Home NDC 80425-0517-1 Diclona
Product NDC 80425-0517
Requested package NDC 80425-0517-1
11-digit product format 804250517
Labeler code 80425
Product ID 80425-0517_346855a0-df4e-6369-e063-6394a90a0737
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lidocaine 4.5%, Diclofenac 1%
Dosage form GEL
Route CUTANEOUS
Labeler Advanced Rx of Tennessee, LLC
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2025-05-05
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 Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 80425-0517-1 Diclona 99 g in 1 TUBE GEL 99 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80425-0517 DICLONA (LIDOCAINE 4.5%, DICLOFENAC 1%) GEL [ADVANCED RX OF TENNESSEE, LLC] 1 Current NDC, 1 package rows 20250508_34685ef2-0015-8941-e063-6294a90ad0f7.zip
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 80425-0517-1 80425051701 99 g in 1 TUBE (80425-0517-1) 99 g 2025-05-05 No No Current