FDA.reportPublic FDA data

Lidothol

Product NDC
80425-0516
11-digit product format
804250516
Labeler code
80425
Product ID
80425-0516_3467f4f8-72ee-4446-e063-6294a90a80c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LIDOCAINE HCl, MENTHOL
Dosage form
GEL
Route
CUTANEOUS
Labeler
Advanced Rx of Tennessee, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2025-05-05
Substance
MENTHOL; LIDOCAINE HYDROCHLORIDE
Active strength
5; 4.5 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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL5 g/100g
LIDOCAINE HYDROCHLORIDE4.5 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
3467f4c7-122c-40df-e063-6394a90ae36eAvailable 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
80425-0516-1Lidothol99.2 g in 1 TUBEGEL99.21
80425-0516-1Lidothol1 in 1 BOXGEL11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0516-1GM - Gram80425-05168f3871ae-4f03-4884-8cf0-e30f50add0f612025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0516LIDOTHOL (LIDOCAINE HCL, MENTHOL) GEL [ADVANCED RX OF TENNESSEE, LLC]1Current NDC, 2 package rows20250508_3467f4c7-122c-40df-e063-6394a90ae36e.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, MENTHOLAdvanced Rx of Tennessee, LLC3467f4c7-122c-40df-e063-6394a90ae36e2025-05-05Warnings, Adverse reactionsExact identifier
ndc (product): 80425-0516

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2257313lidocaine HCl 4.5 % / menthol 5 % Topical GelPSN3467f4c7-122c-40df-e063-6394a90ae36e1
2257313lidocaine hydrochloride 0.045 MG/MG / menthol 0.05 MG/MG Topical GelSCD3467f4c7-122c-40df-e063-6394a90ae36e1
2257313lidocaine HCl 4.5 % / menthol 5 % Topical GelSY3467f4c7-122c-40df-e063-6394a90ae36e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0516-1804250516011 TUBE in 1 BOX (80425-0516-1) / 99.2 g in 1 TUBE1 tube2025-05-05NoNoCurrent