NDC 53225-1070

Diclona Gel

Lidocaine 4.5%, Diclofenac 1%

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

Product ID53225-1070_de09b7d1-6a35-56a6-e053-2995a90a1d8c
NDC53225-1070
Product TypeHuman Prescription Drug
Proprietary NameDiclona Gel
Generic NameLidocaine 4.5%, Diclofenac 1%
Dosage FormGel
Route of AdministrationTOPICAL
Marketing Start Date2022-05-02
Marketing CategoryUNAPPROVED DRUG OTHER /
Labeler NameTerrain Pharmaceuticals
Substance NameDICLOFENAC SODIUM; LIDOCAINE
Active Ingredient Strength0 g/g; g/g
Pharm ClassesAmide Local Anesthetic [EPC], Amides [CS], Anti-Inflammatory Agents, Non-Steroidal [CS], Antiarrhythmic [EPC], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Local Anesthesia [PE], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 53225-1070-1

99 g in 1 TUBE (53225-1070-1)
Marketing Start Date2022-05-02
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Diclona Gel" or generic name "Lidocaine 4.5%, Diclofenac 1%"

NDCBrand NameGeneric Name
53225-1070Diclona GelLidocaine 4.5%, Diclofenac 1%
72189-390Diclona GelDiclona Gel
80425-0250Diclona GelLidocaine HCL and Diclofenac Sodium

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.