sodium fluoride rinse

Product NDC
69892-971
11-digit product format
698920971
Labeler code
69892
Product ID
69892-971_52430b12-4d60-d1e1-e063-6394a90abd64
Type
HUMAN OTC DRUG
Nonproprietary name
sodium fluoride rinse
Dosage form
LIQUID
Route
ORAL
Labeler
Rockland Cosmetics, Inc.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-05-20
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
sodium fluoride 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
313029Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
52430b12-4d5f-d1e1-e063-6394a90abd64Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69892-971-86sodium fluoride rinse1000 mL in 1 BOTTLE, PLASTICLIQUID10001

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 44 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Colgate Kids Space Jam Mild Bubble Fruit FlavorSODIUM FLUORIDEColgate-Palmolive Company54cbfb09-8fd7-ef08-99fd-14fc019c81ff2024-11-14WarningsExact identifier
application number: M021
Colgate Kids Llama Mild Bubble Fruit FlavorSODIUM FLUORIDEColgate-Palmolivea7b02cb2-cfb3-7b35-42da-7924d156dcc32024-11-14WarningsExact identifier
application number: M021
Colgate MaxFresh with Mini Breath Clean MintSODIUM FLUORIDEColgate-Palmolive Company82bc1101-84d7-4e21-be9c-870ad88a4b7c2024-11-14WarningsExact identifier
application number: M021
Colgate MaxFresh KnockoutSODIUM FLUORIDECOLGATE PALMOLIVE COMPANYb6ca4ec7-5087-4693-82b7-199b44d7f9312024-11-13WarningsExact identifier
application number: M021
Listerine Smart Rinse Berry SplashSODIUM FLUORIDEKenvue Brands LLC5c9d763b-7fa2-4b6f-9247-fd28eeda7f0b2024-11-11WarningsExact identifier
application number: M021
Listerine Clinical Solutions Teeth Strength Alpine MintSODIUM FLUORIDEKenvue Brands LLC06e2de03-4a58-3de0-e063-6294a90a58572024-11-11WarningsExact identifier
application number: M021
Listerine Smart Rinse Anticavity Fluoride Rinse - Berry SplashSODIUM FLUORIDEKenvue Brands LLCee9a962d-83c7-4b13-bff6-140e48785e8a2024-11-11WarningsExact identifier
application number: M021
Listerine Smart Rinse Anticavity Fluoride Rinse - Mint ShieldSODIUM FLUORIDEKenvue Brands LLCd69d2e0d-a3e3-4d95-992d-c0c59172b3a52024-11-11WarningsExact identifier
application number: M021
Listerine Smart Rinse Anticavity Fluoride Rinse - Bubble BlastSODIUM FLUORIDEKenvue Brands LLCf09f334b-709c-473e-b91e-3f31480ceb902024-11-11WarningsExact identifier
application number: M021
HIMALAYA PINK SALT Purple Color Corrector plus Intensive Whitening Vanilla MintSODIUM FLUORIDELG H&H Co.,Ltd.2697fa68-b991-ab09-e063-6394a90aec4c2024-11-01WarningsExact identifier
application number: M021
HIMALAYA PINK SALT Purple Color Corrector plus Intensive Whitening Vanilla MintSODIUM FLUORIDETai Guk Pharma. Co., Ltd.2698d6d8-051b-6c10-e063-6394a90a94182024-11-01WarningsExact identifier
application number: M021
Made by Dentist for Kids Chew Toy (Bubblegum)SODIUM FLUORIDEMADE BY DENTISTS INC263c448b-728f-4370-bcdb-148d614d9b342024-10-30WarningsExact identifier
application number: M021
OCEAN FRIENDS ANTICAVITY FLUORIDE BUBBLEGUM FLAVORSODIUM FLUORIDECVS Pharmacy, Inc.17f589e9-f4ba-46d3-a345-db38f9a9067d2024-10-17WarningsExact identifier
application number: M021
ACT Kids Anticavity Fluoride Wild WatermelonSODIUM FLUORIDEChattem, Inc.8d7faeab-ac70-472a-acbb-de67493718ce2024-10-16WarningsExact identifier
application number: M021
Rexall Restore and Defend Sensitive WhiteningSTANNOUS FLUORIDEOld East Main CO.691c9638-75d2-4e53-bec4-2eafacd7216c2024-10-14WarningsExact identifier
application number: M021
Rexall Travel Toothbrush and Tooth-pasteSODIUM MONOFLUOROPHOSPHATEOld East Main CO.1bfba18b-1418-4c39-b666-96fa0674cc702024-10-14WarningsExact identifier
application number: M021
Crest Cavity Protection RegularSODIUM FLUORIDENavajo Manufacturing Company Inc.23851360-e30e-dd97-e063-6394a90a54742024-10-02WarningsExact identifier
application number: M021
Colgate Total SF Clean MintSTANNOUS FLUORIDEColgate-Palmolive Company8e79e33c-88d3-afc2-e5a2-c6ad55db0dc02024-10-02WarningsExact identifier
application number: M021
Colgate Total SF Whitening CharcoalSTANNOUS FLUORIDEColgate-Palmolive Company36cd9cfc-7390-4400-8ede-b9d172d839532024-10-02WarningsExact identifier
application number: M021
Colgate Total SF Deep CleanSTANNOUS FLUORIDEColgate-Palmolive Company85e83b72-2d09-aec0-db7e-6b5715c5a86c2024-10-01WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinsePSN52430b12-4d5f-d1e1-e063-6394a90abd641
313029sodium fluoride 0.2 MG/ML MouthwashSCD52430b12-4d5f-d1e1-e063-6394a90abd641
313029sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral RinseSY52430b12-4d5f-d1e1-e063-6394a90abd641
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinseSY52430b12-4d5f-d1e1-e063-6394a90abd641

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinsePSN52430b12-4d5f-d1e1-e063-6394a90abd641
313029sodium fluoride 0.2 MG/ML MouthwashSCD52430b12-4d5f-d1e1-e063-6394a90abd641
313029sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral RinseSY52430b12-4d5f-d1e1-e063-6394a90abd641
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinseSY52430b12-4d5f-d1e1-e063-6394a90abd641

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69892-971-86698920971861000 mL in 1 BOTTLE, PLASTIC (69892-971-86) 1000 ml2026-05-20NoNoCurrent