Diclofenac Sodium

Product NDC: 80175-1358
11-digit product format: 801751358
Labeler code: 80175
Product ID: 80175-1358_be3ae246-d3db-61ad-e053-2a95a90a3aa2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diclofenac Sodium
Dosage form: SOLUTION
Route: TOPICAL
Labeler: Central Packaging
Application: ANDA203818
Marketing category: ANDA
Marketing start: 2014-11-26
Marketing end: 0000-00-00
Substance: DICLOFENAC SODIUM
Active strength: 16 mg/mL
Pharmacologic classes: Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	80175-1358		I	Inactivated by FDA		2026-08-17
excluded package	package	80175-1358	80175-1358-0	I	Inactivated by FDA		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 · 38 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80175-1358-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80175-1358-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80175-1358-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80175-1358-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	80175-1358-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	80175-1358-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	80175-1358-0	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	80175-1358-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	80175-1358-0	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	80175-1358-0	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	80175-1358-0	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	80175-1358-0	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	80175-1358-0	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	80175-1358-0	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	80175-1358-0	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	80175-1358-0	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	80175-1358-0	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	80175-1358-0	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	80175-1358-0	`8dfbde2a14a4…`	`c9ff85d89658…`

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
A203818-001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203818-001	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 · 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	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT		2014-11-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT		2014-11-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT		2014-11-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT		2014-11-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT		2014-11-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT		2014-11-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203818-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-11-26	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A203818-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203818-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203818-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203818-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203818-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203818-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203818-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203818-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203818-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203818-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203818-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203818-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203818-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203818-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203818-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203818-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203818-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203818-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203818-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203818-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203818-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203818-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203818-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203818-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203818-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203818-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203818-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203818-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203818-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203818-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203818-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203818-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203818-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203818-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203818-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203818-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203818-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203818-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203818-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203818-001	AT	1	`e64feba35796…`

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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
80175-1358-0	Diclofenac Sodium	1 in 1 CARTON	SOLUTION	1		1
80175-1358-0	Diclofenac Sodium	150 mL in 1 BOTTLE, DROPPER	SOLUTION	150		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80175-1358	DICLOFENAC SODIUM SOLUTION [CENTRAL PACKAGING]	1	Legacy NDC, 2 package rows	20210225_bc185822-4754-ff6c-e053-2995a90a7c0e.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 1 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac Sodium	DICLOFENAC SODIUM	Preferred Pharmaceuticals, Inc.	4a3549e0-1e2d-42bf-b82c-1e62837ba2e4	2026-04-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203818 application number: ANDA203818
Diclofenac Sodium	DICLOFENAC SODIUM	REMEDYREPACK INC.	d349d286-b462-4f8f-aa39-6173653175d6	2026-03-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203818 application number: ANDA203818
DICLOFENAC SODIUM	DICLOFENAC SODIUM	DirectRx	d5f215d4-9aa3-2ecf-e053-2995a90a2e89	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203818 application number: ANDA203818
Diclofenac Sodium	DICLOFENAC SODIUM	Sun Pharmaceutical Industries, Inc.	fae53d24-acf1-4250-888d-b8d965ffc3d3	2026-02-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203818 application number: ANDA203818
Diclofenac Sodium	DICLOFENAC SODIUM	Asclemed USA, Inc.	5508f80d-5f11-4959-8e42-9055f0169cfc	2025-02-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203818 application number: ANDA203818
Diclofenac Sodium	DICLOFENAC SODIUM	Direct_Rx	f80b0b95-f4da-2d6c-e053-6294a90acf92	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203818 application number: ANDA203818
Diclofenac Sodium	DICLOFENAC SODIUM	Advanced Rx of Tennessee, LLC	0803345d-7811-bc21-e063-6394a90aa661	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203818 application number: ANDA203818
Diclofenac Sodium	DICLOFENAC SODIUM	A-S Medication Solutions	0379c918-1717-40ab-81cc-268116950fd5	2023-10-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203818 application number: ANDA203818
Diclofenac Sodium	DICLOFENAC SODIUM	Proficient Rx LP	1c1ee94c-60d6-4cfc-bb66-1d4f6e630512	2022-05-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203818 application number: ANDA203818
Diclofenac sodium	DICLOFENAC SODIUM	Proficient Rx LP	b0f9e649-6651-406f-a9fe-157fe04d9d27	2020-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203818 application number: ANDA203818

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
QTG126297Q	DICLOFENAC SODIUM	15307-79-6	DICLOFENAC SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
857700	diclofenac sodium 1.5 % Topical Solution	PSN	bc185822-4754-ff6c-e053-2995a90a7c0e	1
857700	diclofenac sodium 15 MG/ML Topical Solution	SCD	bc185822-4754-ff6c-e053-2995a90a7c0e	1
857700	diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical Solution	SY	bc185822-4754-ff6c-e053-2995a90a7c0e	1
857700	diclofenac sodium 16.05 MG per 1 ML Topical Solution	SY	bc185822-4754-ff6c-e053-2995a90a7c0e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
80175-1358-0	80175135800	1 BOTTLE, DROPPER in 1 CARTON (80175-1358-0) > 150 mL in 1 BOTTLE, DROPPER	2014-11-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diclofenac Sodium - Central Packaging \| Central Packaging, LLC	Central Packaging \| Central Packaging, LLC	2021-02-24	HUMAN PRESCRIPTION DRUG LABEL	1