Diclofenac sodium

Product NDC: 17856-0833
11-digit product format: 178560833
Labeler code: 17856
Product ID: 17856-0833_1892ab63-f781-42b1-9899-98e93d61e505
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diclofenac
Dosage form: GEL
Route: TOPICAL
Labeler: ATLANTIC BIOLOGICALS CORP.
Application: ANDA208077
Marketing category: ANDA
Marketing start: 2019-08-02
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	17856-0833		D	Discontinued by firm		2026-08-07
excluded package	package	17856-0833	17856-0833-1	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 · 8 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17856-0833-1	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	17856-0833-1	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	17856-0833-1	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	17856-0833-1	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

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
A208077-001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	1%	GEL / TOPICAL			2016-03-18

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	AB	2016-03-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	AB	2016-03-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	AB	2016-03-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	AB	2016-03-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`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	A208077-001	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A208077-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208077-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208077-001	AB	1	`ea99ee380514…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
17856-0833-1	2024-05-16	C162847	48780-1	f386c649-e810-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use DICLOFENAC SODIUM TOPICAL GEL safely and effectively. See full prescribing information for DICLOFENAC SODIUM TOPICAL GEL. DICLOFENAC SODIUM topical gel, 1%, for topical use only Initial U.S. Approval: 1988
17856-0833-1	2023-01-30	C162847	48780-1	f386c649-e810-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use DICLOFENAC SODIUM TOPICAL GEL safely and effectively. See full prescribing information for DICLOFENAC SODIUM TOPICAL GEL. DICLOFENAC SODIUM topical gel, 1%, for topical use only Initial U.S. Approval: 1988

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17856-0833	DICLOFENAC SODIUM (DICLOFENAC) GEL [ATLANTIC BIOLOGICALS CORP.]	3	Legacy NDC	20240517_9c0fc644-d3ca-425e-9527-246563ceff55.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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac sodium	DICLOFENAC SODIUM	CVS Pharmacy	591cc2ed-e667-4779-a426-8a2e6f873573	2026-07-22	Warnings	Exact identifier application applno (ANDA): 208077 application number: ANDA208077
Diclofenac sodium	DICLOFENAC SODIUM	CARDINAL HEALTH 110, LLC. DBA LEADER 70000	081b43f9-f594-4b1e-8564-7dbbea6fa5bd	2026-05-26	Warnings	Exact identifier application applno (ANDA): 208077 application number: ANDA208077
Diclofenac sodium	DICLOFENAC SODIUM	Walgreens	33a37e3d-0463-428c-9169-240eeb77af2b	2026-04-21	Warnings	Exact identifier application applno (ANDA): 208077 application number: ANDA208077
Diclofenac sodium	DICLOFENAC SODIUM	Rugby Laboratories	95f3c70c-eded-4d24-b9b0-cfa0b7902d6e	2026-02-10	Warnings	Exact identifier application applno (ANDA): 208077 application number: ANDA208077
Arthritis Pain Reliever	DICLOFENAC SODIUM	Family Dollar (FAMILY WELLNESS)	03ddf347-a3a3-4313-87d1-a246c1d4e0b4	2026-01-29	Warnings	Exact identifier application applno (ANDA): 208077 application number: ANDA208077
Diclofenac sodium	DICLOFENAC SODIUM	Sportpharm LLC	ac631742-119f-408a-8b36-b041bab743e2	2026-01-14	Warnings	Exact identifier application applno (ANDA): 208077 application number: ANDA208077
Arthritis Pain Reliever	DICLOFENAC SODIUM	QUALITY CHOICE (Chain Drug Marketing Association)	98f94aa2-6bc2-4c07-81c8-63b2c262cf39	2026-01-06	Warnings	Exact identifier application applno (ANDA): 208077 application number: ANDA208077
Diclofenac sodium	DICLOFENAC SODIUM	Safeway, Inc.	196d8af7-739f-4d2c-8c4e-9d33e6d722ab	2025-12-23	Warnings	Exact identifier application applno (ANDA): 208077 application number: ANDA208077
Diclofenac sodium	DICLOFENAC SODIUM	Best Choice (Valu Merchandisers Company)	4ea809a9-387a-4193-a176-d8b22eaa55e6	2025-08-21	Warnings	Exact identifier application applno (ANDA): 208077 application number: ANDA208077
Arthritis Pain Reliever	DICLOFENAC SODIUM	Chain Drug Consortium, LLC	8879a2ed-6c66-4489-8adc-9f160241cc7d	2025-06-25	Warnings	Exact identifier application applno (ANDA): 208077 application number: ANDA208077
Diclofenac sodium	DICLOFENAC	Scholl's Wellness Company	8dcbce69-945b-4913-a279-ee10871f6580	2024-11-14	Warnings	Exact identifier application applno (ANDA): 208077 application number: ANDA208077
Salonpas	DICLOFENAC SODIUM	Hisamitsu America, Inc.	f439445d-046e-4220-a4a7-13d750ee0949	2024-11-14	Warnings	Exact identifier application applno (ANDA): 208077 application number: ANDA208077
Diclofenac sodium	DICLOFENAC	Amneal Pharmaceuticals NY LLC	1084e0c3-6d75-4090-84dc-02a18e0299b9	2023-12-29	Warnings	Exact identifier application applno (ANDA): 208077 application number: ANDA208077
Arthritis Pain Reliever	DICLOFENAC SODIUM	Care One (Retail Business Services, LLC.)	4484a332-aab1-46a9-aca8-159e7a09439f	2023-11-17	Warnings	Exact identifier application applno (ANDA): 208077 application number: ANDA208077
Arthritis Pain Reliever	DICLOFENAC SODIUM	CVS PHARMACY, INC	4808015d-cfee-4f4d-a84b-82099f0b4868	2023-10-04	Warnings	Exact identifier application applno (ANDA): 208077 application number: ANDA208077
Arthritis Pain Reliever	DICLOFENAC SODIUM	AmerisourceBergen (Good Neighbor Pharmacy) 46122	30e1f589-b322-48b7-9a97-502afe2a1baa	2023-08-09	Warnings	Exact identifier application applno (ANDA): 208077 application number: ANDA208077
Diclofenac sodium	DICLOFENAC SODIUM	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	2a7019e9-e20f-4897-9b8e-942a7f2b34f6	2023-02-21	Warnings	Exact identifier application applno (ANDA): 208077 application number: ANDA208077
Diclofenac sodium	DICLOFENAC SODIUM	Costco Wholesale	141b6693-6d6c-45c6-9b82-ee1afcfca12a	2023-01-27	Warnings	Exact identifier application applno (ANDA): 208077 application number: ANDA208077
Arthritis Pain Reliever	DICLOFENAC SODIUM	P & L Development, LLC	2596645a-b736-4d3c-82a0-00713f1b6fbd	2022-12-15	Warnings	Exact identifier application applno (ANDA): 208077 application number: ANDA208077
Diclofenac sodium	DICLOFENAC SODIUM	Costco Wholesale	dbe33463-fa5c-4dc9-9d98-4d553fa43465	2022-10-11	Warnings	Exact identifier application applno (ANDA): 208077 application number: ANDA208077

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
17856-0833-1	17856083301	120 SYRINGE in 1 BOTTLE, UNIT-DOSE (17856-0833-1) > 1 g in 1 SYRINGE	120 syringe	2021-01-28	0000-00-00	No	No	Current