Diclona Gel

Product NDC: 53225-1070
Requested package NDC: 53225-1070-1
11-digit product format: 532251070
Labeler code: 53225
Product ID: 53225-1070_de09b7d1-6a35-56a6-e053-2995a90a1d8c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lidocaine 4.5%, Diclofenac 1%
Dosage form: GEL
Route: TOPICAL
Labeler: Terrain Pharmaceuticals
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2022-05-02
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: 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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	53225-1070	53225-1070-1	D	Discontinued by firm		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53225-1070-1	GM - Gram	53225-1070	35f0e3af-f57a-485c-9c0d-df15d8fc9b79	1	2022-07-06

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53225-1070-1	53225107001	99 g in 1 TUBE (53225-1070-1)	99 g	2022-05-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diclona Gel	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2025-02-12	HUMAN PRESCRIPTION DRUG LABEL	1
Diclona Gel	Terrain Pharmaceuticals	2024-10-18	HUMAN PRESCRIPTION DRUG LABEL	3
Diclona Gel - Lidocaine 4.5%, Diclofenac 1% Gel	Advanced Rx Pharmacy of Tennessee, LLC	2024-06-25	HUMAN PRESCRIPTION DRUG LABEL	3
Diclona Gel	Direct_Rx	2022-11-09	HUMAN PRESCRIPTION DRUG LABEL	1

Diclona Gel

NDC auxiliary status#

Observed NDC auxiliary status history#

Reported adverse events (FAERS/openFDA)#

DailyMed Billing Units#

Related Records#

Related UNII Ingredients#

Packages#

Related DailyMed Labels#