FDA.reportPublic FDA data

Numb520

Manufacturer
Clinical Resolution Laboratory, Inc.
Effective date
2025-05-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:01:11

Label at a glance#

ProductNumb520
Active ingredientLIDOCAINE
Label structure8 sections

Indications and uses

for the temporary relief of local and anorectal discomfort associated with anorectal disorders or inflammation.

Dosage and administration

Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth, before application of this product. Apply up to 6 times a day. Children under 12 years of age: consult a doctor. 

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 5%

Purpose

OTC - PURPOSE SECTION

Local Anesthetic

Uses:

INDICATIONS & USAGE SECTION

for the temporary relief of local and anorectal discomfort associated with anorectal disorders or inflammation.

Warnings

WARNINGS SECTION

(For external use only)

Do not use

OTC - DO NOT USE SECTION

this product if

  • pregnant or breastfeeding, ask a health professional before use.
  • in case of accidental overdose, get medical help or contact the Poison Control Center immediately.
  • seal is broken or missing.

When using this product

OTC - WHEN USING SECTION

  • do not exceed the recommended daily dosage unless directed by a doctor.
  • certain persons can develop allergic reactions to ingredients in this product.
  • do not put this product into the rectum by using finger or any medical device or applicator.

Stop use and ask a doctor if

OTC - STOP USE SECTION

the symptom being treated does not subside, or if redness, irritation, swelling, pain, or other symptoms develop or increase.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, seek medical attention immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth, before application of this product.
  • Apply up to 6 times a day.
  • Children under 12 years of age: consult a doctor. 

Other Information

SPL UNCLASSIFIED SECTION

  • keep away from direct sunlight or heat.
  • store at room temperature 15°-30°C (59°-86°F).

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Allantoin, Aloe Barbadensis Leaf Juice, Benzyl Alcohol, Carbomer, Cholesterol, Dimethyl Isosorbide, Disodium EDTA, Hydrogenated Polydecene, Lecithin, Neopentyl Glycol Dicaprylate/Dicaprate, Propylene Glycol, Water, Sodium Polyacrylate, Tocopheryl Acetate, Trideceth-6, Triethanolamine

Package Labeling:63742-033-01 38g

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3838

Package Labeling:63742-033-02 125g

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

125125

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1366789lidocaine 5 % Rectal CreamPSN3
1366789lidocaine 50 MG/ML Rectal CreamSCD3
1366789lidocaine 5 % 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
63742-033-01Numb52038 g in 1 BOTTLECREAM383
63742-033-01Numb5201 in 1 BOXCREAM13
63742-033-02Numb520125 g in 1 BOTTLECREAM1253
63742-033-02Numb5201 in 1 BOXCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63742-033NUMB520 (LIDOCAINE) CREAM [CLINICAL RESOLUTION LABORATORY, INC.]3Current NDC, 4 package rows20250519_a0411950-c6ee-4427-acb6-3cef58b0e93e.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63742-03363742-033-01, 63742-033-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALLANTOIN344S277G0ZIACT
ALOE VERA LEAFZY81Z83H0XIACT
BENZYL ALCOHOLLKG8494WBHIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
CHOLESTEROL97C5T2UQ7JIACT
DIMETHYL ISOSORBIDESA6A6V432SIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATEVLW429K27KIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TRIDECETH-63T5PCR2H0CIACT
TROLAMINE9O3K93S3TKIACT
LIDOCAINE98PI200987ACTIB

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
Numb520LIDOCAINEClinical Resolution Laboratory, Inc.a0411950-c6ee-4427-acb6-3cef58b0e93e2025-05-15WarningsExact identifier
ndc (package): 63742-033-02
ndc (package): 63742-033-01
ndc (product): 63742-033
ndc11 (package): 63742003301
ndc11 (package): 63742003302
spl id: 3532117c-c64a-14b2-e063-6394a90a7016
spl set id: a0411950-c6ee-4427-acb6-3cef58b0e93e

Reported adverse events (FAERS/openFDA)#

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