DFS 75mg DR/MS 25%/MENTH 6%/CAP 0.025% PAK

Product NDC: 70859-046
Requested package NDC: 70859-046-01
11-digit product format: 708590046
Labeler code: 70859
Product ID: 70859-046_c1c39e93-7ae6-0eae-e053-2995a90ac7ce
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diclofenac Sodium, Methyl Salicylate, Menthol, Capsaicin
Dosage form: KIT
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA074514
Marketing category: ANDA
Marketing start: 1996-03-26
Marketing end: 0000-00-00
Active strength: 0
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70859-046	70859-046-01	D	Discontinued by firm		2026-08-03

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 · 15 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A074514-001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB		1996-03-26
A074514-002	DICLOFENAC SODIUM	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB		1996-03-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A074514-001	AB
A074514-002	AB

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 3 · 82 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	A074514-001	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074514-002	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074514-001	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074514-002	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074514-001	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074514-002	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074514-001	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074514-002	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074514-001	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074514-002	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074514-001	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074514-002	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074514-001	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074514-002	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074514-001	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074514-002	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074514-001	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074514-002	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074514-001	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074514-002	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074514-001	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074514-002	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074514-001	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074514-002	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074514-001	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074514-002	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074514-001	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074514-002	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074514-001	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074514-002	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074514-001	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074514-002	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074514-001	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074514-002	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074514-001	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074514-002	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074514-001	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074514-002	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074514-001	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A074514-002	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE / ORAL	AB	1996-03-26	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A074514-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074514-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074514-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074514-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074514-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074514-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074514-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074514-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074514-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074514-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074514-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074514-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074514-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074514-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074514-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074514-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074514-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074514-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074514-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074514-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074514-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074514-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074514-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074514-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074514-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074514-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074514-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074514-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074514-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074514-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074514-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074514-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074514-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074514-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074514-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074514-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074514-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074514-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074514-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A074514-002	AB	1	`782e0a99824c…`

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2024-07-29	These highlights do not include all the information needed to use Diclofenac Sod DR . See full prescribing information for Diclofenac Sod DR . Initial U.S. Approval 40-9184 Revised – October 2017 Rx Only Prescribing Information
2023-01-30	These highlights do not include all the information needed to use Diclofenac Sod DR . See full prescribing information for Diclofenac Sod DR . Initial U.S. Approval 40-9184 Revised – October 2017 Rx Only Prescribing Information
2021-05-07	These highlights do not include all the information needed to use Diclofenac Sod DR . See full prescribing information for Diclofenac Sod DR . Initial U.S. Approval 40-9184 Revised – October 2017 Rx Only Prescribing Information
2021-01-29	These highlights do not include all the information needed to use Diclofenac Sod DR . See full prescribing information for Diclofenac Sod DR . Initial U.S. Approval 40-9184 Revised – October 2017 Rx Only Prescribing Information

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70859-046-01	EA - Each	70859-046	1623d05b-4e7d-484f-ae6e-483534d6e8de	1	2018-09-05

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac Sodium	DICLOFENAC SODIUM	Golden State Medical Supply, Inc.	c1d87003-f54b-4381-9e11-1c39ea2d9eb3	2026-05-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074514 application number: ANDA074514
Diclofenac Sodium	DICLOFENAC SODIUM	PD-Rx Pharmaceuticals, Inc.	663a3dbc-a631-4046-8852-ec619c41c81d	2026-03-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074514 application number: ANDA074514
Diclofenac Sodium	DICLOFENAC SODIUM	A-S Medication Solutions	47793dca-5e9e-44ee-8e66-5e42e1831b1e	2026-01-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074514 application number: ANDA074514
Diclofenac Sodium	DICLOFENAC SODIUM	A-S Medication Solutions	b74be49d-74ff-491b-962b-0edd3a57cbc9	2026-01-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074514 application number: ANDA074514
Diclofenac Sodium	DICLOFENAC SODIUM	PD-Rx Pharmaceuticals, Inc.	87d5a720-f154-4c4b-b2d4-0ae58455dda0	2025-05-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074514 application number: ANDA074514
Diclofenac Sodium	DICLOFENAC SODIUM	Proficient Rx LP	f5b4e308-c156-4865-95ee-1a8e267535ba	2024-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074514 application number: ANDA074514
Diclofenac Sodium	DICLOFENAC SODIUM	Actavis Pharma, Inc.	a57b897e-0cbe-4ac3-969f-b00357a0cfa8	2024-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074514 application number: ANDA074514
Diclofenac Sodium	DICLOFENAC SODIUM	Proficient Rx LP	77c3cb56-c071-4d92-a0d6-022417a27de4	2019-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074514 application number: ANDA074514
Diclofenac Sodium	DICLOFENAC SODIUM	Aphena Pharma Solutions - Tennessee, LLC	e4af374a-1281-46af-a0a9-48820db6c947	2018-05-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074514 application number: ANDA074514

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70859-046-01	70859004601	1 KIT in 1 KIT (70859-046-01) * 60 TABLET, DELAYED RELEASE in 1 BOTTLE (0228-2551-06) * 1 CONTAINER in 1 CARTON (70859-028-03) > 90 mL in 1 CONTAINER	1 kit	2018-07-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DFS 75mg DR/MS 25%/MENTH 6%/CAP 0.025% PAK - NuCare Pharmaceuticals,Inc.	NuCare Pharmaceuticals,Inc.	2021-05-07	HUMAN PRESCRIPTION DRUG LABEL	2