Diclofenac Sodium

Product NDC: 46122-711
Requested package NDC: 46122-711-54
11-digit product format: 461220711
Labeler code: 46122
Product ID: 46122-711_11e975a3-d93b-4f60-91b7-826bee8e47c6
Type: HUMAN OTC DRUG
Nonproprietary name: Diclofenac
Dosage form: GEL
Route: TOPICAL
Labeler: Amerisource Bergen
Application: ANDA204306
Marketing category: ANDA
Marketing start: 2022-06-27
Marketing end: 0000-00-00
Substance: DICLOFENAC SODIUM
Active strength: 10 mg/g
Pharmacologic classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [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	46122-711	46122-711-54	D	Discontinued by firm		2026-08-17

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 · 12 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…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A204306-001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	1%	GEL / TOPICAL			2019-05-06

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	AB	2019-05-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	AB	2019-05-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	AB	2019-05-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	AB	2019-05-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`e64feba35796…`

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	A204306-001	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A204306-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204306-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204306-001	AB	1	`ea99ee380514…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
46122-711-54	2023-11-22	C162847	48780-1	0191ceaa-698d-198a-e063-dbdaa90aec3e	11e975a3-d93b-4f60-91b7-826bee8e47c6
46122-711-54	2023-07-28	C162847	48780-1	0191ceaa-698d-198a-e063-dbdaa90aec3e	11e975a3-d93b-4f60-91b7-826bee8e47c6

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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac Sodium	DICLOFENAC SODIUM	Preferred Pharmaceuticals Inc.	226da8a2-807d-4784-8d33-b434f3951a52	2026-08-12	Warnings	Exact identifier application applno (ANDA): 204306 application number: ANDA204306
Diclofenac Sodium	DICLOFENAC SODIUM	Preferred Pharmaceuticals Inc.	09643e65-f301-4891-96f4-d78bf3621e23	2026-07-02	Warnings	Exact identifier application applno (ANDA): 204306 application number: ANDA204306
Diclofenac Sodium	DICLOFENAC SODIUM	Sportpharm LLC	929f71ab-f0c8-4331-800d-ed4a172e647e	2026-01-14	Warnings	Exact identifier application applno (ANDA): 204306 application number: ANDA204306
Diclofenac Sodium	DICLOFENAC SODIUM	Redpharm Drug	37362eb4-db16-f4ad-e063-6394a90a42aa	2025-12-13	Warnings	Exact identifier application applno (ANDA): 204306 application number: ANDA204306
Diclofenac Sodium	DICLOFENAC SODIUM	Aurobindo Pharma Limited	e5c0863a-edb7-4f46-a396-c9b2d8785cf8	2025-11-19	Warnings	Exact identifier application applno (ANDA): 204306 application number: ANDA204306
Diclofenac Sodium	DICLOFENAC SODIUM	GERI-CARE PHARMACEUTICAL CORP	fc08e58c-6323-e667-e053-6394a90ab754	2025-04-21	Warnings	Exact identifier application applno (ANDA): 204306 application number: ANDA204306
DICLOFENAC SODIUM	DICLOFENAC SODIUM	INNOVUS PHARMACEUTICALS, INC.	ad9d2c28-21bc-4f81-9c90-cce6a96d976a	2025-03-25	Warnings	Exact identifier application applno (ANDA): 204306 application number: ANDA204306
Diclofenac Sodium	DICLOFENAC SODIUM	Harris Teeter	17ed520d-bfbe-4a33-e063-6394a90aa0f6	2024-08-30	Warnings	Exact identifier application applno (ANDA): 204306 application number: ANDA204306
Diclofenac Sodium	DICLOFENAC SODIUM	Aurohealth LLC	81e964ff-6622-4054-bf01-6ed6eef6778f	2024-07-06	Warnings	Exact identifier application applno (ANDA): 204306 application number: ANDA204306
Diclofenac Sodium	DICLOFENAC SODIUM	KROGER COMPANY	15e59aac-a642-91e4-e063-6294a90a1175	2024-06-28	Warnings	Exact identifier application applno (ANDA): 204306 application number: ANDA204306
AMAZON BASIC CARE ARTHRITIS PAIN	DICLOFENAC SODIUM	Amazon.com Services LLC	113e2f87-c408-3e44-e063-6394a90a0a7f	2024-05-17	Warnings	Exact identifier application applno (ANDA): 204306 application number: ANDA204306
Diclofenac Sodium	DICLOFENAC SODIUM	Aurohealth LLC	2a599579-b2b0-4423-8e30-fe04bf815870	2023-08-11	Warnings	Exact identifier application applno (ANDA): 204306 application number: ANDA204306

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
QTG126297Q	DICLOFENAC SODIUM	15307-79-6	DICLOFENAC SODIUM
144O8QL0L1	DICLOFENAC	15307-86-5	Diclofenac

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
46122-711-54	46122071154	1 TUBE in 1 CARTON (46122-711-54) > 100 g in 1 TUBE	1 tube	2022-06-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diclofenac - Amerisource Bergen \| Aurohealth LLC \| Mylan Institutional Inc.	Amerisource Bergen \| Aurohealth LLC \| Mylan Institutional Inc.	2022-06-23	Human OTC Drug Label	1