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
Ingredient	Strength
SODIUM FLUORIDE	.1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8ZYQ1474W7	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
313029	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
32faf47d-b64f-4454-9f14-51503504c6b5	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5eb9f24b-9328-475e-af0a-18021935eb6a	Product name	1	20180220

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53942-435-45	Glowing White	946 mL in 1 BOTTLE, PLASTIC	MOUTHWASH	946		14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SODIUM FLUORIDE	ACTIVE INGREDIENT	8ZYQ1474W7	GLOWING WHITE (SODIUM FLUORIDE) MOUTHWASH [DEMOULAS SUPER MARKETS, INC]	1
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	GLOWING WHITE (SODIUM FLUORIDE) MOUTHWASH [DEMOULAS SUPER MARKETS, INC]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	GLOWING WHITE (SODIUM FLUORIDE) MOUTHWASH [DEMOULAS SUPER MARKETS, INC]	1
HYDROGEN PEROXIDE	INACTIVE INGREDIENT	BBX060AN9V	GLOWING WHITE (SODIUM FLUORIDE) MOUTHWASH [DEMOULAS SUPER MARKETS, INC]	1
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	GLOWING WHITE (SODIUM FLUORIDE) MOUTHWASH [DEMOULAS SUPER MARKETS, INC]	1
PHOSPHORIC ACID	INACTIVE INGREDIENT	E4GA8884NN	GLOWING WHITE (SODIUM FLUORIDE) MOUTHWASH [DEMOULAS SUPER MARKETS, INC]	1
POLOXAMER 407	INACTIVE INGREDIENT	TUF2IVW3M2	GLOWING WHITE (SODIUM FLUORIDE) MOUTHWASH [DEMOULAS SUPER MARKETS, INC]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	GLOWING WHITE (SODIUM FLUORIDE) MOUTHWASH [DEMOULAS SUPER MARKETS, INC]	1
SODIUM PHOSPHATE, DIBASIC ANHYDROUS	INACTIVE INGREDIENT	22ADO53M6F	GLOWING WHITE (SODIUM FLUORIDE) MOUTHWASH [DEMOULAS SUPER MARKETS, INC]	1
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	GLOWING WHITE (SODIUM FLUORIDE) MOUTHWASH [DEMOULAS SUPER MARKETS, INC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	GLOWING WHITE (SODIUM FLUORIDE) MOUTHWASH [DEMOULAS SUPER MARKETS, INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53942-435	GLOWING WHITE (SODIUM FLUORIDE) MOUTHWASH [DEMOULAS SUPER MARKETS, INC]	13	Current NDC, Legacy NDC, 1 package rows	20250418_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 38 of 49 · 974 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
EUTHYMOL WHITENING SET	SODIUM FLUORIDE	LG HOUSEHOLD & HEALTH CARE LTD.	35839b10-4c40-40e5-e063-6294a90a85b4	2025-05-19	Warnings	Exact identifier application number: M021
Hello Unicorn Sparkle	SODIUM FLUORIDE	Colgate-Palmolive Company	5acfbd9b-278c-24dd-8041-5e2cdffbf710	2025-05-13	Warnings	Exact identifier application number: M021
Optimax Anticavity Fluoride Cotton Candy	SODIUM MONOFLUOROPHOSPHATE	WHITE GLO USA INC	25f182cb-ad1e-4c13-bc79-1ec251754cf8	2025-05-12	Warnings	Exact identifier application number: M021
Optimax Anticavity Fluoride Watermelon	SODIUM MONOFLUOROPHOSPHATE	WHITE GLO USA INC	b506df13-649f-4615-bc25-6ae08bd56b18	2025-05-12	Warnings	Exact identifier application number: M021
Listerine Total Care Alcohol Free Anticavity Fluoride Mouthwash Fresh Mint	SODIUM FLUORIDE	Kenvue Brands LLC	346daeae-7590-176c-e063-6294a90a52ea	2025-05-05	Warnings	Exact identifier application number: M021
Evo Sensitive Whitening Anti-cavity Fluoride Mouthwash	SODIUM FLUORIDE	Kingkey MBC Life Technology Group co., LTD.	3de0d71a-7704-97dd-e063-6294a90a5d2c	2025-05-01	Warnings	Exact identifier application number: M021
Handy Solutions Crest Complete MULTI-BENEFIT WHITENING plus Scope	SODIUM FLUORIDE	Navajo Manufacturing Company Inc	3adb1524-0fd6-4728-b757-dcbda4cdd0fb	2025-04-29	Warnings	Exact identifier application number: M021
Listerine Clinical Solutions Enamel Strength Alpine Mint	SODIUM FLUORIDE	Kenvue Brands LLC	11e1c1d0-465b-9e14-e063-6394a90a8cdd	2025-04-22	Warnings	Exact identifier application number: M021
Hello Mighty Multi tasker	STANNOUS FLUORIDE	Colgate-Palmolive Company	48e36e06-3666-9032-b9c8-4be035e751f2	2025-04-15	Warnings	Exact identifier application number: M021
Hello Kids Wild Strawberry Wild Strawberry	SODIUM FLUORIDE	Colgate-Palmolive Company	39dddf11-45a0-b883-e12f-d80c582e8c89	2025-04-15	Warnings	Exact identifier application number: M021
Hello Magical Mermaid	SODIUM FLUORIDE	Colgate-Palmolive Company	bdabf74f-8d1e-0f11-159a-0025bcd0ca3e	2025-04-15	Warnings	Exact identifier application number: M021
Euthymol Whitening Purple Corrector	SODIUM FLUORIDE	LG HOUSEHOLD & HEALTH CARE LTD.	300303e7-ef8b-7449-e063-6294a90ac811	2025-04-09	Warnings	Exact identifier application number: M021
Euthymol Whitening	SODIUM FLUORIDE	LG HOUSEHOLD & HEALTH CARE LTD.	303d4ad0-5a2b-347a-e063-6394a90aa0ba	2025-04-07	Warnings	Exact identifier application number: M021
OralLine Kids	SODIUM FLUORIDE	J.M. Murray Center Inc.	12c5bee5-e228-4f71-9bfd-c377ee2372a9	2025-03-21	Warnings	Exact identifier application number: M021
AdoptaPlatoon	SODIUM FLUORIDE	Yangzhou ONE & ONLY Personal Care Products Co., LTD	c1592b56-cf3d-4a4d-be84-e40eb3f1456e	2025-03-21	Warnings	Exact identifier application number: M021
OralLine Secure	SODIUM FLUORIDE	J.M. Murray Center Inc.	4c0970e9-7417-4234-89e3-3b602a609af5	2025-03-20	Warnings	Exact identifier application number: M021
smart way MINT cavity protection	SODIUM MONOFLUOROPHOSPHATE	The Kroger Co.	45cc7a60-b4a7-4263-a114-f0d1f98a87fc	2025-03-19	Warnings	Exact identifier application number: M021
Hismile	MAGICALLY DELICIOUS FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE	Hismile Pty Ltd	309366f8-6a52-fe9f-e063-6394a90a5de3	2025-03-18	Warnings	Exact identifier application number: M021
Hismile Grape Bubblegum Flavor Sodium Fluoride Anticavity Toothpast	SODIUM FLUORIDE	Hismile Pty Ltd	2b3e72ca-2bbb-adf1-e063-6394a90a2c7a	2025-03-13	Warnings	Exact identifier application number: M021
Hismile Pink Lemonade Sodium Fluoride Anticavity Toothpast	SODIUM FLUORIDE	Hismile Pty Ltd	2b92ff92-3722-3702-e063-6394a90a38b0	2025-03-13	Warnings	Exact identifier application number: M021

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8ZYQ1474W7	SODIUM FLUORIDE	7681-49-4	SODIUM FLUORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
313029	sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral Rinse	PSN	32faf47d-b64f-4454-9f14-51503504c6b5	14
313029	sodium fluoride 0.2 MG/ML Mouthwash	SCD	32faf47d-b64f-4454-9f14-51503504c6b5	14
313029	sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral Rinse	SY	32faf47d-b64f-4454-9f14-51503504c6b5	14
313029	sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral Rinse	SY	32faf47d-b64f-4454-9f14-51503504c6b5	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53942-435-45	53942043545	946 mL in 1 BOTTLE, PLASTIC (53942-435-45)	946 ml	2015-07-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Market Basket 435.000/435AA Glowing White Anticavity Mouthrinse	Demoulas Super Markets, Inc \| Nice-Pak Products, LLC	2026-02-03	HUMAN OTC DRUG LABEL	14