Oral Sore Antiseptic

Product NDC
11822-3024
11-digit product format
118223024
Labeler code
11822
Product ID
11822-3024_499edc10-3e99-6a7b-e063-6394a90a0fee
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrogen Peroxide, Menthol
Dosage form
LIQUID
Route
ORAL
Labeler
Rite Aid Corporation
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-12-02
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
e67046ce-bfe0-4454-bbe8-6a3783afb6f5Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-3024-4Oral Sore Antiseptic473 mL in 1 BOTTLE, PLASTICLIQUID4737

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-3024ORAL SORE ANTISEPTIC (HYDROGEN PEROXIDE, MENTHOL) LIQUID [RITE AID]5Current NDC, Legacy NDC, 1 package rows20240809_e67046ce-bfe0-4454-bbe8-6a3783afb6f5.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, MENTHOLRite Aid Corporatione67046ce-bfe0-4454-bbe8-6a3783afb6f52026-01-30Warnings, Adverse reactionsExact identifier
ndc (product): 11822-3024

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-3024-411822302404473 mL in 1 BOTTLE, PLASTIC (11822-3024-4) 473 ml2021-12-020000-00-00NoNoCurrent