FDA.reportPublic FDA data

MAXOCAINE PAIN RELIEVING ROLL-ON

Product NDC
72188-170
11-digit product format
721880170
Labeler code
72188
Product ID
72188-170_09dc681e-2348-4213-e063-6394a90a41e1
Type
HUMAN OTC DRUG
Nonproprietary name
LIDOCAINE HYDROCHLORIDE, MENTHOL
Dosage form
LIQUID
Route
TOPICAL
Labeler
Prime Commerce, LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-03-01
Substance
LIDOCAINE HYDROCHLORIDE; MENTHOL
Active strength
40; 10 mg/mL; mg/mL
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
MAXOCAINE PAIN RELIEVING ROLL-ON
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE40 mg/mL
MENTHOL10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV13007Z41A, L7T10EIP3A
Rxcui2002008

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72188-170-03MAXOCAINE PAIN RELIEVING ROLL-ON88 mL in 1 BOTTLE, WITH APPLICATORLIQUID883

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72188-170MAXOCAINE PAIN RELIEVING ROLL-ON (LIDOCAINE HYDROCHLORIDE, MENTHOL) LIQUID [PRIME COMMERCE, LLC]3Current NDC, Legacy NDC, 1 package rows20231112_c263d5f2-89b9-4dfd-91c8-f894e5f956c9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2002008lidocaine HCl 4 % / menthol 1 % Topical SolutionPSNc263d5f2-89b9-4dfd-91c8-f894e5f956c93
2002008lidocaine hydrochloride 40 MG/ML / menthol 10 MG/ML Topical SolutionSCDc263d5f2-89b9-4dfd-91c8-f894e5f956c93
2002008lidocaine HCl 4 % / menthol 1 % Topical SolutionSYc263d5f2-89b9-4dfd-91c8-f894e5f956c93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72188-170-037218801700388 mL in 1 BOTTLE, WITH APPLICATOR (72188-170-03) 88 ml2018-03-010000-00-00NoNoCurrent