Diclofenac Sodium

Product NDC: 72603-207
11-digit product format: 726030207
Labeler code: 72603
Product ID: 72603-207_e3058adb-1a77-4e85-bcc2-78fa045bde77
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diclofenac Sodium
Dosage form: SOLUTION
Route: TOPICAL
Labeler: NorthStar Rx LLC
Application: ANDA213040
Marketing category: ANDA
Marketing start: 2024-06-01
Substance: DICLOFENAC SODIUM
Active strength: 20 mg/g
Pharmacologic classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
A213040-001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB		2023-02-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213040-001	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.

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	A213040-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB	2023-02-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213040-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB	2023-02-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213040-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB	2023-02-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213040-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB	2023-02-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213040-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB	2023-02-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213040-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB	2023-02-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213040-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB	2023-02-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213040-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB	2023-02-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213040-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB	2023-02-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213040-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB	2023-02-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213040-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB	2023-02-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213040-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB	2023-02-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213040-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB	2023-02-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213040-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB	2023-02-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213040-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB	2023-02-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213040-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB	2023-02-03	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213040-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB	2023-02-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213040-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB	2023-02-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213040-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB	2023-02-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213040-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB	2023-02-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213040-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB	2023-02-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213040-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB	2023-02-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213040-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB	2023-02-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213040-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB	2023-02-03	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213040-001	DICLOFENAC SODIUM	2%	SOLUTION / TOPICAL	AB	2023-02-03	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A213040-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213040-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213040-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213040-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213040-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213040-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213040-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213040-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213040-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213040-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213040-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213040-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213040-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213040-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213040-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213040-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213040-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213040-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213040-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213040-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213040-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213040-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213040-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213040-001	AB	1	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213040-001	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Diclofenac Sodium
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DICLOFENAC SODIUM	20 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
QTG126297Q	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1487074	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
fd467c1a-6463-4d92-9960-3e308c733edb	Available on FDA.report

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
72603-207-01	Diclofenac Sodium	1 in 1 CARTON	SOLUTION	1		3
72603-207-01	Diclofenac Sodium	112 g in 1 BOTTLE	SOLUTION	112		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72603-207-01	GM - Gram	72603-207	6571277a-d9e6-4434-9573-15a891ad2f51	1	2024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72603-207	DICLOFENAC SODIUM SOLUTION [NORTHSTAR RX LLC]	3	Current NDC, 2 package rows	20250117_fd467c1a-6463-4d92-9960-3e308c733edb.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac Sodium	DICLOFENAC SODIUM	Aurolife Pharma LLC	dfb7afdf-5c05-4487-9044-936e151e5ba6	2026-04-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213040 application number: ANDA213040
Diclofenac Sodium	DICLOFENAC SODIUM	Preferred Pharmaceuticals Inc.	15b280a1-4964-4636-833b-3db44044d289	2026-04-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213040 application number: ANDA213040
Diclofenac Sodium	DICLOFENAC SODIUM	A-S Medication Solutions	ca0f9295-4933-48d6-9387-90345fd5dcaa	2025-08-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213040 application number: ANDA213040
Diclofenac Sodium	DICLOFENAC SODIUM	NorthStar Rx LLC	fd467c1a-6463-4d92-9960-3e308c733edb	2025-01-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213040 application number: ANDA213040 ndc (product): 72603-207
Diclofenac Sodium	DICLOFENAC SODIUM	Proficient Rx LP	ba4677e4-00f8-44f6-a69b-e88ca28f6b2b	2024-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213040 application number: ANDA213040
Diclofenac Sodium	DICLOFENAC SODIUM	Asclemed USA, Inc	2e3e6de9-7e07-4df3-9fea-ac50ddcde840	2024-10-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213040 application number: ANDA213040
Diclofenac Sodium Topical Solution	DICLOFENAC SODIUM TOPICAL SOLUTION	Direct_Rx	15c2cd6d-b7c2-d927-e063-6394a90aa63e	2024-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213040 application number: ANDA213040
Diclofenac Sodium	DICLOFENAC SODIUM	Proficient Rx LP	f104f8fb-066f-4bbf-8894-3b3ed1b8266d	2024-03-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213040 application number: ANDA213040

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
1487074	diclofenac sodium 2 % Topical Solution	PSN	fd467c1a-6463-4d92-9960-3e308c733edb	3
1487074	diclofenac sodium 20 MG/ML Topical Solution	SCD	fd467c1a-6463-4d92-9960-3e308c733edb	3
1487074	diclofenac sodium 2 % Topical Solution	SY	fd467c1a-6463-4d92-9960-3e308c733edb	3
1487074	diclofenac sodium 2 % Topical Solution	PSN	ba4677e4-00f8-44f6-a69b-e88ca28f6b2b	1
1487074	diclofenac sodium 2 % Topical Solution	PSN	ca0f9295-4933-48d6-9387-90345fd5dcaa	1
1487074	diclofenac sodium 20 MG/ML Topical Solution	SCD	ba4677e4-00f8-44f6-a69b-e88ca28f6b2b	1
1487074	diclofenac sodium 20 MG/ML Topical Solution	SCD	ca0f9295-4933-48d6-9387-90345fd5dcaa	1
1487074	diclofenac sodium 2 % Topical Solution	SY	ba4677e4-00f8-44f6-a69b-e88ca28f6b2b	1
1487074	diclofenac sodium 2 % Topical Solution	SY	ca0f9295-4933-48d6-9387-90345fd5dcaa	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72603-207-01	72603020701	1 BOTTLE in 1 CARTON (72603-207-01) / 112 g in 1 BOTTLE	1 bottle	2024-06-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diclofenac Sodium	A-S Medication Solutions	2025-08-20	Human Prescription Drug Label	1
Diclofenac Sodium	NorthStar Rx LLC \| Aurolife Pharma LLC	2025-01-10	Human Prescription Drug Label	3
Diclofenac Sodium	Proficient Rx LP	2024-11-01	HUMAN PRESCRIPTION DRUG LABEL	1