Diclocaine

Product NDC
53225-1095
11-digit product format
532251095
Labeler code
53225
Product ID
53225-1095_e1a5004d-91cc-6110-e053-2995a90a0b54
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine 4.5%, Diclofenac 1.25%
Dosage form
PATCH
Route
TOPICAL
Labeler
Terrain Pharmaceuticals
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2022-06-15
Marketing end
0000-00-00
Substance
DICLOFENAC SODIUM; LIDOCAINE
Active strength
1 mg/100mg; mg/100mg
Pharmacologic classes
Amide 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 flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53225-1095-1532251095011 mg in 1 POUCH (53225-1095-1) 1 mg2022-06-150000-00-00NoNoCurrent