FDA.reportPublic FDA data

Numb Cream

Manufacturer
FlexiGo Inc
Effective date
2025-09-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:14:14

Label at a glance#

ProductMenthol
Active ingredientMENTHOL
Label structure12 sections

Label contents#

Full prescribing information#

OTC - DO NOT USE SECTION

OTC-DO NOT USE SECTIONOTC-DO NOT USE SECTIONOTC-Do not useOTC-Do not use

OTC - PURPOSE SECTION

OTC-PURPOSE SECTIONOTC-PURPOSE SECTION

OTC - ACTIVE INGREDIENT SECTION

OTC-ACTIVE INGREDIENT SECTIONOTC-ACTIVE INGREDIENT SECTION

DOSAGE & ADMINISTRATION SECTION

DIRECTIONSDIRECTIONS

INDICATIONS & USAGE SECTION

USESUSES

OTC - STOP USE SECTION

OTC-STOP USE SECTIONOTC-STOP USE SECTIONOTC-STOP USEOTC-STOP USE

WARNINGS SECTION

WARNINGSWARNINGS

OTC - STOP USE SECTION

OTC-STOP USE SECTIONOTC-STOP USE SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTIONOTC - KEEP OUT OF REACH OF CHILDREN SECTIONOTC - KEEP OUT OF REACH OF CHILDREN SECTIONOTC - KEEP OUT OF REACH OF CHILDREN SECTION

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENT SECTIONINACTIVE INGREDIENT SECTIONINACTIVE INGREDIENT SECTIONINACTIVE INGREDIENT SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Heading Package LabelHeading Package LabelHeading Package LabelHeading Package LabelHeading Package LabelHeading Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANELPACKAGE LABEL.PRINCIPAL DISPLAY PANELPACKAGE LABEL.PRINCIPAL DISPLAY PANELPACKAGE LABEL.PRINCIPAL DISPLAY PANELPACKAGE LABEL.PRINCIPAL DISPLAY PANELPACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85524-2510-6Menthol50 mL in 1 BOTTLEPASTE502
85524-2510-9Menthol60 mL in 1 BOTTLEPASTE602

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85524-251085524-2510-6, 85524-2510-9

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
CARBOMER 934Z135WT9208IACT

Source Document#

Source XML

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
MentholMENTHOLFlexiGo Inc3607c326-6db0-a2cd-e063-6394a90a9eb62025-09-06WarningsExact identifier
ndc (package): 85524-2510-9
ndc (package): 85524-2510-6
ndc (product): 85524-2510
ndc11 (package): 85524251006
ndc11 (package): 85524251009
spl id: 3e1dac2e-a09b-1c0e-e063-6294a90a7cee
spl set id: 3607c326-6db0-a2cd-e063-6394a90a9eb6

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.