Home NDC 72835-201 Varophen
Product NDC 72835-201
11-digit product format 728350201
Labeler code 72835
Product ID 72835-201_6083c25c-8acf-4705-871e-28aafe45944d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Diclofenac Sodium and Menthol, Methyl salicylate
Dosage form KIT
Labeler V2 Pharma, LLC
Application ANDA202027
Marketing category ANDA
Marketing start 2019-06-03
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 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# Additional Listing Data#
Finished product Yes
Brand name base Varophen
Listing expiration 2026-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311498 Internal RxNorm lookup 857700 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 45802-174-53 Varophen 85 g in 1 TUBE CREAM 85 g 15 g in 100g 5 45802-174-53 Varophen 1 in 1 CARTON CREAM 10 g in 100g 5 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 72835-201-02 Varophen 1 in 1 CARTON KIT 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72835-201 VAROPHEN (DICLOFENAC SODIUM AND MENTHOL, METHYL SALICYLATE) KIT [V2 PHARMA, LLC] 5 Current NDC, Legacy NDC, 5 package rows 20250101_1bef5035-70ad-4f75-80c3-6252cd01fa85.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 (product): 72835-201
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 45802-174-53 45802017453 85 g in 1 TUBE 85 g Historical 60505-0399-5 60505039905 1 in 1 CARTON Historical 72835-201-02 72835020102 1 KIT in 1 CARTON (72835-201-02) * 1 BOTTLE in 1 CARTON (60505-0399-5) / 150 mL in 1 BOTTLE * 1 TUBE in 1 CARTON (45802-174-53) / 85 g in 1 TUBE 1 kit 2019-06-03 0000-00-00 No No Current