FDA.reportPublic FDA data

Equate Cool and Heat

Product NDC
49035-888
11-digit product format
490350888
Labeler code
49035
Product ID
49035-888_4dd2ccb8-0558-dc5a-e063-6294a90ad367
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
PATCH
Route
TOPICAL
Labeler
Wal-Mart Stores Inc
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-07-01
Substance
MENTHOL, UNSPECIFIED FORM
Active strength
50 mg/1
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
Equate Cool and Heat
Brand name suffix
Extra Strength
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL, UNSPECIFIED FORM50 mg/1

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
420222Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ca3088a7-e1ec-4e69-80d9-fd0051bde938Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49035-888-302023-02-07C16284748780-1f386c64a-438d-0266-e053-dadaa90a7c1aDrug Facts - Equate Cool and Heat Extra Strength Medicated Patch
49035-888-302023-01-30C16284748780-1f386c64a-438d-0266-e053-dadaa90a7c1aDrug Facts - Equate Cool and Heat Extra Strength Medicated Patch

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-888-30Equate Cool and HeatExtra Strength1 in 1 CARTONPATCH17
49035-888-30Equate Cool and HeatExtra Strength5 in 1 POUCHPATCH57

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3AEQUATE COOL AND HEAT EXTRA STRENGTH (MENTHOL) PATCH [WAL-MART STORES INC]1
MENTHOLACTIVE MOIETYL7T10EIP3AEQUATE COOL AND HEAT EXTRA STRENGTH (MENTHOL) PATCH [WAL-MART STORES INC]1
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENTHHT01ZNK31EQUATE COOL AND HEAT EXTRA STRENGTH (MENTHOL) PATCH [WAL-MART STORES INC]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311EQUATE COOL AND HEAT EXTRA STRENGTH (MENTHOL) PATCH [WAL-MART STORES INC]1
CASTOR OILINACTIVE INGREDIENTD5340Y2I9GEQUATE COOL AND HEAT EXTRA STRENGTH (MENTHOL) PATCH [WAL-MART STORES INC]1
DIHYDROXYALUMINUM AMINOACETATEINACTIVE INGREDIENTDO250MG0W6EQUATE COOL AND HEAT EXTRA STRENGTH (MENTHOL) PATCH [WAL-MART STORES INC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KEQUATE COOL AND HEAT EXTRA STRENGTH (MENTHOL) PATCH [WAL-MART STORES INC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXEQUATE COOL AND HEAT EXTRA STRENGTH (MENTHOL) PATCH [WAL-MART STORES INC]1
HYDROXYPROPYL CELLULOSE (TYPE E)INACTIVE INGREDIENT66O7AQV0RTEQUATE COOL AND HEAT EXTRA STRENGTH (MENTHOL) PATCH [WAL-MART STORES INC]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSEQUATE COOL AND HEAT EXTRA STRENGTH (MENTHOL) PATCH [WAL-MART STORES INC]1
POLYACRYLIC ACID (250000 MW)INACTIVE INGREDIENT9G2MAD7J6WEQUATE COOL AND HEAT EXTRA STRENGTH (MENTHOL) PATCH [WAL-MART STORES INC]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990EQUATE COOL AND HEAT EXTRA STRENGTH (MENTHOL) PATCH [WAL-MART STORES INC]1
SORBITOLINACTIVE INGREDIENT506T60A25REQUATE COOL AND HEAT EXTRA STRENGTH (MENTHOL) PATCH [WAL-MART STORES INC]1
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HEQUATE COOL AND HEAT EXTRA STRENGTH (MENTHOL) PATCH [WAL-MART STORES INC]1
WATERINACTIVE INGREDIENT059QF0KO0REQUATE COOL AND HEAT EXTRA STRENGTH (MENTHOL) PATCH [WAL-MART STORES INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-888EQUATE COOL AND HEAT EXTRA STRENGTH (MENTHOL) PATCH [WAL-MART STORES INC]5Current NDC, Legacy NDC, 2 package rows20241219_ca3088a7-e1ec-4e69-80d9-fd0051bde938.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 5 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RELIBONEOintmentTOPICAL ANALGESICOINTMENTGuangdong Jiaoyu Biotechnology Co., Ltd58ddaaf6-18ec-8c5b-e063-6294a90a28282026-08-12WarningsExact identifier
application number: M017
Capsaicin CreamCAPSAICINTrifecta Pharmaceuticals USA LLC58de3a29-2bec-6e44-e063-6394a90a9c1a2026-08-12WarningsExact identifier
application number: M017
HYDROCORTISONEHYDROCORTISONEAmazon.com Services LLCf40b4223-e81f-4cd0-bc9b-d3d33ce8cce52026-08-12WarningsExact identifier
application number: M017
Muscle Rub CreamMUSCLE RUBALLIED TRADE LINK LLC11d33e60-8c64-4316-a29a-d17e3e6e4a282026-08-11WarningsExact identifier
application number: M017
Gee GasonMALE GENITAL DESENSITIZERMon Gars Boutique Inc58c75e5c-b801-017f-e063-6394a90a1c752026-08-11WarningsExact identifier
application number: M017
Capsaicin CreamCAPSAICINTrifecta Pharmaceuticals USA LLC58c84330-15bf-c397-e063-6394a90aba052026-08-11WarningsExact identifier
application number: M017
Hydrocortisone with AloeHYDROCORTISONETARGET Corporation4a140b9a-0e3c-4b50-b9c0-9e72616bb7d52026-08-11WarningsExact identifier
application number: M017
Itch ReliefDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATECVS Pharmacy0e988da1-1904-431d-a152-bdb2aacc8e162026-08-11WarningsExact identifier
application number: M017
Medicated BODYMENTHOLCVS Pharmacy, Inc.a0f61498-69c8-4ce0-bbd7-3a807f192d362026-08-11WarningsExact identifier
application number: M017
Muscle MoveMENTHOLSaje Natural Wellness Inc.526d3305-4cf8-2fc5-e063-6394a90ad53b2026-08-10WarningsExact identifier
application number: M017
Relieve and Relax Pain RelievingCAMPHOR (SYNTHETIC), MENTHOLMAC Innovations, LLCc0528c36-d322-8110-e053-2995a90add6c2026-08-08WarningsExact identifier
application number: M017
CVS Pain ReliefMENTHOLCVS Pharmacy4aa629f5-8b8f-cc67-e063-6394a90a019f2026-08-07WarningsExact identifier
application number: M017
Instant Cooling Itch ReliefHYDROCORTISONECVS Pharmacy46545d04-5958-d136-e063-6394a90a34622026-08-07WarningsExact identifier
application number: M017
CVS Itch ReliefPRAMOXINE HYDROCHLORIDE, ZINC ACETATECVS Pharmacy46921bea-fcbe-94d6-e063-6394a90a726b2026-08-07WarningsExact identifier
application number: M017
CVS Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLCVS Pharmacy524605f9-8b04-b600-e063-6394a90a4a022026-08-07WarningsExact identifier
application number: M017
LidonexLIDOCAINE HCL, MENTHOLAldama Pharmaceuticals, Inc365cf19c-70e0-c4e9-e063-6294a90ac4282026-08-07WarningsExact identifier
application number: M017
Blaster Pain Relief StickMENTHOL, METHYL SALICYLATE, CAMPHORKalahari Rose, LLC587d660a-5f80-de5a-e063-6394a90aa2872026-08-07WarningsExact identifier
application number: M017
Itch ReliefDIPHENHYDRAMINE HCL, ZINC ACETATECardinal Health, 110 dba Leader3ed7b8a1-012f-459d-878c-813b93d4673c2026-08-06Warnings, Adverse reactionsExact identifier
application number: M017
Gel Cooling Pain ReliefMENTHOLThe Kroger Co.6fb0acc8-8dab-452c-b09e-de97306e1c322026-08-06Warnings, Adverse reactionsExact identifier
application number: M017
Lidocaine Tattoo WipeLIDOCAINE HYDROCHLORIDEMD Tattoo Company369c1d16-597c-e1dc-e063-6394a90a31042026-08-06WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
420222menthol 5 % Medicated PatchPSNca3088a7-e1ec-4e69-80d9-fd0051bde9387
420222menthol 0.05 MG/MG Medicated PatchSCDca3088a7-e1ec-4e69-80d9-fd0051bde9387
420222menthol 5 % Medicated PatchSYca3088a7-e1ec-4e69-80d9-fd0051bde9387

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-888-30490350888301 POUCH in 1 CARTON (49035-888-30) / 5 PATCH in 1 POUCH1 pouch2014-07-010000-00-00NoNoCurrent