FDA.reportPublic FDA data

Orvex

Product NDC
84460-802
11-digit product format
844600802
Labeler code
84460
Product ID
84460-802_673164b0-0ed4-4e3f-881c-861abbd63df1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine and Menthol
Dosage form
KIT
Labeler
Florrax Pharmaceutical
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2025-07-01
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Orvex
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
415976Internal RxNorm lookup
1745091Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3dd9a87e-9860-461a-b9ce-042942de839fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65162-791-08Orvex1 in 1 POUCHPATCH30700 mg4
65162-791-08Orvex30 in 1 CARTONPATCH700 mg4
72667-073-01Orvex89 g in 1 BOTTLE, PLASTICGEL89 g6 g in 100g4
84460-802-01Orvex1 in 1 KITKIT14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
84460-802-01EA - Each84460-802f33dc58b-821b-4bb1-8b8e-031b5d62c7f612026-05-22

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
OrvexLIDOCAINE AND MENTHOLFlorrax Pharmaceutical3dd9a87e-9860-461a-b9ce-042942de839f2026-03-25Warnings, Adverse reactionsExact identifier
ndc (product): 84460-802

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1745091lidocaine 5 % Medicated PatchPSN3dd9a87e-9860-461a-b9ce-042942de839f4
415976menthol 6 % Topical GelPSN3dd9a87e-9860-461a-b9ce-042942de839f4
1745091lidocaine 0.05 MG/MG Medicated PatchSCD3dd9a87e-9860-461a-b9ce-042942de839f4
415976menthol 0.06 MG/MG Topical GelSCD3dd9a87e-9860-461a-b9ce-042942de839f4
1745091lidocaine 5 % Medicated PatchSY3dd9a87e-9860-461a-b9ce-042942de839f4
415976menthol 6 % Topical GelSY3dd9a87e-9860-461a-b9ce-042942de839f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65162-791-08651620791081 in 1 POUCHHistorical
72667-073-017266700730189 g in 1 BOTTLE, PLASTIC89 gHistorical
84460-802-01844600802011 KIT in 1 KIT (84460-802-01) * 30 POUCH in 1 CARTON (65162-791-08) / 1 PATCH in 1 POUCH * 89 g in 1 BOTTLE, PLASTIC (72667-073-01) 1 kit2026-03-24NoNoCurrent