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 19 of 50 · 995 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Burts Bees Charcoal Peppermint SODIUM FLUORIDE Procter & Gamble Manufacturing Company a343853e-4968-2753-e053-2995a90ab152 2026-02-02 Warnings Exact identifier application number: M021 Burts Bees Complete Multi-Care SODIUM FLUORIDE Procter & Gamble Manufacturing Company 12615266-06e8-b891-e063-6394a90ad75d 2026-02-02 Warnings Exact identifier application number: M021 LIVFRESH GUM PROTECT STANNOUS FLUORIDE Livionex Inc. 1da7dcf9-e675-4b4b-8286-bdaa6e59eb0f 2026-02-02 Warnings Exact identifier application number: M021 Brush Buddies Mouthwash Disney Cars Chow Cherry SODIUM FLUORIDE Kingkey MBC Life Technology Group co., LTD. 49d66ad5-cdae-52f4-e063-6294a90a8ee9 2026-02-01 Warnings Exact identifier application number: M021 Crest 3D White Deep Stain Remover Brilliant White SODIUM MONOFLUOROPHOSPHATE The Procter & Gamble Manufacturing Company 4e53a086-6cda-6460-e063-6394a90af1f3 2026-02-01 Exact identifier application number: M021 ACT Kids Berry Blast SODIUM FLUORIDE Chattem, Inc. 4f81ea98-5c74-4473-9764-3f11d627cdf1 2026-02-01 Warnings Exact identifier application number: M021 Anticavity Rinse SODIUM FLUORIDE Rite Aid Corporation c1a22692-b955-498a-a7c1-1cd7bfd54bda 2026-01-30 Warnings, Adverse reactions Exact identifier application number: M021 ARU GUM HEALTH STANNOUS FLUORIDE Ashtel Studios, Inc. d8e8b92e-d8cb-45ad-8353-7dbe43c3dcd3 2026-01-30 Warnings Exact identifier application number: M021 Colgate Anticavity SODIUM MONOFLUOROPHOSPHATE FORMIA LIMITED b5eec445-d93a-4abb-a5e3-bfcde6fa2013 2026-01-28 Warnings Exact identifier application number: M021 Supersmile Original Mint SODIUM MONOFLUOROPHOSPHATE Robell Research, Inc 24fee793-57ed-87e9-e063-6394a90ab4ce 2026-01-28 Warnings Exact identifier application number: M021 Colgate 5g and Toothbrush Dental Kit SODIUM MONOFLUOROPHOSPHATE FORMIA LIMITED 0b269f9a-aa3f-47b5-b7e8-59a5ed0e2b13 2026-01-28 Warnings Exact identifier application number: M021 Brush Buddies SPIDEY and his AMAZING FRIENDS ANTICAVITY FLUORIDE-Spidey Punch SODIUM FLUORIDE Ashtel Studios Inc. 023cb63c-52b4-4723-bff6-c25105a53f76 2026-01-28 Warnings Exact identifier application number: M021 Brush Buddies STAR WARS ANTICAVITY FLUORIDE - Saber Strike Strawberry SODIUM FLUORIDE Ashtel Studios, Inc. ef4ea4a3-c1ac-447f-a70b-e3a330928cfd 2026-01-27 Warnings Exact identifier application number: M021 Toms of Maine Tropical Island ALUMINUM CHLOROHYDRATE Tom's of Maine ae6de376-76fd-4609-a2d5-7a902c0d4c5c 2026-01-27 Warnings Exact identifier application number: M021 Made by Dentists for Kids Fluoride Anticavity Bamboolicious (Bubblegum) SODIUM FLUORIDE Made by Dentists Inc. f3f6b32d-8e47-4f52-bd9a-20bd51c9d007 2026-01-27 Warnings Exact identifier application number: M021 Brush Buddies DISNEY PRINCESS ANTICAVITY FLUORIDE - Grand Grape SODIUM FLUORIDE Ashtel Studios Inc. 6c6d143f-4c2b-4207-bde7-9df8251616a3 2026-01-27 Warnings Exact identifier application number: M021 Brush Buddies TOY STORY ANTICAVITY FLUORIDE - WILD WEST WATERMELON SODIUM FLUORIDE Ashtel Studios, Inc. d80d0a87-5d1f-4114-977a-036ffed77205 2026-01-27 Warnings Exact identifier application number: M021 Brush Buddies DISNEY FROZEN ANTICAVITY FLUORIDE - Blizzard Berry SODIUM FLUORIDE Ashtel Studios, Inc. ac18dd0a-d476-48a7-8493-594a0293b926 2026-01-27 Warnings Exact identifier application number: M021 Brush Buddies Cars ANTICAVITY FLUORIDE - KA-CHOW CHERRY SODIUM FLUORIDE Ashtel Studios, Inc. 2500e14e-6cf4-4ac4-810f-1ef163c5e474 2026-01-27 Warnings Exact identifier application number: M021 Hello Unicorn Splash SODIUM FLUORIDE Accupac LLC 23807810-990a-b723-e063-6394a90aee3e 2026-01-22 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