FDA.reportPublic FDA data

Lidomar

Manufacturer
Oncora Pharma, LLC
Effective date
2026-08-25
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
daily-update
Hydrated at
2026-08-27 00:01:47

Label at a glance#

ProductLidomar
Active ingredientLIDOCAINE
Label structure8 sections

Dosage and administration

Apply to the affected area 3 to 4 times daily or as directed by a healthcare provider.

Storage and handling

Store at 25°C (77°F); excursions permitted to 15°C–30°C (59°F–86°F). [See USP Controlled Room Temperature]. Keep out of reach of children.

Label contents#

Full prescribing information#

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl 3%

Purpose

OTC - PURPOSE SECTION

Topical analgesic — for temporary relief of minor pain and itching.

Use(s)

INDICATIONS & USAGE SECTION

For the temporary relief of pain and itching associated with:

  • minor burns
  • sunburn
  • minor cuts
  • scrapes
  • insect bites
  • minor skin irritations
  • rashes due to poison ivy
  • rashes due to poison oak
  • rashes due to poison sumac 

Warnings

WARNINGS SECTION

For external use only. Do not use if you are allergic to lidocaine or any of the ingredients. Avoid contact with eyes. Keep out of reach of children.

Keep out of reach of childen

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

Apply to the affected area 3 to 4 times daily or as directed by a healthcare provider.

Storage

STORAGE AND HANDLING SECTION

Store at 25°C (77°F); excursions permitted to 15°C–30°C (59°F–86°F). [See USP Controlled Room Temperature].
Keep out of reach of children.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, cetyl alcohol, glyceryl stearate, PEG-75 stearate, ceteth-20, steareth-20, cyclopentasiloxane, dimethicone, capric/capryl triglyceride, Prunus amygdalus dulcis (sweet almond) oil, stearyl alcohol, phenoxyethanol, ethylhexylglycerin, sodium hydroxide, lactic acid.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Lidomar™

Lidocaine 3% Lotion

NDC 85477-311-07

Net Wt. 6 oz (177 mL)

pdp
pdp

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130854770311077GTIN-13: 0854770311077
EAN-13: 0854770311077
GTIN-12: 854770311077
UPC-A: 854770311077
GTIN storage (14 digits): 00854770311077		lidomar-1.jpg

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85477-32685477-326-07

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE98PI200987ACTIB
WATER059QF0KO0RIACT
CETYL ALCOHOL936JST6JCNIACT
GLYCERYL STEARATE230OU9XXE4IACT
PEG-75 STEARATEOT38R0N74HIACT
CETETH-20I835H2IHHXIACT
STEARETH-20L0Q8IK9E08IACT
CYCLOPENTASILOXANE AND DIMETHICONOL (6000 CP)P83WYJ7NW3IACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL66YXD4DKO9IACT
STEARYL ALCOHOL2KR89I4H1YIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
SODIUM HYDROXIDE55X04QC32IIACT
LACTIC ACID33X04XA5ATIACT

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
LidomarLIDOMAROncora Pharma, LLC215bfdca-60bf-480b-b02e-902de52fe5e82026-08-25WarningsExact identifier
ndc (package): 85477-326-07
ndc (product): 85477-326
ndc11 (package): 85477032607
spl id: 90453fa6-3beb-4037-a16a-d9ba2d2694dd
spl set id: 215bfdca-60bf-480b-b02e-902de52fe5e8

Reported adverse events (FAERS/openFDA)#

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