Oral Sore Antiseptic

Product NDC
0363-1045
11-digit product format
003631045
Labeler code
0363
Product ID
0363-1045_4aa443c8-bb2f-8f00-e063-6394a90a430d
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrogen Peroxide, Menthol
Dosage form
LIQUID
Route
ORAL
Labeler
Walgreen Co.
Application
m022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-03-15
Substance
HYDROGEN PEROXIDE; MENTHOL
Active strength
1.5; 1 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Oral Sore Antiseptic
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROGEN PEROXIDE1.5 mg/mL
MENTHOL1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
BBX060AN9VInternal UNII lookup
L7T10EIP3AInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
55807b18-42ed-45a7-845e-fcf7f5d70d04Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-1045-43Oral Sore Antiseptic473 mL in 1 BOTTLE, PLASTICLIQUID47317

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-1045ORAL SORE ANTISEPTIC (HYDROGEN PEROXIDE, MENTHOL) LIQUID [WALGREENS]15Current NDC, Legacy NDC, 1 package rows20240716_55807b18-42ed-45a7-845e-fcf7f5d70d04.zip

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
Oral Sore AntisepticHYDROGEN PEROXIDE, MENTHOLWalgreen Co.55807b18-42ed-45a7-845e-fcf7f5d70d042026-02-12Warnings, Adverse reactionsExact identifier
ndc (product): 0363-1045

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-1045-4300363104543473 mL in 1 BOTTLE, PLASTIC (0363-1045-43) 473 ml2020-03-150000-00-00NoNoCurrent