FDA.reportPublic FDA data

Sore Mouth Cleanser

Product NDC
41250-750
11-digit product format
412500750
Labeler code
41250
Product ID
41250-750_4b33bb2f-aec5-20cf-e063-6394a90a59b6
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrogen Peroxide
Dosage form
MOUTHWASH
Route
TOPICAL
Labeler
Meijer, Inc.
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-12-01
Substance
HYDROGEN PEROXIDE
Active strength
15 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage41250-75041250-750-34DDiscontinued by firm2026-10-16

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage41250-75041250-750-34DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage41250-75041250-750-34DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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
c9c17224-9304-403a-b6a1-9c8bd94e3d94Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41250-750-34Sore Mouth Cleanser236 mL in 1 BOTTLE, PLASTICMOUTHWASH23616
41250-750-77Sore Mouth Cleanser500 mL in 1 BOTTLE, PLASTICMOUTHWASH50016

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-750SORE MOUTH CLEANSER (HYDROGEN PEROXIDE) MOUTHWASH [MEIJER]15Current NDC, Legacy NDC, 2 package rows20250403_c9c17224-9304-403a-b6a1-9c8bd94e3d94.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 % MouthwashPSNc9c17224-9304-403a-b6a1-9c8bd94e3d9416
358975hydrogen peroxide 15 MG/ML MouthwashSCDc9c17224-9304-403a-b6a1-9c8bd94e3d9416
358975hydrogen peroxide 1.5 % MouthwashSYc9c17224-9304-403a-b6a1-9c8bd94e3d9416

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41250-750-3441250075034236 mL in 1 BOTTLE, PLASTIC (41250-750-34) 236 ml2017-12-010000-00-00NoNoCurrent
41250-750-7741250075077500 mL in 1 BOTTLE, PLASTIC (41250-750-77) 500 ml2017-12-01NoNoCurrent