Home NDC 37808-192 HEB
Product NDC 37808-192
11-digit product format 378080192
Labeler code 37808
Product ID 37808-192_437f93d5-d593-6b3a-e063-6294a90ac268
Type HUMAN OTC DRUG
Nonproprietary name Fluoride
Dosage form PASTE, DENTIFRICE
Route DENTAL
Labeler HEB
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2012-12-01
Substance SODIUM FLUORIDE
Active strength .15 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 · 22 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 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 37808-192-00 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 37808-192-00 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 37808-192-00 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 37808-192-00 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 37808-192-00 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 37808-192-00 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 37808-192-00 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 37808-192-00 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 37808-192-00 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 37808-192-00 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 37808-192-00 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 37808-192-00 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…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 37808-192-02 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 37808-192-02 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 37808-192-02 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 37808-192-02 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 37808-192-02 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…
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 HEBuddy
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM 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 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 891775 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 37808-192-00 HEBHEBuddy 12 in 1 CASE PASTE, DENTIFRICE 12 9 37808-192-00 HEBHEBuddy 120 g in 1 TUBE PASTE, DENTIFRICE 120 9 37808-192-02 HEBHEBuddy 120 g in 1 TUBE PASTE, DENTIFRICE 120 9
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SODIUM FLUORIDE ACTIVE INGREDIENT 8ZYQ1474W7 HEB HEBUDDY (FLUORIDE) PASTE, DENTIFRICE [HEB] 4 FLUORIDE ION ACTIVE MOIETY Q80VPU408O HEB HEBUDDY (FLUORIDE) PASTE, DENTIFRICE [HEB] 4 CARBOXYMETHYLCELLULOSE SODIUM INACTIVE INGREDIENT K679OBS311 HEB HEBUDDY (FLUORIDE) PASTE, DENTIFRICE [HEB] 4 COCAMIDOPROPYL BETAINE INACTIVE INGREDIENT 5OCF3O11KX HEB HEBUDDY (FLUORIDE) PASTE, DENTIFRICE [HEB] 4 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA HEB HEBUDDY (FLUORIDE) PASTE, DENTIFRICE [HEB] 4 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX HEB HEBUDDY (FLUORIDE) PASTE, DENTIFRICE [HEB] 4 HYDRATED SILICA INACTIVE INGREDIENT Y6O7T4G8P9 HEB HEBUDDY (FLUORIDE) PASTE, DENTIFRICE [HEB] 4 POLYETHYLENE GLYCOL 600 INACTIVE INGREDIENT NL4J9F21N9 HEB HEBUDDY (FLUORIDE) PASTE, DENTIFRICE [HEB] 4 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY HEB HEBUDDY (FLUORIDE) PASTE, DENTIFRICE [HEB] 4 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU HEB HEBUDDY (FLUORIDE) PASTE, DENTIFRICE [HEB] 4 SORBITOL INACTIVE INGREDIENT 506T60A25R HEB HEBUDDY (FLUORIDE) PASTE, DENTIFRICE [HEB] 4 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP HEB HEBUDDY (FLUORIDE) PASTE, DENTIFRICE [HEB] 4 WATER INACTIVE INGREDIENT 059QF0KO0R HEB HEBUDDY (FLUORIDE) PASTE, DENTIFRICE [HEB] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 37808-192 HEB HEBUDDY (FLUORIDE) PASTE, DENTIFRICE [HEB] 7 Current NDC, Legacy NDC, 3 package rows 20250119_a6af1baf-17bf-428c-8744-1490359b0cfb.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 21 of 50 · 995 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join HISMILE SODIUM FLUORIDE HISMILE PTY LTD 1de591d9-9cab-e63d-e063-6394a90ac8eb 2026-01-15 Warnings Exact identifier application number: M021 Ice Pop Flavor Sodium Fluoride Anticavity Toothpast SODIUM FLUORIDE HISMILE PTY LTD 20e1603e-bcd1-6a5e-e063-6294a90ad1db 2026-01-15 Warnings Exact identifier application number: M021 Hismile CANDY CANE FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE HISMILE PTY LTD 1e725b7e-accc-f51c-e063-6394a90a455c 2026-01-15 Warnings Exact identifier application number: M021 Enamelon Preventive Treatment STANNOUS FLUORIDE Premier Dental Products Company 04c3f178-7905-404d-9ac2-67c453287ddf 2026-01-13 Warnings Exact identifier application number: M021 Enamelon STANNOUS FLUORIDE Premier Dental Products Company 1626375a-f78b-4192-b7f3-ca932acab7fb 2026-01-13 Warnings Exact identifier application number: M021 ARU CAVITY PROTECTION SODIUM FLUORIDE Ashtel Studios, Inc. 97bd2934-4bff-4fdb-9199-fcdc0f77fada 2026-01-13 Warnings Exact identifier application number: M021 ACT Anticavity Fluoride Cinnamon SODIUM FLUORIDE Chattem, Inc. f2952ca5-c1c3-42fc-82a4-08662286be44 2026-01-12 Warnings Exact identifier application number: M021 ACT Anticavity Fluoride Kids Wild Watermelon SODIUM FLUORIDE 0.24 (0.14 W/V FLUORIDE ION) Chattem, Inc. bc578c6e-0186-4ac7-ad3a-e8d1e0dcb8a8 2026-01-12 Warnings Exact identifier application number: M021 ACT Kids Anticavity Fluoride Pineapple Punch SODIUM FLUORIDE Chattem, Inc. 2bb69826-12e5-4a4e-8d4a-23a9da6b4b9b 2026-01-12 Warnings Exact identifier application number: M021 Botao Kids Strawberry Flavored with Fluoride BOTAO KIDS STRAWBERRY FLAVORED TOOTHPASTE WITH FLUORIDE Peer Pharm Ltd. 48b8d884-5e15-4145-8521-ae9ee482e392 2026-01-12 Warnings Exact identifier application number: M021 ACT Total Care Anticavity Fluoride Fresh Mint SODIUM FLUORIDE Chattem, Inc. 4ee6a478-afcf-4540-b427-ba08c942ccb3 2026-01-12 Warnings Exact identifier application number: M021 ACT Anticavity Fluoride Mint SODIUM FLUORIDE Chattem, Inc. e81c83a2-363a-442f-8731-2598a4f4c21e 2026-01-12 Warnings Exact identifier application number: M021 ACT Total Care Anticavity Fluoride Icy Clean Mint SODIUM FLUORIDE Chattem, Inc. 258b78b4-55e7-410c-90f8-a3e456c02579 2026-01-12 Warnings Exact identifier application number: M021 ACT Total Care Dry Mouth Anticavity Mouth SODIUM FLUORIDE Chattem, Inc. 06684b82-aaa0-4ca6-8d56-4f9866269000 2026-01-12 Warnings Exact identifier application number: M021 ACT Anticavity Fluoride Kids Groovy Grape SODIUM FLUORIDE Chattem, Inc. cd167c0b-2086-4204-b0ac-90df404bd4bb 2026-01-12 Warnings Exact identifier application number: M021 ACT Total Care Anticavity Fluoride Icy Clean Mint SODIUM FLUORIDE Chattem, Inc. beded786-bb55-4ba3-82fe-9e9d1b5e2979 2026-01-12 Warnings Exact identifier application number: M021 ACT Kids Pure Protect Anticavity- Simply Strawberry SODIUM FLUORIDE Chattem, Inc. 2fc80727-57c7-4a33-80e0-ab9f9487390d 2026-01-12 Warnings Exact identifier application number: M021 ACT Kids Anticavity Fluoride Groovy Grape SODIUM FLUORIDE Chattem, Inc. 310a3c11-1c66-4dac-99f4-5fdc15d0f77c 2026-01-12 Warnings Exact identifier application number: M021 ACT Anticavity Fluoride Kids Bubblegum SODIUM FLUORIDE Chattem, Inc. fbbccd58-a816-4a93-a658-f28246c11e80 2026-01-12 Warnings Exact identifier application number: M021 ACT Whitening Anticavity Gentle Mint SODIUM FLUORIDE 0.02 (0.009 W/V FLUORIDE ION) Chattem, Inc. cd45a0b8-9ab3-4aed-8214-a6dcc4cdaf49 2026-01-12 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 Sample Exclude flag Status 37808-192-00 37808019200 12 in 1 CASE Historical 37808-192-02 37808019202 120 g in 1 TUBE (37808-192-02) 120 g 2012-12-01 No No Current