NDC 70458-500

Topical Edge

Menthol

Topical Edge is a Topical Lotion in the Human Otc Drug category. It is labeled and distributed by Ampersand Biopharma. The primary component is Menthol.

• Product ID: 70458-500_5815d5b2-5fc0-780a-e053-2a91aa0ae946
• NDC: 70458-500
• Product Type: Human Otc Drug
• Proprietary Name: Topical Edge
• Generic Name: Menthol
• Dosage Form: Lotion
• Route of Administration: TOPICAL
• Marketing Start Date: 2017-09-25
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part348
• Labeler Name: AmperSand Biopharma
• Substance Name: MENTHOL
• Active Ingredient Strength: 1 g/100g
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 70458-500-02

300 g in 1 TUBE (70458-500-02)

• Marketing Start Date: 2017-09-25
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70458-500-02 [70458050002]

Topical Edge LOTION

• Marketing Category: OTC monograph not final
• Application Number: part348
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2017-09-25
• Inactivation Date: 2020-01-31

NDC 70458-500-01 [70458050001]

Topical Edge LOTION

• Marketing Category: OTC monograph not final
• Application Number: part348
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2017-03-04
• Marketing End Date: 2019-03-04

Drug Details

Active Ingredients

Ingredient	Strength
MENTHOL	.5 g/100g

OpenFDA Data

• SPL SET ID: 5815d5b2-5fbf-780a-e053-2a91aa0ae946
• Manufacturer:
  • AmperSand Biopharma
• UNII:
  • L7T10EIP3A
• RxNorm Concept Unique ID - RxCUI:
  • 1293193

NDC Crossover Matching brand name "Topical Edge" or generic name "Menthol"

NDC	Brand Name	Generic Name
70458-500	Topical Edge	Topical Edge
0363-1071	Cherry Cough Drop	Menthol
0363-1086	Cherry Cough Drops	Menthol
0363-0150	Cool n Heat Patch for Arm, Neck and Leg	Menthol
0363-0152	Cool n Heat Patch for Back	Menthol
0363-1072	Honey Lemon Cough Drop	Menthol
0363-1087	Honey Lemon Cough Drop	Menthol
0219-0203	Humphreys Bendito Alcoholado	menthol
0363-1070	Menthol Cough Drop	menthol
0363-1084	Menthol Cough Drop	menthol
0067-2067	Mineral Ice	Menthol
0316-0226	Mineral Ice	Menthol
0316-0290	Mineral Ice Quick Dry Foam	Menthol
0363-0151	Pain Relieving Patch	Menthol
0363-1077	SF Honey Lemon Cough Drop	Menthol
0363-1085	SF Menthol Cough Drop	Menthol
0363-0043	Studio 35 Medicated Body	Menthol
0363-0864	Walgreens Cold Pain Relief	MENTHOL
0363-0874	Walgreens Cold Pain Relief	MENTHOL
0363-0966	Walgreens Sunburn Relief	Menthol