FDA.reportPublic FDA data

Lidothol

Product NDC
76420-253
Requested package NDC
76420-253-04
11-digit product format
764200253
Labeler code
76420
Product ID
76420-253_e837dbef-8ea9-e5cb-e053-2995a90a8ec8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LIDOCAINE HCl, MENTHOL
Dosage form
GEL
Route
TOPICAL
Labeler
Asclemed USA, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2019-04-01
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 SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6d7adaca-67dd-4a4b-a85c-d1c2a568dee2Available 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
76420-253-04Lidothol1 in 1 BOXGEL12
76420-253-04Lidothol99.2 g in 1 TUBEGEL99.22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-253-04GM - Gram76420-25311265e2f-c78c-4fc2-879f-c6e88a55376812022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-253LIDOTHOL (LIDOCAINE HCL, MENTHOL) GEL [ASCLEMED USA, INC.]2Current NDC, Legacy NDC, 2 package rows20220911_6d7adaca-67dd-4a4b-a85c-d1c2a568dee2.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, MENTHOLAsclemed USA, Inc.6d7adaca-67dd-4a4b-a85c-d1c2a568dee22022-09-09Warnings, Adverse reactionsExact identifier
ndc (package): 76420-253-04
ndc (product): 76420-253
ndc11 (package): 76420025304

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76420-253-04764200253041 TUBE in 1 BOX (76420-253-04) / 99.2 g in 1 TUBE1 tube2022-07-190000-00-00NoNoCurrent