NDC 58484-100

Mr Dudleys Topical Pain Relief

Menthol

Mr Dudleys Topical Pain Relief is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Dudley Wellness Company Inc. The primary component is Menthol.

Product ID58484-100_e912b891-a457-4224-8a5b-7b7cb2b9a268
NDC58484-100
Product TypeHuman Otc Drug
Proprietary NameMr Dudleys Topical Pain Relief
Generic NameMenthol
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2013-05-13
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart348
Labeler NameDUDLEY WELLNESS COMPANY INC
Substance NameMENTHOL
Active Ingredient Strength3 g/100g
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 58484-100-01

.2 g in 1 BOTTLE (58484-100-01)
Marketing Start Date2013-05-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58484-100-45 [58484010045]

Mr Dudleys Topical Pain Relief CREAM
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-05-13
Inactivation Date2019-11-27

NDC 58484-100-05 [58484010005]

Mr Dudleys Topical Pain Relief CREAM
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-05-13
Inactivation Date2019-11-27

NDC 58484-100-01 [58484010001]

Mr Dudleys Topical Pain Relief CREAM
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-05-13
Inactivation Date2019-11-27

NDC 58484-100-20 [58484010020]

Mr Dudleys Topical Pain Relief CREAM
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-05-13
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
MENTHOL2.5 g/100g

OpenFDA Data

SPL SET ID:ec239064-987a-4341-acb6-b4de3a6e76be
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1291226
  • UPC Code
  • 0855640003849
  • NDC Crossover Matching brand name "Mr Dudleys Topical Pain Relief" or generic name "Menthol"

    NDCBrand NameGeneric Name
    58484-100Mr Dudleys Topical Pain ReliefMr Dudleys Topical Pain Relief
    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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