FDA.reportPublic FDA data

Mentholatum Lidocaine Heat

Product NDC
10742-8386
11-digit product format
107428386
Labeler code
10742
Product ID
10742-8386_2979a04c-7c90-1189-e063-6394a90ae3a3
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine HCl
Dosage form
CREAM
Route
TOPICAL
Labeler
The Mentholatum Company
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-08-01
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
40 mg/mL
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

Additional Listing Data#

Finished product
Yes
Brand name base
Mentholatum Lidocaine Heat
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE40 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV13007Z41A
Rxcui1010895

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10742-8386-12023-02-07C16284748780-1f386c64a-069b-0266-e053-dadaa90a7c1aDrug Facts - Mentholatum Lidocaine Heat
10742-8386-12023-01-30C16284748780-1f386c64a-069b-0266-e053-dadaa90a7c1aDrug Facts - Mentholatum Lidocaine Heat

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10742-8386-1Mentholatum Lidocaine Heat1 in 1 CARTONCREAM15
10742-8386-1Mentholatum Lidocaine Heat80 mL in 1 BOTTLECREAM805

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10742-8386MENTHOLATUM LIDOCAINE HEAT (LIDOCAINE HCL) CREAM [THE MENTHOLATUM COMPANY]5Current NDC, Legacy NDC, 2 package rows20241219_cc2ef25a-b569-4d48-a666-899f710b4b34.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010895lidocaine HCl 4 % Topical CreamPSNcc2ef25a-b569-4d48-a666-899f710b4b345
1010895lidocaine hydrochloride 40 MG/ML Topical CreamSCDcc2ef25a-b569-4d48-a666-899f710b4b345
1010895lidocaine hydrochloride 4 % Topical CreamSYcc2ef25a-b569-4d48-a666-899f710b4b345

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10742-8386-1107428386011 BOTTLE in 1 CARTON (10742-8386-1) / 80 mL in 1 BOTTLE1 bottle2018-08-010000-00-00NoNoCurrent