CapsFenac Pak

Product NDC: 69420-9001
11-digit product format: 694209001
Labeler code: 69420
Product ID: 69420-9001_49396a39-530c-4fd4-8e16-5441a5099dff
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: diclofenac sodium and capsaicin
Dosage form: KIT
Labeler: SA3, LLC
Application: ANDA206715
Marketing category: ANDA
Marketing start: 2018-11-01
Marketing end: 0000-00-00
Active strength: 0
NDC exclude flag: No
Listing certified through: 2021-12-31
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	69420-9001		D	Discontinued by firm		2026-09-14
excluded package	package	69420-9001	69420-9001-1	D	Discontinued by firm		2026-09-14

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 · 30 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	69420-9001-1	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	69420-9001-1	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69420-9001-1	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69420-9001-1	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69420-9001-1	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69420-9001-1	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69420-9001-1	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69420-9001-1	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69420-9001-1	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69420-9001-1	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69420-9001-1	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69420-9001-1	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	69420-9001-1	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	69420-9001-1	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	69420-9001-1	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`

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
A206715-001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL			2017-08-07

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	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2017-08-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2017-08-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206715-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL		2017-08-07	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-09-15 20:21 UTC	2019-09	A206715-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206715-001	AT	1	`ea99ee380514…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69420-9001-1	2022-10-28	C162847	48780-1	d6a99b39-86d9-a426-e053-dadaa90af4c2	Diclofenac Sodium Topical Solution, 1.5% (w/w) These highlights do not include all the information needed to use DICLOFENAC SODIUM TOPICAL SOLUTION safely and effectively. See full prescribing information for DICLOFENAC SODIUM TOPICAL SOLUTION. DICLOFENAC SODIUM topical solution. Initial U.S. Approval: 1988
69420-9001-1	2022-01-28	C162847	48780-1	d6a99b39-86d9-a426-e053-dadaa90af4c2	Diclofenac Sodium Topical Solution, 1.5% (w/w) These highlights do not include all the information needed to use DICLOFENAC SODIUM TOPICAL SOLUTION safely and effectively. See full prescribing information for DICLOFENAC SODIUM TOPICAL SOLUTION. DICLOFENAC SODIUM topical solution. Initial U.S. Approval: 1988

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69420-9001-1	EA - Each	69420-9001	0be9fa95-7d89-408d-885a-93b86fa1adfb	1	2019-01-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69420-9001-1	69420900101	1 KIT in 1 KIT (69420-9001-1) * 150 mL in 1 BOTTLE * 1 TUBE in 1 CARTON > 120 g in 1 TUBE	1 kit	2018-11-01	0000-00-00	No	No	Current