Diclofenac Sodium

Product NDC: 52959-987
11-digit product format: 529590987
Labeler code: 52959
Product ID: 52959-987_1fb5dcde-d854-4df6-8fc7-35affe0adc11
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diclofenac Sodium
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: H.J. Harkins Company, Inc.
Application: ANDA078792
Marketing category: ANDA
Marketing start: 2007-12-28
Marketing end: 0000-00-00
Substance: DICLOFENAC SODIUM
Active strength: 1 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: E
Listing certified through: 2017-12-31
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	52959-987		I	Inactivated by FDA		2026-08-11
excluded package	package	52959-987	52959-987-05	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	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	52959-987-05	`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	52959-987-05	`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	52959-987-05	`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	52959-987-05	`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	52959-987-05	`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	52959-987-05	`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	52959-987-05	`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	52959-987-05	`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	52959-987-05	`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	52959-987-05	`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	52959-987-05	`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	52959-987-05	`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	52959-987-05	`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	52959-987-05	`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	52959-987-05	`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	52959-987-05	`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	52959-987-05	`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	52959-987-05	`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	52959-987-05	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	52959-987-05	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	52959-987-05	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	52959-987-05	`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
A078792-001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2007-12-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078792-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2007-12-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2007-12-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2007-12-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2007-12-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2007-12-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2007-12-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2007-12-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2007-12-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2007-12-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2007-12-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2007-12-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2007-12-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2007-12-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2007-12-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2007-12-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2007-12-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2007-12-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT		2007-12-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2007-12-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2007-12-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT		2007-12-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT		2007-12-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT		2007-12-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT		2007-12-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT		2007-12-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT		2007-12-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT		2007-12-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2007-12-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2007-12-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2007-12-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2007-12-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2007-12-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2007-12-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2007-12-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2007-12-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2007-12-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2007-12-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2007-12-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2007-12-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078792-001	DICLOFENAC SODIUM	0.1%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2007-12-28	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A078792-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078792-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078792-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078792-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078792-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078792-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078792-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078792-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078792-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078792-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078792-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078792-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078792-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078792-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078792-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078792-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078792-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078792-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078792-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078792-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078792-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078792-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078792-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078792-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078792-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078792-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078792-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078792-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078792-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078792-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078792-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078792-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078792-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078792-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078792-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078792-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078792-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078792-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078792-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078792-001	AT	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75	Product name	2	20250814
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
52959-987-05	2019-11-13	C162847	48780-1	97449f38-bb61-f6ea-e053-dbdaa90aa703	Diclofenac Sodium Ophthalmic Solution, 0.1% (Sterile)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52959-987-05	Diclofenac Sodium	1 in 1 CARTON	SOLUTION/ DROPS	1		1
52959-987-05	Diclofenac Sodium	5 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	5		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DICLOFENAC SODIUM	ACTIVE INGREDIENT	QTG126297Q	DICLOFENAC SODIUM SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.]	1
DICLOFENAC	ACTIVE MOIETY	144O8QL0L1	DICLOFENAC SODIUM SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.]	1
BORIC ACID	INACTIVE INGREDIENT	R57ZHV85D4	DICLOFENAC SODIUM SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	DICLOFENAC SODIUM SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.]	1
POLYOXYL 35 CASTOR OIL	INACTIVE INGREDIENT	6D4M1DAL6O	DICLOFENAC SODIUM SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.]	1
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	DICLOFENAC SODIUM SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.]	1
TROMETHAMINE	INACTIVE INGREDIENT	023C2WHX2V	DICLOFENAC SODIUM SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	DICLOFENAC SODIUM SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52959-987	DICLOFENAC SODIUM SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.]	1	Legacy NDC, 2 package rows	20111205_41c80e79-36fd-4b90-bae1-55d6042c3ca2.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac Sodium	DICLOFENAC SODIUM	Bausch & Lomb Incorporated	39dfffb0-612a-48f3-8db5-1a59899b91e9	2026-01-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078792 application number: ANDA078792
Diclofenac Sodium	DICLOFENAC SODIUM	A-S Medication Solutions	5d74488c-e092-415d-b19b-05318380d9b1	2024-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078792 application number: ANDA078792

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
854801	diclofenac sodium 0.1 % Ophthalmic Solution	PSN	41c80e79-36fd-4b90-bae1-55d6042c3ca2	1
854801	diclofenac sodium 1 MG/ML Ophthalmic Solution	SCD	41c80e79-36fd-4b90-bae1-55d6042c3ca2	1
854801	diclofenac sodium 0.1 % Ophthalmic Solution	SY	41c80e79-36fd-4b90-bae1-55d6042c3ca2	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
52959-987-05	52959098705	1 in 1 CARTON	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diclofenac Sodium Ophthalmic Solution, 0.1% (Sterile)	H.J. Harkins Company, Inc. \| Bausch & Lomb Incorporated \| Esteve Quimca S.A.	2011-10-27	HUMAN PRESCRIPTION DRUG LABEL	1