Diclofenac Sodium

Product NDC: 84386-120
11-digit product format: 843860120
Labeler code: 84386
Product ID: 84386-120_e5c0863a-edb7-4f46-a396-c9b2d8785cf8
Type: HUMAN OTC DRUG
Nonproprietary name: Diclofenac Sodium
Dosage form: GEL
Route: TOPICAL
Labeler: Aurobindo Pharma Limited
Application: ANDA204306
Marketing category: ANDA
Marketing start: 2025-10-15
Substance: DICLOFENAC SODIUM
Active strength: 10 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
A204306-001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	1%	GEL / TOPICAL			2019-05-06

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 · 43 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
2026-09-14 22:38:34	2026-08	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	AB	2019-05-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	AB	2019-05-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	AB	2019-05-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	AB	2019-05-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204306-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-06	`f41ea6bd6efb…`

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	A204306-001	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A204306-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204306-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204306-001	AB	1	`ea99ee380514…`

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	10 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
855633	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
e5c0863a-edb7-4f46-a396-c9b2d8785cf8	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
84386-120-01	Diclofenac Sodium	100 g in 1 TUBE	GEL	100		1
84386-120-01	Diclofenac Sodium	1 in 1 CARTON	GEL	1		1

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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AMAZON BASIC CARE ARTHRITIS PAIN	DICLOFENAC SODIUM	Amazon.com Services LLC	113e2f87-c408-3e44-e063-6394a90a0a7f	2026-08-20	Warnings	Exact identifier application applno (ANDA): 204306 application number: ANDA204306
Diclofenac Sodium	DICLOFENAC SODIUM	Preferred Pharmaceuticals Inc.	226da8a2-807d-4784-8d33-b434f3951a52	2026-08-12	Warnings	Exact identifier application applno (ANDA): 204306 application number: ANDA204306
Diclofenac Sodium	DICLOFENAC SODIUM	Preferred Pharmaceuticals Inc.	09643e65-f301-4891-96f4-d78bf3621e23	2026-07-02	Warnings	Exact identifier application applno (ANDA): 204306 application number: ANDA204306
Diclofenac Sodium	DICLOFENAC SODIUM	Sportpharm LLC	929f71ab-f0c8-4331-800d-ed4a172e647e	2026-01-14	Warnings	Exact identifier application applno (ANDA): 204306 application number: ANDA204306
Diclofenac Sodium	DICLOFENAC SODIUM	Redpharm Drug	37362eb4-db16-f4ad-e063-6394a90a42aa	2025-12-13	Warnings	Exact identifier application applno (ANDA): 204306 application number: ANDA204306
Diclofenac Sodium	DICLOFENAC SODIUM	Aurobindo Pharma Limited	e5c0863a-edb7-4f46-a396-c9b2d8785cf8	2025-11-19	Warnings	Exact identifier application applno (ANDA): 204306 application number: ANDA204306 ndc (product): 84386-120
Diclofenac Sodium	DICLOFENAC SODIUM	GERI-CARE PHARMACEUTICAL CORP	fc08e58c-6323-e667-e053-6394a90ab754	2025-04-21	Warnings	Exact identifier application applno (ANDA): 204306 application number: ANDA204306
DICLOFENAC SODIUM	DICLOFENAC SODIUM	INNOVUS PHARMACEUTICALS, INC.	ad9d2c28-21bc-4f81-9c90-cce6a96d976a	2025-03-25	Warnings	Exact identifier application applno (ANDA): 204306 application number: ANDA204306
Diclofenac Sodium	DICLOFENAC SODIUM	Harris Teeter	17ed520d-bfbe-4a33-e063-6394a90aa0f6	2024-08-30	Warnings	Exact identifier application applno (ANDA): 204306 application number: ANDA204306
Diclofenac Sodium	DICLOFENAC SODIUM	Aurohealth LLC	81e964ff-6622-4054-bf01-6ed6eef6778f	2024-07-06	Warnings	Exact identifier application applno (ANDA): 204306 application number: ANDA204306
Diclofenac Sodium	DICLOFENAC SODIUM	KROGER COMPANY	15e59aac-a642-91e4-e063-6294a90a1175	2024-06-28	Warnings	Exact identifier application applno (ANDA): 204306 application number: ANDA204306
Diclofenac Sodium	DICLOFENAC SODIUM	Aurohealth LLC	2a599579-b2b0-4423-8e30-fe04bf815870	2023-08-11	Warnings	Exact identifier application applno (ANDA): 204306 application number: ANDA204306

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
855633	diclofenac sodium 1 % Topical Gel	PSN	e5c0863a-edb7-4f46-a396-c9b2d8785cf8	1
855633	diclofenac sodium 0.01 MG/MG Topical Gel	SCD	e5c0863a-edb7-4f46-a396-c9b2d8785cf8	1
855633	diclofenac sodium 1 % Topical Gel	SY	e5c0863a-edb7-4f46-a396-c9b2d8785cf8	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
84386-120-01	84386012001	1 TUBE in 1 CARTON (84386-120-01) / 100 g in 1 TUBE	1 tube	2025-10-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DICLOFENAC - Aurobindo Pharma Limited \| Aurohealth LLC \| APL HEALTHCARE LIMITED	Aurobindo Pharma Limited \| Aurohealth LLC \| APL HEALTHCARE LIMITED	2025-11-19	Human OTC Drug Label	1