FDA.reportPublic FDA data

Sore Mouth Cleanser

Product NDC
0363-0085
11-digit product format
003630085
Labeler code
0363
Product ID
0363-0085_4aa4a2ca-3bc4-815f-e063-6294a90abdfa
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrogen Peroxide
Dosage form
MOUTHWASH
Route
TOPICAL
Labeler
Walgreen Co.
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-05-02
Substance
HYDROGEN PEROXIDE
Active strength
15 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
Sore Mouth Cleanser
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROGEN PEROXIDE15 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
358975Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
33223589-4ff4-4e4e-96da-6fa2e4d0f187Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0085-34Sore Mouth Cleanser236 mL in 1 BOTTLE, PLASTICMOUTHWASH23614

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0085SORE MOUTH CLEANSER (HYDROGEN PEROXIDE) MOUTHWASH [WALGREENS]12Current NDC, Legacy NDC, 1 package rows20240716_33223589-4ff4-4e4e-96da-6fa2e4d0f187.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 36 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcetaminophenACETAMINOPHENNuCare Pharmaceuticals,Inc.872365ca-0c6b-550a-e053-2a91aa0ab25a2024-06-14WarningsExact identifier
application number: M022
Amosan Oral Wound Cleanser SpearmintSODIUM PERBORATE MONOHYDRATEVintage Brands Limited7ac6c649-758f-4128-9920-466c0967b86a2024-05-21WarningsExact identifier
application number: M022
SensodynePOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC9e8e7b9f-3ccd-4935-b886-93f3a5045b672024-05-15WarningsExact identifier
application number: M022
Sensodyne Extra WhiteningPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC1ed4a62b-f1d3-4740-8150-b94e023987402024-05-15WarningsExact identifier
application number: M022
Attitude Adult Fluoride-free - Sensitive - SpearmintPOTASSIUM NITRATE9055-7588 Qubec Inc. DBA Attitude46d5c908-f0e3-444c-9d96-461feef391372024-05-14WarningsExact identifier
application number: M022
sensodynePOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC16225f06-1d40-416a-aaec-7890e398fe4b2024-05-13WarningsExact identifier
application number: M022
Sore Throat CherryPHENOLQUALITY CHOICE (Chain Drug Marketing Association)9162ae27-ddbb-4336-9655-487995919de42024-05-01WarningsExact identifier
application number: M022
BIO SPECTRA ATTITUDESODIUM FLUORIDE AND POTASSIUM NITRATE9055-7588 Quebec Inc. DBA Attitude42b79ec5-f37f-4dc9-9631-c8b1c153fe882024-04-26WarningsExact identifier
application number: M022
Quality Choice Oral Pain ReliefBENZOCAINE 20%, BENZALKONIUM CHLORIDE 1%Quality Choice (CHAIN DRUG MARKETING ASSOCIATION)162702b4-4bf7-8868-e063-6294a90a59212024-04-15WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc9991de96-99a1-42f0-9ddd-e530ca9ceab12024-04-11WarningsExact identifier
application number: M022
Aquafresh Extreme Clean Pure Breath ActionSODIUM FLUORIDEHaleon US Holdings LLC462eb309-deca-4464-b13a-7ae314e53ede2024-04-08WarningsExact identifier
application number: M022
Sore Throat CherryPHENOLFamily Dollar (FAMILY WELLNESS)7806fac7-736e-44b0-baa2-42feb72374172024-03-27WarningsExact identifier
application number: M022
SucretsDYCLONINE HCL, MENTHOL, AND PECTINInsight Pharmaceuticals LLC2a2839ea-11d3-4390-930d-0da912a9c6f52024-03-20WarningsExact identifier
application number: M022
Sucrets Sore Throat Wild CherryDYCLONINE HYDROCHLORIDEInsight Pharmaceuticals LLCda4967c7-ee18-42e7-8c97-8919f3bb1b7d2024-03-20WarningsExact identifier
application number: M022
NATEAN Clean plus Sensitivity ReliefPOTASSIUM NITRATE, SODIUM FLUORIDEHaleon US Holdings LLCcea6f992-8a44-4eb8-baea-97b7b181b2272024-03-19WarningsExact identifier
application number: M022
NATEAN Clean and WhitenSODIUM FLUORIDEHaleon US Holdings LLC71b95962-2693-49f5-94d2-f2a035b5e0c82024-03-19WarningsExact identifier
application number: M022
SENSODYNE Sensitivity and Gum MintSTANNOUS FLUORIDEHaleon US Holdings LLCed093acd-255c-40ff-a010-d276f58444532024-03-07WarningsExact identifier
application number: M022
SENSODYNE Sensitivity Gum and Enamel MintSTANNOUS FLUORIDEHaleon US Holdings LLCd4e9e5cf-d058-4c3f-ab5e-0b5a20a012e22024-03-07WarningsExact identifier
application number: M022
Sensodyne True whitePOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC671f8f45-389c-4375-be43-f5500ee21a0e2024-03-07WarningsExact identifier
application number: M022
Sensodyne Pronamel Strong and Bright Enamel MintPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLCbe1ae382-0e01-4db8-90d7-fdadec2ff8612024-03-06WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
358975hydrogen peroxide 1.5 % MouthwashPSN33223589-4ff4-4e4e-96da-6fa2e4d0f18714
358975hydrogen peroxide 15 MG/ML MouthwashSCD33223589-4ff4-4e4e-96da-6fa2e4d0f18714
358975hydrogen peroxide 1.5 % MouthwashSY33223589-4ff4-4e4e-96da-6fa2e4d0f18714

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0085-3400363008534236 mL in 1 BOTTLE, PLASTIC (0363-0085-34) 236 ml2014-05-020000-00-00NoNoCurrent