NDC 69643-101

ONEBACK

Menthol

ONEBACK is a Topical Gel in the Human Otc Drug category. It is labeled and distributed by World Wide Medical Services, Inc.. The primary component is Menthol.

• Product ID: 69643-101_3b6d85e0-ea4b-4b96-b73a-bbcdae142a3f
• NDC: 69643-101
• Product Type: Human Otc Drug
• Proprietary Name: ONEBACK
• Generic Name: Menthol
• Dosage Form: Gel
• Route of Administration: TOPICAL
• Marketing Start Date: 2015-03-03
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part348
• Labeler Name: WORLD WIDE MEDICAL SERVICES, INC.
• Substance Name: MENTHOL
• Active Ingredient Strength: 4 g/100mL
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 69643-101-11

88.8 mL in 1 BOTTLE (69643-101-11)

• Marketing Start Date: 2015-03-03
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69643-101-11 [69643010111]

ONEBACK GEL

• Marketing Category: OTC monograph not final
• Application Number: part348
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2015-03-03
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
MENTHOL	3.9 g/100mL

OpenFDA Data

• SPL SET ID: 740db6f0-e002-411b-95a4-3807fba6ff52
• Manufacturer:
  • WORLD WIDE MEDICAL SERVICES, INC.
• UNII:
  • L7T10EIP3A
• RxNorm Concept Unique ID - RxCUI:
  • 1486765
• UPC Code:
  • 0092237614129

NDC Crossover Matching brand name "ONEBACK" or generic name "Menthol"

NDC	Brand Name	Generic Name
69643-101	ONEBACK	ONEBACK
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