FDA.reportPublic FDA data

Anorectal

Manufacturer
Walmart | Product Quest
Effective date
2017-12-29
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 22:53:52

Label at a glance#

ProductAnorectal Equate
Active ingredientLIDOCAINE
Label structure7 sections

Label contents#

Full prescribing information#

Active ingredient                               Purpose

OTC - ACTIVE INGREDIENT SECTION


Lidocaine 5%......................................Local anesthetic

INDICATIONS & USAGE SECTION

Uses For temporary relief of pain, soreness and burning.

Warnings For external use only

WARNINGS SECTION

When using this product do not get into eyes.
Stop use and ask a doctor if • condition worsens or does
not improve within 7 days • do not exceed the
recommended daily dosage unless directed by a doctor
• in case of bleeding, consult a doctor promptly • do not
put this product into the rectum by using fingers or any
mechanical device or applicator

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical
help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions Apply externally to affected area up to 6
times daily.

OTHER SAFETY INFORMATION

Other information Store at 25° C (77° F);
excursions permitted to 15-30˚ C (59-86˚ F).

INACTIVE INGREDIENT SECTION

Inactive ingredients
Benzyl Alcohol, Carbomer 940, Cholesterol, Hydrogenated Lecithin, Isopropyl Myristate, Polysorbate 80, Propylene Glycol, Purified Water, Trolamine, Vitamin E Acetate.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1366789lidocaine 5 % Rectal CreamPSN4
1366789lidocaine 50 MG/ML Rectal CreamSCD4
1366789lidocaine 5 % Rectal CreamSY4

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
49035-655-012020-01-31C16284748780-19d75b9d0-f397-f424-e053-dadaa90a57ceDrug Facts FR#44-61PQ

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-655-01AnorectalEquate1 in 1 CARTONCREAM14
49035-655-01AnorectalEquate29.6 mL in 1 TUBECREAM29.64

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-655ANORECTAL EQUATE (LIDOCAINE) CREAM [WALMART]4Legacy NDC, 2 package rows20171230_a16cba6c-22a7-483f-bd72-8437f6aa16cd.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49035-65549035-655-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZYL ALCOHOLLKG8494WBHIACT
CHOLESTEROL97C5T2UQ7JIACT
HYDROGENATED SOYBEAN LECITHINH1109Z9J4NIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
POLYSORBATE 806OZP39ZG8HIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
TROLAMINE9O3K93S3TKIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
LIDOCAINE98PI200987ACTIB

Source Document#

Source XML · Source PDF

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
6181b25a-5c29-daa7-e053-2991aa0abf21a16cba6c-22a7-483f-bd72-8437f6aa16cd2017-12-29WarningsExact identifier
spl id: 6181b25a-5c29-daa7-e053-2991aa0abf21
spl set id: a16cba6c-22a7-483f-bd72-8437f6aa16cd

Reported adverse events (FAERS/openFDA)#

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