NDC 53113-100

Ice Quake

Menthol

Ice Quake is a Topical Gel in the Human Otc Drug category. It is labeled and distributed by Gadal Laboratories, Inc.. The primary component is Menthol.

• Product ID: 53113-100_a6f37e88-1493-4c23-8f17-3136964406ca
• NDC: 53113-100
• Product Type: Human Otc Drug
• Proprietary Name: Ice Quake
• Generic Name: Menthol
• Dosage Form: Gel
• Route of Administration: TOPICAL
• Marketing Start Date: 2012-08-23
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part348
• Labeler Name: Gadal Laboratories, Inc.
• Substance Name: MENTHOL
• Active Ingredient Strength: 17 g/113g
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 53113-100-01

113 g in 1 TUBE (53113-100-01)

• Marketing Start Date: 2012-08-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 53113-100-01 [53113010001]

Ice Quake GEL

• Marketing Category: OTC MONOGRAPH FINAL
• Application Number: part348
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2012-08-23
• Inactivation Date: 2019-11-13

Drug Details

Active Ingredients

Ingredient	Strength
MENTHOL	16.95 g/113g

OpenFDA Data

• SPL SET ID: 1de1c714-cc53-45dc-a678-b36e59b15184
• Manufacturer:
  • Gadal Laboratories, Inc.
• UNII:
  • L7T10EIP3A
• RxNorm Concept Unique ID - RxCUI:
  • 1311523
• UPC Code:
  • 0854933102603

NDC Crossover Matching brand name "Ice Quake" or generic name "Menthol"

NDC	Brand Name	Generic Name
69822-100	Ice Quake	Ice Quake
53113-100	Ice Quake	Ice Quake
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