDCBrand NameGeneric Name
    65121-828PainKoolersMENTHOL, CAPSAICIN
    46144-162ALLEVESSMENTHOL, CAPSAICIN
    73454-002Better Nature Pain Relief CreamMenthol, Capsaicin
    14448-316BLUE SPRING Foot and Leg Comfort Cream with Pain ReliefMENTHOL, CAPSAICIN
    69650-001CapmentMenthol, Capsaicin
    69889-027CMX Topical PainMENTHOL, CAPSAICIN
    79551-002Complete hempMENTHOL, CAPSAICIN
    46144-941FESIMENTHOL, CAPSAICIN
    81765-184FORS PAIN RELIEFMENTHOL, CAPSAICIN
    71178-775FYZICAL SPORTS Pain Relief 1-COOLMENTHOL, CAPSAICIN
    72514-353InstaSoothe Pain ReliefMENTHOL, CAPSAICIN
    33261-884MEDROXMENTHOL, CAPSAICIN
    50436-9991MEDROXMENTHOL, CAPSAICIN
    68258-2993MEDROXMENTHOL, CAPSAICIN
    68788-6755MEDROXMENTHOL, CAPSAICIN
    69329-013MENDEXMENTHOL, CAPSAICIN
    71205-334Menthozen HydrogelMENTHOL, CAPSAICIN
    71574-601Menthozen HydrogelMENTHOL, CAPSAICIN
    71856-271N-LABS SOLAR MAX Topical AnalgesicMENTHOL, CAPSAICIN
    70745-749Nopiate Topical Pain ReliefMENTHOL, CAPSAICIN
    70859-022NuDroxicinMENTHOL, CAPSAICIN
    46144-163RELIEVERMENTHOL, CAPSAICIN
    54162-560REME DMenthol, Capsaicin
    73279-0009Toplast Cool and Hot Menthol 1.25percent plus Capsaicin 0.025percentMenthol, Capsaicin
    73279-0016Toplast Cool and Hot Menthol 1.25percent plus Capsaicin 0.025percentMenthol, Capsaicin
    73279-0010Toplast Cool and Hot Menthol 4percent plus Capsaicin 0.025percentMenthol, Capsaicin
    73279-0017Toplast Cool and Hot Menthol 4percent plus Capsaicin 0.025percentMenthol, Capsaicin
    73279-0011Toplast Cool and Hot Menthol 5percent plus Capsaicin 0.025percentMenthol, Capsaicin
    73279-0018Toplast Cool and Hot Menthol 5percent plus Capsaicin 0.025percentMenthol, Capsaicin

    Trademark Results [PainKoolers]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PAINKOOLERS
    PAINKOOLERS
    86873849 not registered Dead/Abandoned
    GA HEALTH & BEAUTY CO LIMITED
    2016-01-13

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.