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 51 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Certain Dri Clinical Strength Prescription Protection RollonCERTAIN DRI CLINICAL STRENGTH PRESCRIPTION PROTECTION ROLLONClarion Brands LLC46a1f92e-4411-3989-e063-6394a90a70382025-12-23WarningsExact identifier
application number: M017
PREMIERES PAINMENTHOLPremiere Enterprises128bd1e7-e961-416c-933b-fbd146e3d3862025-12-23WarningsExact identifier
application number: M017
PREMIERES PAINMENTHOLPremiere Enterprises35ff19df-4cc4-4fce-bd30-d87d835e0e262025-12-23WarningsExact identifier
application number: M017
Premieres PainMENTHOLPremiere Enterprises1f081913-6106-4d06-a37a-631f710dbacb2025-12-23WarningsExact identifier
application number: M017
ABSORBINE jr.LIDOCAINE HCL, PHENOLClarion Brands, LLCe1de73bb-917c-48d1-9a78-00c76edddb982025-12-23WarningsExact identifier
application number: M017
ABSORBINE jr. PLUS KneeCAMPHOR, MENTHOLClarion Brands, LLC3ad8718d-ebf1-474f-8a91-48c78ab3b5c12025-12-23WarningsExact identifier
application number: M017
Absorbine Jr. PlusMENTHOLClarion Brands, LLCfd5d77fc-dc73-2aec-2c7f-0fca5d7d3a752025-12-23WarningsExact identifier
application number: M017
ABSORBINE JR PLUS ULTRA STRENGTH PAINMENTHOLClarion Brands, LLCcf329707-d90a-29dd-f2c2-acfd5af614f32025-12-23WarningsExact identifier
application number: M017
Absorbine Jr Pro CreamLIDOCAINE HCL, PHENOLClarion Brands, LLC17b3f1e6-5554-4f3e-b133-76ae8ffea9192025-12-23WarningsExact identifier
application number: M017
Absorbine Jr Pro No Mess Roll-on PlusLIDOCAINE HCL, PHENOLClarion Brands, LLCa7172f17-1525-4738-b72c-92479c730af22025-12-23WarningsExact identifier
application number: M017
ABSORBINE JRMENTHOLClarion Brands, LLCd656e7f6-ca26-1873-6c11-08aa82091bb02025-12-23WarningsExact identifier
application number: M017
Relief RecoveryMETHYL SALICYLATEMayway Corporation27afd45e-2dc5-d099-e063-6394a90ad2b72025-12-23WarningsExact identifier
application number: M017
MobilityMETHYL SALICYLATEMayway Corporation27af9d17-9c15-5e2a-e063-6394a90aeda52025-12-23WarningsExact identifier
application number: M017
medlot pain relief gel patchLIDOCAINELotfancy, Inc.3ce4af20-b227-5b98-e063-6394a90ab9922025-12-23WarningsExact identifier
application number: M017
Nizoral Scalp Itch ReliefHYDROCORTISONEKramer Laboratoriesdba59238-6beb-447e-8c4c-e4bc00fd2c202025-12-23WarningsExact identifier
application number: M017
Salonpas LIDOCAINE Pain RelievingLIDOCAINEHisamitsu America, Inc.63911880-8194-4c7d-a72f-cab94761b2d72025-12-23WarningsExact identifier
application number: M017
The Body Builders CreamMENTHOLSmart Cookie Solutionsf803325e-eb86-4b9e-a401-0a91bdcd63892025-12-22WarningsExact identifier
application number: M017
PROINNATE Numbing CreamLIDOCAINE,MENTHOLGuangdong Aimu Biological Technology Co., Ltd46895ddb-0b9f-675e-e063-6394a90adf232025-12-22WarningsExact identifier
application number: M017
Caring Mills Vaginal Anti-Itch CreamBENZOCAINE, RESORCINOLVeridian Healthcaref2362658-aea2-438e-a66c-738022e6e0472025-12-22WarningsExact identifier
application number: M017
HealthWise Pain Relieving Menthol GelMENTHOL 2%Veridian Healthcare396d0fd4-67be-4de1-8f0c-42c83dfe91202025-12-22WarningsExact 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