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 5 of 50 · 995 matching rows.
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