FDA.reportPublic FDA data

Lidothol

Product NDC
83881-455
11-digit product format
838810455
Labeler code
83881
Product ID
83881-455_3159e71f-14be-9c36-e063-6394a90a8733
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LIDOCAINE HCl, MENTHOL
Dosage form
GEL
Route
CUTANEOUS
Labeler
Clinic Pharma
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2025-03-27
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lidothol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL4.5 g/100g
LIDOCAINE HYDROCHLORIDE5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup
V13007Z41AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2257313Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3159db23-6439-7c2e-e063-6294a90a310bAvailable 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
83881-455-35Lidothol1 in 1 BOXGEL11
83881-455-35Lidothol99.2 g in 1 TUBEGEL99.21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83881-455-35GM - Gram83881-4559aea71b7-e7d1-4029-a1c7-16bda0ca01bc12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83881-455LIDOTHOL (LIDOCAINE HCL, MENTHOL) GEL [CLINIC PHARMA]1Current NDC, 2 package rows20250413_3159db23-6439-7c2e-e063-6294a90a310b.zip

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
LidotholLIDOCAINE HCL, MENTHOLClinic Pharma3159db23-6439-7c2e-e063-6294a90a310b2025-03-27Warnings, Adverse reactionsExact identifier
ndc (product): 83881-455

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
2257313lidocaine HCl 4.5 % / menthol 5 % Topical GelPSN3159db23-6439-7c2e-e063-6294a90a310b1
2257313lidocaine HCl 4.5 % / menthol 5 % Topical GelPSN3467f4c7-122c-40df-e063-6394a90ae36e1
2257313lidocaine HCl 4.5 % / menthol 5 % Topical GelPSN4e2fad18-13f1-4e61-86db-d721029287171
2257313lidocaine hydrochloride 0.045 MG/MG / menthol 0.05 MG/MG Topical GelSCD3159db23-6439-7c2e-e063-6294a90a310b1
2257313lidocaine hydrochloride 0.045 MG/MG / menthol 0.05 MG/MG Topical GelSCD3467f4c7-122c-40df-e063-6394a90ae36e1
2257313lidocaine hydrochloride 0.045 MG/MG / menthol 0.05 MG/MG Topical GelSCD4e2fad18-13f1-4e61-86db-d721029287171
2257313lidocaine HCl 4.5 % / menthol 5 % Topical GelSY3159db23-6439-7c2e-e063-6294a90a310b1
2257313lidocaine HCl 4.5 % / menthol 5 % Topical GelSY3467f4c7-122c-40df-e063-6394a90ae36e1
2257313lidocaine HCl 4.5 % / menthol 5 % Topical GelSY4e2fad18-13f1-4e61-86db-d721029287171

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83881-455-35838810455351 TUBE in 1 BOX (83881-455-35) / 99.2 g in 1 TUBE1 tube2025-03-27NoNoCurrent