DicloPR

Product NDC: 71437-525
11-digit product format: 714370525
Labeler code: 71437
Product ID: 71437-525_8a15b540-62c0-4024-8d47-084c59a69aa0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: diclofenac gel, METHYL SALICYLATE, MENTHOL cream
Dosage form: KIT
Labeler: 19 And Pacific, Llc
Application: ANDA208077
Marketing category: ANDA
Marketing start: 2017-02-01
Marketing end: 0000-00-00
Active strength: 0
NDC exclude flag: E
Listing certified through: 2018-12-31
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	71437-525		I	Inactivated by FDA		2026-08-11
excluded package	package	71437-525	71437-525-01	I	Inactivated by FDA		2026-08-11

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 · 44 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		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71437-525-01	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71437-525-01	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71437-525-01	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71437-525-01	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71437-525-01	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71437-525-01	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71437-525-01	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71437-525-01	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71437-525-01	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	71437-525-01	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	71437-525-01	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	71437-525-01	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	71437-525-01	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	71437-525-01	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71437-525-01	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
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	71437-525-01	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	71437-525-01	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	71437-525-01	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	71437-525-01	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	71437-525-01	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	71437-525-01	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	71437-525-01	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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
A208077-001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	1%	GEL / TOPICAL			2016-03-18

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	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	AB	2016-03-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	AB	2016-03-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	AB	2016-03-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	AB	2016-03-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208077-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2016-03-18	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A208077-001	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A208077-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208077-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208077-001	AB	1	`ea99ee380514…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71437-525-01	2020-01-31	C162847	48780-1	9d75b9d0-c5bf-f424-e053-dadaa90a57ce	fa136af1-d3ea-4038-95af-e937555f8f5d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65162-833-66	DicloPR	100 g in 1 TUBE	GEL	300 g	10 mg in 1g	3
65162-833-66	DicloPR	1 in 1 CARTON	GEL		10 mg in 1g	3
69837-019-01	DicloPR	1 in 1 CARTON	CREAM		3 g in 10g	3
69837-019-02	DicloPR	118 g in 1 TUBE	CREAM	118 g	3 g in 10g	3
71437-525-01	DicloPR	1 in 1 KIT	KIT	1		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71437-525-01	GM - Gram	71437-525	8ed05cd8-bfec-42fe-99dc-d22ed5c2b9b8	1	2018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71437-525	DICLOPR (DICLOFENAC GEL, METHYL SALICYLATE, MENTHOL CREAM) KIT [19 AND PACIFIC, LLC]	3	Legacy NDC, 5 package rows	20171113_fa136af1-d3ea-4038-95af-e937555f8f5d.zip

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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac sodium	DICLOFENAC SODIUM	CVS Pharmacy	591cc2ed-e667-4779-a426-8a2e6f873573	2026-07-22	Warnings	Exact identifier application applno (ANDA): 208077 application number: ANDA208077
Diclofenac sodium	DICLOFENAC SODIUM	CARDINAL HEALTH 110, LLC. DBA LEADER 70000	081b43f9-f594-4b1e-8564-7dbbea6fa5bd	2026-05-26	Warnings	Exact identifier application applno (ANDA): 208077 application number: ANDA208077
Diclofenac sodium	DICLOFENAC SODIUM	Walgreens	33a37e3d-0463-428c-9169-240eeb77af2b	2026-04-21	Warnings	Exact identifier application applno (ANDA): 208077 application number: ANDA208077
Diclofenac sodium	DICLOFENAC SODIUM	Rugby Laboratories	95f3c70c-eded-4d24-b9b0-cfa0b7902d6e	2026-02-10	Warnings	Exact identifier application applno (ANDA): 208077 application number: ANDA208077
Arthritis Pain Reliever	DICLOFENAC SODIUM	Family Dollar (FAMILY WELLNESS)	03ddf347-a3a3-4313-87d1-a246c1d4e0b4	2026-01-29	Warnings	Exact identifier application applno (ANDA): 208077 application number: ANDA208077
Diclofenac sodium	DICLOFENAC SODIUM	Sportpharm LLC	ac631742-119f-408a-8b36-b041bab743e2	2026-01-14	Warnings	Exact identifier application applno (ANDA): 208077 application number: ANDA208077
Arthritis Pain Reliever	DICLOFENAC SODIUM	QUALITY CHOICE (Chain Drug Marketing Association)	98f94aa2-6bc2-4c07-81c8-63b2c262cf39	2026-01-06	Warnings	Exact identifier application applno (ANDA): 208077 application number: ANDA208077
Diclofenac sodium	DICLOFENAC SODIUM	Safeway, Inc.	196d8af7-739f-4d2c-8c4e-9d33e6d722ab	2025-12-23	Warnings	Exact identifier application applno (ANDA): 208077 application number: ANDA208077
Diclofenac sodium	DICLOFENAC SODIUM	Best Choice (Valu Merchandisers Company)	4ea809a9-387a-4193-a176-d8b22eaa55e6	2025-08-21	Warnings	Exact identifier application applno (ANDA): 208077 application number: ANDA208077
Arthritis Pain Reliever	DICLOFENAC SODIUM	Chain Drug Consortium, LLC	8879a2ed-6c66-4489-8adc-9f160241cc7d	2025-06-25	Warnings	Exact identifier application applno (ANDA): 208077 application number: ANDA208077
Diclofenac sodium	DICLOFENAC	Scholl's Wellness Company	8dcbce69-945b-4913-a279-ee10871f6580	2024-11-14	Warnings	Exact identifier application applno (ANDA): 208077 application number: ANDA208077
Salonpas	DICLOFENAC SODIUM	Hisamitsu America, Inc.	f439445d-046e-4220-a4a7-13d750ee0949	2024-11-14	Warnings	Exact identifier application applno (ANDA): 208077 application number: ANDA208077
Diclofenac sodium	DICLOFENAC	Amneal Pharmaceuticals NY LLC	1084e0c3-6d75-4090-84dc-02a18e0299b9	2023-12-29	Warnings	Exact identifier application applno (ANDA): 208077 application number: ANDA208077
Arthritis Pain Reliever	DICLOFENAC SODIUM	Care One (Retail Business Services, LLC.)	4484a332-aab1-46a9-aca8-159e7a09439f	2023-11-17	Warnings	Exact identifier application applno (ANDA): 208077 application number: ANDA208077
Arthritis Pain Reliever	DICLOFENAC SODIUM	CVS PHARMACY, INC	4808015d-cfee-4f4d-a84b-82099f0b4868	2023-10-04	Warnings	Exact identifier application applno (ANDA): 208077 application number: ANDA208077
Arthritis Pain Reliever	DICLOFENAC SODIUM	AmerisourceBergen (Good Neighbor Pharmacy) 46122	30e1f589-b322-48b7-9a97-502afe2a1baa	2023-08-09	Warnings	Exact identifier application applno (ANDA): 208077 application number: ANDA208077
Diclofenac sodium	DICLOFENAC SODIUM	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	2a7019e9-e20f-4897-9b8e-942a7f2b34f6	2023-02-21	Warnings	Exact identifier application applno (ANDA): 208077 application number: ANDA208077
Diclofenac sodium	DICLOFENAC SODIUM	Costco Wholesale	141b6693-6d6c-45c6-9b82-ee1afcfca12a	2023-01-27	Warnings	Exact identifier application applno (ANDA): 208077 application number: ANDA208077
Arthritis Pain Reliever	DICLOFENAC SODIUM	P & L Development, LLC	2596645a-b736-4d3c-82a0-00713f1b6fbd	2022-12-15	Warnings	Exact identifier application applno (ANDA): 208077 application number: ANDA208077
Diclofenac sodium	DICLOFENAC SODIUM	Costco Wholesale	dbe33463-fa5c-4dc9-9d98-4d553fa43465	2022-10-11	Warnings	Exact identifier application applno (ANDA): 208077 application number: ANDA208077

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
855633	diclofenac sodium 1 % Topical Gel	PSN	fa136af1-d3ea-4038-95af-e937555f8f5d	3
311500	menthol 10 % / methyl salicylate 30 % Topical Cream	PSN	fa136af1-d3ea-4038-95af-e937555f8f5d	3
855633	diclofenac sodium 0.01 MG/MG Topical Gel	SCD	fa136af1-d3ea-4038-95af-e937555f8f5d	3
311500	menthol 100 MG/ML / methyl salicylate 300 MG/ML Topical Cream	SCD	fa136af1-d3ea-4038-95af-e937555f8f5d	3
855633	diclofenac sodium 1 % Topical Gel	SY	fa136af1-d3ea-4038-95af-e937555f8f5d	3
311500	menthol 10 % / methyl salicylate 30 % Topical Cream	SY	fa136af1-d3ea-4038-95af-e937555f8f5d	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
65162-833-66	65162083366	100 g in 1 TUBE	100 g	Historical
69837-019-01	69837001901	1 in 1 CARTON		Historical
69837-019-02	69837001902	118 g in 1 TUBE	118 g	Historical
71437-525-01	71437052501	1 in 1 KIT		Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
diclofenac gel, METHYL SALICYLATE, MENTHOL cream - 19 And Pacific, Llc	19 And Pacific, Llc	2017-11-12	HUMAN PRESCRIPTION DRUG LABEL	3