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 138 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cool n HeatCOOL N HEATNeilMed Pharmaceuticals, Inc.a24cde17-280b-8358-e053-2a95a90af67d2024-01-11WarningsExact identifier
application number: M017
NeilMed Anti-ItchANTI-ITCH SPRAYNeilMed Pharmaceuticals Inc.b3d34d9e-85d9-df4e-e053-2a95a90ac8d92024-01-11WarningsExact identifier
application number: M017
NeilMed Hot and Cold Pain ReliefPAIN RELIEF SPRAYNeilMed Pharmaceuticals Inc.b3d02111-7499-c2d4-e053-2a95a90ae1de2024-01-11WarningsExact identifier
application number: M017
Cooling Itch ReliefCOOLING ITCH RELIEFNeilMed Pharmaceuticals, Inca24bdea0-18e8-8a5e-e053-2995a90acea22024-01-11WarningsExact identifier
application number: M017
Lightning X BurnLIDOCAINENantong Health & Beyond Hygienic Products Inc.0e69a971-0c6e-6ebe-e063-6394a90a0b332024-01-08WarningsExact identifier
application number: M017
Theraworx Pain Relief Roll-On with Lidocaine for DiabeticsLIDOCAINE HYDROCHLORIDEAVADIM HOLDINGS, INC.e07f5bf7-5a9a-468c-8c3f-2c6f0b17af292024-01-08WarningsExact identifier
application number: M017
2nd CHANCE MOBILITY Pain ReliefHISTAMINE DIHYDROCHLORIDEALPHA NUTRITION, LLC575097ac-9fc9-4391-99d1-dff9b34817e32024-01-08WarningsExact identifier
application number: M017
Tiger Balm Arthritis RubCAMPHOR (SYNTHETIC) AND MENTHOL, UNSPECIFIED FORMHaw Par Healthcare Ltd.80932288-4797-40d3-aa8a-6af686fb67ad2024-01-08WarningsExact identifier
application number: M017
OPRAVAMETHYL SALICYLATE, MENTHOL, CAPSAICINBiological M.D. Solutions LLC05552560-e283-5eba-e063-6294a90a65f72024-01-06WarningsExact identifier
application number: M017
MED O-3 BIO-METHYL SALICYLATE, MENTHOL, CAPSAICINBiological M.D. Solutions LLC02707552-03d9-3ad2-e063-6294a90a34722024-01-06WarningsExact identifier
application number: M017
Sumifun Knee Relieving PatchKNEE RELIEVING PATCHZhengzhou Miaoqi Pharmaceutical Technology Co., Ltd0e7e73ec-ab33-9235-e063-6394a90ad9502024-01-06WarningsExact identifier
application number: M017
Lidocaine Numbing CreamLIDOCAINEYYBA Corpde6dc194-c6ef-4cb5-be3f-e772ace9abaf2024-01-03WarningsExact identifier
application number: M017
Equate Vagicaine20% BENZOCAINE AND 3% RESORCINOL CREAMWalmart Inc.0cdc9323-f5c3-468c-a7ae-83dfd2d766262024-01-03WarningsExact identifier
application number: M017
OWELL NATURALS Deep Penetrating Pain ReliefMENTHOLOWELL NATURALS BRAND, LLCb36eb017-ed8d-476e-994b-22b275e005432024-01-02WarningsExact identifier
application number: M017
DibucaineDIBUCAINE 1%Trifecta Pharmaceuticals USA LLCe8a56651-a292-7609-e053-2a95a90a7c362024-01-02WarningsExact identifier
application number: M017
Anti-Itch CreamDIPHENHYDRAMINE HYDROCHLORIDE 2%, ZINC ACETATE 0.1%Trifecta Pharmaceuticals USA, LLC.44d17651-a31b-64ca-e054-00144ff8d46c2024-01-02WarningsExact identifier
application number: M017
Muscle Rub CreamMENTHOL 10%, METHYL SALICYLATE 15%Trifecta Pharmaceuticals USA, LLC.e0a13344-5493-eb51-e053-2995a90a81832024-01-02WarningsExact identifier
application number: M017
Sumifun Knee Relieve PatchKNEE RELIEVE PATCHZhengzhou Miaoqi Pharmaceutical Technology Co., Ltd0e031aa5-edf4-8c9d-e063-6394a90afee32024-01-02WarningsExact identifier
application number: M017
OKeeffes Healthy FeetALLANTOIN, LIDOCAINEThe Gorilla Glue Company/O'Keeffe's Companyd73709db-3932-3c56-e053-2995a90a7d0a2024-01-01WarningsExact identifier
application number: M017
PERSONAL CARE ICE COLDMENTHOLNINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.1994356c-e347-5b7d-e063-6394a90a476c2024-01-01WarningsExact 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