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 UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
98PI200987Internal UNII lookup
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1552201Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b456b63b-cead-4bed-aa2e-881fe88a77dcAvailable on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidothol ESMENTHOL 5%, LIDOCAINE 4%Clinic Pharmab456b63b-cead-4bed-aa2e-881fe88a77dc2026-05-04Warnings, Adverse reactionsExact identifier
ndc (product): 83881-445

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 pouch2026-01-06NoNoCurrent