Diclofenac Sodium

Product NDC: 55700-735
11-digit product format: 557000735
Labeler code: 55700
Product ID: 55700-735_9cda37d7-14d0-451c-a980-f8872a90d465
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diclofenac
Dosage form: SOLUTION
Route: TOPICAL
Labeler: Quality Care Products, LLC
Application: ANDA206116
Marketing category: ANDA
Marketing start: 2019-03-22
Marketing end: 0000-00-00
Substance: DICLOFENAC SODIUM
Active strength: 16 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: 2023-12-31
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	55700-735		D	Discontinued by firm		2026-08-11
excluded package	package	55700-735	55700-735-15	D	Discontinued by firm		2026-08-11

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
A206116-001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT		2016-09-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206116-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206116-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	2016-09-02	`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	A206116-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206116-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206116-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206116-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206116-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206116-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206116-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206116-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206116-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206116-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206116-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206116-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206116-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206116-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206116-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206116-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206116-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206116-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206116-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206116-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206116-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206116-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206116-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206116-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206116-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206116-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206116-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206116-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206116-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206116-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206116-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206116-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206116-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206116-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206116-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206116-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206116-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206116-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206116-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206116-001	AT	1	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55700-735-15	ML - Milliliter	55700-735	1db06651-c38c-42b3-b9c0-8ec3c8fc8bbb	1	2019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55700-735	DICLOFENAC SODIUM (DICLOFENAC) SOLUTION [QUALITY CARE PRODUCTS, LLC]	4	Legacy NDC	20241220_27c3b050-ba58-47ca-9b8c-e04998b50bb3.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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac Sodium	DICLOFENAC	Preferred Pharmaceuticals Inc.	937e9ba5-cdad-4e72-a77a-bad699e1b236	2026-04-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206116 application number: ANDA206116
Diclofenac Sodium	DICLOFENAC SODIUM	SOLA Pharmaceuticals, LLC	11e88ced-cdcf-4101-9297-c4c3dde9d089	2026-02-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206116 application number: ANDA206116
Diclofenac Sodium	DICLOFENAC SODIUM	Advanced Rx of Tennessee, LLC	0b4fd47f-903c-097b-e063-6394a90a49ab	2025-11-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206116 application number: ANDA206116
Diclofenac Sodium	DICLOFENAC	PHOENIX RX LLC	41dab520-5651-a4c5-e063-6394a90a2962	2025-10-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206116 application number: ANDA206116
Diclofenac Sodium	DICLOFENAC SODIUM	Direct_Rx	0c41977f-8dad-1d26-e063-6294a90a9b22	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206116 application number: ANDA206116
DICLOFENAC SODIUM	DICLOFENAC SODIUM	DIRECT RX	a5b33bf7-8113-9c54-e053-2995a90a79d8	2025-01-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206116 application number: ANDA206116
Diclofenac Sodium	DICLOFENAC SODIUM	Advanced Rx Pharmacy of Tennessee, LLC	f1896c84-b18a-d49d-e053-2995a90aaab3	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206116 application number: ANDA206116
Diclofenac Sodium	DICLOFENAC	Amneal Pharmaceuticals LLC	78873f83-cea9-44d4-8ad4-8cb9257e5c7f	2024-07-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206116 application number: ANDA206116
Diclofenac Sodium	DICLOFENAC	Proficient Rx LP	f4da38af-c5bd-4d4a-a6f3-c2933f223809	2023-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206116 application number: ANDA206116
Diclofenac Sodium	DICLOFENAC	Bryant Ranch Prepack	e5f8284a-1aa9-4a36-a6ad-fa153c613f34	2023-05-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206116 application number: ANDA206116
Diclofenac Sodium	DICLOFENAC	A-S Medication Solutions	58178f0d-3960-48e3-91ba-150f691be241	2023-05-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206116 application number: ANDA206116
Diclofenac Sodium	DICLOFENAC	Asclemed USA, Inc.	9df599de-6412-a94e-e053-2995a90a1741	2022-10-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206116 application number: ANDA206116

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
QTG126297Q	DICLOFENAC SODIUM	15307-79-6	DICLOFENAC SODIUM
144O8QL0L1	DICLOFENAC	15307-86-5	Diclofenac

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55700-735-15	55700073515	1 BOTTLE in 1 CARTON (55700-735-15) > 150 mL in 1 BOTTLE	1 bottle	2019-03-22	0000-00-00	No	No	Current