FDA.reportPublic FDA data

NuLido

Manufacturer
All Pharma LLC
Effective date
2017-10-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:47:18

Label at a glance#

ProductNuLido
Active ingredientLIDOCAINE, MENTHOL
Label structure12 sections

Indications and uses

Temporarily relieves minor aches and muscle pains associated with: ■ arthritis ■ simple back pain ■ strains ■ muscle soreness

Label contents#

Full prescribing information#

Active Ingedients

OTC - ACTIVE INGREDIENT SECTION

Each milliliter contains
 Active Ingredient Purpose
 Lidocaine Hydrochloride 4.0% Topical Anesthetic
 Menthol 1.0% Topical Anesthetic

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Carbomer copolymer type b, Isopropyl Alcohol, water, trolamine

Warnings

WARNINGS SECTION

For external use only.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away. Package not child resistant.

When using this product

OTC - WHEN USING SECTION

■ avoid contact with eyes, genitals, and other mucous membranes. If eye contact occurs, rinse thoroughly with water.
■ do not use on open wounds, cuts, damaged or infected skin
■ do not use With a bandage or a heating pad

Ask your doctor before use if

OTC - ASK DOCTOR SECTION

■ you are allergic to any ingredients
■ you are pregnant or breast-feeding

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves minor aches and muscle pains associated with:


■ arthritis

■ simple back pain

■ strains

■ muscle soreness

Purpose

OTC - PURPOSE SECTION

Temporarily relieves minor aches and muscle pains associated with:

■ arthritis
■ simple back pain
■ strains
■ muscle soreness

Dosage & Administration

DOSAGE & ADMINISTRATION SECTION

Apply to the affected area.
 Adults and children 12 years and older

 Apply to the affected area.
Product may be used as necessary, but should not
be used more than four times per day.


Wash hands immediately afterwards.

Children under 2Ask a doctor

Other Information

OTHER SAFETY INFORMATION

■ avoid storing product in direct sunlight
■ protect product from excessive moisture
■ store at 67-77°F (19-25°C)

Stop Use and Ask Doctor

OTC - STOP USE SECTION

■ if condition worsens or symptoms persist for more than 7 days
■ if excessive skin irritation occurs

Label Image

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Manufactured by:
All Pharma, LLC
Hialeah, FL 33016
www.allpharmallc.com
Made in the U.S.A.

NuLido LabelNuLido Label

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53149-2100-42023-07-28C16284748780-10191ceaa-632c-198a-e063-dbdaa90aec3eNuLido

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53149-2100-4NuLido120 mL in 1 TUBEGEL1203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53149-2100NULIDO (LIDOCAINE HYDROCLORIDE 4%) GEL [ALL PHARMA LLC]3Legacy NDC, 1 package rows20220121_57904d54-494d-4859-8a8f-619e662d7fef.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53149-2100-4ML - Milliliter53149-21001a657f11-089b-4217-bf10-57c906cd878712018-01-12

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53149-210053149-2100-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE98PI200987ACTIB
MENTHOLL7T10EIP3AACTIB
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)809Y72KV36IACT
ISOPROPYL ALCOHOLND2M416302IACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT

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
5b0d2255-bb8b-4b79-8c92-249bd776115c57904d54-494d-4859-8a8f-619e662d7fef2017-10-18WarningsExact identifier
spl id: 5b0d2255-bb8b-4b79-8c92-249bd776115c
spl set id: 57904d54-494d-4859-8a8f-619e662d7fef

Reported adverse events (FAERS/openFDA)#

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