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

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 1 of 42 · 825 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Opalescence Whitening Sensitivity ReliefPOTASSIUM NITRATE AND SODIUM FLUORIDEUltradent Products, Inc.44e94663-895b-67da-e063-6394a90a5fe62026-09-09WarningsExact identifier
application number: M022
Opalescence Sensitivity Relief WhiteningPOTASSIUM NITRATE AND SODIUM FLUORIDEUltradent Products, Inc.b5176a84-76a3-4ad0-a2e2-4997a12da9a52026-09-09WarningsExact identifier
application number: M022
Opal by Opalescence SensitivityPOTASSIUM NITRATE AND SODIUM FLUORIDEUltradent Products, Inc.5ffc0d14-0290-47bb-90e5-90a25a5acc282026-09-09WarningsExact identifier
application number: M022
SalineNASALRaritan Pharmaceuiticals Inc4b178e4e-a10f-4b75-8140-1f7548e203ad2026-09-09WarningsExact identifier
application number: M022
SORE THROATPHENOLRaritan Pharmaceuticals Inc43ce374a-824c-4034-bf04-c351b4d8015b2026-09-08WarningsExact identifier
application number: M022
Colgate Optic White Stain Fighter Sens ReliefSODIUM FLUORIDEColgate-Palmolive Company6ec2fff7-df44-4302-be2d-97946c6cd66a2026-09-08WarningsExact identifier
application number: M022
DRx Choice Sore Throat Menthol FlavorPHENOLRARITAN PHARMACEUTICALS INCe3269b12-5c05-45a6-81f2-65d9f016c3aa2026-09-08WarningsExact identifier
application number: M022
Hydrogen PeroxideHYDROGEN PEROXIDEAmerisourceBergen (Good Neighbor Pharmacy) 461220733015b-e81a-4a62-82ad-dacaf3f163cb2026-09-02WarningsExact identifier
application number: M022
KROGER SalineNASALKROGER COMPANYc84b242b-f46e-4ea8-a3c1-109a476446462026-09-02WarningsExact identifier
application number: M022
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWALMART INC. (see also Equate)ceb125d9-8c1b-498c-b0f0-f18756ede4422026-09-01WarningsExact identifier
application number: M022
Orajel 4X Medicated Toothache and Gum CreamBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.5a1c82b4-02b3-d456-e063-6294a90a16bb2026-08-31WarningsExact identifier
application number: M022
Orajel 4X Medicated Toothache and Gum PM CreamBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.5a1cdaf4-3388-280c-e063-6294a90ac70f2026-08-31WarningsExact identifier
application number: M022
MUCINEX INSTASOOTHE SORE THROAT PLUS SOOTHING COMFORTHEXYLRESORCINOLReckitt Benckiser LLC91cd2964-5d83-4e40-bc18-e3e5462f454a2026-08-31WarningsExact identifier
application number: M022
MUCINEX INSTASOOTHE SORE THROAT PLUS PAIN RELIEFHEXYLRESORCINOLReckitt Benckiser LLC4c150222-06ea-4fcf-967f-84e19846bd662026-08-31WarningsExact identifier
application number: M022
Orajel 4X Medicated Toothache and GumBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.5a1b4133-0eac-2f8f-e063-6394a90af8f62026-08-28WarningsExact identifier
application number: M022
LUDENS SUGAR FREE WILD CHERRY THROATPECTINPrestige Brands Holdings, Inc.274fc80c-e5b2-41c7-a119-287d6e8a22582026-08-28WarningsExact identifier
application number: M022
Medline Peroxi Fresh MouthwashHYDROGEN PEROXIDEMedline Industries, LPec7a9240-6c66-4471-b8b6-776e08a14fbc2026-08-27WarningsExact identifier
application number: M022
SalineSALINE NASAL SPRAYDynarex Corporation3247ae7d-554f-baab-e063-6294a90aa3ec2026-08-25WarningsExact identifier
application number: M022
Tumeez Organic AppleCALCIUM CARBONATEBFY LLCf561685a-5260-59c6-e053-2a95a90ae2062026-08-25WarningsExact identifier
application number: M022
Ludens Watermelon Throat DropsPECTINPrestige Brands Holdings, Inc.adfb248a-96bb-4742-9df6-c47edccdd6712026-08-20WarningsExact 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