Home NDC 37808-681 HEB
Product NDC 37808-681
11-digit product format 378080681
Labeler code 37808
Product ID 37808-681_441bb7e0-ebf7-602d-e063-6294a90aba7e
Type HUMAN OTC DRUG
Nonproprietary name Fluoride
Dosage form PASTE, DENTIFRICE
Route DENTAL
Labeler HEB
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2011-01-20
Substance SODIUM FLUORIDE; POTASSIUM NITRATE
Active strength .15; 5 g/100g; g/100g
NDC exclude flag No
Listing certified through 2026-12-31
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 · 1 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 37808-681 37808-681-19 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
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 HEB
Brand name suffix Extra Whitening
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE .15 g/100g POTASSIUM NITRATE 5 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8ZYQ1474W7 Internal UNII lookup RU45X2JN0Z Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1038929 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 37808-681-19 HEBExtra Whitening 113 g in 1 TUBE PASTE, DENTIFRICE 113 9 37808-681-19 HEBExtra Whitening 1 in 1 CARTON PASTE, DENTIFRICE 1 9 37808-681-29 HEBExtra Whitening 1 in 1 CARTON PASTE, DENTIFRICE 1 9 37808-681-29 HEBExtra Whitening 113 g in 1 TUBE PASTE, DENTIFRICE 113 9
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded POTASSIUM NITRATE ACTIVE INGREDIENT RU45X2JN0Z HEB EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [HEB] 2 SODIUM FLUORIDE ACTIVE INGREDIENT 8ZYQ1474W7 HEB EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [HEB] 2 FLUORIDE ION ACTIVE MOIETY Q80VPU408O HEB EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [HEB] 2 NITRATE ION ACTIVE MOIETY T93E9Y2844 HEB EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [HEB] 2 COCAMIDOPROPYL BETAINE INACTIVE INGREDIENT 5OCF3O11KX HEB EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [HEB] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX HEB EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [HEB] 2 HYDRATED SILICA INACTIVE INGREDIENT Y6O7T4G8P9 HEB EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [HEB] 2 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ HEB EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [HEB] 2 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY HEB EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [HEB] 2 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I HEB EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [HEB] 2 SODIUM METHYL COCOYL TAURATE INACTIVE INGREDIENT JVL98CG53G HEB EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [HEB] 2 SORBITOL INACTIVE INGREDIENT 506T60A25R HEB EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [HEB] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP HEB EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [HEB] 2 WATER INACTIVE INGREDIENT 059QF0KO0R HEB EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [HEB] 2 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE HEB EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [HEB] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 37808-681 HEB EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [HEB] 6 Current NDC, Legacy NDC, 4 package rows 20250119_9bdcbd3f-095b-43d1-8a8e-0ba3eab14e0e.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 25 of 40 · 786 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Candee Caine Topical Anesthetic BENZOCAINE American Medical & Hospital Supply Co., Inc. 0192ccf9-1715-4e23-a6bf-8bd838cd8b0d 2025-01-09 Warnings Exact identifier application number: M022 Candee Caine Topical Anesthetic BENZOCAINE American Medical & Hospital Supply Co., Inc. edcb8451-6fa7-4bc2-95f6-2a0806f7f3da 2025-01-09 Warnings Exact identifier application number: M022 Candee Caine Topical Anesthetic BENZOCAINE American Medical & Hospital Supply Co., Inc. 576660ed-203a-4842-9d39-c5be10daf976 2025-01-09 Warnings Exact identifier application number: M022 Candee Caine Topical Anesthetic BENZOCAINE American Medical & Hospital Supply Co., Inc. 1796b3ec-833a-4cf1-ba50-bc4da827f84f 2025-01-09 Warnings Exact identifier application number: M022 Candee Caine Topical Anesthetic BENZOCAINE American Medical & Hospital Supply Co., Inc. d923fa75-f556-45e3-9f52-39a62e89984b 2025-01-09 Warnings Exact identifier application number: M022 Candee Caine Topical Anesthetic BENZOCAINE American Medical & Hospital Supply Co., Inc. cd3ede8c-2c77-4d81-8dff-8198025a2156 2025-01-09 Warnings Exact identifier application number: M022 KAYLAAN ZERO WASTE REFILL FOR TOOTHPASTE Kaylaan LLC cb7f5f9b-4192-15e6-e053-2995a90a6457 2025-01-09 Warnings Exact identifier application number: M022 KAYLAAN ZERO WASTE REFILL FOR TOOTHPASTE Kaylaan LLC 2b494372-de59-e462-e063-6294a90a08da 2025-01-09 Warnings Exact identifier application number: M022 Dental City Topical Anesthetic BENZOCAINE ICP Inc DBA Dental City a225d515-430d-4e34-846c-0bfec3e74109 2025-01-09 Warnings Exact identifier application number: M022 Dental City Topical Anesthetic BENZOCAINE ICP Inc DBA Dental City 372f99c9-4ad3-4631-b8c8-2a34c47343cc 2025-01-09 Warnings Exact identifier application number: M022 Dental City Topical Anesthetic BENZOCAINE ICP Inc DBA Dental City e554b5b2-cf91-464a-a930-3e1087f12c8d 2025-01-09 Warnings Exact identifier application number: M022 Dental City Topical Anesthetic BENZOCAINE ICP Inc DBA Dental City 98da331c-76c2-49fe-b687-6bfba4ae2e75 2025-01-09 Warnings Exact identifier application number: M022 Dental City Topical Anesthetic BENZOCAINE ICP Inc DBA Dental City d2195efa-597d-4ba9-a9b0-8df0d8f49311 2025-01-09 Warnings Exact identifier application number: M022 Dental City Topical Anesthetic BENZOCAINE ICP Inc DBA Dental City fba82d55-94db-4432-b532-603fe57202be 2025-01-09 Warnings Exact identifier application number: M022 Dental City Topical Anesthetic BENZOCAINE ICP Inc DBA Dental City 9ed0fe31-e5f2-4d6d-8686-1286c6659847 2025-01-09 Warnings Exact identifier application number: M022 Dental City Topical Anesthetic BENZOCAINE ICP Inc DBA Dental City d5f42c30-343c-4e1d-950c-89bbd361fd27 2025-01-09 Warnings Exact identifier application number: M022 Dental City Topical Anesthetic BENZOCAINE ICP Inc DBA Dental City 7dce407f-bbe4-4a27-97ff-be33fd447461 2025-01-09 Warnings Exact identifier application number: M022 KAYLAAN ZERO WASTE REFILL FOR TOOTHPASTE Kaylaan LLC cb7f28f3-a908-47a9-e053-2995a90a6cbd 2025-01-09 Warnings Exact identifier application number: M022 GPS Topical Anesthetic BENZOCAINE Group Practice Solutions, Inc. 921bdb76-f6d3-4e0a-a0ac-277dcc4e8d28 2025-01-09 Warnings Exact identifier application number: M022 GPS Topical Anesthetic BENZOCAINE Group Practice Solutions, Inc. a80cfd29-8314-4639-a811-afd5fdb630b0 2025-01-09 Warnings Exact identifier application number: M022
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 37808-681-19 37808068119 1 TUBE in 1 CARTON (37808-681-19) > 113 g in 1 TUBE 1 tube 2012-11-30 0000-00-00 No No Current 37808-681-29 37808068129 1 TUBE in 1 CARTON (37808-681-29) / 113 g in 1 TUBE 1 tube 2025-11-21 No No Current