FDA.reportPublic FDA data

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

Additional Listing Data#

Finished product
Yes
Brand name base
Varophen
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui311498, 857700

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
111d457e-3138-4512-b0ba-d0cd760c4055Product name320250225
0426261e-1bb9-b78b-abd2-80da765a7e3eProduct name220240513
7b6158ae-c3f4-3d73-c35f-6f5d18b9efd7Product name520240320
0ac2f11f-f58d-baf2-71a0-680993b48a61Product name220231211
855d63c3-b090-4636-8fc7-6d39ad23c44fProduct name120230829
bb58f410-04be-65dd-9211-e89ead899698Product name620230323
0fcbc38a-8b29-3348-1cef-5222ea53484fProduct name420220516
c4e1eedc-aca2-4551-8382-89144ed9d049Product name320220126
8d368a34-1453-43ea-828d-0dbcd72b8794Product name820210622
d6bab9d2-edce-a213-4796-226ab15472c3Product name620200616
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
2487e6ef-d419-42fc-aaf8-7acc805d2370Product name220170718
e071c814-e5e7-e7ed-ec76-428765d9c66bProduct name220151120
93148e06-b8d7-4e6c-853e-62f807d17fbbProduct name120151014
dbb00be6-fb1c-4b0a-a770-31f7e05e247eProduct name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-174-53Varophen85 g in 1 TUBECREAM85 g15 g in 100g5
45802-174-53Varophen1 in 1 CARTONCREAM10 g in 100g5
60505-0399-5Varophen1 in 1 CARTONSOLUTION16.05 mg in 1mL5
60505-0399-5Varophen150 mL in 1 BOTTLESOLUTION150 mL16.05 mg in 1mL5
72835-201-02Varophen1 in 1 CARTONKIT15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72835-201-02EA - Each72835-201d757dd13-ffcf-4fe1-8438-09d6b68e55ca12019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72835-201VAROPHEN (DICLOFENAC SODIUM AND MENTHOL, METHYL SALICYLATE) KIT [V2 PHARMA, LLC]5Current NDC, Legacy NDC, 5 package rows20250101_1bef5035-70ad-4f75-80c3-6252cd01fa85.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857700diclofenac sodium 1.5 % Topical SolutionPSN1bef5035-70ad-4f75-80c3-6252cd01fa855
311498menthol 10 % / methyl salicylate 15 % Topical CreamPSN1bef5035-70ad-4f75-80c3-6252cd01fa855
857700diclofenac sodium 15 MG/ML Topical SolutionSCD1bef5035-70ad-4f75-80c3-6252cd01fa855
311498menthol 100 MG/ML / methyl salicylate 150 MG/ML Topical CreamSCD1bef5035-70ad-4f75-80c3-6252cd01fa855
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSY1bef5035-70ad-4f75-80c3-6252cd01fa855
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSY1bef5035-70ad-4f75-80c3-6252cd01fa855
311498menthol 10 % / methyl salicylate 15 % Topical CreamSY1bef5035-70ad-4f75-80c3-6252cd01fa855
311498menthol 10 GM / methyl salicylate 15 GM per 100 GM Topical CreamSY1bef5035-70ad-4f75-80c3-6252cd01fa855

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-174-534580201745385 g in 1 TUBE85 gHistorical
60505-0399-5605050399051 in 1 CARTONHistorical
72835-201-02728350201021 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 TUBE1 kit2019-06-030000-00-00NoNoCurrent