FDA.reportPublic FDA data

Quip Anticavity Fluoride

Manufacturer
Quip NYC Inc.
Effective date
2025-01-30
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:54:08

Label at a glance#

ProductQuip Anticavity Fluoride Concentrate
Active ingredientSODIUM FLUORIDE
Label structure13 sections

Storage and handling

Other information Do not store the diluted product Store concentrate at room temperature Do not use if seal under cap is broken or missing.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient(diluted solution)

0.05% Sodium fluoride (0.02% w/v fluoride ion)

OTC - PURPOSE SECTION

Purpose

Anticavity

INDICATIONS & USAGE SECTION

Use

Aids in prevention of dental cavities

WARNINGS SECTION

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Do not use before mixing with water
  • Measure 2.5ml. Dilute with water to 4x volume (10ml). Use immediately
  • Adults and children 6 years of age and older:
  • Use once a day after brushing your teeth with a toothpaste
  • Vigorously swish 10ml of rinse between your teeth for 1 minute and then spit out
  • Do not swallow the rinse
  • Do not eat or drink for 30 minutes after rinsing
  • Supervise children as necessary until capable of using without supervision
  • Children under 6 years of age:consult a dentist or doctor

STORAGE AND HANDLING SECTION

Other information

  • Do not store the diluted product
  • Store concentrate at room temperature
  • Do not use if seal under cap is broken or missing.

INACTIVE INGREDIENT SECTION

Inactive ingredients

Water, Xylitol, Erythritol, Polysorbate 20, Flavor, Sucralose, Disodium EDTA, Cetylpyridinium Chloride, Sodium Hydroxide

SPL UNCLASSIFIED SECTION

Distributed by: quip NYC Inc., 45 Main Street, Brooklyn, NY 11201, USA

Questions?hello@getquip.com

BOTTLE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Anticavity Fluoride Mouthwash Refill
Mint
CONCENTRATE 4x470mL DILUTED
QUIP
117.5 ML (3.97 FL OZ)

IMPORTANT:Read directions for proper use

201215 Hudson_BOTTLE201215 Hudson_BOTTLE

RETAIL CARTON

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

QUIP

CONCENTRATE 4x470mL DILUTED

  • Kills bad breath germs
  • Freshens breath
  • Strengthens teeth
  • Helps prevent cavities
  • Alcohol-free formula
  • Vegan-friendly

Anticavity Fluoride Mouthwash Refill
Mint
117.5 ML (3.97 FL OZ)
IMPORTANT: Read directions for proper use 201215 Hudson Retail Refill_CARTON201215 Hudson Retail Refill_CARTON

STARTER KIT

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

QUIP

MouthwashStarter Kit

Refillable Dispenser & Cup

One pump for perfect daily dose

Mint Anticavity Fluoride Mouthwash Refill

Kills bad breath germs
Freshens breath
Strengthens teeth
Helps prevent cavities
Alcohol-free formula
Vegan-friendly

4XCONCENTRATE 470mL DILUTED

117.5 ML (3.97 FL OZ)
IMPORTANT: Read directions for proper use

201215_Hudson_PACKAGE201215_Hudson_PACKAGE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinsePSN3
240698sodium fluoride 0.5 MG/ML MouthwashSCD3
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinseSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69261-005-032025-02-01C16284748780-1f386c649-b084-0266-e053-dadaa90a7c1aQuip Anticavity Fluoride Mouthwash Concentrate
69261-005-042025-02-01C16284748780-1f386c649-b084-0266-e053-dadaa90a7c1aQuip Anticavity Fluoride Mouthwash Concentrate
69261-005-052025-02-01C16284748780-1f386c649-b084-0266-e053-dadaa90a7c1aQuip Anticavity Fluoride Mouthwash Concentrate
69261-005-032023-01-30C16284748780-1f386c649-b084-0266-e053-dadaa90a7c1aQuip Anticavity Fluoride Mouthwash Concentrate
69261-005-042023-01-30C16284748780-1f386c649-b084-0266-e053-dadaa90a7c1aQuip Anticavity Fluoride Mouthwash Concentrate
69261-005-052023-01-30C16284748780-1f386c649-b084-0266-e053-dadaa90a7c1aQuip Anticavity Fluoride Mouthwash Concentrate

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69261-005-03Quip Anticavity FluorideConcentrate117.5 mL in 1 BOTTLEMOUTHWASH117.53
69261-005-04Quip Anticavity FluorideConcentrate1 in 1 CARTONMOUTHWASH13
69261-005-04Quip Anticavity FluorideConcentrate117.5 mL in 1 BOTTLEMOUTHWASH117.53
69261-005-05Quip Anticavity FluorideConcentrate117.5 mL in 1 BOTTLEMOUTHWASH117.53
69261-005-05Quip Anticavity FluorideConcentrate1 in 1 PACKAGEMOUTHWASH13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69261-005QUIP ANTICAVITY FLUORIDE CONCENTRATE (SODIUM FLUORIDE) MOUTHWASH [QUIP NYC INC.]3Current NDC, Legacy NDC, 5 package rows20250201_b3da65bb-0871-34e7-e053-2a95a90a310e.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69261-00569261-005-04, 69261-005-03, 69261-005-05

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
ERYTHRITOLRA96B954X6IACT
WATER059QF0KO0RIACT
POLYSORBATE 207T1F30V5YHIACT
XYLITOLVCQ006KQ1EIACT
SODIUM HYDROXIDE55X04QC32IIACT
SUCRALOSE96K6UQ3ZD4IACT
CETYLPYRIDINIUM CHLORIDED9OM4SK49PIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Quip Anticavity Fluoride ConcentrateSODIUM FLUORIDEQuip NYC Inc.b3da65bb-0871-34e7-e053-2a95a90a310e2025-01-30WarningsExact identifier
ndc (package): 69261-005-03
ndc (package): 69261-005-04
ndc (package): 69261-005-05
ndc (product): 69261-005
ndc11 (package): 69261000504
ndc11 (package): 69261000503
ndc11 (package): 69261000505
spl id: 2cefad39-aaec-e49b-e063-6394a90adc9d
spl set id: b3da65bb-0871-34e7-e053-2a95a90a310e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.