NDC 53225-1095

Diclocaine

Lidocaine 4.5%, Diclofenac 1.25%

Diclocaine is a Topical Patch in the Human Otc Drug category. It is labeled and distributed by Terrain Pharmaceuticals. The primary component is Diclofenac Sodium; Lidocaine.

Product ID53225-1095_e1a5004d-91cc-6110-e053-2995a90a0b54
NDC53225-1095
Product TypeHuman Otc Drug
Proprietary NameDiclocaine
Generic NameLidocaine 4.5%, Diclofenac 1.25%
Dosage FormPatch
Route of AdministrationTOPICAL
Marketing Start Date2022-06-15
Marketing CategoryOTC MONOGRAPH NOT FINAL /
Application Numberpart348
Labeler NameTerrain Pharmaceuticals
Substance NameDICLOFENAC SODIUM; LIDOCAINE
Active Ingredient Strength1 mg/100mg; mg/100mg
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 53225-1095-1

1 mg in 1 POUCH (53225-1095-1)
Marketing Start Date2022-06-15
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Diclocaine" or generic name "Lidocaine 4.5%, Diclofenac 1.25%"

NDCBrand NameGeneric Name
53225-1095DiclocaineLidocaine 4.5%, Diclofenac 1.25%
72594-1095DiclocaineLidocaine 4.5%, Diclofenac 1.25%
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