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Voltaren

diclofenac sodium · Kit

Over-the-counter NDA RLD

Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information.

Overview

Brand name

Voltaren Arthritis Pain

Generic name

diclofenac sodium

Dosage form

Kit

Route

—

Marketing category

NDA · NDA

Labeler

Haleon US Holdings LLC

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

NDC product codes

Packages

Data completeness

54% of corroborating sources present

Forms, strengths and routes

Source: NDC Directory

Dosage form

Kit

Route of administration

—

Presentations

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

022122

Application type

NDA · New Drug Application

Approval date

October 17, 2007

Sponsor

HALEON US HOLDINGS

Products on application

Submissions recorded

Products approved under application 022122.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
022122-001	VOLTAREN ARTHRITIS PAIN	GEL		DICLOFENAC SODIUM	Over-the-counter	—	RLD RS

Therapeutic equivalence

Source: Orange Book

TE code

—

Reference Listed Drug

Yes

Reference Standard

Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA

Most recent submissions on application 022122.
Type	No.	Action	Status	Date	Review
Supplement	26	Labeling	Approved	August 7, 2024	Standard
Supplement	25	Labeling	Approved	November 29, 2023	Standard
Supplement	23	Labeling	Approved	February 21, 2023	Standard
Supplement	22	Manufacturing (CMC)	Approved	November 23, 2022	N/A
Supplement	18	Labeling	Approved	November 3, 2021	Standard
Supplement	17	Manufacturing (CMC)	Approved	July 19, 2021	N/A
Supplement	16	Labeling	Approved	December 12, 2020	Standard
Supplement	14	Efficacy	Approved	February 14, 2020	Standard
Supplement	11	Labeling	Approved	February 21, 2018	Standard
Supplement	10	Labeling	Approved	May 9, 2016	Standard
Supplement	9	Manufacturing (CMC)	Approved	May 11, 2015	Standard
Supplement	7	Labeling	Approved	November 25, 2014	Standard
Supplement	8	Manufacturing (CMC)	Approved	September 29, 2014	N/A
Supplement	3	Manufacturing (CMC)	Approved	December 7, 2010	N/A
Supplement	6	Labeling	Approved	September 23, 2009	901 Required
Supplement	4	Manufacturing (CMC)	Approved	September 4, 2009	N/A
Original application	1	Type 3 - New Dosage Form	Approved	October 17, 2007	Standard

Review documents

0 · Supplement · August 9, 2024
0 · Supplement · August 9, 2024
0 · Supplement · December 15, 2023
0 · Supplement · December 15, 2023
0 · Supplement · February 22, 2023
0 · Supplement · February 22, 2023
0 · Supplement · November 27, 2022
0 · Supplement · November 25, 2022
0 · Supplement · November 9, 2021
0 · Supplement · November 5, 2021
0 · Supplement · September 8, 2021
0 · Supplement · September 8, 2021
0 · Supplement · January 19, 2021
0 · Supplement · December 15, 2020
0 · Supplement · February 14, 2020
0 · Supplement · February 14, 2020
0 · Supplement · June 5, 2018
0 · Supplement · February 26, 2018
0 · Supplement · February 23, 2018
0 · Supplement · February 23, 2018
0 · Supplement · May 11, 2016
0 · Supplement · May 11, 2016
0 · Supplement · January 5, 2015
0 · Supplement · November 28, 2014
0 · Supplement · November 10, 2009
0 · Supplement · October 1, 2009
0 · Original application · February 22, 2008
0 · Original application · February 22, 2008
0 · Original application · October 22, 2007
0 · Original application · October 22, 2007

Packaging and NDCs

Source: NDC Directory

Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC	Product NDC	Labeler	Description	Marketing start
0067-8153-01	0067-8153	Haleon US Holdings LLC	1 KIT in 1 CARTON (0067-8153-01) * 2 TUBE in 1 KIT / 150 g in 1 TUBE * 1 TUBE in 1 KIT / 50 g in 1 TUBE	May 13, 2020
0067-8154-01	0067-8154	Haleon US Holdings LLC	1 KIT in 1 CARTON (0067-8154-01) * 1 TUBE in 1 CARTON (0067-8152-03) / 100 g in 1 TUBE * 1 TUBE in 1 CARTON (0067-8152-01) / 20 g in 1 TUBE	February 19, 2025
0067-8153	0067-8153	Haleon US Holdings LLC	—	May 13, 2020
0067-8154	0067-8154	Haleon US Holdings LLC	—	February 19, 2025

Sources for this page

Every dataset that contributed a fact to this page.
Dataset	Agency	Used for
NDC Directory	FDA	Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA	FDA	Application, sponsor, submissions, review documents, marketing status

Generated September 25, 2026 · 7 sections on this page.