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 42 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EUTHYMOL Extraordinary Pink WhiteningSODIUM FLUORIDETai Guk Pharm. Co., Ltd.05a9cee1-bd6e-6b93-e063-6294a90a5c102025-01-01WarningsExact identifier
application number: M021
PERIOE POP Advanced Whitening Prebiotic Cool MintSODIUM FLUORIDETai Guk Pharm. Co., Ltd.f546470a-7fae-4988-e053-2995a90ab61b2025-01-01WarningsExact identifier
application number: M021
PERIOE Microbiome Whitening Cool MintSODIUM FLUORIDETai Guk Pharm. Co., Ltd.de97dbea-dc8c-ebfa-e053-2995a90a22702025-01-01WarningsExact identifier
application number: M021
POP Gel Pumpin StrawberrySODIUM FLUORIDETai Guk Pharm. Co., Ltd.05b1020b-a1c3-e1eb-e063-6394a90ac2662025-01-01WarningsExact identifier
application number: M021
PERIOE POP Complete Protection Prebiotic Mint BlastSODIUM FLUORIDETai Guk Pharm. Co., Ltd.f547a468-d2fd-7176-e053-2995a90a55392025-01-01WarningsExact identifier
application number: M021
PERIOE Whitening Essentials 10X Charcoal Black Clean MintSODIUM FLUORIDETai Guk Pharm. Co., Ltd.b4530d56-3a17-6868-e053-2995a90a25242025-01-01WarningsExact identifier
application number: M021
PERIOE Microbiome Total Care Strong MintSODIUM FLUORIDETai Guk Pharm. Co., Ltd.de996aeb-9ac0-836f-e053-2a95a90aeda62025-01-01WarningsExact identifier
application number: M021
POP Hint Of MintSODIUM FLUORIDETai Guk Pharm. Co., Ltd.05aafc53-49ca-eacd-e063-6394a90a606b2025-01-01WarningsExact identifier
application number: M021
POP Gel Whatzzup WatermelonSODIUM FLUORIDETai Guk Pharm. Co., Ltd.05b18bb6-9fbf-469b-e063-6294a90a4f2f2025-01-01WarningsExact identifier
application number: M021
AVON Whitening Essentials 10X Charcoal Black Clean MintSODIUM FLUORIDETai Guk Pharm. Co., Ltd.9c820740-9148-3a9c-e053-2a95a90a39682025-01-01WarningsExact identifier
application number: M021
PERIOE Whitening Essentials Fresh Aloe Green MintSODIUM FLUORIDETai Guk Pharm. Co., Ltd.a3b21ceb-5aa5-29b4-e053-2a95a90a95452025-01-01WarningsExact identifier
application number: M021
POP Gel Pumpin StrawberrySODIUM FLUORIDELG H&H Co., Ltd.05b25897-460c-2dfb-e063-6294a90ada3b2025-01-01WarningsExact identifier
application number: M021
EUTHYMOL Extraordinary Pink WhiteningSODIUM FLUORIDELG H&H Co., Ltd.05b1f105-6f75-7a45-e063-6394a90a58bc2025-01-01WarningsExact identifier
application number: M021
POP Hint Of MintSODIUM FLUORIDELG H&H Co., Ltd.05b25083-12f3-7a85-e063-6394a90a492e2025-01-01WarningsExact identifier
application number: M021
POP Gel Whatzzup WatermelonSODIUM FLUORIDELG H&H Co., Ltd.05b276a1-3778-104d-e063-6294a90a75372025-01-01WarningsExact identifier
application number: M021
kids kareSTANNOUS FLUORIDEDEN-MAT HOLDINGS, LLC.66d7ae1f-ff7a-7fe4-e053-2991aa0a9f912024-12-31WarningsExact identifier
application number: M021
Kids KareSODIUM FLUORIDEDEN-MAT HOLDINGS, LLC.66d6b20f-d0ff-4dfe-e053-2991aa0a99ca2024-12-31WarningsExact identifier
application number: M021
Morning FreshSODIUM FLUORIDEDynarex Corporation1d0457d7-0228-4ea3-9755-73bacd2201e62024-12-27WarningsExact identifier
application number: M021
Bubble Fresh Toothpaste, with FluorideBUBBLE FRESH TOOTHPASTE, WITH FLUORIDEDynarex Corporation2a2f5ed9-31ec-f6c8-e063-6394a90a44d62024-12-26WarningsExact identifier
application number: M021
Brush Buddies Crayola Swirl ANTICAVITY FLUORIDE WATERMELON FLAVORSODIUM FLUORIDEAshtel Studios, Inc.b3006c29-1f7f-4d9f-ab46-5a36df1a04712024-12-25WarningsExact 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