Home NDC 11344-004 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.
DailyMed Product Concepts# 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 34 of 50 · 995 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Hello Whipped Mellow Mint Dream Flavor SODIUM MONOFLUOROPHOSPHATE Colgate-Palmolive Company 7a72b687-475d-437a-9734-a29637e5516a 2025-11-11 Warnings Exact identifier application number: M021 Spry Dentifrice TOOTHPASTE Xlear Inc. 43567bbc-b07e-b605-e063-6294a90aad78 2025-11-11 Warnings Exact identifier application number: M021 Hello Naturally Whitening SODIUM MONOFLUOROPHOSPHATE COLGATE PALMOLIVE COMPANY 5ad241e1-6bfc-7863-6a7a-100753651f0a 2025-11-11 Warnings Exact identifier application number: M021 Hello Whipped Peppermint Stick Flavor SODIUM MONOFLUOROPHOSPHATE Colgate-Palmolive Company d6c4ac9e-f55e-4ebc-bd6a-e39eaeb4f813 2025-11-11 Warnings Exact identifier application number: M021 Super Mint MINT TOOTHPASTE SuperMouth, LLC. d23e89f5-7b65-4ed9-803a-38233f30d8f2 2025-11-07 Warnings Exact identifier application number: M021 Dentisse SODIUM FLUORIDE Dentisse, Inc. 326b290a-9bd2-468e-e054-00144ff8d46c 2025-11-04 Warnings Exact identifier application number: M021 Home Care Fluoride STANNOUS FLUORIDE Dental Technologies, Inc. 51f1d84c-809a-4c96-a117-7a8d8aa1e6b4 2025-11-04 Warnings Exact identifier application number: M021 Home Care Fluoride STANNOUS FLUORIDE Dental Technologies, Inc. c44686f8-93ee-4a8f-8481-3439d123f6d2 2025-11-04 Warnings Exact identifier application number: M021 Home Care Fluoride STANNOUS FLUORIDE Dental Technologies, Inc. 16ebcb37-5703-4e10-b965-570e18434b52 2025-11-04 Warnings Exact identifier application number: M021 Plak Smacker GREAT WHITE SHARK SODIUM FLUORIDE YOUNG PS ACQUISITION, LLC ca5b91aa-f69c-4553-a2b6-acf0ca1d920e 2025-11-04 Warnings Exact identifier application number: M021 Plak Smacker STANNOUS FLUORIDE Young Innovations, Inc. e65fa41e-ce2e-53e4-e053-2995a90a24d2 2025-11-04 Warnings Exact identifier application number: M021 Plak Smacker STANNOUS FLUORIDE Young Innovations, Inc. e65c62d9-e8a6-3101-e053-2995a90a1494 2025-11-04 Warnings Exact identifier application number: M021 Home Care Fluoride STANNOUS FLUORIDE Dental Technologies, Inc. 15bdc03e-2cc7-4b7d-96fc-4f3236ed5c75 2025-11-04 Warnings Exact identifier application number: M021 Strawberry Flavor Sodium Fluoride Anticavity Toothpast SODIUM FLUORIDE HISMILE PTY LTD 426c2aca-ca2b-5e34-e063-6294a90ae37c 2025-11-02 Warnings Exact identifier application number: M021 Watermelon Flavor Sodium Fluoride Anticavity Toothpast SODIUM FLUORIDE HISMILE PTY LTD 426e40cb-e30d-0db1-e063-6294a90a762b 2025-10-31 Warnings Exact identifier application number: M021 Classic Mint Flavor Sodium Fluoride Anticavity Toothpast SODIUM FLUORIDE HISMILE PTY LTD 425a9b71-5a7f-83e6-e063-6394a90ab703 2025-10-30 Warnings Exact identifier application number: M021 Grape Bubblegum Flavor Sodium Fluoride Anticavity Toothpast SODIUM FLUORIDE HISMILE PTY LTD 425b1a2e-7576-13a7-e063-6394a90aa865 2025-10-30 Warnings Exact identifier application number: M021 The Simpsons Pink Donut Flavor Sodium Fluoride Anticavity Toothpast SODIUM FLUORIDE HISMILE PTY LTD 426b8efa-e691-a67d-e063-6394a90abf8d 2025-10-30 Warnings Exact identifier application number: M021 Blue Raspberry Flavor Sodium Fluoride Anticavity Toothpast SODIUM FLUORIDE HISMILE PTY LTD 42583b32-525f-925d-e063-6294a90af76f 2025-10-29 Warnings Exact identifier application number: M021 PERIOE KAKAO KIDS Strawberry SODIUM FLUORIDE LG HOUSEHOLD & HEALTH CARE LTD. 4239f8c2-a5f5-3fa6-e063-6294a90acb47 2025-10-28 Warnings Exact identifier application number: M021
DailyMed RxNorm Mappings# 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