FDA.reportPublic FDA data

Walgreens Cool n Heat

Product NDC
0363-3036
11-digit product format
003633036
Labeler code
0363
Product ID
0363-3036_28f11064-64e4-531d-e063-6394a90a1f10
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine 4%
Dosage form
CREAM
Route
TOPICAL
Labeler
Walgreens
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-03-01
Substance
MENTHOL, UNSPECIFIED FORM; LIDOCAINE HYDROCHLORIDE
Active strength
1; 4 g/100g; g/100g
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
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
Walgreens Cool n Heat
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL, UNSPECIFIED FORM1 g/100g
LIDOCAINE HYDROCHLORIDE4 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup
V13007Z41AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1595624Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ce1b21d6-7aa6-2b18-e053-2995a90a4c91Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-3036-02Walgreens Cool n Heat76.5 g in 1 BOTTLECREAM76.54
0363-3036-02Walgreens Cool n Heat1 in 1 CARTONCREAM14
0363-3036-04Walgreens Cool n Heat1 in 1 CARTONCREAM14
0363-3036-04Walgreens Cool n Heat133 g in 1 BOTTLECREAM1334

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-3036WALGREENS COOL N HEAT (LIDOCAINE 4%) CREAM [WALGREENS]4Current NDC, 4 package rows20241213_ce1b21d6-7aa6-2b18-e053-2995a90a4c91.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 52 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HERSTAT GST Genital Sore TreatmentCAMPHOR, MENTHOLHerstat (USA) Inc.e8d27684-fb15-2e6a-e053-2a95a90a248f2025-12-19WarningsExact identifier
application number: M017
Kroger Anti ItchHYDROCORTISONEThe Kroger Co46547277-f11a-b9e7-e063-6294a90a2ccd2025-12-19WarningsExact identifier
application number: M017
Kroger Cool and Heat Roll-OnMENTHOLKroger46551d07-3006-c3ec-e063-6294a90aa3f22025-12-19WarningsExact identifier
application number: M017
Naughty Kitty KatNO GAG DEEP THROAT SPRAYINKED SUGAR, INC170eb644-c72c-5744-e063-6394a90a767d2025-12-19WarningsExact identifier
application number: M017
Tiger Balm Red Extra StrengthCAMPHOR (SYNTHETIC) AND MENTHOLHaw Par Healthcare Ltd.ce703715-4c11-472c-9270-daac87b7be052025-12-19WarningsExact identifier
application number: M017
Aspercreme with Lidocaine Foot Pain CremeLIDOCAINE HYDROCHLORIDEChattem, Inc.da82cc0e-cc39-408e-87e1-c35bb6f9f51e2025-12-19WarningsExact identifier
application number: M017
Health Trak Plus Menthol-Infused Pain Relief SocksMENTHOLRailroad Sock LLC43413e55-1db2-fc1a-e063-6394a90a71672025-12-18WarningsExact identifier
application number: M017
BIO-ICEMENTHOL, CAMPHORElectrostim Medical Services Inc. d/b/a EMSI1bfd1468-9139-43b1-9709-d47b63d17cfb2025-12-18WarningsExact identifier
application number: M017
LidotrodeLIDOCAINEStrand Health Group1fd20b9a-b8bc-c94f-e063-6394a90a2b692025-12-18WarningsExact identifier
application number: M017
A Health Itch Relief GelITCH RELIEF GELBionpharma, Inc.ecf5decb-c98b-7739-e053-2995a90a55412025-12-18WarningsExact identifier
application number: M017
After Burn2.5% LIDOCAINE HCLTender Corporation d/b/a Adventure Ready Brands4640395f-a76c-d022-e063-6294a90adde62025-12-18WarningsExact identifier
application number: M017
SPARTAN WIPESENDURANCE WIPESTIV PRIME SRL26d02431-2c95-001c-e063-6394a90a29c72025-12-18WarningsExact identifier
application number: M017
Stopain Extra Strength ContinuousMENTHOLTroy Manufacturing, Inc.a0f76968-d22c-4b1c-a9e6-8d0179a2e98e2025-12-18WarningsExact identifier
application number: M017
ZIMS MAX FREEZELIDOCAINE HYDROCHLORIDE AND MENTHOL,KOBAYASHI Healthcare International, Inc.e364ff83-4aaf-4897-a7da-06581bc321f22025-12-18WarningsExact identifier
application number: M017
Tiger Balm White Regular StrengthCAMPHOR (SYNTHETIC) AND MENTHOLHaw Par Healthcare Ltd.f406161e-a9c4-47d1-8b21-93b1b79380632025-12-17WarningsExact identifier
application number: M017
ResinolPETROLATUM AND RESORCINOLResiCal, Inc.03f57a4a-f94b-4ba6-b709-41cfb6e162612025-12-17WarningsExact identifier
application number: M017
HealthWise Maximum Pain ReliefLIDOCAINEVeridian Healthcareafc3c16d-0076-44b2-ae7e-5f36d4d8088e2025-12-17WarningsExact identifier
application number: M017
HealthWise Max Lidocaine plus MentholLIDOCAINE, MENTHOLVeridian Healthcaref39a27da-6799-4fc6-97ca-101eac4a93602025-12-17WarningsExact identifier
application number: M017
HealthWise Original MentholMENTHOLVeridian Healthcaree4bfb6b0-545e-4fbc-8538-4f41a6be10252025-12-17WarningsExact identifier
application number: M017
Welly Polka First Aid KitHYDROCORTISONE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEDongguan Shenglian Tins Products Co., Ltd.d7c4314c-c4c6-4adf-b384-3ac7a71083192025-12-17WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1595624lidocaine HCl 4 % / menthol 1 % Topical CreamPSNce1b21d6-7aa6-2b18-e053-2995a90a4c914
1595624lidocaine hydrochloride 40 MG/ML / menthol 10 MG/ML Topical CreamSCDce1b21d6-7aa6-2b18-e053-2995a90a4c914
1595624lidocaine hydrochloride 4 % / menthol 1 % Topical CreamSYce1b21d6-7aa6-2b18-e053-2995a90a4c914

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0363-3036-02003633036021 BOTTLE in 1 CARTON (0363-3036-02) / 76.5 g in 1 BOTTLE1 bottle2022-03-01NoNoCurrent
0363-3036-04003633036041 BOTTLE in 1 CARTON (0363-3036-04) / 133 g in 1 BOTTLE1 bottle2022-03-23NoNoCurrent