FDA.reportPublic FDA data

COOLING PAIN RELIEF

Product NDC
49283-581
11-digit product format
492830581
Labeler code
49283
Product ID
49283-581_4a156400-7002-d00d-e063-6294a90aa714
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL, CAMPHOR
Dosage form
GEL
Route
TOPICAL
Labeler
CHEMCO CORPORATION
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-29
Substance
MENTHOL; CAMPHOR (SYNTHETIC)
Active strength
6; 3 g/100mL; g/100mL
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
COOLING PAIN RELIEF
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL6 g/100mL
CAMPHOR (SYNTHETIC)3 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup
5TJD82A1ETInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4a156400-7001-d00d-e063-6294a90aa714Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49283-581-20COOLING PAIN RELIEF59 mL in 1 TUBEGEL594

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 129 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ReliefMENTHOLLa Mend, Inc.1f92de3a-7180-5884-e063-6294a90aebf52024-08-01WarningsExact identifier
application number: M017
Meijer Medicated Foot PowderMENTHOLMeijer Distribution07ec6c20-73c4-e5e4-e063-6294a90a7e552024-07-29WarningsExact identifier
application number: M017
Ralli Rapid Pain ReliefMENTHOLTroy Manufacturing, Inc.e05ec3b7-e9ab-4eaa-8518-86304336697c2024-07-29WarningsExact identifier
application number: M017
Walgreens Roll-OnCAPSAISIN 0.1%Walgreens Co1e65bf31-15c7-5e6a-e063-6394a90ac9562024-07-29WarningsExact identifier
application number: M017
CamphotrexCAMPHOR, MENTHOLPureTek Corporation3b6c6eef-e92d-497d-afe8-82356637c2b82024-07-26WarningsExact identifier
application number: M017
CamphotrolCAMPHOR, MENTHOLPureTek Corporationccac9f37-a374-4765-e053-2a95a90ad2f72024-07-26WarningsExact identifier
application number: M017
Real Time Pain Relief FootMENTHOLReal Time Products Inc.29c8e06d-9b29-44f9-ac21-9160d06475cb2024-07-24WarningsExact identifier
application number: M017
Capsaicin 0.075 PercentCAPSAICINAlexso, Inc33d2a9cd-0ca1-4e19-8b7a-f899f1205cbd2024-07-22WarningsExact identifier
application number: M017
TIDL Pain Relief CRYO Therapy Limited EditionPAIN RELIEF CRYO THERAPY LIMITED EDITIONShenzhen Sam Technology Co., Ltd.1d966b67-fd9c-eab6-e063-6294a90aa75e2024-07-19WarningsExact identifier
application number: M017
Fruit of the Earth Aloe Vera Cool BlueLIDOCAINE HYDROCHLORIDEFruit of the Earth, Inc.1d65bc34-2bc2-4f52-a9b3-1cb08324eb792024-07-19WarningsExact identifier
application number: M017
Ultra BalmMENTHOL AND METHYL SALICYLATELing Nam Medicine Factory (H.K.) Ltd.de997baf-aa04-474e-b912-3fc67e720d0b2024-07-19WarningsExact identifier
application number: M017
Ling Nam Hak Kwai OilTURPENTINE OILLing Nam Medicine Factory (H.K.) Ltd.3f16cce3-366f-41f3-8829-6de4082a8c192024-07-19WarningsExact identifier
application number: M017
Koong Yick Hak Kwai OilTURPENTINE OILLing Nam Medicine Factory (H.K.) Ltd.bc33e185-3b42-98b5-e053-2995a90a63082024-07-18WarningsExact identifier
application number: M017
Koong Yick Hung FaMETHYL SALICYLATELing Nam Medicine Factory (H.K.) Ltd.9c8a121d-6da2-4435-a2d7-a0b71d10740d2024-07-18WarningsExact identifier
application number: M017
Ling Nam Hung FarMETHYL SALICYLATELing Nam Medicine Factory (H.K.) Ltd.b6916b6e-b7eb-1eb7-e053-2995a90ae6fb2024-07-18WarningsExact identifier
application number: M017
itch reliefDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATEBionpharma Inc.178ed513-4f22-8f11-e063-6294a90a109b2024-07-16WarningsExact identifier
application number: M017
POWERECT Benzocaine Male Delay GelBENZOCAINESKINS SEXUAL HEALTH LIMITED2fafe1f2-a31e-4b2a-bc51-81e16b319c3a2024-07-16WarningsExact identifier
application number: M017
SKINS DELAY Climax Control Benzocaine GelBENZOCAINESKINS SEXUAL HEALTH LIMITED53730576-2609-4f28-8bfa-a1ceea698b832024-07-16WarningsExact identifier
application number: M017
TIDL PAIN RELIEF CRYO THERAPY Unscented formula Spray.PAIN RELIEF CRYO THERAPY UNSCENTED FORMULA SPRAYShenzhen Sam Technology Co., Ltd.1d1a0346-3b00-4803-e063-6294a90aec6d2024-07-13WarningsExact identifier
application number: M017
Tidl Pain Relief Evening Therapy Spray.PAIN RELIEF EVENING THERAPY SPRAYShenzhen Sam Technology Co., Ltd.1d1a2f4a-7b25-e595-e063-6394a90a00d52024-07-13WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
49283-581-204928305812059 mL in 1 TUBE (49283-581-20) 59 ml2026-01-29NoNoCurrent