FDA.reportPublic FDA data

Lidotral Five Percent with Menthol

Product NDC
59088-308
11-digit product format
590880308
Labeler code
59088
Product ID
59088-308_27ea6384-0b8c-d8ca-e063-6394a90a0df1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride, Menthol
Dosage form
LIQUID
Route
TOPICAL
Labeler
PureTek Corporation
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2023-10-06
Substance
LIDOCAINE HYDROCHLORIDE; MENTHOL
Active strength
50; 30 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
Lidotral Five Percent with Menthol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE50 mg/mL
MENTHOL30 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV13007Z41A, L7T10EIP3A
Rxcui2667468

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
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59088-308-03Lidotral Five Percent with Menthol30 mL in 1 BOTTLE, SPRAYLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-308LIDOTRAL FIVE PERCENT WITH MENTHOL (LIDOCAINE HYDROCHLORIDE, MENTHOL) LIQUID [PURETEK CORPORATION]2Current NDC, 1 package rows20241204_06ff69f7-1ded-b5c8-e063-6394a90a300f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2667468lidocaine HCl 5 % / menthol 3 % Topical SprayPSN06ff69f7-1ded-b5c8-e063-6394a90a300f2
2667468lidocaine hydrochloride 50 MG/ML / menthol 30 MG/ML Topical SpraySCD06ff69f7-1ded-b5c8-e063-6394a90a300f2
2667468lidocaine HCl 5 % / menthol 3 % Topical SpraySY06ff69f7-1ded-b5c8-e063-6394a90a300f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59088-308-035908803080330 mL in 1 BOTTLE, SPRAY (59088-308-03) 30 ml2023-10-06NoNoHistorical