Voltaren

Product NDC: 35356-187
11-digit product format: 353560187
Labeler code: 35356
Product ID: 35356-187_aff34837-89a8-429f-b8e1-9ec2470943e5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: diclofenac sodium
Dosage form: GEL
Route: TOPICAL
Labeler: Lake Erie Medical DBA Quality Care Products LLC
Application: NDA022122
Marketing category: NDA
Marketing start: 2011-11-11
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: 2020-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	35356-187		D	Discontinued by firm	2026-08-07
excluded package	package	35356-187	35356-187-00	D	Discontinued by firm	2026-08-07
excluded package	package	35356-187	35356-187-03	D	Discontinued by firm	2026-08-07
excluded package	package	35356-187	35356-187-05	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 · 48 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	35356-187-00	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	35356-187-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	35356-187-05	`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	35356-187-00	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	35356-187-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	35356-187-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	35356-187-00	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	35356-187-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	35356-187-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	35356-187-00	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	35356-187-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	35356-187-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	35356-187-00	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	35356-187-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	35356-187-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	35356-187-00	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	35356-187-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	35356-187-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	35356-187-00	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	35356-187-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	35356-187-05	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	35356-187-00	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	35356-187-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	35356-187-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	35356-187-00	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	35356-187-03	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	35356-187-05	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	35356-187-00	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	35356-187-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	35356-187-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	35356-187-00	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	35356-187-03	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	35356-187-05	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	35356-187-00	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	35356-187-03	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	35356-187-05	`557ba5c1ecfa…`	`9c80585c8c6e…`

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
35356-187-00	GM - Gram	35356-187	280e85fc-7383-4de7-95aa-62ba633a5432	1	2012-07-24
35356-187-03	GM - Gram	35356-187	4bb0c9f2-7007-41b0-9158-863f45ff980c	1	2012-07-24
35356-187-05	GM - Gram	35356-187	77b1cf53-293f-43d7-b8cd-bb2e4112d856	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DICLOFENAC SODIUM	ACTIVE INGREDIENT	QTG126297Q	VOLTAREN (DICLOFENAC SODIUM) GEL [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	3191
DICLOFENAC	ACTIVE MOIETY	144O8QL0L1	VOLTAREN (DICLOFENAC SODIUM) GEL [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	3191
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	VOLTAREN (DICLOFENAC SODIUM) GEL [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	3191
CARBOMER HOMOPOLYMER TYPE C	INACTIVE INGREDIENT	4Q93RCW27E	VOLTAREN (DICLOFENAC SODIUM) GEL [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	3191
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	VOLTAREN (DICLOFENAC SODIUM) GEL [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	3191
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	VOLTAREN (DICLOFENAC SODIUM) GEL [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	3191
POLYOXYL 20 CETOSTEARYL ETHER	INACTIVE INGREDIENT	YRC528SWUY	VOLTAREN (DICLOFENAC SODIUM) GEL [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	3191
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	VOLTAREN (DICLOFENAC SODIUM) GEL [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	3191
WATER	INACTIVE INGREDIENT	059QF0KO0R	VOLTAREN (DICLOFENAC SODIUM) GEL [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]	3191

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Voltaren	Lake Erie Medical DBA Quality Care Products LLC	2019-04-30	HUMAN PRESCRIPTION DRUG LABEL	3194