NDC 54305-153

COOL RELIEF ORAL ANESTHETIC

Menthol

COOL RELIEF ORAL ANESTHETIC is a Oral Lozenge in the Human Otc Drug category. It is labeled and distributed by Ricola Ag. The primary component is Menthol.

Product ID54305-153_06a90f0b-3d50-4033-84ac-028e2f225117
NDC54305-153
Product TypeHuman Otc Drug
Proprietary NameCOOL RELIEF ORAL ANESTHETIC
Generic NameMenthol
Dosage FormLozenge
Route of AdministrationORAL
Marketing Start Date2018-06-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameRicola Ag
Substance NameMENTHOL
Active Ingredient Strength15 mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 54305-153-19

19 LOZENGE in 1 BAG (54305-153-19)
Marketing Start Date2018-06-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54305-153-24 [54305015324]

COOL RELIEF ORAL ANESTHETIC LOZENGE
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-06-01
Inactivation Date2020-01-31
Reactivation Date2020-02-10

NDC 54305-153-45 [54305015345]

COOL RELIEF ORAL ANESTHETIC LOZENGE
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-06-01
Inactivation Date2020-01-31
Reactivation Date2020-02-10

NDC 54305-153-19 [54305015319]

COOL RELIEF ORAL ANESTHETIC LOZENGE
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-06-01
Inactivation Date2020-01-31
Reactivation Date2020-02-10

Drug Details

Active Ingredients

IngredientStrength
MENTHOL15.3 mg/1

OpenFDA Data

SPL SET ID:951e9836-e6a3-4094-8a6b-f226c85c897a
Manufacturer
UNII
UPC Code
  • 0036602420540
  • NDC Crossover Matching brand name "COOL RELIEF ORAL ANESTHETIC" or generic name "Menthol"

    NDCBrand NameGeneric Name
    54305-153COOL RELIEF ORAL ANESTHETICCOOL RELIEF ORAL ANESTHETIC
    63667-153COOL RELIEF ORAL ANESTHETICCOOL RELIEF ORAL ANESTHETIC
    54305-513COOL RELIEF ORAL ANESTHETICCOOL RELIEF ORAL ANESTHETIC
    63667-513COOL RELIEF ORAL ANESTHETICCOOL RELIEF ORAL ANESTHETIC
    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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