Anticavity Fluoride Rinse

Product NDC: 11344-004
11-digit product format: 113440004
Labeler code: 11344
Product ID: 11344-004_59e0f541-aeac-02e8-e063-6294a90aa592
Type: HUMAN OTC DRUG
Nonproprietary name: Sodium fluoride
Dosage form: MOUTHWASH
Route: ORAL
Labeler: Nice-Pak Products, LLC
Application: M021
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-02-29
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
Ingredient	Strength
SODIUM FLUORIDE	.2 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
240698	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
c71d4064-f938-477b-9346-eb38be65390d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
777d68c6-a5ab-e06c-d314-677b0b9af0c8	Product name	2	20240508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
11344-004-44	Anticavity Fluoride Rinse	532 mL in 1 BOTTLE, PLASTIC	MOUTHWASH	532		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11344-004	ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [CONSUMER PRODUCT PARTNERS, LLC]	3	Current NDC, 1 package rows	20250315_c71d4064-f938-477b-9346-eb38be65390d.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 27 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Crest plus Tartar Protection Whitening	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	08776dfc-b07a-3729-e063-6394a90aeeed	2026-01-08	Warnings	Exact identifier application number: M021
Crest Plus Active Fresh plus Whitening Scope	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	17f3b749-01ea-2561-e063-6294a90a5d3b	2026-01-08	Warnings	Exact identifier application number: M021
Crest 3D White Advanced Deep Clean	SODIUM FLUORIDE	Procter & Gamble Manfuacturing Company	128613c4-c06b-bdf5-e063-6294a90acd34	2026-01-08	Warnings	Exact identifier application number: M021
Crest 3D White Brilliance Pro Rinse	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	13a01190-a6f3-17b3-e063-6294a90a36c2	2026-01-08	Warnings	Exact identifier application number: M021
HEB HEBuddy	FLUORIDE	HEB	2c972c65-34aa-4348-b997-c5e65a884575	2026-01-08	Warnings	Exact identifier application number: M021
ARC 2 in 1 Whitening and Anticavity	SODIUM MONOFLUOROPHOSPHATE	The Procter & Gamble Manufacturing Company	12634efa-35e3-76d7-e063-6294a90a3de4	2026-01-08		Exact identifier application number: M021
Crest Plus Whitening Deep Clean	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	15482445-39f3-7e02-e063-6294a90ad1dc	2026-01-08	Warnings	Exact identifier application number: M021
H E B Restore and Defend	FLUORIDE	HEB	56080493-9ab8-4b4f-be5f-7df22dee133f	2026-01-08	Warnings	Exact identifier application number: M021
Crest Plus Cinnamon Expressions plus Whitening	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	151d2a0a-448f-7744-e063-6294a90acd3b	2026-01-08	Warnings	Exact identifier application number: M021
Oral B Mouth Sore Special Care Rinse	HYDROGEN PEROXIDE	The Procter & Gamble Manufacturing Company	22e2dc15-5794-28ed-e063-6394a90a36d3	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro-Health Advanced Anti-Cavity Max Cavity	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	15d70b80-3b25-bc32-e063-6394a90a163e	2026-01-08	Warnings	Exact identifier application number: M021
Crest 3D White Brilliance Bright Mint	SODIUM FLUORIDE	Procter & Gamble Manfuacturing Company	1dee0584-0fed-61c6-e063-6394a90adbcd	2026-01-08	Warnings	Exact identifier application number: M021
HEB Gleaming White Arctic Mint	SODIUM FLUORIDE	HEB	8248eddb-20a5-7084-e053-2991aa0a16b5	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro-Health Gum Rescue Pro Soothing Clean	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	2f10c7ac-eb60-011e-e063-6394a90aca13	2026-01-08	Warnings	Exact identifier application number: M021
Crest Deep Cleanse Cavity Defense	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	2e09cb3b-cf59-15b1-e063-6394a90a5c6a	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro-Health Maximum Cavity Protection	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	2eaeddc5-1559-9378-e063-6394a90a4ed7	2026-01-08	Warnings	Exact identifier application number: M021
Crest 3D White Deep Stain Remover Dazzling Mint	SODIUM MONOFLUOROPHOSPHATE	The Procter & Gamble Manufacturing Company	2f11e935-1711-5f1a-e063-6294a90af7d8	2026-01-08		Exact identifier application number: M021
HEB Gleaming White Fresh Mint	SODIUM FLUORIDE	HEB	82491c8f-d2c2-2e4a-e053-2a91aa0a572f	2026-01-08	Warnings	Exact identifier application number: M021
Crest 3D White Brilliance Pro Ultra White	SODIUM MONOFLUOROPHOSPHATE	The Procter & Gamble Manufacturing Company	338acdf2-548c-0614-e063-6294a90af635	2026-01-08		Exact identifier application number: M021
KIDS Crest Advanced Sugar and Bacteria Shield	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	2f371af0-a2d4-25a6-e063-6394a90a923d	2026-01-08	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
240698	sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral Rinse	PSN	c71d4064-f938-477b-9346-eb38be65390d	4
240698	sodium fluoride 0.5 MG/ML Mouthwash	SCD	c71d4064-f938-477b-9346-eb38be65390d	4
240698	sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral Rinse	SY	c71d4064-f938-477b-9346-eb38be65390d	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
11344-004-44	11344000444	532 mL in 1 BOTTLE, PLASTIC (11344-004-44)	532 ml	2024-02-29	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Swan 004.002/004AE Anticavity Fluoride Rinse	Nice-Pak Products, LLC	2026-08-25	HUMAN OTC DRUG LABEL	5