FDA.reportPublic FDA data

LidoPro Pain Relief

Product NDC
80425-0452
11-digit product format
804250452
Labeler code
80425
Product ID
80425-0452_2bc81112-204c-2514-e063-6394a90a80ed
Type
HUMAN OTC DRUG
Nonproprietary name
Capsaicin and Lidocaine
Dosage form
OINTMENT
Route
TRANSDERMAL
Labeler
Advanced Rx of Tennessee, LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-11-26
Substance
CAPSAICIN; LIDOCAINE HYDROCHLORIDE; MENTHOL, (+)-; METHYL SALICYLATE
Active strength
.0325; 4; 10; 27.5 mg/100mg; mg/100mg; mg/100mg; mg/100mg
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
LidoPro Pain Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL, (+)-.0325 mg/100mg
LIDOCAINE HYDROCHLORIDE4 mg/100mg
METHYL SALICYLATE10 mg/100mg
CAPSAICIN27.5 mg/100mg

Harmonized Identifiers#

Field, Values table
FieldValues
UniiC6B1OE8P3W, V13007Z41A, LAV5U5022Y, S07O44R1ZM

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
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
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
80425-0452-1LidoPro Pain Relief9900 mg in 1 TUBE, WITH APPLICATOROINTMENT99002
80425-0452-1LidoPro Pain Relief1 in 1 BOXOINTMENT12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0452-1GM - Gram80425-04521d6ff2da-a46f-4654-9491-812655a6c75e12025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0452LIDOPRO PAIN RELIEF (CAPSAICIN AND LIDOCAINE) OINTMENT [ADVANCED RX OF TENNESSEE, LLC]2Current NDC, 2 package rows20250117_27d5997b-1cc2-41c2-e063-6394a90ac74a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
80425-0452-1804250452011 TUBE, WITH APPLICATOR in 1 BOX (80425-0452-1) / 9900 mg in 1 TUBE, WITH APPLICATOR2024-11-26NoNoCurrent