FDA.reportPublic FDA data

TheraCare 4% Lidocaine and 1% Menthol Cream

Product NDC
71101-931
11-digit product format
711010931
Labeler code
71101
Product ID
71101-931_18fad642-24ee-746c-e063-6294a90ae791
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol and Lidocaine
Dosage form
CREAM
Route
TOPICAL
Labeler
Veridian Healthcare
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-07-01
Substance
LIDOCAINE; MENTHOL
Active strength
4; 1 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
TheraCare 4% Lidocaine and 1% Menthol Cream
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE4 g/100g
MENTHOL1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
98PI200987Internal UNII lookup
L7T10EIP3AInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c80ba251-91a5-0858-e053-2995a90a9cffAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71101-931-01TheraCare 4% Lidocaine and 1% Menthol Cream1 in 1 CARTONCREAM13
71101-931-01TheraCare 4% Lidocaine and 1% Menthol Cream49.6 g in 1 BOTTLECREAM49.63

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71101-931THERACARE 4% LIDOCAINE AND 1% MENTHOL CREAM (MENTHOL AND LIDOCAINE) CREAM [VERIDIAN HEALTHCARE]3Current NDC, Legacy NDC, 2 package rows20240522_c80ba251-91a5-0858-e053-2995a90a9cff.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 80 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain RelievingMENTHOL, CAMPHOR, CAPSAICINAHC VENTURES CORP DBA CRY27679d31-a5f3-417b-b0c5-5f6b001ecff92025-09-02WarningsExact identifier
application number: M017
Cold TherapyMENTHOLAHC VENTURES CORP DBA CRYODERM52fff03e-eba2-4604-a71c-2522468f627b2025-09-02WarningsExact identifier
application number: M017
Pain Relieving Cold TherapyMENTHOLAHC VENTURES CORP DBA CRYODERMde210c3a-c24e-cefd-e053-2a95a90a93ff2025-09-02WarningsExact identifier
application number: M017
Pain Relieving Roll-OnMENTHOL, CAMPHOR, CAPSAICINAHC VENTURES CORP DBA CRY799751f3-726a-42de-934e-dbc3cd1cb8b82025-09-02WarningsExact identifier
application number: M017
Pain Relieving Cold TherapyMENTHOLAHC VENTURES CORP DBA CRYODERMde0c9a73-dbc0-599e-e053-2a95a90a79862025-09-02WarningsExact identifier
application number: M017
Cold TherapyMENTHOLAHC VENTURES CORP DBA CRYODERM90334420-5f81-4284-9a57-42e134ce362f2025-09-02WarningsExact identifier
application number: M017
KNEE PAIN RELIRF PatchCAMPHOR, MENTHOLShenzhen Finona Information Technology Co., Ltd3db971ef-d7fa-0171-e063-6294a90aa58b2025-09-01WarningsExact identifier
application number: M017
Bikini Zone Medicated CremeLIDOCAINEKingsway Pharmaceuticals dba NFI, LLC300ac57e-844a-4840-b285-41ff5518e6b62025-08-29WarningsExact identifier
application number: M017
Bikini Zone Medicated GelLIDOCAINEKingsway Pharmaceuticals dba NFI, LLC30b85890-e72d-4af7-bda9-e7744abc92af2025-08-29WarningsExact identifier
application number: M017
Sumifun Lidocaine Pain Relief Gel-PatchLIDOCAINEGuangzhou Zhupuyou E-commerce Co., Ltd3d7dc8cc-0680-d94d-e063-6394a90ac8e82025-08-29WarningsExact identifier
application number: M017
TKTALKER NUMBINGNUMBINGShenzhen Shandian Jingling Technology Co., Ltd.3d7e6757-f183-2a68-e063-6294a90ae4ca2025-08-29WarningsExact identifier
application number: M017
PBZ OTCTRIPELENNAMINE HCL 1%Kingsway Pharmaceuticals dba NFI, LLC12f72d74-018f-4bc6-acd4-175ca3af4c6d2025-08-29WarningsExact identifier
application number: M017
else.LIDOCAINEElse Co.3d6c7b10-ed03-bbde-e063-6294a90ae92f2025-08-28WarningsExact identifier
application number: M017
Mountain Ice Pain ReliefMENTHOLMountainside Medical Equipment, Inc.c79fdd91-16f4-4ae0-bee4-d37c05ed20742025-08-28WarningsExact identifier
application number: M017
HealthWise 4% Lidocaine Cream 2.7 ozLIDOCAINE HYDROCHLORIDEVeridian Healthcaref39eb3d0-e153-4f50-85b1-ad5c677d176c2025-08-28WarningsExact identifier
application number: M017
HealthWise Overnight Menthol PatchMENTHOLVeridian Healthcare6379f50d-2878-46ca-8acb-71c4554585e92025-08-28WarningsExact identifier
application number: M017
CapsaicinCAPSAICINPHARMACURE LLC119bab58-f129-4ff0-8d81-9c6a7b508dd62025-08-28WarningsExact identifier
application number: M017
Anti Itch Maximum ReliefPRAMOXINE HYDROCHLORIDE AND MENTHOLNatureplex LLC75de3d5e-ecbe-4d04-a39d-792200e6ee322025-08-28WarningsExact identifier
application number: M017
NicDuic Quit Smoking Nicotine PatchesNICOTINE TRANSDERMAL PATCHESShenzhen Paxi Trading Co., Ltd.3d5718f3-c175-6b64-e063-6394a90aa6f12025-08-27WarningsExact identifier
application number: M017
ARCTIC HEATMENTHOL, METHYL SALICYLATERenu Laboratories, LLC402df5c1-b8cb-17a2-e054-00144ff8d46c2025-08-27WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71101-931-01711010931011 BOTTLE in 1 CARTON (71101-931-01) / 49.6 g in 1 BOTTLE1 bottle2021-07-010000-00-00NoNoCurrent