Diclofenac sodium

Product NDC: 68071-5307
Requested package NDC: 68071-5307-1
11-digit product format: 680715307
Labeler code: 68071
Product ID: 68071-5307_57c83158-f073-6fa2-e063-6394a90aee2c
Type: HUMAN OTC DRUG
Nonproprietary name: Diclofenac sodium
Dosage form: GEL
Route: TOPICAL
Labeler: NuCare Pharmaceuticals, Inc.
Application: ANDA209903
Marketing category: ANDA
Marketing start: 2024-08-05
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A209903-001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	1%	GEL / TOPICAL			2018-08-03

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 · 43 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
2026-09-14 22:38:34	2026-08	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-08-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-08-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-08-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-08-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-08-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-08-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-08-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-08-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-08-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-08-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-08-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-08-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-08-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-08-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-08-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-08-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-08-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-08-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	AB	2018-08-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	AB	2018-08-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	AB	2018-08-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	AB	2018-08-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	AB	2018-08-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	AB	2018-08-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	AB	2018-08-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	AB	2018-08-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	AB	2018-08-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	AB	2018-08-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	AB	2018-08-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-08-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-08-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-08-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-08-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-08-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-08-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-08-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-08-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-08-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-08-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209903-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2018-08-03	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-04-04 05:41 UTC	2022-04	A209903-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209903-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209903-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209903-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209903-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209903-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209903-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209903-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209903-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209903-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209903-001	AB	1	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Diclofenac sodium
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DICLOFENAC SODIUM	10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
QTG126297Q	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
855633	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
57c83158-f072-6fa2-e063-6394a90aee2c	Available on FDA.report

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac sodium	DICLOFENAC SODIUM	NuCare Pharmaceuticals, Inc.	57c83158-f072-6fa2-e063-6394a90aee2c	2026-07-29	Warnings	Exact identifier application applno (ANDA): 209903 application number: ANDA209903 ndc (package): 68071-5307-1 ndc (product): 68071-5307 ndc11 (package): 68071530701
Diclofenac sodium	DICLOFENAC SODIUM	Cipla USA Inc.	daf52f5a-1bb7-4808-ab98-483ab9e8cfa0	2025-03-11	Warnings	Exact identifier application applno (ANDA): 209903 application number: ANDA209903
Diclofenac Sodium	DICLOFENAC SODIUM	Quality Care Products, LLC	12e1f808-9f24-4f6d-b5bc-12ce0059ab7a	2024-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209903 application number: ANDA209903
Diclofenac Sodium	DICLOFENAC SODIUM	NuCare Pharmaceuticals, Inc.	200c2800-a703-e138-e063-6394a90acc09	2024-08-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209903 application number: ANDA209903
Diclofenac Sodium	DICLOFENAC SODIUM	A-S Medication Solutions	203f96bb-ae63-475c-b7a6-03c0dbc43597	2024-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209903 application number: ANDA209903
Diclofenac Sodium	DICLOFENAC SODIUM	EXELAN PHARMACEUTICALS INC.	be25c19e-cbea-4f87-a581-9f0d350e5adf	2024-08-02	Warnings	Exact identifier application applno (ANDA): 209903 application number: ANDA209903
Diclofenac Sodium	DICLOFENAC SODIUM	A-S Medication Solutions	51756947-e802-4b4d-883e-fd6f22e9a725	2023-10-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209903 application number: ANDA209903

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	Sample	Exclude flag	Status
68071-5307-1	68071530701	1 TUBE in 1 CARTON (68071-5307-1) / 100 g in 1 TUBE	1 tube	2026-07-29	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diclofenac Sodium Topical Gel, 1% (NSAID) - Arthritis Pain Reliever	NuCare Pharmaceuticals, Inc.	2026-07-29	HUMAN OTC DRUG LABEL	1