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#

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 150 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Biofreeze Roll-OnMENTHOLA-S Medication Solutions814b37ea-5441-4cec-8794-71ca01d849ae2023-10-30WarningsExact identifier
application number: M017
Dr. Sheffield Hydrocortisone Anti itchHYDROCORTISONESheffield Pharmaceuticals LLC71c9f2f4-2188-45eb-b55e-3856ac78070b2023-10-30WarningsExact identifier
application number: M017
Family WellnessBENZOCAINE, RESORCINOLZhejiang Jingwei Pharmaceutic Al Co., Ltd.df540eb8-6773-4647-9cc2-c3fd14d7355e2023-10-27WarningsExact identifier
application number: M017
Family WellnessHYDROCORTISONE 1%FRONT PHARMACEUTICAL PLCea26265d-f24e-458e-8bf0-287b2d49f4f42023-10-27WarningsExact identifier
application number: M017
Joint Formula 88 MAX PLUSCAMPHORSarati International, Inc.f5d78335-b78d-4909-a88b-9daa3c18ba152023-10-27WarningsExact identifier
application number: M017
OsmoFlexMENTHOLSarati International, Inc.479147c0-4cf4-4d7a-8b8e-1a0de49ed73e2023-10-27WarningsExact identifier
application number: M017
Thera plus Anti-itch with aloe HydrocortisoneHYDROCORTISONEFourstar Group USA, Inc.c69d0670-a65b-1680-e053-2995a90a2ee52023-10-26WarningsExact identifier
application number: M017
Family WellnessDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEFRONT PHARMACEUTICAL PLCfde2069b-344e-46da-bb95-c5113e0f35d62023-10-26WarningsExact identifier
application number: M017
MAXIMUM STRENGTH HEMORRHOIDAL RELIEFLIDOCAINECVS PHARMACY, INCb61424bf-3b23-420b-a7bc-256ddb96aa222023-10-25WarningsExact identifier
application number: M017
AssuredHYDROCORTISONEZhejiang Jingwei Pharmaceutic Al Co., Ltd.bc97f364-9443-47b8-9c2d-b5dcc00cc9b72023-10-25WarningsExact identifier
application number: M017
Stopain ClinicalMENTHOL, UNSPECIFIED FORMTroy Manufacturing, Inc.b41091b4-0dc0-4a88-8ff6-11979b3d307a2023-10-25WarningsExact identifier
application number: M017
Thera PlusHYDROCORTISONEZhejiang Jingwei Pharmaceutical Co., Ltd.bcc99e5a-2403-46da-9c9d-8411fa4104e02023-10-25WarningsExact identifier
application number: M017
AssuredLIDOCAINE HYDROCHLORIDEZhejiang Jingwei Pharmaceutical Co., Ltd.ab25c47d-bbe6-4e2b-9e39-dd9f4da3ee8c2023-10-25WarningsExact identifier
application number: M017
Red hotCAPSAICINThe Hygenic Company, LLCd100092c-e10b-2063-e053-2995a90aedb22023-10-25WarningsExact identifier
application number: M017
Stopain ClinicalMENTHOLTroy Manufacturing, Inc.c8d4ae28-efc4-6a00-e053-2a95a90a40bf2023-10-25WarningsExact identifier
application number: M017
Cryo10 Topical AnalgesicMENTHOLElement 26 LLCff1d2140-9302-918c-e053-6394a90acb9a2023-10-25WarningsExact identifier
application number: M017
Stopain ClinicalMENTHOLTroy Manufacturing, Inc.3336cc35-e773-4705-84b5-61040604beef2023-10-25WarningsExact identifier
application number: M017
CARMEX Multi-Symptom 3 in 1 COLD Sore treatment External Analgesic Skin ProtectantBENZOCAINE, WHITE PETROLATUMCarma Laboratories, Inc.bbf0abcd-b7d6-b5e4-e053-2995a90a52402023-10-25WarningsExact identifier
application number: M017
Carmex Classic Lip Balm MedicatedCAMPHOR (SYNTHETIC), WHITE PETROLATUMCarma Laboratories, Inc.bbee66b9-39ff-4e7e-e053-2995a90a43be2023-10-25WarningsExact identifier
application number: M017
XtraCare Ice Cold Topical Analgesic GelMENTHOLRejoice Internationald38f3099-d940-44d8-aa7f-404157c5e0e32023-10-24WarningsExact 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