Diclofenac Sodium

Product NDC: 85509-1581
Requested package NDC: 85509-1581-1
11-digit product format: 855091581
Labeler code: 85509
Product ID: 85509-1581_3a645e5d-e1e4-6f2a-e063-6394a90a4ddc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diclofenac Sodium Topical
Dosage form: GEL
Route: TOPICAL
Labeler: PHOENIX RX LLC
Application: ANDA212351
Marketing category: ANDA
Marketing start: 2022-09-15
Substance: DICLOFENAC SODIUM
Active strength: 30 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 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
A212351-001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB		2022-07-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212351-001	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
2026-02-19 14:30 UTC	2026-02	A212351-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	BX	2022-07-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212351-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	BX	2022-07-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212351-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	BX	2022-07-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212351-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2022-07-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212351-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2022-07-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212351-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2022-07-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212351-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2022-07-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212351-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2022-07-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212351-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2022-07-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212351-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2022-07-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212351-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2022-07-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212351-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2022-07-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212351-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2022-07-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212351-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2022-07-27	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212351-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2022-07-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212351-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2022-07-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212351-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2022-07-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212351-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2022-07-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212351-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2022-07-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212351-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2022-07-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212351-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2022-07-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212351-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2022-07-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212351-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2022-07-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212351-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2022-07-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212351-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2022-07-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212351-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2022-07-27	`e64feba35796…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212351-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2022-07-27	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212351-001	BX	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212351-001	BX	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212351-001	BX	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212351-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212351-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212351-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212351-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212351-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212351-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212351-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212351-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212351-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212351-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212351-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212351-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212351-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212351-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212351-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212351-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212351-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212351-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212351-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212351-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212351-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212351-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212351-001	AB	1	`e64feba35796…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212351-001	AB	1	`a50c72e98297…`

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	30 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
855642	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
3a63e26f-27d7-9a25-e063-6294a90a55fe	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
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
85509-1581-1	Diclofenac Sodium	100 g in 1 TUBE	GEL	100		2
85509-1581-1	Diclofenac Sodium	1 in 1 CARTON	GEL	1		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
85509-1581-1	GM - Gram	85509-1581	3ce600e8-01eb-4404-8ad1-03590d077ba6	1	2025-09-12

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 TOPICAL	REMEDYREPACK INC.	cc8c3125-ee43-40bb-8500-339efa901b8c	2026-06-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212351 application number: ANDA212351
Diclofenac Sodium	DICLOFENAC SODIUM TOPICAL	ASCLEMED USA INC.	fd94964b-167b-41b7-a612-8febe9ae0511	2026-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212351 application number: ANDA212351
Diclofenac Sodium Gel	DICLOFENAC SODIUM GEL	Direct_Rx	fc0c9cfe-998b-d22a-e053-6294a90afa42	2026-03-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212351 application number: ANDA212351
Diclofenac Sodium	DICLOFENAC SODIUM TOPICAL	Proficient Rx LP	140a2c64-4996-4da3-b10f-1b8235ebde9d	2025-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212351 application number: ANDA212351
Diclofenac Sodium	DICLOFENAC SODIUM TOPICAL	PHOENIX RX LLC	3a63e26f-27d7-9a25-e063-6294a90a55fe	2025-07-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212351 application number: ANDA212351 ndc (package): 85509-1581-1 ndc (product): 85509-1581 ndc11 (package): 85509158101
Diclofenac Sodium	DICLOFENAC SODIUM TOPICAL	Preferred Pharmaceuticals Inc.	6d5243ae-4a1a-4583-9337-085520e1f14a	2025-03-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212351 application number: ANDA212351
Diclofenac Sodium	DICLOFENAC SODIUM TOPICAL	Alembic Pharmaceuticals Limited	11adfe0f-e774-4ccf-8a57-0c7d47aeb0dd	2025-03-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212351 application number: ANDA212351
Diclofenac Sodium	DICLOFENAC SODIUM TOPICAL	Alembic Pharmaceuticals Inc.	30c3c3c5-b4f3-4321-ae25-b2c588ad0551	2025-01-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212351 application number: ANDA212351
Diclofenac Sodium	DICLOFENAC SODIUM TOPICAL	Advanced Rx Pharmacy of Tennessee, LLC	fc0e6a51-bec3-f7ee-e053-6394a90ada9a	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212351 application number: ANDA212351
Diclofenac Sodium	DICLOFENAC SODIUM TOPICAL	Medsource Pharmaceuticals	1495ed53-0489-a465-e063-6394a90af68d	2024-03-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212351 application number: ANDA212351

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
855642	diclofenac sodium 3 % Topical Gel	PSN	3a63e26f-27d7-9a25-e063-6294a90a55fe	2
855642	diclofenac sodium 0.03 MG/MG Topical Gel	SCD	3a63e26f-27d7-9a25-e063-6294a90a55fe	2
855642	diclofenac sodium 3 % Topical Gel	SY	3a63e26f-27d7-9a25-e063-6294a90a55fe	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
85509-1581-1	85509158101	1 TUBE in 1 CARTON (85509-1581-1) / 100 g in 1 TUBE	1 tube	2025-07-21	No	No	Current