FDA.reportPublic FDA data

Numbing Cream

Product NDC
85524-2519
11-digit product format
855242519
Labeler code
85524
Product ID
85524-2519_41a2f9a5-0217-708f-e063-6294a90a1571
Type
HUMAN OTC DRUG
Nonproprietary name
menthol
Dosage form
CREAM
Route
TOPICAL
Labeler
FlexiGo Inc
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-10-17
Substance
MENTHOL
Active strength
1 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2475473Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
41571c8f-332b-f423-e063-6394a90a8897Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85524-2519-1Numbing Cream50 g in 1 BOTTLECREAM502
85524-2519-2Numbing Cream1 in 1 BOXCREAM12
85524-2519-3Numbing Cream50 g in 1 BOTTLECREAM502
85524-2519-4Numbing Cream1 in 1 BOXCREAM12

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 145 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AMINO ACTIVE Topical Analgesic CreamHISTAMINE DIHYDROCHLORIDEVIREO SYSTEMS, INC.591b1e7e-a8c0-4640-a592-4e0f3538a40e2023-11-11WarningsExact identifier
application number: M017
NERVE ACTIVE Pain Relief CreamMENTHOLTOP DOG DIRECT, LLCa8b85dcb-fd3e-4340-a945-609fc741443c2023-11-11WarningsExact identifier
application number: M017
GeriGentle FrostyHeat Pain Relief Patch 4 Lodocaine BackLIDOCAINEGeri-Gentle Corporatione4427928-c063-9ca6-e053-2995a90a1aa12023-11-10WarningsExact identifier
application number: M017
GeriGentle FrostyHeat Pain Relief Patch Arm and NeckMENTHOLGeri-Gentle Corporatione4429f70-667e-662b-e053-2a95a90a62ba2023-11-10WarningsExact identifier
application number: M017
GeriGentle FrostyHeat Pain Relief Patch BackMENTHOLGeri-Gentle Corporatione442b8ec-a3de-65e8-e053-2995a90af3ec2023-11-10WarningsExact identifier
application number: M017
SUPER WHITE STUFF Pain ReliefMENTHOLBLUE SPRING WELLNESS, L.L.C.9f948fb4-4275-4a1f-83f8-cd708db4a2962023-11-10WarningsExact identifier
application number: M017
SUPER WHITE STUFF PAIN RELIEFMENTHOLBLUE SPRING WELLNESS, L.L.C.b4278b70-e9a6-4d1f-bbad-257fe437b86a2023-11-10WarningsExact identifier
application number: M017
BLUE SPRING Foot and Leg Comfort Cream with Pain ReliefMENTHOL, CAPSAICINBLUE SPRING WELLNESS, L.L.C.2f9cf514-48be-49ec-b424-0b228b4b874a2023-11-10WarningsExact identifier
application number: M017
SUPER WHITE STUFF Pain ReliefMENTHOLBLUE SPRING WELLNESS, L.L.C.1231ddd2-7661-45b2-ab15-32f7fdc078a82023-11-10WarningsExact identifier
application number: M017
SUPER WHITE Stuff Pain ReliefMENTHOLBLUE SPRING WELLNESS, L.L.C.7779b26b-ae3b-4639-a6b0-826c7ab37a862023-11-10WarningsExact identifier
application number: M017
Alo Therapeutic MassageMENTHOL, HISTAMINE DIHYDROCHLORIDETheraplex Solutionsa898d2ef-5fa0-4144-8bb5-f6d5fc3ff0d42023-11-10WarningsExact identifier
application number: M017
SUPER BLUE STUFF Pain Relief CreamMENTHOLBLUE SPRING WELLNESS, L.L.C.066a2106-2e25-4df6-9a8d-4417ba1902052023-11-10WarningsExact identifier
application number: M017
INVIGO FLEX Pain Relief GelMENTHOLWYNNPHARM INC.909e1d8c-c517-4d6a-8682-894f042c00f82023-11-10WarningsExact identifier
application number: M017
ARNIMAX Penetrating Pain Relief GelMENTHOLWYNNPHARM INC.3a31f805-19c6-4036-a663-ebef9b2120072023-11-10WarningsExact identifier
application number: M017
KERA HCHYDROCORTISONEClinical Therapeutic Solutionsac215c8f-b224-480c-9295-3a34316293ba2023-11-10WarningsExact identifier
application number: M017
ALO THERAPEUTIC MASSAGE PAIN RELIEVINGMENTHOL, HISTAMINE DIHYDROCHLORIDETheraplex Solutionsda004500-5e48-487b-b96f-520a3094096c2023-11-10WarningsExact identifier
application number: M017
Osteo Bi-Flex JOINT HEALTH PAIN RELIEVINGMENTHOL, METHYL SALICYLATERexall Sundown, LLC55c55f1c-d2b3-6363-e054-00144ff88e882023-11-10WarningsExact identifier
application number: M017
NEUROFLEX Topical Pain Relieving LiquidCAMPHOR (SYNTHETIC), MENTHOLAlmark Products Inc6da3aa84-7a01-4041-8792-a4bbf49e6e4e2023-11-10WarningsExact identifier
application number: M017
SMOOTH GATOR 60-second Pain ReliefCAMPHOR (SYNTHETIC), MENTHOLSmooth Gator LLC3b74b542-202f-469e-8025-4372e95e6b012023-11-10WarningsExact identifier
application number: M017
Alo Therapeutic MassageMENTHOL, HISTAMINE DIHYDROCHLORIDECMI Therapy Solutions40f8b8d1-a20b-54b0-e054-00144ff88e882023-11-10WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2475473menthol 1 % Topical CreamPSN41571c8f-332b-f423-e063-6394a90a88972
2475473menthol 10 MG/ML Topical CreamSCD41571c8f-332b-f423-e063-6394a90a88972
2475473menthol 1 % Topical CreamSY41571c8f-332b-f423-e063-6394a90a88972

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85524-2519-18552425190150 g in 1 BOTTLE50 gHistorical
85524-2519-2855242519021 BOTTLE in 1 BOX (85524-2519-2) / 50 g in 1 BOTTLE (85524-2519-1) 1 bottle2025-10-17YesNoCurrent
85524-2519-38552425190350 g in 1 BOTTLE50 gHistorical
85524-2519-4855242519041 BOTTLE in 1 BOX (85524-2519-4) / 50 g in 1 BOTTLE (85524-2519-3) 1 bottle2025-10-17YesNoCurrent