Kope Pain relief gel

Product NDC
35192-026
Requested package NDC
35192-026-10
11-digit product format
351920026
Labeler code
35192
Product ID
35192-026_ef67e4d4-6462-2f17-e053-2a95a90a4a89
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine
Dosage form
GEL
Route
TOPICAL
Labeler
CA-BOTANA INTERNATIONAL
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2017-06-30
Marketing end
0000-00-00
Substance
LIDOCAINE
Active strength
4 g/50g
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage35192-02635192-026-10DDiscontinued by firm2026-10-12

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35192-026KOPE PAIN RELIEF GEL (LIDOCAINE) GEL [CA-BOTANA INTERNATIONAL]18Legacy NDC20241211_52f64082-9065-10a9-e054-00144ff8d46c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35192-026-103519200261050 g in 1 BOTTLE, PUMP (35192-026-10) 50 g2017-06-300000-00-00NoNoCurrent