FDA.reportPublic FDA data

Orthrexo

Product NDC
72835-333
11-digit product format
728350333
Labeler code
72835
Product ID
72835-333_007b9a39-1c4b-4d92-b007-726f888bffe8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium and Menthol, Methyl salicylate
Dosage form
KIT
Labeler
V2 Pharma, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2026-04-02
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Orthrexo
Listing expiration
2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
311498Internal RxNorm lookup
857700Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
eb070904-4f6f-42c0-981d-8dc850040185Available on FDA.report

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
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
51824-105-03Orthrexo85 g in 1 TUBECREAM85 g150 mg in 1g1
65162-911-74Orthrexo1 in 1 CARTONSOLUTION16.05 mg in 1mL1
65162-911-74Orthrexo150 mL in 1 BOTTLESOLUTION150 mL16.05 mg in 1mL1
72835-333-02Orthrexo1 in 1 CARTONKIT11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72835-333-02EA - Each72835-333cfe2095d-47ad-4dbf-9653-590c84cc130112026-05-22

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OrthrexoDICLOFENAC SODIUM AND MENTHOL, METHYL SALICYLATEV2 Pharma, LLCeb070904-4f6f-42c0-981d-8dc8500401852026-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (product): 72835-333

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857700diclofenac sodium 1.5 % Topical SolutionPSNeb070904-4f6f-42c0-981d-8dc8500401851
311498menthol 10 % / methyl salicylate 15 % Topical CreamPSNeb070904-4f6f-42c0-981d-8dc8500401851
857700diclofenac sodium 15 MG/ML Topical SolutionSCDeb070904-4f6f-42c0-981d-8dc8500401851
311498menthol 100 MG/ML / methyl salicylate 150 MG/ML Topical CreamSCDeb070904-4f6f-42c0-981d-8dc8500401851
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSYeb070904-4f6f-42c0-981d-8dc8500401851
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSYeb070904-4f6f-42c0-981d-8dc8500401851
311498menthol 10 % / methyl salicylate 15 % Topical CreamSYeb070904-4f6f-42c0-981d-8dc8500401851
311498menthol 10 GM / methyl salicylate 15 GM per 100 GM Topical CreamSYeb070904-4f6f-42c0-981d-8dc8500401851

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51824-105-035182401050385 g in 1 TUBE85 gHistorical
65162-911-74651620911741 in 1 CARTONHistorical
72835-333-02728350333021 KIT in 1 CARTON (72835-333-02) * 1 BOTTLE in 1 CARTON (65162-911-74) / 150 mL in 1 BOTTLE * 85 g in 1 TUBE (51824-105-03) 1 kit2026-04-02NoNoCurrent