FDA.reportPublic FDA data

Lidocaine Cream

Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-12-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:50:21

Label at a glance#

ProductLidocaine
Active ingredientLIDOCAINE
Label structure11 sections

Indications and uses

temporarily relieves pain and itching due to minor cuts minor scrapes minor burns sunburn minor skin irritation insect bites

Dosage and administration

Adult and children 2 years and older: Apply externally to the affected area up to 3 to 4 times a day. Children under 2 years of age: Consult a doctor.

Storage and handling

May be applied under occlusive dressing. Store at room temperature, 20–25°C (68–77°F) Excursions permitted 15–30°C (59–86°F) [see USP Controlled Room Temperature].

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4% w/w

Purpose

OTC - PURPOSE SECTION

Topical anesthetic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves pain and itching due to

  • minor cuts
  • minor scrapes
  • minor burns
  • sunburn
  • minor skin irritation
  • insect bites

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adult and children 2 years and older: Apply externally to the affected area up to 3 to 4 times a day.
  • Children under 2 years of age: Consult a doctor.

Warnings

WARNINGS SECTION

SPL UNCLASSIFIED SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use

  • in or near the eyes
  • in large quantities, particularly over raw or blistered areas

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • allergic reaction occurs
  • condition worsens or does not improve within 7 days
  • symptoms clear up and return within a few days
  • redness, irritation, swelling, pain or other symptoms begin or increase

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.

Other Information

STORAGE AND HANDLING SECTION

  • May be applied under occlusive dressing.
  • Store at room temperature, 20–25°C (68–77°F) Excursions permitted 15–30°C (59–86°F) [see USP Controlled Room Temperature].

Inactive ingredients

INACTIVE INGREDIENT SECTION

Benzyl Alcohol, Carbopol 940, Hydrogenated Lecithin, Polysorbate 80, Propylene Glycol, Purified Water, Trolamine and Vitamin E Acetate.

Questions?

OTC - QUESTIONS SECTION

Call 800-936-3088

How Supplied/Storage and Handling

HOW SUPPLIED SECTION

Lidocaine 4% Cream is supplied in:

15g tube NDC: 80425-0351-01

Store at room temperature, 20–25°C (68–77°F) Excursions permitted 15–30°C (59–86°F) [see USP Controlled Room Temperature].

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label 1label 1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1421893lidocaine 4 % Topical CreamPSN2
1421893lidocaine 40 MG/ML Topical CreamSCD2
1421893lidocaine 4 % Topical CreamSY2

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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0351-1Lidocaine15 g in 1 TUBECREAM152
80425-0351-1Lidocaine1 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0351LIDOCAINE CREAM [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 2 package rows20250102_01cb19a4-ce22-144d-e063-6294a90a8aa3.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0351-1GM - Gram80425-035122d3f3d6-511d-4bc9-b3db-eb3609834b7a12023-09-05
39328-024-15GM - Gram39328-02409e9a1cb-1849-4eda-a51f-44a57c140fa812019-01-24
39328-024-30GM - Gram39328-024969e2fc4-f4e2-4d0a-8998-246081561f3112019-01-24
39328-024-55GM - Gram39328-0248dda2cba-ba47-45dd-9fe5-b9e637fd929212019-01-24
39328-024-56EA - Each39328-02416386988-efdf-4d26-8894-7363ee4d47ee12019-06-19

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80425-035180425-0351-1
39328-024

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZYL ALCOHOLLKG8494WBHIACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
HYDROGENATED SOYBEAN LECITHINH1109Z9J4NIACT
POLYSORBATE 806OZP39ZG8HIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
TROLAMINE9O3K93S3TKIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LidocaineLIDOCAINEAdvanced Rx Pharmacy of Tennessee, LLC01cb19a4-ce22-144d-e063-6294a90a8aa32024-12-31WarningsExact identifier
ndc (package): 80425-0351-1
ndc (product): 80425-0351
ndc11 (package): 80425035101
spl id: 2a9c0c91-2b38-4def-e063-6294a90a58ef
spl set id: 01cb19a4-ce22-144d-e063-6294a90a8aa3
LidocaineLIDOCAINEPatrin Pharma Inc.91eedf9d-53b8-49d5-af59-25019606a0b22024-11-15WarningsExact identifier
ndc (product): 39328-024

Reported adverse events (FAERS/openFDA)#

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