Diclofenac Sodium

Product NDC: 51672-1358
Requested package NDC: 51672-1358-4
11-digit product format: 516721358
Labeler code: 51672
Product ID: 51672-1358_4b20d36c-e921-489d-e063-6294a90ad63b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diclofenac Sodium
Dosage form: SOLUTION
Route: TOPICAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA203818
Marketing category: ANDA
Marketing start: 2014-11-26
Substance: DICLOFENAC SODIUM
Active strength: 16.05 mg/mL
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: 2027-12-31
Current FDA listing: Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	51672-1358	51672-1358-4	D	Discontinued by firm		2026-08-17

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Diclofenac Sodium
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DICLOFENAC SODIUM	16.05 mg/mL

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
857700	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
fae53d24-acf1-4250-888d-b8d965ffc3d3	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
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
0fcbc38a-8b29-3348-1cef-5222ea53484f	Product name	4	20220516
c4e1eedc-aca2-4551-8382-89144ed9d049	Product name	3	20220126
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
8d368a34-1453-43ea-828d-0dbcd72b8794	Product name	8	20210622
473d070d-1c38-488e-b991-c4d1bf45aab8	Product name	1	20210201
d6bab9d2-edce-a213-4796-226ab15472c3	Product name	6	20200616
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
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
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
dbb00be6-fb1c-4b0a-a770-31f7e05e247e	Product name	1	20150316
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51672-1358-2	Diclofenac Sodium	1 in 1 CARTON	SOLUTION	1		13
51672-1358-2	Diclofenac Sodium	150 mL in 1 BOTTLE, DROPPER	SOLUTION	150		13
51672-1358-4	Diclofenac Sodium	60 mL in 1 BOTTLE, DROPPER	SOLUTION	60		13
51672-1358-4	Diclofenac Sodium	1 in 1 CARTON	SOLUTION	1		13
51672-1358-2	Clofenax	150 mL in 1 BOTTLE, DROPPER	SOLUTION	150 mL	16.05 mg in 1mL	3
51672-1358-2	Clofenax	1 in 1 CARTON	SOLUTION		16.05 mg in 1mL	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51672-1358-2	ML - Milliliter	51672-1358	3cbc277c-c918-43ae-bce6-4cff117c87f9	1	2015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Diclofenac Sodium	ACTIVE INGREDIENT	QTG126297Q	DICLOFENAC SODIUM SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]	5
Diclofenac	ACTIVE MOIETY	144O8QL0L1	DICLOFENAC SODIUM SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]	5
alcohol	INACTIVE INGREDIENT	3K9958V90M	DICLOFENAC SODIUM SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]	5
dimethyl sulfoxide	INACTIVE INGREDIENT	YOW8V9698H	DICLOFENAC SODIUM SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]	5
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	DICLOFENAC SODIUM SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]	5
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	DICLOFENAC SODIUM SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]	5
water	INACTIVE INGREDIENT	059QF0KO0R	DICLOFENAC SODIUM SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51672-1358	DICLOFENAC SODIUM SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]	10	Current NDC, Legacy NDC, 4 package rows	20220814_fae53d24-acf1-4250-888d-b8d965ffc3d3.zip
51672-1358	CLOFENAX (DICLOFENAC SODIUM, KINESIOLOGY TAPE) KIT [PURETEK CORPORATION]	2	Current NDC, Legacy NDC	20230112_b60e6572-0624-40c5-e053-2995a90ade48.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 ndc (package): 51672-1358-4 ndc (product): 51672-1358 ndc11 (package): 51672135804
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	fae53d24-acf1-4250-888d-b8d965ffc3d3	13
857700	diclofenac sodium 15 MG/ML Topical Solution	SCD	fae53d24-acf1-4250-888d-b8d965ffc3d3	13
857700	diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical Solution	SY	fae53d24-acf1-4250-888d-b8d965ffc3d3	13
857700	diclofenac sodium 16.05 MG per 1 ML Topical Solution	SY	fae53d24-acf1-4250-888d-b8d965ffc3d3	13
857700	diclofenac sodium 1.5 % Topical Solution	PSN	d349d286-b462-4f8f-aa39-6173653175d6	10
857700	diclofenac sodium 15 MG/ML Topical Solution	SCD	d349d286-b462-4f8f-aa39-6173653175d6	10
857700	diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical Solution	SY	d349d286-b462-4f8f-aa39-6173653175d6	10
857700	diclofenac sodium 16.05 MG per 1 ML Topical Solution	SY	d349d286-b462-4f8f-aa39-6173653175d6	10
857700	diclofenac sodium 1.5 % Topical Solution	PSN	4a3549e0-1e2d-42bf-b82c-1e62837ba2e4	7
857700	diclofenac sodium 15 MG/ML Topical Solution	SCD	4a3549e0-1e2d-42bf-b82c-1e62837ba2e4	7
857700	diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical Solution	SY	4a3549e0-1e2d-42bf-b82c-1e62837ba2e4	7
857700	diclofenac sodium 16.05 MG per 1 ML Topical Solution	SY	4a3549e0-1e2d-42bf-b82c-1e62837ba2e4	7
857700	diclofenac sodium 1.5 % Topical Solution	PSN	f267b75c-e141-41dd-e053-2995a90afe30	4
857700	diclofenac sodium 15 MG/ML Topical Solution	SCD	f267b75c-e141-41dd-e053-2995a90afe30	4
857700	diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical Solution	SY	f267b75c-e141-41dd-e053-2995a90afe30	4
857700	diclofenac sodium 16.05 MG per 1 ML Topical Solution	SY	f267b75c-e141-41dd-e053-2995a90afe30	4
1039731	camphor 4 % / menthol 10 % Topical Gel	PSN	1e2bb4e5-bb65-48a0-e063-6294a90a54d1	3
198555	capsaicin 0.025 % Topical Cream	PSN	042765e5-bd75-8224-e063-6394a90a141b	3
857700	diclofenac sodium 1.5 % Topical Solution	PSN	1e2a687b-a838-9b16-e063-6394a90a69f3	3
857700	diclofenac sodium 1.5 % Topical Solution	PSN	1e2bb4e5-bb65-48a0-e063-6294a90a54d1	3
857700	diclofenac sodium 1.5 % Topical Solution	PSN	d5f215d4-9aa3-2ecf-e053-2995a90a2e89	3
857700	diclofenac sodium 1.5 % Topical Solution	PSN	b60e6572-0624-40c5-e053-2995a90ade48	3
857700	diclofenac sodium 1.5 % Topical Solution	PSN	042765e5-bd75-8224-e063-6394a90a141b	3
1039731	camphor 0.04 MG/MG / menthol 0.1 MG/MG Topical Gel	SCD	1e2bb4e5-bb65-48a0-e063-6294a90a54d1	3
198555	capsaicin 0.25 MG/ML Topical Cream	SCD	042765e5-bd75-8224-e063-6394a90a141b	3
857700	diclofenac sodium 15 MG/ML Topical Solution	SCD	1e2a687b-a838-9b16-e063-6394a90a69f3	3
857700	diclofenac sodium 15 MG/ML Topical Solution	SCD	1e2bb4e5-bb65-48a0-e063-6294a90a54d1	3
857700	diclofenac sodium 15 MG/ML Topical Solution	SCD	d5f215d4-9aa3-2ecf-e053-2995a90a2e89	3
857700	diclofenac sodium 15 MG/ML Topical Solution	SCD	b60e6572-0624-40c5-e053-2995a90ade48	3
857700	diclofenac sodium 15 MG/ML Topical Solution	SCD	042765e5-bd75-8224-e063-6394a90a141b	3
1039731	camphor 4 % / menthol 10 % Topical Gel	SY	1e2bb4e5-bb65-48a0-e063-6294a90a54d1	3
198555	capsaicin 0.025 % Topical Cream	SY	042765e5-bd75-8224-e063-6394a90a141b	3
857700	diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical Solution	SY	1e2bb4e5-bb65-48a0-e063-6294a90a54d1	3
857700	diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical Solution	SY	1e2a687b-a838-9b16-e063-6394a90a69f3	3
857700	diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical Solution	SY	b60e6572-0624-40c5-e053-2995a90ade48	3
857700	diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical Solution	SY	d5f215d4-9aa3-2ecf-e053-2995a90a2e89	3
857700	diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical Solution	SY	042765e5-bd75-8224-e063-6394a90a141b	3
857700	diclofenac sodium 16.05 MG per 1 ML Topical Solution	SY	1e2bb4e5-bb65-48a0-e063-6294a90a54d1	3
857700	diclofenac sodium 16.05 MG per 1 ML Topical Solution	SY	d5f215d4-9aa3-2ecf-e053-2995a90a2e89	3
857700	diclofenac sodium 16.05 MG per 1 ML Topical Solution	SY	1e2a687b-a838-9b16-e063-6394a90a69f3	3
857700	diclofenac sodium 16.05 MG per 1 ML Topical Solution	SY	b60e6572-0624-40c5-e053-2995a90ade48	3
857700	diclofenac sodium 16.05 MG per 1 ML Topical Solution	SY	042765e5-bd75-8224-e063-6394a90a141b	3
857700	diclofenac sodium 1.5 % Topical Solution	PSN	1c1ee94c-60d6-4cfc-bb66-1d4f6e630512	2
857700	diclofenac sodium 15 MG/ML Topical Solution	SCD	1c1ee94c-60d6-4cfc-bb66-1d4f6e630512	2
857700	diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical Solution	SY	1c1ee94c-60d6-4cfc-bb66-1d4f6e630512	2
857700	diclofenac sodium 16.05 MG per 1 ML Topical Solution	SY	1c1ee94c-60d6-4cfc-bb66-1d4f6e630512	2
857700	diclofenac sodium 1.5 % Topical Solution	PSN	0379c918-1717-40ab-81cc-268116950fd5	1
857700	diclofenac sodium 1.5 % Topical Solution	PSN	bc185822-4754-ff6c-e053-2995a90a7c0e	1
857700	diclofenac sodium 1.5 % Topical Solution	PSN	b42e8082-557b-ab2b-e053-2995a90a622c	1
857700	diclofenac sodium 1.5 % Topical Solution	PSN	5508f80d-5f11-4959-8e42-9055f0169cfc	1
857700	diclofenac sodium 15 MG/ML Topical Solution	SCD	bc185822-4754-ff6c-e053-2995a90a7c0e	1
857700	diclofenac sodium 15 MG/ML Topical Solution	SCD	b42e8082-557b-ab2b-e053-2995a90a622c	1
857700	diclofenac sodium 15 MG/ML Topical Solution	SCD	5508f80d-5f11-4959-8e42-9055f0169cfc	1
857700	diclofenac sodium 15 MG/ML Topical Solution	SCD	0379c918-1717-40ab-81cc-268116950fd5	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 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical Solution	SY	b42e8082-557b-ab2b-e053-2995a90a622c	1
857700	diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical Solution	SY	5508f80d-5f11-4959-8e42-9055f0169cfc	1
857700	diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical Solution	SY	0379c918-1717-40ab-81cc-268116950fd5	1
857700	diclofenac sodium 16.05 MG per 1 ML Topical Solution	SY	bc185822-4754-ff6c-e053-2995a90a7c0e	1
857700	diclofenac sodium 16.05 MG per 1 ML Topical Solution	SY	b42e8082-557b-ab2b-e053-2995a90a622c	1
857700	diclofenac sodium 16.05 MG per 1 ML Topical Solution	SY	5508f80d-5f11-4959-8e42-9055f0169cfc	1
857700	diclofenac sodium 16.05 MG per 1 ML Topical Solution	SY	0379c918-1717-40ab-81cc-268116950fd5	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
51672-1358-4	51672135804	1 BOTTLE, DROPPER in 1 CARTON (51672-1358-4) > 60 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
Clofenax	PureTek Corporation \| Sun Pharma Canada Inc.	2026-07-24	HUMAN PRESCRIPTION DRUG LABEL	4
Diclofenac Sodium	Preferred Pharmaceuticals, Inc.	2026-04-02	HUMAN PRESCRIPTION DRUG LABEL	7
Diclofenac Sodium	REMEDYREPACK INC.	2026-03-30	HUMAN PRESCRIPTION DRUG LABEL	10
Diclofenac Sodium	DirectRx	2026-03-17	HUMAN PRESCRIPTION DRUG LABEL	3
Diclofenac Sodium	Sun Pharmaceutical Industries, Inc. \| Sun Pharma Canada Inc.	2026-02-18	HUMAN PRESCRIPTION DRUG LABEL	13
Lextol	PureTek Corporation	2025-12-19	HUMAN PRESCRIPTION DRUG LABEL	3
Diclogen	PureTek Corporation	2025-12-18	HUMAN PRESCRIPTION DRUG LABEL	3
Lixofen	PureTek Corporation	2025-12-18	HUMAN PRESCRIPTION DRUG LABEL	3
Diclofenac Sodium	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2025-02-08	HUMAN PRESCRIPTION DRUG LABEL	1
Diclofenac Sodium	PureTek Corporation	2024-10-25	HUMAN PRESCRIPTION DRUG LABEL	4
Diclofenac Sodium	A-S Medication Solutions	2023-10-03	HUMAN PRESCRIPTION DRUG LABEL	1
Lextol	PureTek Corporation	2023-08-23	HUMAN PRESCRIPTION DRUG LABEL	1
Diclotrex	PureTek Corporation	2023-05-04	HUMAN PRESCRIPTION DRUG LABEL	9
NuDiclo SoluPak	NuCare Pharmaceuticals,Inc.	2023-02-08	HUMAN PRESCRIPTION DRUG LABEL	1
Diclofenac Sodium	Quality Care Products, LLC	2022-09-23	HUMAN PRESCRIPTION DRUG LABEL	2
Diclofenac Sodium	Proficient Rx LP	2022-05-02	HUMAN PRESCRIPTION DRUG LABEL	2
Diclofenac Sodium - Central Packaging \| Central Packaging, LLC	Central Packaging \| Central Packaging, LLC	2021-02-24	HUMAN PRESCRIPTION DRUG LABEL	1
Diclofenac Sodium	St. Mary's Medical Park Pharmacy \| St Mary's Medical Park Pharmacy	2020-11-19	HUMAN PRESCRIPTION DRUG LABEL	2
Diclofenac Sodium	Medsource Pharmaceuticals	2020-11-15	HUMAN PRESCRIPTION DRUG LABEL	1