FDA.reportPublic FDA data

Mentholatum Lidocaine Ice

Product NDC
10742-1389
11-digit product format
107421389
Labeler code
10742
Product ID
10742-1389_292c447d-ea07-2df7-e063-6294a90aabf6
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine HCl, Menthol
Dosage form
GEL
Route
TOPICAL
Labeler
The Mentholatum Company
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-08-01
Substance
LIDOCAINE HYDROCHLORIDE; MENTHOL, UNSPECIFIED FORM
Active strength
40; 10 mg/mL; 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 Ice
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE40 mg/mL
MENTHOL, UNSPECIFIED FORM10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV13007Z41A, L7T10EIP3A
Rxcui1373137

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
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
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10742-1389-12023-02-07C16284748780-1f386c649-edb1-0266-e053-dadaa90a7c1aDrug Facts - Mentholatum Lidocaine Ice
10742-1389-12023-01-30C16284748780-1f386c649-edb1-0266-e053-dadaa90a7c1aDrug Facts - Mentholatum Lidocaine Ice

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10742-1389-1Mentholatum Lidocaine Ice80 mL in 1 BOTTLEGEL805
10742-1389-1Mentholatum Lidocaine Ice1 in 1 CARTONGEL15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10742-1389MENTHOLATUM LIDOCAINE ICE (LIDOCAINE HCL, MENTHOL) GEL [THE MENTHOLATUM COMPANY]5Current NDC, Legacy NDC, 2 package rows20241215_4d74cbab-31cd-4579-9360-6852ee215b5e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1373137lidocaine HCl 4 % / menthol 1 % Topical GelPSN4d74cbab-31cd-4579-9360-6852ee215b5e5
1373137lidocaine hydrochloride 0.04 MG/MG / menthol 0.01 MG/MG Topical GelSCD4d74cbab-31cd-4579-9360-6852ee215b5e5
1373137lidocaine hydrochloride 4 % / menthol 1 % Topical GelSY4d74cbab-31cd-4579-9360-6852ee215b5e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10742-1389-1107421389011 BOTTLE in 1 CARTON (10742-1389-1) / 80 mL in 1 BOTTLE1 bottle2018-08-010000-00-00NoNoCurrent