FDA.reportPublic FDA data

LidoPro Pain Relief

Product NDC
83881-001
11-digit product format
838810001
Labeler code
83881
Product ID
83881-001_274611ea-7fc3-ba3f-e063-6294a90aa50f
Type
HUMAN OTC DRUG
Nonproprietary name
Capsaicin and Lidocaine
Dosage form
OINTMENT
Route
TRANSDERMAL
Labeler
Clinic Pharma
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-11-19
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
CAPSAICIN.0325 mg/100mg
LIDOCAINE HYDROCHLORIDE4 mg/100mg
MENTHOL, (+)-10 mg/100mg
METHYL SALICYLATE27.5 mg/100mg

Harmonized Identifiers#

Field, Values table
FieldValues
UniiS07O44R1ZM, V13007Z41A, C6B1OE8P3W, LAV5U5022Y

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
83881-001-35LidoPro Pain Relief1 in 1 BOXOINTMENT11
83881-001-35LidoPro Pain Relief9900 mg in 1 TUBE, WITH APPLICATOROINTMENT99001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83881-001-35GM - Gram83881-001e57a98cf-db46-483d-b965-2dec11cc439612025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83881-001LIDOPRO PAIN RELIEF (CAPSAICIN AND LIDOCAINE) OINTMENT [CLINIC PHARMA]1Current NDC, 2 package rows20241121_274611ea-7fc2-ba3f-e063-6294a90aa50f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1601095capsaicin 0.0325 % / lidocaine HCl 4 % / menthol 10 % / methyl salicylate 27.5 % Topical OintmentPSNc259ef92-5d07-4590-adf1-3a106333eee01
1601097LidoPro 0.0325 % / 4 % / 10 % / 27.5 % Topical OintmentPSNc259ef92-5d07-4590-adf1-3a106333eee01
1601097capsaicin 0.000325 MG/MG / lidocaine hydrochloride 0.04 MG/MG / menthol 0.1 MG/MG / methyl salicylate 0.275 MG/MG Topical Ointment [LidoPro]SBDc259ef92-5d07-4590-adf1-3a106333eee01
1601095capsaicin 0.000325 MG/MG / lidocaine hydrochloride 0.04 MG/MG / menthol 0.1 MG/MG / methyl salicylate 0.275 MG/MG Topical OintmentSCDc259ef92-5d07-4590-adf1-3a106333eee01
1601095capsaicin 0.0325 % / lidocaine HCl 4 % / menthol 10 % / methyl salicylate 27.5 % Topical OintmentSYc259ef92-5d07-4590-adf1-3a106333eee01
1601097LidoPro (capsaicin 0.0325 % / lidocaine HCl 4 % / menthol 10 % / methyl salicylate 27.5 % ) Topical OintmentSYc259ef92-5d07-4590-adf1-3a106333eee01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
83881-001-35838810001351 TUBE, WITH APPLICATOR in 1 BOX (83881-001-35) / 9900 mg in 1 TUBE, WITH APPLICATOR2024-11-19NoNoHistorical