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 135 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nova Natura Topical AnalgesicCAMPHOR, CAPSICUM OLEORESIN, METHYL SALICYLATESEYITLER KIMYA SANAYI ANONIM SIRKETIabf00f73-f0b1-439e-85aa-bbce8a1ec9202024-02-06WarningsExact identifier
application number: M017
Leader Burn ReliefLIDOCAINECardinal Healthf4e8e3b7-fd84-bdbc-e053-2a95a90aeab22024-02-06WarningsExact identifier
application number: M017
Pain Relieving Petro CarboPHENOLJ.R. Watkins, LLC.050cf17d-3be7-45b9-8524-ad82af309a0e2024-02-06WarningsExact identifier
application number: M017
White CreamCAMPHOR (NATURAL) AND TURPENTINE OILJ.R. Watkins, LLC.e4de0734-59d5-478c-86ea-66fc2ba003e72024-02-05WarningsExact identifier
application number: M017
Pain Relieving Roll-OnMENTHOL, UNSPECIFIED FORMSafetec of America, Inc.80118260-9c88-402d-9a90-ecfe62b4b54f2024-02-05WarningsExact identifier
application number: M017
Pain RelievingMENTHOL, UNSPECIFIED FORMSafetec of America, Inc.df512ce6-ce1b-434d-9571-fb2e1d76e1d02024-02-05WarningsExact identifier
application number: M017
Pain RelievingMENTHOLSafetec of America, Inc.52ebf64d-095f-467e-bf51-dd8d33b58c7d2024-02-05WarningsExact identifier
application number: M017
Itch ReliefDIPHENHYDRAMINE HYDROCHLORIDESafetec of America, Inc.4f4c801b-d894-4fa3-b024-6ca41a5f2a952024-02-04WarningsExact identifier
application number: M017
AnalgesicMENTHOLSafetec of America, Inc.79e3b0e7-4ba5-4b9d-a980-5b6f18dba8022024-02-04WarningsExact identifier
application number: M017
HAV EZ Penetrating Pain ReliefMENTHOLPALM ORTHOPEDICS & INTERVENTIONAL PAIN LLC70006efc-9cc8-4490-b28c-fcb23b1737c42024-02-01WarningsExact identifier
application number: M017
Rugby Capsaicin External AnalgesicCAPSAICINProficient Rx LP7c733a30-5002-49e7-a6bd-7737a1d2461e2024-02-01WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEProficient Rx LPccb62898-b614-45b9-95ea-23e5e31893a82024-02-01WarningsExact identifier
application number: M017
Hydrocortisone with AloeHYDROCORTISONEProficient Rx LP0b26d92f-9d0e-46d4-a8bc-75d6da5f61992024-02-01WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEProficient Rx LPc57d5f8e-5934-4cbb-999a-cdd55e5b105f2024-02-01WarningsExact identifier
application number: M017
hydrocortisoneHYDROCORTISONEProficient Rx LP47e9fe84-bd0c-40ea-85de-e950bcacc5572024-02-01WarningsExact identifier
application number: M017
Joint and Muscle PainMENTHOLShaklee Corporation3943824f-1f4f-4d6f-bd73-0b1be02162a52024-01-30WarningsExact identifier
application number: M017
Mirakel Pain Relief Roll-OnLIDOCAINE HCLSanvio, Inc.102f3618-13ad-37e3-e063-6294a90a80862024-01-30WarningsExact identifier
application number: M017
Blistex Lip MedexPETROLATUM, MENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC), AND PHENOLBlistex Inc.8ad39005-9419-4f1a-a1ae-2f76d212455e2024-01-26WarningsExact identifier
application number: M017
Point Relief Cold Spot Pain RelievingMENTHOLFabrication Enterprisesad5d6f04-15e6-4548-95c2-32271c186bc12024-01-25WarningsExact identifier
application number: M017
MIND BODY MATRIX PAIN RELIEFMENTHOLFunctional Energetic, Inc.3667dd0d-942e-4101-ba98-cb013ae77cf52024-01-25WarningsExact 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