Home NDC 41163-213 Anticavity Fluoride Rinse
Product NDC 41163-213
11-digit product format 411630213
Labeler code 41163
Product ID 41163-213_4af77d6f-72cf-9e71-e063-6294a90ab81c
Type HUMAN OTC DRUG
Nonproprietary name Sodium Fluoride
Dosage form MOUTHWASH
Route ORAL
Labeler United Natural Foods, Inc. dba UNFI
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2009-05-14
Substance SODIUM FLUORIDE
Active strength .2 mg/mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 14 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 41163-213-44 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 41163-213-44 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 41163-213-44 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 41163-213-44 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 41163-213-44 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 41163-213-44 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 41163-213-44 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 41163-213-44 Anticavity Fluoride Rinse 532 mL in 1 BOTTLE, PLASTIC MOUTHWASH 532 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SODIUM FLUORIDE ACTIVE INGREDIENT 8ZYQ1474W7 ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [SUPERVALU, INC] 1 FLUORIDE ION ACTIVE MOIETY Q80VPU408O ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [SUPERVALU, INC] 1 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [SUPERVALU, INC] 1 CETYLPYRIDINIUM CHLORIDE INACTIVE INGREDIENT D9OM4SK49P ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [SUPERVALU, INC] 1 MENTHOL INACTIVE INGREDIENT L7T10EIP3A ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [SUPERVALU, INC] 1 METHYL SALICYLATE INACTIVE INGREDIENT LAV5U5022Y ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [SUPERVALU, INC] 1 POLOXAMER 407 INACTIVE INGREDIENT TUF2IVW3M2 ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [SUPERVALU, INC] 1 POLYSORBATE 20 INACTIVE INGREDIENT 7T1F30V5YH ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [SUPERVALU, INC] 1 POTASSIUM SORBATE INACTIVE INGREDIENT 1VPU26JZZ4 ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [SUPERVALU, INC] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [SUPERVALU, INC] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [SUPERVALU, INC] 1 SODIUM PHOSPHATE INACTIVE INGREDIENT SE337SVY37 ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [SUPERVALU, INC] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [SUPERVALU, INC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [SUPERVALU, INC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 41163-213 ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [UNITED NATURAL FOODS, INC. DBA UNFI] 7 Current NDC, Legacy NDC, 1 package rows 20250410_e696038c-182e-4325-9b90-87fe498d9f67.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 36 of 50 · 995 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Cloveden Sensitive Care Tooth SODIUM FLUORIDE DONG IL PHARMS CO.,LTD 3fb153f1-ba6e-7251-e063-6294a90abe62 2025-09-26 Warnings Exact identifier application number: M021 Cloveden 100 times higher concentrated CETYLPYRIDINIUM CHLORIDE DONG IL PHARMS CO.,LTD 3fb1a2ee-381e-a9e8-e063-6394a90a864b 2025-09-26 Warnings Exact identifier application number: M021 unpa Cha Cha Toothpaste SODIUM MONOFLUOROPHOSPHATE Lycl Inc. 230b3cf2-053a-4e8b-8d50-05bbc877faa8 2025-09-25 Warnings Exact identifier application number: M021 TheraBreath Anticavity SODIUM FLUORIDE Church & Dwight Co., Inc. 3c5d58f1-ea8c-4708-bbc6-21e1cd1446da 2025-09-19 Warnings Exact identifier application number: M021 Optimax Professional Whitening Anticavity Fluoride SODIUM MONOFLUOROPHOSPHATE WHITE GLO USA INC 8c4b9db9-8f23-4dd5-ab6e-1c2f9a3da5b1 2025-09-18 Warnings Exact identifier application number: M021 Optimax Professional Whitening Anticavity Fluoride SODIUM MONOFLUOROPHOSPHATE WHITE GLO USA INC c1bbdd36-53fb-43a3-ba20-afbeb6359d31 2025-09-18 Warnings Exact identifier application number: M021 Brush Buddies Cookies n Cream Ice Cream FLAVORED Anticavity Fluoride SODIUM FLUORIDE Ashtel Studios, Inc. f70d378b-d4d6-454c-90a9-794459960c8c 2025-09-17 Warnings Exact identifier application number: M021 Brush Buddies Chocolate Ice Cream FLAVORED Anticavity Fluoride SODIUM FLUORIDE Ashtel Studios, Inc. 26b9b2dd-7cb2-47c3-8bbb-94a48f02dd21 2025-09-16 Warnings Exact identifier application number: M021 Brush Buddies Mint Chocolate Chip Ice Cream FLAVORED Anticavity Fluoride SODIUM FLUORIDE Ashtel Studios, Inc. 3436532d-e078-4dbb-a823-b4542e961534 2025-09-16 Warnings Exact identifier application number: M021 Colgate Total Plaque Pro Release Fresh Mint STANNOUS FLUORIDE Colgate-Palmolive Company 9b1671c4-8680-6e2a-9f10-0400840ca5a9 2025-09-12 Warnings Exact identifier application number: M021 Colgate Total Plaque Pro Release Whitening STANNOUS FLUORIDE Colgate-Palmolive Company ddc09ce5-181a-1b50-7094-314bb58a15cf 2025-09-12 Warnings Exact identifier application number: M021 Cavity Protection Fresh Mint Anticavity Mouthwash SODIUM FLUORIDE Oxyfresh Worldwide Inc 3efc66b2-fcf9-4d26-9cdd-1af8225312b4 2025-09-10 Warnings Exact identifier application number: M021 CLOSE UP Freshening with Mouthwash SODIUM FLUORIDE Church & Dwight Co., Inc. e660b0d7-4cc5-4028-bdf5-016b85899728 2025-09-09 Warnings Exact identifier application number: M021 Essentials Healthy Teeth and Gums SODIUM FLUORIDE 0.24% Church & Dwight Co., Inc. 9652c004-6b47-840f-e053-2995a90a6e98 2025-09-09 Warnings Exact identifier application number: M021 Complete Care Whole Mouth Protection SODIUM FLUORIDE Church & Dwight Co., Inc. d00f9d16-de0e-4ffc-e053-2a95a90a2069 2025-09-09 Warnings Exact identifier application number: M021 Brush Buddies Vanilla Ice Cream FLAVORED Anticavity Fluoride SODIUM FLUORIDE Ashtel Studios, Inc. e911effb-d59f-4054-9501-803b64369ab4 2025-09-05 Warnings Exact identifier application number: M021 The Simpsons Purple Squishee Flavor Sodium Fluoride Anticavity Toothpast SODIUM FLUORIDE HISMILE PTY LTD 3de10638-1a39-b747-e063-6294a90a4ca5 2025-09-03 Warnings Exact identifier application number: M021 Optimax Purple Anticavity Fluoride SODIUM MONOFLUOROPHOSPHATE WHITE GLO USA INC 8264e849-a6b3-4953-a85b-da9d4e7f5a70 2025-09-02 Warnings Exact identifier application number: M021 CAREKON ANTI-CAVITY FLUORIDE SODIUM MONOFLUOROPHOSPHATE Hunan Yinhuatang Pharmaceutical Technology Co., Ltd. 3baca3b6-ff48-0579-e063-6394a90abd08 2025-08-29 Warnings Exact identifier application number: M021 Brush Buddies 2 VALUE PACK CAVITY PROTECTION ANTI-CAVITY FLUORIDE SODIUM MONOFLUOROPHOSPHATE Ashtel Studios, Inc. fc794fe5-7135-4b2b-b002-a75908223f20 2025-08-13 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 41163-213-44 41163021344 532 mL in 1 BOTTLE, PLASTIC (41163-213-44) 532 ml 2009-05-14 No No Current