FDA.reportPublic FDA data

Cold Therapy Roll on

Product NDC
69168-483
11-digit product format
691680483
Labeler code
69168
Product ID
69168-483_bb264a96-9bd7-4230-b80f-3c62c0c80cf8
Type
HUMAN OTC DRUG
Nonproprietary name
Cold Therapy Roll on
Dosage form
GEL
Route
TOPICAL
Labeler
Allegiant Health
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-07-29
Substance
MENTHOL
Active strength
.04 g/mL
NDC exclude flag
No
Listing certified through
2027-12-31
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
Cold Therapy Roll on
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL.04 g/mL

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
415974Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
36463acb-7c28-416f-a45f-a93f0be5692bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69168-483-67Cold Therapy Roll on74 mL in 1 BOTTLEGEL742

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 94 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mqforu Pain PatchPAIN PATCHZhengzhou Miaoqi Medical Technology Co., Ltd.1f878abd-54cd-1963-e063-6294a90a18842025-04-22WarningsExact identifier
application number: M017
PICKLEBALM LIDOCAINE WITH MENTHOL ARNICA CUCUMBER SEED ROLL ONLIDOCAINE, MENTHOLCompass Health Brands Corp.2c25fa5e-9546-ba74-e063-6294a90aadf42025-04-22WarningsExact identifier
application number: M017
PICKLEBALM LIDOCAINE WITH MENTHOL ARNICA CUCUMBER SEED BALMLIDOCAINE, MENTHOLCompass Health Brands Corp.2bd8cfb6-ab6c-9e04-e063-6294a90a2d522025-04-22WarningsExact identifier
application number: M017
Maximum Strength 4% Lidocaine PatchLIDOCAINEPharmheal32e57c0f-d138-88dc-e063-6394a90ac0852025-04-16WarningsExact identifier
application number: M017
COLD HOT CHINESE RED TIGER PAIN RELIEF GeI-PatchMENTHOLGuangzhou Zhupuyou E-commerce Co., Ltd32b7d73c-a191-7843-e063-6394a90aa6312025-04-14WarningsExact identifier
application number: M017
Methyl Salicylate 25% CreamMETHYL SALICYLATEMARCELLA HEALTH32c153c7-de30-504e-e063-6294a90a40202025-04-14WarningsExact identifier
application number: M017
Dollar General Cold-Hot Medicated PatchesMENTHOLDOLGENCORP, LLCe13ab4d3-eb58-4874-925a-6a59df4dd29a2025-04-14WarningsExact identifier
application number: M017
AY BENDITO - PAIN RELIEFCAMPHOR, MENTHOLAY BENDITO INTERNATIONAL, INCb97f6b71-7de7-3217-e053-2a95a90aa4262025-04-14WarningsExact identifier
application number: M017
AY BENDITO - THERMOACTIVECAMPHOR, MENTHOLAY BENDITO INTERNATIONAL, INCbbf0d85e-269d-0342-e053-2995a90ac63c2025-04-14WarningsExact identifier
application number: M017
Biofreeze MentholMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLC71a36691-9d9e-479d-bfdc-6f6b192ad2d02025-04-11WarningsExact identifier
application number: M017
Eagle MedicatedMENTHOL METHYL SALICYLATEBorden Company (Private) Limitedda3358ae-8679-6045-e053-2a95a90a50e32025-04-10WarningsExact identifier
application number: M017
JointflexJOINTFLEXStrides Consumer LLCb82ec69c-bd00-400b-bd94-ac15fb620f9b2025-04-09WarningsExact identifier
application number: M017
Zepol Topical AnalgesicCAMPHOR, MENTHOLLaboratorios Zepol S.A.ca20ade6-9b35-40bb-b3b2-fc3a0e1eece92025-04-09WarningsExact identifier
application number: M017
JointflexCAMPHORStrides Consumer LLCcb5ca02b-0bc1-4b0b-b4b1-abef3222aa562025-04-09WarningsExact identifier
application number: M017
Foster and Thrive Lidocaine Pain Relief PatchLIDOCAINE 4%Strategic Sourcing Services LLC32456887-aa09-8912-e063-6394a90a4ae72025-04-08WarningsExact identifier
application number: M017
MUSCLEMENTHOLWATER-JEL TECHNOLOGIES1af399af-07b0-4899-9bcc-1e244b63b1cf2025-04-08WarningsExact identifier
application number: M017
Lidocaine with MentholLIDOCAINE HCL AND MENTHOLKareway Product, Inc.9ee46a5b-d00c-4254-e053-2995a90aeb3a2025-04-08WarningsExact identifier
application number: M017
Foster and Thrive Lidocaine Pain Relief PatchLIDOCAINE 4%Strategic Sourcing Services LLC324802c9-e2c2-bf74-e063-6394a90a86972025-04-08WarningsExact identifier
application number: M017
OARS AND ALPS MUSCLE RECOVERY BALMMENTHOL, METHYL SALICYLATECosco International, Inc8745802f-018d-4cf8-bbf3-3b04c8f545382025-04-08WarningsExact identifier
application number: M017
NOVUM APRMENTHOLNOVUM SOLUTIONS INC1b869a1f-5787-4d03-a546-43a8217b2b2c2025-04-07WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
415974menthol 4 % Topical GelPSN36463acb-7c28-416f-a45f-a93f0be5692b2
415974menthol 0.04 MG/MG Topical GelSCD36463acb-7c28-416f-a45f-a93f0be5692b2
415974menthol 4 % Topical GelSY36463acb-7c28-416f-a45f-a93f0be5692b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69168-483-676916804836774 mL in 1 BOTTLE (69168-483-67) 74 ml2025-07-29NoNoCurrent