FDA.reportPublic FDA data

LidoPro

Product NDC
68788-8314
11-digit product format
687888314
Labeler code
68788
Product ID
68788-8314_f0f7b609-28f8-4f7a-8a34-63f82aedc5c0
Type
HUMAN OTC DRUG
Nonproprietary name
Capsaicin, Lidocaine, Menthol, and Methyl Salicylate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Preferred Pharmaceuticals Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2022-07-08
Substance
CAPSAICIN; LIDOCAINE HYDROCHLORIDE; MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE
Active strength
.000325; .04; .1; .275 g/g; g/g; g/g; g/g
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAPSAICIN.000325 g/g
LIDOCAINE HYDROCHLORIDE.04 g/g
MENTHOL, UNSPECIFIED FORM.1 g/g
METHYL SALICYLATE.275 g/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiS07O44R1ZM, V13007Z41A, L7T10EIP3A, LAV5U5022Y
Rxcui1601095, 1601097

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
68788-8314-1LidoPro92 g in 1 BOTTLEOINTMENT923

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8314-1GM - Gram68788-83146a328cc4-317a-4110-898a-52e93277030712023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8314LIDOPRO (CAPSAICIN, LIDOCAINE, MENTHOL, AND METHYL SALICYLATE) OINTMENT [PREFERRED PHARMACEUTICALS INC.]2Current NDC, 1 package rows20240621_3b5ea9b4-6a5b-4ee8-b4d8-ece9b840adfd.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 OintmentPSN3b5ea9b4-6a5b-4ee8-b4d8-ece9b840adfd3
1601097LidoPro 0.0325 % / 4 % / 10 % / 27.5 % Topical OintmentPSN3b5ea9b4-6a5b-4ee8-b4d8-ece9b840adfd3
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]SBD3b5ea9b4-6a5b-4ee8-b4d8-ece9b840adfd3
1601095capsaicin 0.000325 MG/MG / lidocaine hydrochloride 0.04 MG/MG / menthol 0.1 MG/MG / methyl salicylate 0.275 MG/MG Topical OintmentSCD3b5ea9b4-6a5b-4ee8-b4d8-ece9b840adfd3
1601095capsaicin 0.0325 % / lidocaine HCl 4 % / menthol 10 % / methyl salicylate 27.5 % Topical OintmentSY3b5ea9b4-6a5b-4ee8-b4d8-ece9b840adfd3
1601097LidoPro (capsaicin 0.0325 % / lidocaine HCl 4 % / menthol 10 % / methyl salicylate 27.5 % ) Topical OintmentSY3b5ea9b4-6a5b-4ee8-b4d8-ece9b840adfd3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8314-16878883140192 g in 1 BOTTLE (68788-8314-1) 92 g2022-07-08NoNoCurrent