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 48 of 50 · 995 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join EUTHYMOL Extraordinary Pink Whitening SODIUM FLUORIDE LG H&H CO., LTD. 13910b55-9b5d-af53-e063-6294a90acf5d 2024-03-13 Warnings Exact identifier application number: M021 BIO SPECTRA ATTITUDE SODIUM FLUORIDE 9055-7588 Quebec Inc. DBA Attitude e3bb60f8-2a06-42d6-a182-8c31bb982a2a 2024-03-01 Warnings Exact identifier application number: M021 Maximum Security SODIUM FLUORIDE Bob Barker Company Inc. e29f30ec-72ea-4944-a2c2-b1696d31b639 2024-02-27 Warnings Exact identifier application number: M021 Made by Dentists For Kids Monster Slime Sour Apple SODIUM FLUORIDE MADE BY DENTISTS INC dfddc67c-3626-48c4-8120-bcc6c455d119 2024-02-23 Warnings Exact identifier application number: M021 Orajel Gabbys Dollhouse SODIUM FLUORIDE Church & Dwight Co., Inc. cd47bd1e-44ac-465f-8529-6073ade14706 2024-02-23 Warnings Exact identifier application number: M021 Colgate Kids Maximum Cavity Protection SODIUM FLUORIDE Colgate-Palmolive c44c7a7e-fc3e-a81b-1961-ff89614b678f 2024-02-22 Warnings Exact identifier application number: M021 TheraBreath Fresh Breath Anticavity Mild Mint SODIUM FLUORIDE Church & Dwight Co., Inc. 19ce5324-7d8d-4d70-ad9b-238f7e612eac 2024-02-06 Warnings Exact identifier application number: M021 Nature Mint Anticavity SODIUM MONOFLUOROPHOSPHATE Bob Barker Company Inc. 916891d3-5234-46a8-a492-21a31f36a852 2024-02-02 Warnings Exact identifier application number: M021 Treatment Rinse Mint ANTICARIES DENTAL ALLIANCE HOLDINGS LLC f1255065-b7c3-4eb6-e053-2995a90afcdb 2024-01-31 Warnings Exact identifier application number: M021 Maintenance Rinse Mint ANTICARIES Dental Alliance Holdings LLC f1273510-aa83-3ef9-e053-2a95a90aea27 2024-01-31 Warnings Exact identifier application number: M021 ATOMY PROPOLIS TOOTHPAS TE 50G SODIUM MONOFLUOROPHOSPHATE, SODIUM FLUORIDE ATOMY CO., LTD. 98d839e3-a1aa-c83d-e053-2995a90a7e79 2024-01-30 Warnings Exact identifier application number: M021 ATOMY PROPOLIS TOOTHPAS TE 200G SODIUM MONOFLUOROPHOSPHATE, SODIUM FLUORIDE ATOMY CO., LTD. 98aebbec-aec0-1478-e053-2a95a90a03ea 2024-01-30 Warnings Exact identifier application number: M021 Toms Childrens Anticavity Mouthwash Silly Strawberry SODIUM FLUORIDE Tom's of Maine, Inc. 998c6f35-20f4-4cb8-bc48-6aa39e61481a 2024-01-18 Warnings Exact identifier application number: M021 Gel-Kam Fruit and Berry STANNOUS FLUORIDE Colgate Oral Pharmaceuticals, Inc. 8c2c3c5c-ddef-4a4d-8bc3-5a98c577e74c 2024-01-18 Warnings Exact identifier application number: M021 Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Gushing Grape Fluoride SODIUM FLUORIDE Colgate Oral Pharmaceuticals, Inc. 9a976ac8-d966-4d94-93da-45652f2d2481 2024-01-12 Warnings Exact identifier application number: M021 Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Mint Fluoride SODIUM FLUORIDE Colgate Oral Pharmaceuticals, Inc. 2b4b6f9a-0e31-4891-8721-d1b9a58cca96 2024-01-12 Warnings Exact identifier application number: M021 Colgate MaxFresh with Mini Breath Cool Mint SODIUM FLUORIDE Colgate-Palmolive Company 51abd6bc-7a3d-4b0e-a810-af9e94926438 2024-01-09 Warnings Exact identifier application number: M021 Colgate Enamel Strength Mouthwash SODIUM FLUORIDE Colgate-Palmolive - do not use f0cca38b-c0a3-4788-8cca-727a5684c16b 2024-01-09 Warnings Exact identifier application number: M021 PerCara Oral Health Rinse Fresh Mint CETYLPYRIDINIUM CHLORIDE LEC Custom Products, Inc bd98c654-218b-15ac-e053-2a95a90a75d1 2024-01-01 Warnings Exact identifier application number: M021 PerCara Kids Bubble Gum SODIUM FLUORIDE LEC Custom Products, Inc. be3a7272-acfb-7d14-e053-2995a90a9420 2024-01-01 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 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