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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage37808-19237808-192-00DDiscontinued by firm2026-10-12

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 dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage37808-192-00DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage37808-192-00DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage37808-192-00DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage37808-192-00DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage37808-192-00DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage37808-192-00DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage37808-192-00DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage37808-192-00DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage37808-192-00DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage37808-192-00DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage37808-192-00DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage37808-192-00DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage37808-192-02IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage37808-192-02IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage37808-192-02IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage37808-192-02IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage37808-192-02IInactivated by FDAe2bbac7714bc…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
IngredientStrength
SODIUM FLUORIDE.15 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
891775Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a6af1baf-17bf-428c-8744-1490359b0cfbAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-192-00HEBHEBuddy12 in 1 CASEPASTE, DENTIFRICE129
37808-192-00HEBHEBuddy120 g in 1 TUBEPASTE, DENTIFRICE1209
37808-192-02HEBHEBuddy120 g in 1 TUBEPASTE, DENTIFRICE1209

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7HEB HEBUDDY (FLUORIDE) PASTE, DENTIFRICE [HEB]4
FLUORIDE IONACTIVE MOIETYQ80VPU408OHEB HEBUDDY (FLUORIDE) PASTE, DENTIFRICE [HEB]4
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311HEB HEBUDDY (FLUORIDE) PASTE, DENTIFRICE [HEB]4
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXHEB HEBUDDY (FLUORIDE) PASTE, DENTIFRICE [HEB]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHEB HEBUDDY (FLUORIDE) PASTE, DENTIFRICE [HEB]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXHEB HEBUDDY (FLUORIDE) PASTE, DENTIFRICE [HEB]4
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9HEB HEBUDDY (FLUORIDE) PASTE, DENTIFRICE [HEB]4
POLYETHYLENE GLYCOL 600INACTIVE INGREDIENTNL4J9F21N9HEB HEBUDDY (FLUORIDE) PASTE, DENTIFRICE [HEB]4
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYHEB HEBUDDY (FLUORIDE) PASTE, DENTIFRICE [HEB]4
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUHEB HEBUDDY (FLUORIDE) PASTE, DENTIFRICE [HEB]4
SORBITOLINACTIVE INGREDIENT506T60A25RHEB HEBUDDY (FLUORIDE) PASTE, DENTIFRICE [HEB]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHEB HEBUDDY (FLUORIDE) PASTE, DENTIFRICE [HEB]4
WATERINACTIVE INGREDIENT059QF0KO0RHEB HEBUDDY (FLUORIDE) PASTE, DENTIFRICE [HEB]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-192HEB HEBUDDY (FLUORIDE) PASTE, DENTIFRICE [HEB]7Current NDC, Legacy NDC, 3 package rows20250119_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 8 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Crest Plus Scope plus Whitening Minty Fresh with MouthwashSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company54ed8e02-3c2f-750c-e063-6394a90a4d332026-06-23WarningsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDEH E Bc68b0644-685d-4c62-bf5d-3a5bbea3b0522026-06-22Warnings, Adverse reactionsExact identifier
application number: M021
Tom Whole Care Peppermint fights cavities whitening fresh breath helps fight tartarSODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.fdbadaae-eab7-4d9a-acf7-815ca93f877c2026-06-16WarningsExact identifier
application number: M021
Natural Fluoride Fresh Mint cavity protection whitening fresh breathSODIUM FLUORIDETom's of Maine, Inc.fce5e8b5-34f8-4a45-a662-82c9034198092026-06-16WarningsExact identifier
application number: M021
Toms Whole Care Spearmint fights cavities whitening fresh breath helps fight tartarSODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.ebb62015-0027-459a-a9cf-56b640f9f4562026-06-16WarningsExact identifier
application number: M021
Toms Wicked Fresh Spearmint Ice fresh breath / cavity protectionSODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.b9962eac-186e-4da2-929d-393f18ed02342026-06-16WarningsExact identifier
application number: M021
Toms Wicked Fresh Cool Peppermint fresh breath / cavity protectionSODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.1c029b10-29b0-4131-9134-cebfca4328a32026-06-16WarningsExact identifier
application number: M021
Toms Whole Care Cinnamon Clove FIGHTS CAVITIES WHITENING FRESH BREATH HELPS FIGHT TARTARSODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.3e7ab39a-989c-4924-af3e-689404912bee2026-06-16WarningsExact identifier
application number: M021
Crest Plus Cinnamon plus WhiteningSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company53fb780d-3e8b-6747-e063-6294a90a82112026-06-11WarningsExact identifier
application number: M021
Colgate Total SF WhiteningSTANNOUS FLUORIDECOLGATE PALMOLIVE COMPANY7f6b6aa8-50da-151b-c448-9e427d37398f2026-06-11WarningsExact identifier
application number: M021
Colgate MaxClean with Whitening SmartfoamSODIUM FLUORIDEColgate-Palmolive Companyc712ae6b-eff3-4c54-b1fc-37304758d0592026-06-11WarningsExact identifier
application number: M021
Colgate Total Sensitivity Mineral ShieldSTANNOUS FLUORIDEColgate-Palmolive Companyf065318c-1e2a-c04d-f254-f8127b05a88f2026-06-10WarningsExact identifier
application number: M021
Toms Whole Care Mouthwash Fresh MintSODIUM FLUORIDETom's of Maine, Inc.6875f5c1-853c-43da-8226-c09a5518f9bb2026-06-10WarningsExact identifier
application number: M021
Colgate Total SF Fresh Mint StripeSTANNOUS FLUORIDECOLGATE PALMOLIVE COMPANY657020c7-e85c-4c61-9f62-b50351e4b4e52026-06-10WarningsExact identifier
application number: M021
Optimax Anticavity Fluoride BubblegumSODIUM MONOFLUOROPHOSPHATEWhite Glo USA Inc1adc752b-2ba8-4d8f-b4f1-5741f864255b2026-06-09WarningsExact identifier
application number: M021
Kids Crest Cavity Protection Sparkle FunSODIUM FLUORIDEProcter & Gamble Manufactura, S. de R.L. de C.V.df182c22-bbf1-448d-81e8-35cb431d2afc2026-06-08WarningsExact identifier
application number: M021
PEROXICARESODIUM FLUORIDEChurch & Dwight Co., Inc.55262538-15ce-455c-93b1-bb02b5f81d6b2026-06-07WarningsExact identifier
application number: M021
Optimax Anticavity Fluoride RaspberrySODIUM MONOFLUOROPHOSPHATEWhite Glo USA Inc57e1d1cb-da58-4cd2-b960-4056e0b0d2142026-06-05WarningsExact identifier
application number: M021
3ECARE Dual FormulaWhiteningToothpasteSODIUM FLUORIDEHangzhou Namei Zhikang Technology Co., Ltd.533fb7dd-7f84-59c5-e063-6394a90accad2026-06-02WarningsExact identifier
application number: M021
3ECARE Dual FormulaToothpastefor sensitiveteethPOTASSIUM NITRATE SODIUM MONOFLUOROPHOSPHATEHangzhou Namei Zhikang Technology Co., Ltd.533fc83e-a8cf-15c1-e063-6294a90a7b742026-06-02WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891775sodium fluoride 0.243 % ToothpastePSNa6af1baf-17bf-428c-8744-1490359b0cfb9
891775sodium fluoride 0.00243 MG/MG ToothpasteSCDa6af1baf-17bf-428c-8744-1490359b0cfb9
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSYa6af1baf-17bf-428c-8744-1490359b0cfb9
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSYa6af1baf-17bf-428c-8744-1490359b0cfb9
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSYa6af1baf-17bf-428c-8744-1490359b0cfb9
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSYa6af1baf-17bf-428c-8744-1490359b0cfb9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
37808-192-003780801920012 in 1 CASEHistorical
37808-192-0237808019202120 g in 1 TUBE (37808-192-02) 120 g2012-12-01NoNoCurrent