Diclofenac Sodium 1.5%

Product NDC: 68788-8084
11-digit product format: 687888084
Labeler code: 68788
Product ID: 68788-8084_51b4bcee-b586-4476-8ce8-898537958b66
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diclofenac Sodium Topical
Dosage form: SOLUTION
Route: TOPICAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA204132
Marketing category: ANDA
Marketing start: 2021-10-05
Substance: DICLOFENAC SODIUM
Active strength: 16.05 mg/mL
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: 2026-12-31
Current FDA listing: Yes

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	68788-8084	68788-8084-1	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 · 10 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 package	package	68788-8084-1	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-8084-1	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68788-8084-1	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68788-8084-1	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68788-8084-1	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68788-8084-1	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68788-8084-1	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68788-8084-1	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68788-8084-1	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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
A204132-001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT		2015-08-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A204132-001	AT

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	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204132-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2015-08-20	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204132-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204132-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204132-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204132-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204132-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204132-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204132-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204132-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204132-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204132-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204132-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204132-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204132-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204132-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204132-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204132-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204132-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204132-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204132-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204132-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204132-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204132-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204132-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204132-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204132-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204132-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204132-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204132-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204132-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204132-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204132-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204132-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204132-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204132-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204132-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204132-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204132-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204132-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204132-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204132-001	AT	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Diclofenac Sodium 1.5%
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DICLOFENAC SODIUM	16.05 mg/mL

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 SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
dbcd42cf-d44a-4d47-9149-66ffcf9a0587	Available on FDA.report

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-8084-1	ML - Milliliter	68788-8084	61a2196c-f314-4b30-bde4-c4289e8e3859	1	2021-11-09

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac Sodium 1.5%	DICLOFENAC SODIUM TOPICAL	SOLA Pharmaceuticals	c3f33952-44a8-71b2-e053-2a95a90abda2	2025-12-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204132 application number: ANDA204132
Diclofenac Sodium 1.5%	DICLOFENAC SODIUM TOPICAL	PHOENIX RX LLC	3b40a448-3f5e-fe6f-e063-6394a90a32df	2025-11-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204132 application number: ANDA204132
DICLOFENAC SODIUM	DICLOFENAC SODIUM	DIRECT RX	a5b33bf7-8113-9c54-e053-2995a90a79d8	2025-01-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204132 application number: ANDA204132
Diclofenac Sodium 1.5%	DICLOFENAC SODIUM TOPICAL	Preferred Pharmaceuticals Inc.	dbcd42cf-d44a-4d47-9149-66ffcf9a0587	2025-01-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204132 application number: ANDA204132 ndc (product): 68788-8084
Diclofenac Sodium	DICLOFENAC SODIUM	Advanced Rx of Tennessee, LLC	f18a4691-93a1-01e6-e053-2995a90a0069	2024-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204132 application number: ANDA204132
Diclofenac Sodium 1.5%	DICLOFENAC SODIUM TOPICAL	Proficient Rx LP	90b25b9b-3930-48af-b139-d24f2fccfcdc	2023-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204132 application number: ANDA204132
Diclofenac Sodium	DICLOFENAC SODIUM	Asclemed USA, Inc.	f3f60cd3-8f1f-4ca4-9621-805b4a6c35a8	2021-01-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204132 application number: ANDA204132
Diclofenac Sodium	DICLOFENAC SODIUM	Proficient Rx LP	20107264-e533-4de9-9a37-59fde7981c92	2020-09-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204132 application number: ANDA204132

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
68788-8084-1	68788808401	1 BOTTLE in 1 CARTON (68788-8084-1) > 150 mL in 1 BOTTLE	1 bottle	2021-10-05	0000-00-00	No	No	Current