Voltaren

Product NDC: 63187-582
11-digit product format: 631870582
Labeler code: 63187
Product ID: 63187-582_c57cc18e-48b1-4979-99f2-e66722aca356
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: diclofenac sodium
Dosage form: GEL
Route: TOPICAL
Labeler: Proficient Rx LP
Application: NDA022122
Marketing category: NDA
Marketing start: 2007-10-17
Marketing end: 0000-00-00
Substance: DICLOFENAC SODIUM
Active strength: 10 mg/g
Pharmacologic classes: Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 2022-12-31
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	63187-582		D	Discontinued by firm		2026-08-07
excluded package	package	63187-582	63187-582-00	D	Discontinued by firm		2026-08-07

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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63187-582-00	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63187-582-00	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022122-001	VOLTAREN ARTHRITIS PAIN	DICLOFENAC SODIUM	1%	GEL / TOPICAL		RLD, RS	2007-10-17

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022122-001	VOLTAREN	1%	GEL / TOPICAL	AB	RLD, RS	2007-10-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022122-001	VOLTAREN	1%	GEL / TOPICAL	AB	RLD, RS	2007-10-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022122-001	VOLTAREN	1%	GEL / TOPICAL	AB	RLD, RS	2007-10-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022122-001	VOLTAREN	1%	GEL / TOPICAL	AB	RLD, RS	2007-10-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022122-001	VOLTAREN ARTHRITIS PAIN	1%	GEL / TOPICAL		RLD, RS	2007-10-17	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022122-001	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N022122-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022122-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022122-001	AB	1	`ea99ee380514…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DICLOFENAC SODIUM	ACTIVE INGREDIENT	QTG126297Q	VOLTAREN (DICLOFENAC SODIUM) GEL [PROFICIENT RX LP]	1
DICLOFENAC	ACTIVE MOIETY	144O8QL0L1	VOLTAREN (DICLOFENAC SODIUM) GEL [PROFICIENT RX LP]	1
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	VOLTAREN (DICLOFENAC SODIUM) GEL [PROFICIENT RX LP]	1
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	4Q93RCW27E	VOLTAREN (DICLOFENAC SODIUM) GEL [PROFICIENT RX LP]	1
COCO-CAPRYLATE/CAPRATE	INACTIVE INGREDIENT	8D9H4QU99H	VOLTAREN (DICLOFENAC SODIUM) GEL [PROFICIENT RX LP]	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	VOLTAREN (DICLOFENAC SODIUM) GEL [PROFICIENT RX LP]	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	VOLTAREN (DICLOFENAC SODIUM) GEL [PROFICIENT RX LP]	1
POLYOXYL 20 CETOSTEARYL ETHER	INACTIVE INGREDIENT	YRC528SWUY	VOLTAREN (DICLOFENAC SODIUM) GEL [PROFICIENT RX LP]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	VOLTAREN (DICLOFENAC SODIUM) GEL [PROFICIENT RX LP]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	VOLTAREN (DICLOFENAC SODIUM) GEL [PROFICIENT RX LP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-582	VOLTAREN (DICLOFENAC SODIUM) GEL [PROFICIENT RX LP]	3	Legacy NDC	20210113_9d6cf386-7fa1-433d-8fe9-4aa3617ba0e1.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Voltaren Arthritis Pain	DICLOFENAC SODIUM	Haleon US Holdings LLC	30a94282-0892-442a-aa10-6525cbd4fe88	2025-02-11	Warnings	Exact identifier application applno (NDA): 022122 application number: NDA022122
Diclofenac Sodium	DICLOFENAC SODIUM	Proficient Rx LP	a7447467-79e0-436e-a273-d1ddd06169cf	2019-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022122 application number: NDA022122

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
QTG126297Q	DICLOFENAC SODIUM	15307-79-6	DICLOFENAC SODIUM

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63187-582-00	63187058200	1 TUBE in 1 CARTON (63187-582-00) > 100 g in 1 TUBE	1 tube	2018-12-01	0000-00-00	No	No	Current