Diclofenac Sodium

Product NDC: 60505-0399
Requested package NDC: 60505-0399-5
11-digit product format: 605050399
Labeler code: 60505
Product ID: 60505-0399_e3840ac9-7879-6607-42de-5f6dbf78c23d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diclofenac Sodium
Dosage form: SOLUTION
Route: TOPICAL
Labeler: Apotex Corp.
Application: ANDA202027
Marketing category: ANDA
Marketing start: 2014-05-28
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	60505-0399	60505-0399-5	D	Discontinued by firm		2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A202027-001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL			2014-05-27

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202027-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL			2014-05-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202027-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL			2014-05-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202027-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL			2014-05-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202027-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL			2014-05-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202027-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL			2014-05-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202027-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL			2014-05-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202027-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL			2014-05-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202027-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL			2014-05-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202027-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL			2014-05-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202027-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL			2014-05-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202027-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL			2014-05-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202027-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL			2014-05-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202027-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL			2014-05-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202027-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL			2014-05-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202027-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL			2014-05-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202027-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL			2014-05-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202027-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL			2014-05-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202027-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-05-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202027-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL			2014-05-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202027-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL			2014-05-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202027-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL			2014-05-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202027-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL			2014-05-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202027-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-05-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202027-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-05-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202027-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-05-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202027-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-05-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202027-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL	AT	RS	2014-05-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202027-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL			2014-05-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202027-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL			2014-05-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202027-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL			2014-05-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202027-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL			2014-05-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202027-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL			2014-05-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202027-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL			2014-05-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202027-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL			2014-05-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202027-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL			2014-05-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202027-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL			2014-05-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202027-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL			2014-05-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202027-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL			2014-05-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202027-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL			2014-05-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202027-001	DICLOFENAC SODIUM	1.5%	SOLUTION / TOPICAL			2014-05-27	`cb3db0bc1861…`

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	A202027-001	AT	1	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	A202027-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202027-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202027-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202027-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202027-001	AT	1	`ea99ee380514…`

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
473d070d-1c38-488e-b991-c4d1bf45aab8	Product name	1	20210201
d6bab9d2-edce-a213-4796-226ab15472c3	Product name	6	20200616
dea2eded-d1e7-46bb-9a3d-f8dc20de6277	Product name	1	20190408
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
60505-0399-5	Varophen	1 in 1 CARTON	SOLUTION		16.05 mg in 1mL	5
60505-0399-5	Varophen	150 mL in 1 BOTTLE	SOLUTION	150 mL	16.05 mg in 1mL	5
60505-0399-5	Diclotral Pak	150 mL in 1 BOTTLE	SOLUTION	150 mL	16.05 mg in 1mL	4
60505-0399-5	Diclotral Pak	1 in 1 CARTON	SOLUTION		16.05 mg in 1mL	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60505-0399-5	ML - Milliliter	60505-0399	0fcc0d41-2908-48b7-8c54-3300c0909a33	1	2014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Diclofenac Sodium	ACTIVE INGREDIENT	QTG126297Q	DICLOFENAC SODIUM SOLUTION [APOTEX CORP.]	2
Diclofenac	ACTIVE MOIETY	144O8QL0L1	DICLOFENAC SODIUM SOLUTION [APOTEX CORP.]	2
Alcohol	INACTIVE INGREDIENT	3K9958V90M	DICLOFENAC SODIUM SOLUTION [APOTEX CORP.]	2
Dimethyl Sulfoxide	INACTIVE INGREDIENT	YOW8V9698H	DICLOFENAC SODIUM SOLUTION [APOTEX CORP.]	2
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	DICLOFENAC SODIUM SOLUTION [APOTEX CORP.]	2
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	DICLOFENAC SODIUM SOLUTION [APOTEX CORP.]	2
Water	INACTIVE INGREDIENT	059QF0KO0R	DICLOFENAC SODIUM SOLUTION [APOTEX CORP.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60505-0399	VAROPHEN (DICLOFENAC SODIUM AND MENTHOL, METHYL SALICYLATE) KIT [V2 PHARMA, LLC]	5	Legacy NDC	20250101_1bef5035-70ad-4f75-80c3-6252cd01fa85.zip
60505-0399	DICLOTRAL PAK (DICLOFENAC SODIUM, CAPSAICIN) KIT [PATCHWERX LABS, INC.]	4	Legacy NDC	20160312_2d8f4048-14cb-7484-e054-00144ff88e88.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Varophen	DICLOFENAC SODIUM AND MENTHOL, METHYL SALICYLATE	V2 Pharma, LLC	1bef5035-70ad-4f75-80c3-6252cd01fa85	2024-12-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202027 application number: ANDA202027 ndc (package): 60505-0399-5 ndc11 (package): 60505039905

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	1bef5035-70ad-4f75-80c3-6252cd01fa85	5
311498	menthol 10 % / methyl salicylate 15 % Topical Cream	PSN	1bef5035-70ad-4f75-80c3-6252cd01fa85	5
857700	diclofenac sodium 15 MG/ML Topical Solution	SCD	1bef5035-70ad-4f75-80c3-6252cd01fa85	5
311498	menthol 100 MG/ML / methyl salicylate 150 MG/ML Topical Cream	SCD	1bef5035-70ad-4f75-80c3-6252cd01fa85	5
857700	diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical Solution	SY	1bef5035-70ad-4f75-80c3-6252cd01fa85	5
857700	diclofenac sodium 16.05 MG per 1 ML Topical Solution	SY	1bef5035-70ad-4f75-80c3-6252cd01fa85	5
311498	menthol 10 % / methyl salicylate 15 % Topical Cream	SY	1bef5035-70ad-4f75-80c3-6252cd01fa85	5
311498	menthol 10 GM / methyl salicylate 15 GM per 100 GM Topical Cream	SY	1bef5035-70ad-4f75-80c3-6252cd01fa85	5
198555	capsaicin 0.025 % Topical Cream	PSN	2d8f4048-14cb-7484-e054-00144ff88e88	4
857700	diclofenac sodium 1.5 % Topical Solution	PSN	2d8f4048-14cb-7484-e054-00144ff88e88	4
198555	capsaicin 0.25 MG/ML Topical Cream	SCD	2d8f4048-14cb-7484-e054-00144ff88e88	4
857700	diclofenac sodium 15 MG/ML Topical Solution	SCD	2d8f4048-14cb-7484-e054-00144ff88e88	4
198555	capsaicin 0.025 % Topical Cream	SY	2d8f4048-14cb-7484-e054-00144ff88e88	4
857700	diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical Solution	SY	2d8f4048-14cb-7484-e054-00144ff88e88	4
857700	diclofenac sodium 16.05 MG per 1 ML Topical Solution	SY	2d8f4048-14cb-7484-e054-00144ff88e88	4
857700	diclofenac sodium 1.5 % Topical Solution	PSN	5cd96e45-e027-3c9a-e053-2a91aa0a807e	2
857700	diclofenac sodium 1.5 % Topical Solution	PSN	aa272926-7fe0-4e43-9a64-bfeb8cbf0c19	2
857700	diclofenac sodium 15 MG/ML Topical Solution	SCD	5cd96e45-e027-3c9a-e053-2a91aa0a807e	2
857700	diclofenac sodium 15 MG/ML Topical Solution	SCD	aa272926-7fe0-4e43-9a64-bfeb8cbf0c19	2
857700	diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical Solution	SY	5cd96e45-e027-3c9a-e053-2a91aa0a807e	2
857700	diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical Solution	SY	aa272926-7fe0-4e43-9a64-bfeb8cbf0c19	2
857700	diclofenac sodium 16.05 MG per 1 ML Topical Solution	SY	5cd96e45-e027-3c9a-e053-2a91aa0a807e	2
857700	diclofenac sodium 16.05 MG per 1 ML Topical Solution	SY	aa272926-7fe0-4e43-9a64-bfeb8cbf0c19	2
857700	diclofenac sodium 1.5 % Topical Solution	PSN	2bf4c5e6-8486-473f-9692-34394079ec2c	1
857700	diclofenac sodium 15 MG/ML Topical Solution	SCD	2bf4c5e6-8486-473f-9692-34394079ec2c	1
857700	diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical Solution	SY	2bf4c5e6-8486-473f-9692-34394079ec2c	1
857700	diclofenac sodium 16.05 MG per 1 ML Topical Solution	SY	2bf4c5e6-8486-473f-9692-34394079ec2c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60505-0399-5	60505039905	1 BOTTLE in 1 CARTON (60505-0399-5) > 150 mL in 1 BOTTLE	1 bottle	2014-05-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Varophen	V2 Pharma, LLC \| Apotex Inc \| Perrigo New York Inc	2024-12-30	HUMAN PRESCRIPTION DRUG LABEL	5
Diclofenac Sodium	Apotex Corp.	2022-12-05	HUMAN PRESCRIPTION DRUG LABEL	9
DFS 1.5%/MS 25%/MENTH 6%/CAP 0.025% PAK	Nucare Pharmaceuticals Inc \| NuCare Pharmaceuticals,Inc.	2021-05-04	HUMAN PRESCRIPTION DRUG LABEL	2
Diclofenac Sodium	REMEDYREPACK INC.	2021-04-01	HUMAN PRESCRIPTION DRUG LABEL	5
DICLOFENAC SODIUM TOPICAL SOLUTION 1.5%	DIRECT RX	2020-01-20	HUMAN PRESCRIPTION DRUG LABEL	2
Diclofenac Sodium	A-S Medication Solutions	2019-01-22	HUMAN PRESCRIPTION DRUG LABEL	1
Diclofenac Sodium	Unit Dose Services	2018-06-20	HUMAN PRESCRIPTION DRUG LABEL	2
Diclotral Pak	Patchwerx Labs, Inc.	2016-03-11	HUMAN PRESCRIPTION DRUG LABEL	4