Anticavity fluoride rinse

Product NDC
76162-838
11-digit product format
761620838
Labeler code
76162
Product ID
76162-838_4ab9cdfd-2e94-8a3c-e063-6394a90ac07a
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
2024-09-06
Substance
SODIUM FLUORIDE
Active strength
.2 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
Anticavity fluoride rinse
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.2 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
240698Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c3f2e952-a8d5-4e9d-a5c6-09e4f2544179Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76162-838-38Anticavity fluoride rinse296 mL in 1 BOTTLE, PLASTICMOUTHWASH2963

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76162-838ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [TOPCO ASSOCIATES LLC]1Current NDC, 1 package rows20240907_c3f2e952-a8d5-4e9d-a5c6-09e4f2544179.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 28 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Crest Pro-Health Gum Detoxify PlusSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company2f9e346e-d664-81d5-e063-6394a90a45252026-01-08WarningsExact identifier
application number: M021
Crest 3D White Holiday Smile Deep Stain Remover and WhitestripsSODIUM MONOFLUOROPHOSPHATEThe Procter & Gamble Manufacturing Company3c57d487-a3c7-b238-e063-6294a90aed812026-01-08Exact identifier
application number: M021
Crest Complete plus Scope Pro Advanced FreshnessSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company325c3ab2-aaa2-a06f-e063-6294a90abefb2026-01-08WarningsExact identifier
application number: M021
Crest Tartar ProtectionSODIUM FLUORIDEProcter & Gamble Manufactura, S. de R.L. de C.V.5940711d-71b7-cb7d-e053-2a91aa0aef182026-01-08WarningsExact identifier
application number: M021
Meijer Restore and Defend SensitiveSTANNOUS FLUORIDEMeijer Distribution Inc82bdfdb5-39f2-8c09-e053-2991aa0a096c2026-01-08WarningsExact identifier
application number: M021
Crest StrawberrySODIUM FLUORIDEProcter & Gamble Manufactura, S. de R.L. de C.V.01f69824-e886-6e7b-e063-6294a90acf772026-01-08WarningsExact identifier
application number: M021
Crest BubblegumSODIUM FLUORIDEProcter & Gamble Manufacturing Mxico, S. de R.L. de C.V.01f64874-6363-3dcc-e063-6394a90a2aec2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Fresh MintSODIUM FLUORIDEProcter & Gamble Manufactura, S. de R.L. de C.V.01f27a63-15f3-cee4-e063-6394a90afa3b2026-01-08WarningsExact identifier
application number: M021
Crest BubblegumSODIUM FLUORIDEProcter & Gamble Manufacturing Mxico, S. de R.L. de C.V.01f618d7-be07-18c3-e063-6294a90a2d972026-01-08WarningsExact identifier
application number: M021
Crest StrawberrySODIUM FLUORIDEProcter & Gamble Manufactura, S. de R.L. de C.V.01f35279-76ce-6027-e063-6294a90a8e342026-01-08WarningsExact identifier
application number: M021
Crest SnowberrySTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company42ca1f06-3e7d-8fed-e063-6394a90afbff2026-01-08WarningsExact identifier
application number: M021
Crest StrawberrySODIUM FLUORIDEProcter & Gamble Manufactura, S. de R.L. de C.V.7d615c52-f9c9-4856-e053-2991aa0a79272026-01-08WarningsExact identifier
application number: M021
Crest Fresh and WhiteSODIUM FLUORIDEProcter & Gamble Manufactura, S. de R.L. de C.V.5a1bb1fb-12a5-5fd1-e053-2991aa0a628b2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Stain Eraser Icy Clean MintSODIUM FLUORIDEProcter & Gamble Manufacturing Mxico, S. de R.L. de C.V.8de12c9f-eb16-aa26-e053-2a95a90a1b9c2026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Peppermint FrostSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company42c84772-d406-b6ca-e063-6394a90a920f2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Sparkle MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company42cb1b2a-55ad-cb9c-e063-6294a90ac88c2026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Gum RecessionSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company47be4eff-1ab5-17a1-e063-6394a90ae4652026-01-08WarningsExact identifier
application number: M021
Supersmile Professional Whitening TPSODIUM MONOFLUOROPHOSPHATERobell Research, Inc25021787-44e8-0b29-e063-6394a90a0af62026-01-08WarningsExact identifier
application number: M021
Supersmile Professional whitening TP Original MintSODIUM MONOFLUOROPHOSPHATERobell Research, Inc2502c305-71ab-bb71-e063-6394a90a0a842026-01-08WarningsExact identifier
application number: M021
Supersmile Professional Whitening TP Original MintSODIUM MONOFLUOROPHOSPHATERobell Research, Inc2502840c-82ee-12cb-e063-6394a90a5b3f2026-01-08WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinsePSNc3f2e952-a8d5-4e9d-a5c6-09e4f25441793
240698sodium fluoride 0.5 MG/ML MouthwashSCDc3f2e952-a8d5-4e9d-a5c6-09e4f25441793
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinseSYc3f2e952-a8d5-4e9d-a5c6-09e4f25441793

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76162-838-3876162083838296 mL in 1 BOTTLE, PLASTIC (76162-838-38) 296 ml2024-09-06NoNoCurrent