Home NDC 68788-4013 Diclona
Product NDC 68788-4013
11-digit product format 687884013
Labeler code 68788
Product ID 68788-4013_4cc1d80b-2435-404f-949f-bd207a863631
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lidocaine 4.5%, Diclofenac 1%
Dosage form GEL
Route CUTANEOUS
Labeler Preferred Pharmaceuticals Inc.
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2025-09-05
Substance DICLOFENAC SODIUM; LIDOCAINE
Active strength .01; .045 g/g; g/g
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 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Diclona
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DICLOFENAC SODIUM .01 g/g LIDOCAINE .045 g/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination QTG126297Q Internal UNII lookup 98PI200987 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2600049 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68788-4013-9 Diclona 99 g in 1 TUBE GEL 99 1
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Diclona LIDOCAINE 4.5%, DICLOFENAC 1% Preferred Pharmaceuticals Inc. 4cc1d80b-2435-404f-949f-bd207a863631 2025-09-05 Warnings, Adverse reactions Exact identifier ndc (product): 68788-4013
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 68788-4013-9 68788401309 99 g in 1 TUBE (68788-4013-9) 99 g 2025-09-05 No No Current