Home NDC 37808-230 H E B
Product NDC 37808-230
11-digit product format 378080230
Labeler code 37808
Product ID 37808-230_47e52621-fd2a-850a-e063-6294a90affff
Type HUMAN OTC DRUG
Nonproprietary name Fluoride
Dosage form PASTE, DENTIFRICE
Route DENTAL
Labeler HEB
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2014-07-01
Substance STANNOUS FLUORIDE
Active strength .15 g/100g
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 · 3 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 2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 37808-230 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 37808-230 37808-230-09 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 37808-230 37808-230-92 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
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 H E B
Brand name suffix Restore and Defend
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength STANNOUS FLUORIDE .15 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3FTR44B32Q Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 416784 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 37808-230-09 H E BRestore and Defend 1 in 1 CARTON PASTE, DENTIFRICE 1 15 37808-230-09 H E BRestore and Defend 96.4 g in 1 TUBE PASTE, DENTIFRICE 96.4 15 37808-230-92 H E BRestore and Defend 2 in 1 CARTON PASTE, DENTIFRICE 2 15 37808-230-92 H E BRestore and Defend 96.4 g in 1 TUBE PASTE, DENTIFRICE 96.4 15
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded STANNOUS FLUORIDE ACTIVE INGREDIENT 3FTR44B32Q H E B RESTORE AND DEFEND (FLUORIDE) PASTE, DENTIFRICE [HEB] 1 FLUORIDE ION ACTIVE MOIETY Q80VPU408O H E B RESTORE AND DEFEND (FLUORIDE) PASTE, DENTIFRICE [HEB] 1 CARBOXYMETHYLCELLULOSE SODIUM INACTIVE INGREDIENT K679OBS311 H E B RESTORE AND DEFEND (FLUORIDE) PASTE, DENTIFRICE [HEB] 1 COCAMIDOPROPYL BETAINE INACTIVE INGREDIENT 5OCF3O11KX H E B RESTORE AND DEFEND (FLUORIDE) PASTE, DENTIFRICE [HEB] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX H E B RESTORE AND DEFEND (FLUORIDE) PASTE, DENTIFRICE [HEB] 1 HYDRATED SILICA INACTIVE INGREDIENT Y6O7T4G8P9 H E B RESTORE AND DEFEND (FLUORIDE) PASTE, DENTIFRICE [HEB] 1 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY H E B RESTORE AND DEFEND (FLUORIDE) PASTE, DENTIFRICE [HEB] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J H E B RESTORE AND DEFEND (FLUORIDE) PASTE, DENTIFRICE [HEB] 1 SODIUM TRIPOLYPHOSPHATE ANHYDROUS INACTIVE INGREDIENT 9SW4PFD2FZ H E B RESTORE AND DEFEND (FLUORIDE) PASTE, DENTIFRICE [HEB] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R H E B RESTORE AND DEFEND (FLUORIDE) PASTE, DENTIFRICE [HEB] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP H E B RESTORE AND DEFEND (FLUORIDE) PASTE, DENTIFRICE [HEB] 1 WATER INACTIVE INGREDIENT 059QF0KO0R H E B RESTORE AND DEFEND (FLUORIDE) PASTE, DENTIFRICE [HEB] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 37808-230 H E B RESTORE AND DEFEND (FLUORIDE) PASTE, DENTIFRICE [HEB] 13 Current NDC, Legacy NDC, 4 package rows 20250316_56080493-9ab8-4b4f-be5f-7df22dee133f.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 33 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 37808-230-09 37808023009 1 TUBE in 1 CARTON (37808-230-09) / 96.4 g in 1 TUBE 1 tube 2014-07-01 0000-00-00 No No Current 37808-230-92 37808023092 2 TUBE in 1 CARTON (37808-230-92) / 96.4 g in 1 TUBE 2 tube 2019-02-21 0000-00-00 No No Current