FDA.reportPublic FDA data

CVS Health Cold and Hot Pain Relieving

Product NDC
59779-791
11-digit product format
597790791
Labeler code
59779
Product ID
59779-791_29790008-78c7-b8ca-e063-6294a90aa6e6
Type
HUMAN OTC DRUG
Nonproprietary name
menthol, methyl salicylate
Dosage form
CREAM
Route
TOPICAL
Labeler
CVS Pharmacy
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-10-03
Substance
MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE
Active strength
100; 300 mg/g; mg/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
CVS Health Cold and Hot Pain Relieving
Brand name suffix
Extra Strength
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL, UNSPECIFIED FORM100 mg/g
METHYL SALICYLATE300 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup
LAV5U5022YInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
311500Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1ca1a631-cb2c-46cd-bd41-05469b08d208Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59779-791-01CVS Health Cold and Hot Pain RelievingExtra Strength85 g in 1 TUBECREAM859
59779-791-01CVS Health Cold and Hot Pain RelievingExtra Strength1 in 1 CARTONCREAM19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-791CVS HEALTH COLD AND HOT PAIN RELIEVING EXTRA STRENGTH (MENTHOL, METHYL SALICYLATE) CREAM [CVS PHARMACY]9Current NDC, Legacy NDC, 2 package rows20241220_1ca1a631-cb2c-46cd-bd41-05469b08d208.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 30 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RICHTOFIT RAPID ACTIVE ARTHRITISMENTHOL AND CAMPHORRICHTOFIT LIMITED LIABILITY COMPANY4b1cdab1-3e50-4ec3-e063-6394a90af75e2026-03-12WarningsExact identifier
application number: M017
5Kind DMSO 4 Lidocaine HCl Pain RelievingLIDOCAINE HYDROCHLORIDE, MENTHOL5KIND TRADING LTD67d8d045-7fa0-46c2-8072-645d8823903b2026-03-11WarningsExact identifier
application number: M017
Rapid ReliefPAIN RELIEF PATCH LIDOCAINE 4%RAPID AID VIET NAM COMPANY LIMITED4ca541b4-7afe-77c5-e063-6294a90ad6922026-03-10WarningsExact identifier
application number: M017
Lidocaine Cream, 4%LIDOCAINEIPG PHARMACEUTICALS, INC.7775bfdd-7eac-4f09-b83f-fc4a16a245582026-03-10WarningsExact identifier
application number: M017
MENTHOL, CAMPHORMENTHOL, CAMPHORCHEMCO CORPORATION4c989283-9a27-e8d2-e063-6294a90a8bfa2026-03-09WarningsExact identifier
application number: M017
Prequel Anti-Itch Solution Medicated CalmingMEDICATED CALMING LOTIONThe Center Brands, LLC419fa45b-992b-676e-e063-6394a90add812026-03-09WarningsExact identifier
application number: M017
Careland Lidocaine 4 Plus Menthol Pain Relieving Gel Patches for back, neck shoulders knees and elbows with borderLIDOCAINE, MENTHOLPlanet (Anhui) Pharmaceutical Co., Ltd.1fda69f7-2bb6-42fc-bcef-677e7b3d7f012026-03-09WarningsExact identifier
application number: M017
Careland Lidocaine 4 plus menthol pain relieving gel-patches with border for kneeMENTHOL, LAUROCAPRAMPlanet (Anhui) Pharmaceutical Co., Ltd.7577625c-87eb-4639-aeab-8a2ab97033fd2026-03-09WarningsExact identifier
application number: M017
Careland Lidocaine Pain RelievingLIDOCAINEPlanet (Anhui) Pharmaceutical Co., Ltd.7de99b81-b3b3-49f1-8aa7-2ff42e1b46a42026-03-09WarningsExact identifier
application number: M017
Rapid ReliefPAIN RELIEF PATCH LIDOCAINE 4%RAPID AID VIET NAM COMPANY LIMITED4ca35030-958c-8f62-e063-6294a90a4d632026-03-09WarningsExact identifier
application number: M017
Welmate Lidocaine Pain Relieving PatchLIDOCAINEYYBA Corpcff71b75-fc4e-29ac-e053-2995a90abd502026-03-06WarningsExact identifier
application number: M017
Heal and Rescue Bunion Pain ReliefLIDOCAINE HCL, MENTHOLRooftop Consumer Health, Inc4c60d4d3-e0a9-6f93-e063-6394a90a16af2026-03-06WarningsExact identifier
application number: M017
JUST CBD - PAIN RELIEFMENTHOL, CAMPHORJust Brands LLC4c493c0b-c58e-cb56-e063-6394a90a93952026-03-05WarningsExact identifier
application number: M017
Hug a BooBoo Medicated booboo WipesBENZOCAINELights Medical Manufacture Co., Ltd.509aaafc-2ef7-4205-818c-7ff5b146e1592026-03-04WarningsExact identifier
application number: M017
CVS Foot PainLIDOCAINE HYDROCHLORIDECVS Pharmacy4c3350c3-2e3e-093c-e063-6394a90a34752026-03-04WarningsExact identifier
application number: M017
Game On SportMENTHOLNatural Essentials, Inc4c3411dc-5378-bd93-e063-6394a90a84062026-03-04WarningsExact identifier
application number: M017
Hydrocortisone 1%HYDROCORTISONETrifecta Pharmaceuticals Usa Llcf4d4a56b-b4b7-9a07-e053-2a95a90ad8532026-03-04WarningsExact identifier
application number: M017
Hydrocortisone 1%HYDROCORTISONETrifecta Pharmaceuticals Usa Llc9987165c-1a0f-dd57-e053-2a95a90ae7352026-03-04WarningsExact identifier
application number: M017
Walgreens Unscented Pain RelievingLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLWalgreen Co.41eadb4f-2ca5-42a1-e063-6294a90ab4e22026-03-04WarningsExact identifier
application number: M017
Careland Pain Relief Patch PlusLIDOCAINEPlanet (Anhui) Pharmaceutical Co., Ltd.d55d8a9e-ed2b-4c9b-9ecb-6ec1fd43c9e32026-03-04WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311500menthol 10 % / methyl salicylate 30 % Topical CreamPSN1ca1a631-cb2c-46cd-bd41-05469b08d2089
311500menthol 100 MG/ML / methyl salicylate 300 MG/ML Topical CreamSCD1ca1a631-cb2c-46cd-bd41-05469b08d2089
311500menthol 10 % / methyl salicylate 30 % Topical CreamSY1ca1a631-cb2c-46cd-bd41-05469b08d2089

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-791-01597790791011 TUBE in 1 CARTON (59779-791-01) / 85 g in 1 TUBE1 tube2016-10-030000-00-00NoNoCurrent