FDA.reportPublic FDA data

Glowing White

Product NDC
53942-435
11-digit product format
539420435
Labeler code
53942
Product ID
53942-435_49f0a50b-0413-6830-e063-6394a90a5404
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium fluoride
Dosage form
MOUTHWASH
Route
ORAL
Labeler
Demoulas Super Markets, Inc
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-07-29
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
Glowing White
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
32faf47d-b64f-4454-9f14-51503504c6b5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53942-435-45Glowing White946 mL in 1 BOTTLE, PLASTICMOUTHWASH94614

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7GLOWING WHITE (SODIUM FLUORIDE) MOUTHWASH [DEMOULAS SUPER MARKETS, INC]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OGLOWING WHITE (SODIUM FLUORIDE) MOUTHWASH [DEMOULAS SUPER MARKETS, INC]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MGLOWING WHITE (SODIUM FLUORIDE) MOUTHWASH [DEMOULAS SUPER MARKETS, INC]1
HYDROGEN PEROXIDEINACTIVE INGREDIENTBBX060AN9VGLOWING WHITE (SODIUM FLUORIDE) MOUTHWASH [DEMOULAS SUPER MARKETS, INC]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3AGLOWING WHITE (SODIUM FLUORIDE) MOUTHWASH [DEMOULAS SUPER MARKETS, INC]1
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NNGLOWING WHITE (SODIUM FLUORIDE) MOUTHWASH [DEMOULAS SUPER MARKETS, INC]1
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2GLOWING WHITE (SODIUM FLUORIDE) MOUTHWASH [DEMOULAS SUPER MARKETS, INC]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYGLOWING WHITE (SODIUM FLUORIDE) MOUTHWASH [DEMOULAS SUPER MARKETS, INC]1
SODIUM PHOSPHATE, DIBASIC ANHYDROUSINACTIVE INGREDIENT22ADO53M6FGLOWING WHITE (SODIUM FLUORIDE) MOUTHWASH [DEMOULAS SUPER MARKETS, INC]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4GLOWING WHITE (SODIUM FLUORIDE) MOUTHWASH [DEMOULAS SUPER MARKETS, INC]1
WATERINACTIVE INGREDIENT059QF0KO0RGLOWING WHITE (SODIUM FLUORIDE) MOUTHWASH [DEMOULAS SUPER MARKETS, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53942-435GLOWING WHITE (SODIUM FLUORIDE) MOUTHWASH [DEMOULAS SUPER MARKETS, INC]13Current NDC, Legacy NDC, 1 package rows20250418_32faf47d-b64f-4454-9f14-51503504c6b5.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 40 of 49 · 974 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DawnMistTOOTHPASTEDukal LLC147f7738-5080-9907-e063-6294a90a61702025-02-07WarningsExact identifier
application number: M021
DawnMist Gel FluorideGEL FLUORIDE TOOTHPASTEDukal LLC14443184-1694-70b9-e063-6394a90a86fe2025-02-07WarningsExact identifier
application number: M021
Quip Anticavity Fluoride ConcentrateSODIUM FLUORIDEQuip NYC Inc.b3da65bb-0871-34e7-e053-2a95a90a310e2025-01-30WarningsExact identifier
application number: M021
Quip AnticavitySODIUM FLUORIDEQuip NYC Inc.b6d4cfe3-535e-9163-e053-2a95a90ae1402025-01-30WarningsExact identifier
application number: M021
Quip AnticavitySODIUM FLUORIDEQuip NYC Inc.b6d8a9b6-1fdd-6a54-e053-2995a90a2c1a2025-01-30WarningsExact identifier
application number: M021
QuipSODIUM FLUORIDEQuip NYC Inc.714b7205-444d-929b-e053-2995a90a958e2025-01-30WarningsExact identifier
application number: M021
Cool sense Care PlusSODIUM FLUORIDEDOCSMEDI Co., Ltd.ea18ac56-4ef1-4bf0-8c26-6885183fd6842025-01-22WarningsExact identifier
application number: M021
DOCTRUST DOUBLEX ToothSODIUM FLUORIDEDOCSMEDI Co., Ltd.aaf08481-a2ff-48f6-8611-73a469efe1db2025-01-22WarningsExact identifier
application number: M021
Double X CONCENTRATEDCETYLPYRIDINIUM CHLORIDEDOCSMEDI Co., Ltd.411be334-364c-4074-8d0b-8dda332f87de2025-01-22WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Quebec Inc. DBA Attituded33e3778-ba1d-4560-bafa-74f7ab88c6b52025-01-20WarningsExact identifier
application number: M021
AMERFRESH FLUORIDE gelSODIUM FLUORIDEYangzhou ONE & ONLY Personal Care Products Co., LTD86279b4d-82e5-45b5-9ba7-94fe3620b8502025-01-16WarningsExact identifier
application number: M021
AMERFRESH FLUORIDESODIUM FLUORIDEYangzhou ONE & ONLY Personal Care Products Co., LTD827e45bb-84c0-48ee-a60b-2cc32b8f33e32025-01-16WarningsExact identifier
application number: M021
Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel ToothSODIUM FLUORIDEYangzhou ONE & ONLY Personal Care Products Co., LTDbb93fb1a-885a-4d2a-a1c2-3b37bc305d572025-01-16WarningsExact identifier
application number: M021
MedprideSODIUM MONOFLUOROPHOSPHATEShield Line LLC9c1b0420-6b57-4914-99fe-df6a494815c32025-01-16WarningsExact identifier
application number: M021
Sodium FluorideSODIUM FLUORIDESafco Dental Supply LLC7a295974-c400-4442-9149-138a805ffb202025-01-09WarningsExact identifier
application number: M021
SaliveaFLUORIDE TOOTHPASTELaclede, Inc.6398ae96-dd38-44da-bc34-1d4d4c4a78ca2025-01-08WarningsExact identifier
application number: M021
EUTHYMOL Extraordinary Pink WhiteningSODIUM FLUORIDETai Guk Pharm. Co., Ltd.098a29d5-3836-d362-e063-6394a90a9fea2025-01-01WarningsExact identifier
application number: M021
PERIOE POP Sensitivity Care Prebiotic Clean MintSTANNOUS FLUORIDETai Guk Pharm. Co., Ltd.f4ef8ee7-7197-b3dc-e053-2a95a90a1c1b2025-01-01WarningsExact identifier
application number: M021
PERIOE Microbiome Sensitive Clean MintSTANNOUS FLUORIDETai Guk Pharm. Co., Ltd.dec29c9f-6ddb-0b4e-e053-2995a90a64b12025-01-01WarningsExact identifier
application number: M021
AVON Whitening Essentials Original Cool MintSODIUM FLUORIDETai Guk Pharm. Co., Ltd.8e5de76b-535a-9c95-e053-2995a90afcab2025-01-01WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinsePSN32faf47d-b64f-4454-9f14-51503504c6b514
313029sodium fluoride 0.2 MG/ML MouthwashSCD32faf47d-b64f-4454-9f14-51503504c6b514
313029sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral RinseSY32faf47d-b64f-4454-9f14-51503504c6b514
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinseSY32faf47d-b64f-4454-9f14-51503504c6b514

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53942-435-4553942043545946 mL in 1 BOTTLE, PLASTIC (53942-435-45) 946 ml2015-07-290000-00-00NoNoCurrent