FDA.reportPublic FDA data

Menthol Pain Relieving Cream with Menthol 10%

Product NDC
55629-018
11-digit product format
556290018
Labeler code
55629
Product ID
55629-018_b3126f77-144f-47d0-9a8b-b8b840f96bdc
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol 10% Cream
Dosage form
CREAM
Route
TOPICAL
Labeler
ONE2ZEE LIMITED LIABILITY COMPANY
Application
M
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-04-21
Substance
MENTHOL
Active strength
.1 g/g
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
Menthol Pain Relieving Cream with Menthol 10%
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL.1 g/g

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
253020Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ae09e93f-3988-4477-ae53-b2f3df9769fbAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55629-018-05Menthol Pain Relieving Cream with Menthol 10%141 g in 1 JARCREAM1412

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55629-018MENTHOL PAIN RELIEVING CREAM WITH MENTHOL 10% (MENTHOL 10% CREAM) CREAM [ONE2ZEE LIMITED LIABILITY COMPANY]2Current NDC, 1 package rows20250507_ae09e93f-3988-4477-ae53-b2f3df9769fb.zip

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 6 of 6 · 111 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MAX relief juniorACETAMINOPHENATLANTIC BIOLOGICALS CORP.396903dc-ae2d-4bf4-b1fd-0017b84abef92024-02-28WarningsExact identifier
application number: M
MAX relief juniorACETAMINOPHENATLANTIC BIOLOGICALS CORP.44730cbd-5b98-49bd-b3b8-6fecb0ccd1532024-02-28WarningsExact identifier
application number: M
HYDROCORTISONEHYDROCORTISONE ACETATEHART Health779f945f-ab69-40de-8d86-ab76debc5c7c2024-02-16WarningsExact identifier
application number: M
First Aid and BurnBENZALKONIUM CHLORIDE, LIDOCAINEHART Healthf5746bba-9d7f-4691-b466-14985473bf142024-02-16WarningsExact identifier
application number: M
IBUPROFENIBUPROFENHART Health1c1374e1-890f-48ab-8f93-e84da9d5bf842024-01-25WarningsExact identifier
application number: M
Hand SanitizerANTISEPTIC GELHART Healthf07daf29-d0db-4cf8-8baf-d175c2b2ef502024-01-25WarningsExact identifier
application number: M
Hydrogen PeroxideHYDROGEN PEROXIDEHART Health0346a322-8f6e-405a-8d17-8bc6ce5105a32024-01-24WarningsExact identifier
application number: M
AlcoholISOPROPYL ALCOHOLNorMed441b915a-287f-4734-b4d9-730b3d95e04c2024-01-24WarningsExact identifier
application number: M
Sooth-a-StingBENZOCAINEHART Healthbd7229b6-813a-4149-bfe2-fe682f270ff42024-01-18WarningsExact identifier
application number: M
First AidBENZALKONIUM CHLORIDE, BENZOCAINEHART Healtha6d258ed-6d6d-42f0-9994-6c2c4c3d0f4a2024-01-18WarningsExact identifier
application number: M
TRIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEHART Healthd8f175f9-f526-4c73-a171-49309ca16cb02024-01-18Warnings, Adverse reactionsExact identifier
application number: M

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
253020menthol 10 % Topical CreamPSNae09e93f-3988-4477-ae53-b2f3df9769fb2
253020menthol 100 MG/ML Topical CreamSCDae09e93f-3988-4477-ae53-b2f3df9769fb2
253020menthol 10 % Topical CreamSYae09e93f-3988-4477-ae53-b2f3df9769fb2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55629-018-0555629001805141 g in 1 JAR (55629-018-05) 141 g2025-04-21NoNoCurrent