FDA.reportPublic FDA data

LIDOCAINE

Manufacturer
Two Hip Consulting, LLC
Effective date
2019-02-06
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 20:27:46

Label at a glance#

ProductLIDOCAINE
Active ingredientLIDOCAINE
Label structure4 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

USES: For temporary relief of minor aches and muscle pains associated with arthritis, simple backache, strains, muscle soreness, and stiffness.

WARNINGS SECTION

WARNING: KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN

OTHER SAFETY INFORMATION

Store at 20 to 25 degrees C (68 to 77 degrees F): Protect from freezing. See crimp of tube and/or carton for lot number and expiration date.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Medi-Sulting-Lidocaine Ointment Label Rx NDCMedi-Sulting-Lidocaine Ointment Label Rx NDC

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1543069lidocaine 5 % Topical OintmentPSN3
1543069lidocaine 0.05 MG/MG Topical OintmentSCD3
1543069lidocaine 5 % Topical OintmentSY3

DailyMed Pharmacologic Classes#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76074-135-112021-01-29C16284748780-1ba0f9c33-2efb-a910-e053-dadaa90a0b85d5e2e8c0-48b3-4666-95a2-d9aef29f1a1c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76074-135-11LIDOCAINE50 g in 1 TUBEOINTMENT503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76074-135LIDOCAINE OINTMENT [TWO HIP CONSULTING, LLC]3Legacy NDC, 1 package rows20190207_d5e2e8c0-48b3-4666-95a2-d9aef29f1a1c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76074-135-11GM - Gram76074-135ae2c8d44-d591-454c-8bc3-b989185ce8b312016-06-14

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76074-13576074-135-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE98PI200987ACTIB
POLYETHYLENE GLYCOL 3005655G9Y8AQIACT
POLYETHYLENE GLYCOL 1450OJ4Z5Z32L4IACT
PEPPERMINT OILAV092KU4JHIACT

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
6fa06fbd-1f94-4829-bc7d-9b4aebefa917d5e2e8c0-48b3-4666-95a2-d9aef29f1a1c2019-02-06WarningsExact identifier
spl id: 6fa06fbd-1f94-4829-bc7d-9b4aebefa917
spl set id: d5e2e8c0-48b3-4666-95a2-d9aef29f1a1c

Reported adverse events (FAERS/openFDA)#

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