FDA.reportPublic FDA data

Lidothol Gel

Product NDC
72189-621
11-digit product format
721890621
Labeler code
72189
Product ID
72189-621_4d3a4f73-0e3f-76f6-e063-6394a90aee8b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidothol Gel
Dosage form
GEL
Route
CUTANEOUS
Labeler
Direct_Rx
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2025-05-12
Substance
LIDOCAINE HYDROCHLORIDE; MENTHOL
Active strength
4.5; 5 g/100g; g/100g
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lidothol Gel
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE4.5 g/100g
MENTHOL5 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV13007Z41A, L7T10EIP3A
Rxcui2257313

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-621-35Lidothol Gel1 g in 1 BOXGEL12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-621-35GM - Gram72189-6216672aa00-7905-44a4-9e8c-b2875c109db812025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-621LIDOTHOL GEL GEL [DIRECT_RX]1Current NDC, 1 package rows20250523_34f15ceb-87c1-526d-e063-6294a90a3789.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2257313lidocaine HCl 4.5 % / menthol 5 % Topical GelPSN34f15ceb-87c1-526d-e063-6294a90a37892
2257313lidocaine hydrochloride 0.045 MG/MG / menthol 0.05 MG/MG Topical GelSCD34f15ceb-87c1-526d-e063-6294a90a37892
2257313lidocaine HCl 4.5 % / menthol 5 % Topical GelSY34f15ceb-87c1-526d-e063-6294a90a37892

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72189-621-35721890621351 g in 1 BOX (72189-621-35) 1 g2025-05-12NoNoHistorical