NDC 70983-022

Restoral

Menthol

Restoral is a Topical Ointment in the Human Otc Drug category. It is labeled and distributed by Saje Natural Business Inc.. The primary component is Menthol.

Product ID70983-022_75aeee31-f62d-23fe-e053-2991aa0af7c1
NDC70983-022
Product TypeHuman Otc Drug
Proprietary NameRestoral
Generic NameMenthol
Dosage FormOintment
Route of AdministrationTOPICAL
Marketing Start Date2018-09-12
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart348
Labeler NameSaje Natural Business Inc.
Substance NameMENTHOL
Active Ingredient Strength0 g/100g
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 70983-022-01

1 CONTAINER in 1 BOX (70983-022-01) > 54.1 g in 1 CONTAINER
Marketing Start Date2018-09-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70983-022-01 [70983002201]

Restoral OINTMENT
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-09-12

NDC 70983-022-02 [70983002202]

Restoral OINTMENT
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-09-12

Drug Details

Active Ingredients

IngredientStrength
MENTHOL.2 g/100g

OpenFDA Data

SPL SET ID:5b6176c1-9ed9-1950-e053-2a91aa0a434e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 418609

    • NDC Crossover Matching brand name "Restoral" or generic name "Menthol"

    NDCBrand NameGeneric Name
    69204-023RestoralRestoral
    69435-1805RestoralRestoral
    70983-022RestoralRestoral
    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

    Trademark Results [Restoral]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    RESTORAL
    RESTORAL
    79240817 5682835 Live/Registered
    LEVONA 3009 LTD.
    2018-03-08
    RESTORAL
    RESTORAL
    78444992 not registered Dead/Abandoned
    Ashby, William G
    2004-07-01
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.