Home NDC 37808-163 Anticavity Fluoride Rinse
Product NDC 37808-163
11-digit product format 378080163
Labeler code 37808
Product ID 37808-163_500ee303-72f4-68d5-e063-6394a90ac6d4
Type HUMAN OTC DRUG
Nonproprietary name SODIUM FLUORIDE
Dosage form MOUTHWASH
Route ORAL
Labeler H E B
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2010-09-29
Substance SODIUM FLUORIDE
Active strength .1 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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 37808-163 37808-163-77 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 37808-163 37808-163-77 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
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 .1 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 313029 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 37808-163-77 Anticavity Fluoride Rinse 500 mL in 1 BOTTLE, PLASTIC MOUTHWASH 500 15 37808-163-86 Anticavity Fluoride Rinse 1000 mL in 1 BOTTLE, PLASTIC MOUTHWASH 1000 15
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 37808-163 ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [HEB] 12 Current NDC, Legacy NDC, 2 package rows 20240922_87327a36-a314-4daa-83b6-b4bd3e26bba2.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 Marketing end Sample Exclude flag Status 37808-163-77 37808016377 500 mL in 1 BOTTLE, PLASTIC (37808-163-77) 500 ml 2010-09-29 0000-00-00 No No Current 37808-163-86 37808016386 1000 mL in 1 BOTTLE, PLASTIC (37808-163-86) 1000 ml 2010-09-29 0000-00-00 No No Current