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 54 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Welly First Aid Kit RefillHYDROCORTISONE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINEDongguan Shenglian Tins Products Co., Ltd.4bc93855-4009-4b49-9fb4-e5864054153d2025-12-16WarningsExact identifier
application number: M017
LidocainePain pain reliving gel-patchPAIN RELIVING GEL-PATCHShenzhen Yuetai Electronic Commerce Co., Ltd461ebbdd-0f26-a333-e063-6394a90a7a3e2025-12-16WarningsExact identifier
application number: M017
ZestamaCAPSAICINV2 Pharma LLCc9b46759-b8df-4ff4-815e-8e032c2635c02025-12-15WarningsExact identifier
application number: M017
equate hydrocortisoneHYDROCORTISONEWal-Mart Stores Inc70f4636d-4137-498b-ab81-0330de883e532025-12-15WarningsExact identifier
application number: M017
SALONPAS-HOT CAPSICUMCAPSAICINHisamitsu Pharmaceutical Co., Inc.ef5373aa-9857-4d01-95af-2d7716e54ae42025-12-15WarningsExact identifier
application number: M017
First Aid Burn CreamFIRST AID BURN CREAMProStat First Aid LLCf70a442e-7ba7-4860-e053-6394a90ac2bd2025-12-15WarningsExact identifier
application number: M017
Burn Ease, 3.5gBURN EASE, 3.5GProStat First Aid LLC004aa18f-3a97-f454-e063-6394a90afcff2025-12-15WarningsExact identifier
application number: M017
PS-3866 Burn Ease, 0.9gPS-3866 BURN EASE, 0.9GProStat First Aid LLC004d00a5-9cff-29ff-e063-6294a90aeb8c2025-12-15WarningsExact identifier
application number: M017
First Aid Burn CreamFIRST AID BURN CREAMProStat First Aid LLC0037a1a4-d747-2567-e063-6394a90a721c2025-12-15WarningsExact identifier
application number: M017
PS-3885 Burn Ease, 3.5gPS-3885 BURN EASE, 3.5GProStat First Aid LLC004c6deb-2844-a0d0-e063-6394a90ae5e42025-12-15WarningsExact identifier
application number: M017
2677 First Aid Burn Cream2677 FIRST AID BURN CREAMProStat First Aid LLCff5bb628-8ef7-4540-e053-6394a90a55ed2025-12-15WarningsExact identifier
application number: M017
Burn EaseBURN EASEProStat First Aid LLCf71b98b4-22d0-0124-e053-6394a90ae4cf2025-12-15WarningsExact identifier
application number: M017
Burn EaseBURN EASEProStat First Aid LLCf71eb4f5-2280-5867-e053-6394a90aac572025-12-15WarningsExact identifier
application number: M017
Burn Ease 3.5gBURN EASE 3.5GFront Line Safety0f8e6842-c889-d5d3-e063-6394a90af8802025-12-15WarningsExact identifier
application number: M017
Burn Ease 3.5gBURN EASE 3.5GFront Line Safety0f8c59fb-3622-2bb7-e063-6294a90adc6e2025-12-15WarningsExact identifier
application number: M017
Burn EaseBURN EASEFront Line Safety0e34cb09-d8c6-f8c0-e063-6294a90a0be02025-12-15WarningsExact identifier
application number: M017
Burn Ease 3.5gBURN EASE 3.5GFront Line Safety0f52021f-af8a-5b95-e063-6294a90a2c2a2025-12-15WarningsExact identifier
application number: M017
Burn EaseBURN EASEProStat First Aid LLC0e25c936-e40a-e23c-e063-6294a90ac0e42025-12-15WarningsExact identifier
application number: M017
Sting Relief WipesSTING RELIEF WIPESProStat First Aid LLC0e20252a-5ecb-2526-e063-6294a90a8cde2025-12-15WarningsExact identifier
application number: M017
First Aid Burn CreamFIRST AID BURN CREAMFront Line Safety0f4ce2c2-f306-d95f-e063-6394a90ae7b32025-12-15WarningsExact 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