Mouth Rinse

Product NDC
36800-001
11-digit product format
368000001
Labeler code
36800
Product ID
36800-001_4ab7fbe5-4281-9c7d-e063-6394a90a2392
Type
HUMAN OTC DRUG
Nonproprietary name
sodium fluoride
Dosage form
MOUTHWASH
Route
ORAL
Labeler
Topco Associates LLC
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-12-30
Substance
SODIUM FLUORIDE
Active strength
.1 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
Mouth Rinse
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1038904Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c640adc0-e178-4b6a-af44-07d2f7da81d3Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-001-86Mouth Rinse1000 mL in 1 BOTTLE, PLASTICMOUTHWASH100016

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-001MOUTH RINSE (SODIUM FLUORIDE) MOUTHWASH [TOPCO ASSOCIATES LLC]15Current NDC, Legacy NDC, 1 package rows20250323_c640adc0-e178-4b6a-af44-07d2f7da81d3.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 14 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AnticavitySODIUM FLUORIDEOld East Main Co.64f3d92d-f58c-4bc2-8819-f91492221ddb2026-03-02Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEOld East Main Co.c7b9e9cd-3cf7-4657-83c9-e221e1c359772026-03-02Warnings, Adverse reactionsExact identifier
application number: M021
Instant WhiteningINSTANT WHITENING TOOTHPASTEGuangzhou City Caiye Cosmetics CO., Ltd2807ece8-a1a5-b626-e063-6394a90aac622026-03-02WarningsExact identifier
application number: M021
Coffe Tea Stain Remover ToothCOFFE TEA STAIN REMOVER TOOTHPASTEGuangzhou City Caiye Cosmetics CO., Ltd2845d7af-7a0b-9bc8-e063-6294a90ac8b32026-03-02WarningsExact identifier
application number: M021
Professional whitening toothPROFESSIONAL WHITENING TOOTHPASTEGuangzhou City Caiye Cosmetics CO., Ltd291eba71-14da-fac3-e063-6294a90aa3cc2026-03-02WarningsExact identifier
application number: M021
purple toothPURPLE TOOTHPASTEGuangzhou City Caiye Cosmetics CO., Ltd291f0312-238c-71d5-e063-6294a90a39e12026-03-02WarningsExact identifier
application number: M021
Professional ChoicePROFESSIONAL CHOICE TOOTHPASTEGuangzhou City Caiye Cosmetics CO., Ltd28406739-6a8c-1ce8-e063-6394a90a08f82026-03-02WarningsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEThe Kroger Co.27a98b64-8369-4f3d-b487-d7ce98abc69f2026-02-27Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEThe Kroger Co.390dd1b5-2dd1-4b55-b4b3-e441ada612382026-02-27Warnings, Adverse reactionsExact identifier
application number: M021
Alcohol-Free AnticavitySODIUM FLUORIDEThe Kroger Co.5459eeee-adf0-4afe-b190-62d4fa1138062026-02-27Warnings, Adverse reactionsExact identifier
application number: M021
Oral AntivavitySODIUM FLUORIDEThe Kroger Co.932723b8-9875-4f37-8c11-018c94ae0ae12026-02-27Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEThe Kroger Co.d0c552d8-44ad-4d95-b3fb-17015f44b3342026-02-27Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity RinseSODIUM FLUORIDEWalmart Inc.3beb65e4-ae8e-4e51-b9ba-181cbec41eff2026-02-27Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEWalmart Inc.61669087-0af6-4192-b514-afcfe7d8ba982026-02-27Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEWalmart Inc.e79e43e6-d6b6-4df4-9d9f-fe9fe35f180d2026-02-27Warnings, Adverse reactionsExact identifier
application number: M021
Alcohol-Free AnticavitySODIUM FLUORIDEWalmart Inc.1fd2f3ca-066e-282a-e063-6294a90a05a92026-02-27Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEWalmart Inc.af5b93e7-5cce-4e01-8df2-54494d8b29102026-02-27Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEWalmart Inc.4590ca97-130c-46b2-9ba0-38f4703ef30a2026-02-27Warnings, Adverse reactionsExact identifier
application number: M021
Colgate AnticavitySODIUM MONOFLUOROPHOSPHATEMING FAI ENTERPRISE (CAMBODIA) CO., LTD.4ba81636-cdb7-e904-e063-6394a90a8bd52026-02-25WarningsExact identifier
application number: M021
Anticavity RinseSODIUM FLUORIDEFamily Dollar Stores, Inc32a92add-c9db-4733-8e35-613825fdf0812026-02-24Warnings, Adverse reactionsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038904sodium fluoride 0.0221 % (fluoride ion 0.01 % ) MouthwashPSNc640adc0-e178-4b6a-af44-07d2f7da81d316
1038904sodium fluoride 0.221 MG/ML MouthwashSCDc640adc0-e178-4b6a-af44-07d2f7da81d316
1038904sodium fluoride 0.0221 % (fluoride 0.01 % ) Oral RinseSYc640adc0-e178-4b6a-af44-07d2f7da81d316

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-001-86368000001861000 mL in 1 BOTTLE, PLASTIC (36800-001-86) 1000 ml2010-12-300000-00-00NoNoCurrent