NDC 70458-104

Dyve Comfort B

Benzocaine, Lidocaine

Dyve Comfort B is a Topical Gel in the Human Otc Drug category. It is labeled and distributed by Ampersand Biopharmaceuticals. The primary component is Menthol; Benzocaine.

Product ID70458-104_67ef2aad-b291-c0c8-e053-2991aa0a6093
NDC70458-104
Product TypeHuman Otc Drug
Proprietary NameDyve Comfort B
Generic NameBenzocaine, Lidocaine
Dosage FormGel
Route of AdministrationTOPICAL
Marketing Start Date2018-04-01
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart348
Labeler NameAmperSand Biopharmaceuticals
Substance NameMENTHOL; BENZOCAINE
Active Ingredient Strength1 g/100g; g/100g
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 70458-104-20

1 JAR in 1 BOX (70458-104-20) > 200 g in 1 JAR
Marketing Start Date2018-04-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70458-104-20 [70458010420]

Dyve Comfort B GEL
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-04-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
MENTHOL1 g/100g

OpenFDA Data

SPL SET ID:67ef2aad-b290-c0c8-e053-2991aa0a6093
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2003131

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