NDC 70458-103

Dyve Comfort L

Menthol, Lidocaine

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

• Product ID: 70458-103_67e42947-3e06-c72c-e053-2991aa0adb99
• NDC: 70458-103
• Product Type: Human Otc Drug
• Proprietary Name: Dyve Comfort L
• Generic Name: Menthol, Lidocaine
• Dosage Form: Gel
• Route of Administration: TOPICAL
• Marketing Start Date: 2018-04-01
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part348
• Labeler Name: AmperSand Biopharmaceuticals
• Substance Name: MENTHOL; LIDOCAINE
• Active Ingredient Strength: 1 g/100g; g/100g
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 70458-103-20

1 JAR in 1 BOX (70458-103-20) > 200 g in 1 JAR

• Marketing Start Date: 2018-04-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70458-103-20 [70458010320]

Dyve Comfort L GEL

• Marketing Category: OTC monograph not final
• Application Number: part348
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2018-04-01
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
MENTHOL	1 g/100g

OpenFDA Data

• SPL SET ID: 67e42947-3e05-c72c-e053-2991aa0adb99
• Manufacturer:
  • AmperSand Biopharmaceuticals
• UNII:
  • 98PI200987
  • L7T10EIP3A
• RxNorm Concept Unique ID - RxCUI:
  • 1804176

NDC Crossover Matching brand name "Dyve Comfort L" or generic name "Menthol, Lidocaine"

NDC	Brand Name	Generic Name
70458-103	Dyve Comfort L	Menthol, lidocaine
69561-463	Lidothal Relief	Menthol, Lidocaine
71437-463	Lidothal Relief	Menthol, Lidocaine
79884-001	RX300 Topical Pain Cream	MENTHOL, LIDOCAINE