NDC 53225-1026

Lidothol Gel

Lidocaine, Menthol Gel

Lidothol Gel is a Topical Gel in the Human Prescription Drug category. It is labeled and distributed by Terrain Pharmaceuticals. The primary component is Menthol; Lidocaine.

• Product ID: 53225-1026_8723bb57-31e6-54d6-e053-2a91aa0a3e90
• NDC: 53225-1026
• Product Type: Human Prescription Drug
• Proprietary Name: Lidothol Gel
• Generic Name: Lidocaine, Menthol Gel
• Dosage Form: Gel
• Route of Administration: TOPICAL
• Marketing Start Date: 2019-04-01
• Marketing Category: UNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER
• Labeler Name: Terrain Pharmaceuticals
• Substance Name: MENTHOL; LIDOCAINE
• Active Ingredient Strength: 5 g/g; g/g
• Pharm Classes: Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 53225-1026-1

1 TUBE in 1 BOX (53225-1026-1) > 99.2 g in 1 TUBE

• Marketing Start Date: 2019-04-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 53225-1026-1 [53225102601]

Lidothol GEL

• Marketing Category: unapproved drug other
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2019-04-01

Drug Details

Active Ingredients

Ingredient	Strength
MENTHOL	5 g/g

OpenFDA Data

• SPL SET ID: 8723bb57-31e7-54d6-e053-2a91aa0a3e90
• Manufacturer:
  • Terrain Pharmaceuticals
• UNII:
  • 98PI200987
  • L7T10EIP3A
• UPC Code:
  • 0353225102616

Pharmacological Class

• Amide Local Anesthetic [EPC]
• Amides [CS]
• Antiarrhythmic [EPC]
• Local Anesthesia [PE]

NDC Crossover Matching brand name "Lidothol Gel" or generic name "Lidocaine, Menthol Gel"

NDC	Brand Name	Generic Name
53225-1026	Lidothol Gel	LIDOCAINE, MENTHOL Gel
72189-086	Lidothol Gel	Lidothol Gel