FDA.reportPublic FDA data

Nupharmisto Lidocaine Numbing Cream 5%

Manufacturer
Orange Lab, Inc
Effective date
2024-02-28
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:09:11

Label at a glance#

ProductNupharmisto
Active ingredientMENTHOL, LIDOCAINE
Label structure13 sections

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Drug facts - activeDrug facts - active

Purpose

OTC - PURPOSE SECTION

Local AnestheticLocal Anesthetic

UsesUses

Warnings

WARNINGS SECTION

WarningsWarnings

When using this product

OTC - WHEN USING SECTION

when using this productwhen using this product

Stop use and ask a doctor if

OTC - STOP USE SECTION

pregnantpregnant

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of childrenkeep out of reach of children

How to use it correctly?

OTHER SAFETY INFORMATION

How to use it correctly?How to use it correctly?

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredientsInactive ingredients

Other information : storage

STORAGE AND HANDLING SECTION

Other informationOther information

Directions for use

INSTRUCTIONS FOR USE SECTION

DirectionsDirections

Active ingredient and directions

DOSAGE & ADMINISTRATION SECTION

Active IngredientActive Ingredientdirectionsdirections

Usage section

INDICATIONS & USAGE SECTION

UsageUsage

Label Images

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 01Label 01

Label 02Label 02

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2675779lidocaine 5 % / menthol 0.7 % Rectal CreamPSN3
2675779lidocaine 50 MG/ML / menthol 7 MG/ML Rectal CreamSCD3
2675779lidocaine 5 % / menthol 0.7 % Rectal CreamSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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
71331-113-05Nupharmisto60 g in 1 PACKAGECREAM603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71331-113NUPHARMISTO (LIDOCAINE) CREAM [ORANGE LAB, INC]31 package rows20240301_1210b56f-e447-65e8-e063-6294a90a5b6e.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71331-11371331-113-05

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALLANTOIN344S277G0ZIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
EMU OIL344821WD61IACT
TRIDECETH-63T5PCR2H0CIACT
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)8Z5ZAL5H3VIACT
HYDROGENATED POLYDECENE (1500 CST)4YI0729529IACT
SUNFLOWER OIL UNSAPONIFIABLEST7ZE2WA4MBIACT
ETHYLHEXYL PALMITATE2865993309IACT
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM POLYACRYLATE (8000 MW)285CYO341LIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
DIMETHYL ISOSORBIDESA6A6V432SIACT
MENTHOLL7T10EIP3AACTIB
LIDOCAINE98PI200987ACTIB
EDETATE SODIUMMP1J8420LUIACT

Source Document#

Source XML

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
1274ec14-b480-c326-e063-6294a90aece91210b56f-e447-65e8-e063-6294a90a5b6e2024-02-28WarningsExact identifier
spl id: 1274ec14-b480-c326-e063-6294a90aece9
spl set id: 1210b56f-e447-65e8-e063-6294a90a5b6e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.