Pennsaid

Product NDC: 75987-040
11-digit product format: 759870040
Labeler code: 75987
Product ID: 75987-040_7cc3f603-fa83-493c-8faf-e02ead6f3a25
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: diclofenac sodium
Dosage form: SOLUTION
Route: TOPICAL
Labeler: Horizon Therapeutics USA, Inc.
Application: NDA204623
Marketing category: NDA
Marketing start: 2014-02-03
Marketing end: 0000-00-00
Substance: DICLOFENAC SODIUM
Active strength: 20 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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	75987-040		D	Discontinued by firm	2026-08-17
excluded package	package	75987-040	75987-040-05	D	Discontinued by firm	2026-08-17
excluded package	package	75987-040	75987-040-74	D	Discontinued by firm	2026-08-17
excluded package	package	75987-040	75987-040-75	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 · 4 matching rows.

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

Dataset, Scope, Package NDC table
Dataset	Scope	Package NDC
excluded product	product
excluded package	package	75987-040-05
excluded package	package	75987-040-74
excluded package	package	75987-040-75

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
N204623-001	PENNSAID	DICLOFENAC SODIUM	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD	2014-01-16

Orange Book patents#

Current patent rows page 1 of 1 · 20 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N204623-001	8563613	2027-10-17	U-1488	Drug product	2014-02-25
N204623-001	8871809	2027-10-17	U-1614		2014-11-18
N204623-001	9066913	2027-10-17	U-1488	Drug product	2015-06-30
N204623-001	9101591	2027-10-17	U-1488	Drug product	2015-08-11
N204623-001	9132110	2027-10-17	U-1488		2015-09-16
N204623-001	9168304	2027-10-17		Drug product	2015-10-27
N204623-001	9168305	2027-10-17	U-1488		2015-10-27
N204623-001	9220784	2027-10-17	U-1488		2016-01-28
N204623-001	9339551	2027-10-17	U-1488		2016-06-16
N204623-001	9339552	2027-10-17	U-1488	Drug product	2016-06-16
N204623-001	9539335	2027-10-17	U-1614		2016-02-06
N204623-001	8252838	2028-04-21	U-1489	Drug product	2014-02-25
N204623-001	8217078	2029-07-10	U-1477		2014-02-25
N204623-001	8618164	2029-07-10	U-1477		2014-02-25
N204623-001	8741956	2029-07-10	U-1435		2014-06-05
N204623-001	9370501	2029-07-10	U-1614		2016-07-19
N204623-001	9375412	2029-07-10	U-1614		2016-07-26
N204623-001	9415029	2029-07-10	U-1614		2016-09-13
N204623-001	8546450	2030-08-09	U-1435		2014-02-25
N204623-001	8546450	2030-08-09	U-1436		2014-02-25

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N204623-001	PENNSAID	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD	2014-01-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204623-001	PENNSAID	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD	2014-01-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204623-001	PENNSAID	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD	2014-01-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204623-001	PENNSAID	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD	2014-01-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204623-001	PENNSAID	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD	2014-01-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204623-001	PENNSAID	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD	2014-01-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204623-001	PENNSAID	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD	2014-01-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204623-001	PENNSAID	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD	2014-01-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204623-001	PENNSAID	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD	2014-01-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204623-001	PENNSAID	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD	2014-01-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204623-001	PENNSAID	2% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / TOPICAL		RLD	2014-01-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204623-001	PENNSAID	2%	SOLUTION / TOPICAL		RLD	2014-01-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204623-001	PENNSAID	2%	SOLUTION / TOPICAL		RLD	2014-01-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204623-001	PENNSAID	2%	SOLUTION / TOPICAL		RLD	2014-01-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N204623-001	PENNSAID	2%	SOLUTION / TOPICAL		RLD	2014-01-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204623-001	PENNSAID	2%	SOLUTION / TOPICAL	AB	RLD, RS	2014-01-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N204623-001	PENNSAID	2%	SOLUTION / TOPICAL		RLD, RS	2014-01-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N204623-001	PENNSAID	2%	SOLUTION / TOPICAL		RLD, RS	2014-01-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N204623-001	PENNSAID	2%	SOLUTION / TOPICAL		RLD, RS	2014-01-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N204623-001	PENNSAID	2%	SOLUTION / TOPICAL		RLD, RS	2014-01-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N204623-001	PENNSAID	2%	SOLUTION / TOPICAL		RLD, RS	2014-01-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204623-001	PENNSAID	2%	SOLUTION / TOPICAL		RLD, RS	2014-01-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N204623-001	PENNSAID	2%	SOLUTION / TOPICAL		RLD, RS	2014-01-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N204623-001	PENNSAID	2%	SOLUTION / TOPICAL		RLD, RS	2014-01-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N204623-001	PENNSAID	2%	SOLUTION / TOPICAL		RLD, RS	2014-01-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N204623-001	PENNSAID	2%	SOLUTION / TOPICAL		RLD, RS	2014-01-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N204623-001	PENNSAID	2%	SOLUTION / TOPICAL		RLD, RS	2014-01-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N204623-001	PENNSAID	2%	SOLUTION / TOPICAL		RLD, RS	2014-01-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N204623-001	PENNSAID	2%	SOLUTION / TOPICAL	AB	RLD, RS	2014-01-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N204623-001	PENNSAID	2%	SOLUTION / TOPICAL	AB	RLD, RS	2014-01-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N204623-001	PENNSAID	2%	SOLUTION / TOPICAL	AB	RLD, RS	2014-01-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N204623-001	PENNSAID	2%	SOLUTION / TOPICAL	AB	RLD, RS	2014-01-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N204623-001	PENNSAID	2%	SOLUTION / TOPICAL	AB	RLD, RS	2014-01-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N204623-001	PENNSAID	2%	SOLUTION / TOPICAL	AB	RLD, RS	2014-01-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N204623-001	PENNSAID	2%	SOLUTION / TOPICAL	AB	RLD, RS	2014-01-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N204623-001	PENNSAID	2%	SOLUTION / TOPICAL	AB	RLD, RS	2014-01-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N204623-001	PENNSAID	2%	SOLUTION / TOPICAL	AB	RLD, RS	2014-01-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N204623-001	PENNSAID	2%	SOLUTION / TOPICAL	AB	RLD, RS	2014-01-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N204623-001	PENNSAID	2%	SOLUTION / TOPICAL	AB	RLD, RS	2014-01-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N204623-001	PENNSAID	2%	SOLUTION / TOPICAL	AB	RLD, RS	2014-01-16	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204623-001	AB	1	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N204623-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N204623-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N204623-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N204623-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N204623-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N204623-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N204623-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N204623-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N204623-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N204623-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N204623-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N204623-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N204623-001	AB	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 21 · 840 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N204623-001	8563613	2027-10-17	U-1488	Drug product	2014-02-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204623-001	8871809	2027-10-17	U-1614		2014-11-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204623-001	9066913	2027-10-17	U-1488	Drug product	2015-06-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204623-001	9101591	2027-10-17	U-1488	Drug product	2015-08-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204623-001	9132110	2027-10-17	U-1488		2015-09-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204623-001	9168304	2027-10-17		Drug product	2015-10-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204623-001	9168305	2027-10-17	U-1488		2015-10-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204623-001	9220784	2027-10-17	U-1488		2016-01-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204623-001	9339551	2027-10-17	U-1488		2016-06-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204623-001	9339552	2027-10-17	U-1488	Drug product	2016-06-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204623-001	9539335	2027-10-17	U-1614		2016-02-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204623-001	8252838	2028-04-21	U-1489	Drug product	2014-02-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204623-001	8217078	2029-07-10	U-1477		2014-02-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204623-001	8618164	2029-07-10	U-1477		2014-02-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204623-001	8741956	2029-07-10	U-1435		2014-06-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204623-001	9370501	2029-07-10	U-1614		2016-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204623-001	9375412	2029-07-10	U-1614		2016-07-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204623-001	9415029	2029-07-10	U-1614		2016-09-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204623-001	8546450	2030-08-09	U-1435		2014-02-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204623-001	8546450	2030-08-09	U-1436		2014-02-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204623-001	8563613	2027-10-17	U-1488	Drug product	2014-02-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204623-001	8871809	2027-10-17	U-1614		2014-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204623-001	9066913	2027-10-17	U-1488	Drug product	2015-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204623-001	9101591	2027-10-17	U-1488	Drug product	2015-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204623-001	9132110	2027-10-17	U-1488		2015-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204623-001	9168304	2027-10-17		Drug product	2015-10-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204623-001	9168305	2027-10-17	U-1488		2015-10-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204623-001	9220784	2027-10-17	U-1488		2016-01-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204623-001	9339551	2027-10-17	U-1488		2016-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204623-001	9339552	2027-10-17	U-1488	Drug product	2016-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204623-001	9539335	2027-10-17	U-1614		2016-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204623-001	8252838	2028-04-21	U-1489	Drug product	2014-02-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204623-001	8217078	2029-07-10	U-1477		2014-02-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204623-001	8618164	2029-07-10	U-1477		2014-02-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204623-001	8741956	2029-07-10	U-1435		2014-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204623-001	9370501	2029-07-10	U-1614		2016-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204623-001	9375412	2029-07-10	U-1614		2016-07-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204623-001	9415029	2029-07-10	U-1614		2016-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204623-001	8546450	2030-08-09	U-1435		2014-02-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204623-001	8546450	2030-08-09	U-1436		2014-02-25	`011fe1cb6892…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
111d457e-3138-4512-b0ba-d0cd760c4055	Product name	3	20250225
0426261e-1bb9-b78b-abd2-80da765a7e3e	Product name	2	20240513
7b6158ae-c3f4-3d73-c35f-6f5d18b9efd7	Product name	5	20240320
0ac2f11f-f58d-baf2-71a0-680993b48a61	Product name	2	20231211
855d63c3-b090-4636-8fc7-6d39ad23c44f	Product name	1	20230829
bb58f410-04be-65dd-9211-e89ead899698	Product name	6	20230323
0fcbc38a-8b29-3348-1cef-5222ea53484f	Product name	4	20220516
c4e1eedc-aca2-4551-8382-89144ed9d049	Product name	3	20220126
8d368a34-1453-43ea-828d-0dbcd72b8794	Product name	8	20210622
d6bab9d2-edce-a213-4796-226ab15472c3	Product name	6	20200616
2487e6ef-d419-42fc-aaf8-7acc805d2370	Product name	2	20170718
e071c814-e5e7-e7ed-ec76-428765d9c66b	Product name	2	20151120
93148e06-b8d7-4e6c-853e-62f807d17fbb	Product name	1	20151014
dbb00be6-fb1c-4b0a-a770-31f7e05e247e	Product name	1	20150316

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
75987-040-05	GM - Gram	75987-040	6f9c435a-b29b-4ce8-90e4-ead8b534cf4e	1	2015-01-05
75987-040-74	GM - Gram	75987-040	db4cf3dc-fc9f-4388-9873-03f7fe156fe9	1	2017-07-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
diclofenac sodium	ACTIVE INGREDIENT	QTG126297Q	PENNSAID (DICLOFENAC SODIUM) SOLUTION [HORIZON PHARMA INC.]	1
diclofenac	ACTIVE MOIETY	144O8QL0L1	PENNSAID (DICLOFENAC SODIUM) SOLUTION [HORIZON PHARMA INC.]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	PENNSAID (DICLOFENAC SODIUM) SOLUTION [HORIZON PHARMA INC.]	1
DIMETHYL SULFOXIDE	INACTIVE INGREDIENT	YOW8V9698H	PENNSAID (DICLOFENAC SODIUM) SOLUTION [HORIZON PHARMA INC.]	1
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	PENNSAID (DICLOFENAC SODIUM) SOLUTION [HORIZON PHARMA INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PENNSAID (DICLOFENAC SODIUM) SOLUTION [HORIZON PHARMA INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	PENNSAID (DICLOFENAC SODIUM) SOLUTION [HORIZON PHARMA INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
75987-040	PENNSAID (DICLOFENAC SODIUM) SOLUTION [HORIZON THERAPEUTICS USA, INC.]	14	Legacy NDC	20241207_802cd382-443d-48e3-9c9d-fd946c73c79f.zip

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
75987-040-05	75987004005	1 BOTTLE, PUMP in 1 CARTON (75987-040-05) > 112 g in 1 BOTTLE, PUMP		2014-02-03	0000-00-00	No	No	Current
75987-040-74	75987004074	2 g in 1 POUCH (75987-040-74)	2 g	2014-02-03	0000-00-00	No	No	Current
75987-040-75	75987004075	1 BOTTLE, PUMP in 1 CARTON (75987-040-75) > 112 g in 1 BOTTLE, PUMP		2014-02-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pennsaid	Horizon Therapeutics USA, Inc. \| Esteve Quimica, SA	2025-11-28	HUMAN PRESCRIPTION DRUG LABEL	15
Pennsaid	REMEDYREPACK INC.	2022-07-12	HUMAN PRESCRIPTION DRUG LABEL	7