Diclona Gel

Product NDC: 80425-0250
11-digit product format: 804250250
Labeler code: 80425
Product ID: 80425-0250_f1f00a9c-2920-f720-e053-2995a90a486a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lidocaine HCL and Diclofenac Sodium
Dosage form: GEL
Route: TOPICAL
Labeler: Advanced Rx Pharmacy of Tennessee, LLC
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2023-01-10
Marketing end: 0000-00-00
Substance: DICLOFENAC SODIUM; LIDOCAINE
Active strength: 0 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: 2024-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	80425-0250		D	Discontinued by firm		2026-09-14
excluded package	package	80425-0250	80425-0250-1	D	Discontinued by firm		2026-09-14

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80425-0250-1	GM - Gram	80425-0250	42747e1d-a6aa-49b8-b3b1-477442d4eed9	1	2023-03-13

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80425-0250	DICLONA GEL (LIDOCAINE HCL AND DICLOFENAC SODIUM) GEL [ADVANCED RX PHARMACY OF TENNESSEE, LLC]	3	Legacy NDC	20240627_f18c3240-61e7-66cc-e053-2a95a90a1656.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
QTG126297Q	DICLOFENAC SODIUM	15307-79-6	DICLOFENAC SODIUM
98PI200987	LIDOCAINE	137-58-6	LIDOCAINE

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
80425-0250-1	80425025001	99 g in 1 TUBE (80425-0250-1)	99 g	2023-01-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diclona Gel - Lidocaine 4.5%, Diclofenac 1% Gel	Advanced Rx Pharmacy of Tennessee, LLC	2024-06-25	HUMAN PRESCRIPTION DRUG LABEL	3