FDA.reportPublic FDA data

Lidothol ES

Product NDC
83881-445
11-digit product format
838810445
Labeler code
83881
Product ID
83881-445_51019c41-c37c-c822-e063-6394a90a9077
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
menthol 5%, lidocaine 4%
Dosage form
SYSTEM
Route
TRANSDERMAL
Labeler
Clinic Pharma
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2026-01-06
Substance
LIDOCAINE; MENTHOL
Active strength
.04; .05 g/g; g/g
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 ES
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE.04 g/g
MENTHOL.05 g/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii98PI200987, L7T10EIP3A
Rxcui1552201

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
83881-445-15Lidothol ES1 in 1 POUCHSYSTEM13
83881-445-15Lidothol ES15 in 1 BOXSYSTEM153

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83881-445-15EA - Each83881-445866de495-3520-4206-8404-dfebd75cac5f12026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1552201lidocaine 4 % / menthol 5 % Medicated PatchPSNb456b63b-cead-4bed-aa2e-881fe88a77dc3
1552201lidocaine 0.04 MG/MG / menthol 0.05 MG/MG Medicated PatchSCDb456b63b-cead-4bed-aa2e-881fe88a77dc3
1552201lidocaine 4 % / menthol 5 % Medicated PatchSYb456b63b-cead-4bed-aa2e-881fe88a77dc3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83881-445-158388104451515 POUCH in 1 BOX (83881-445-15) / 1 PATCH in 1 POUCH / 1.38 g in 1 PATCH15 pouch2026-01-06NoNoHistorical