FDA.reportPublic FDA data

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

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 packagepackage37808-68137808-681-19DDiscontinued by firm2026-10-16

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 dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage37808-68137808-681-19DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…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
IngredientStrength
SODIUM FLUORIDE.15 g/100g
POTASSIUM NITRATE5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup
RU45X2JN0ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1038929Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9bdcbd3f-095b-43d1-8a8e-0ba3eab14e0eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-681-19HEBExtra Whitening113 g in 1 TUBEPASTE, DENTIFRICE1139
37808-681-19HEBExtra Whitening1 in 1 CARTONPASTE, DENTIFRICE19
37808-681-29HEBExtra Whitening1 in 1 CARTONPASTE, DENTIFRICE19
37808-681-29HEBExtra Whitening113 g in 1 TUBEPASTE, DENTIFRICE1139

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POTASSIUM NITRATEACTIVE INGREDIENTRU45X2JN0ZHEB EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [HEB]2
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7HEB EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [HEB]2
FLUORIDE IONACTIVE MOIETYQ80VPU408OHEB EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [HEB]2
NITRATE IONACTIVE MOIETYT93E9Y2844HEB EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [HEB]2
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXHEB EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [HEB]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXHEB EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [HEB]2
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9HEB EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [HEB]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQHEB EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [HEB]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYHEB EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [HEB]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IHEB EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [HEB]2
SODIUM METHYL COCOYL TAURATEINACTIVE INGREDIENTJVL98CG53GHEB EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [HEB]2
SORBITOLINACTIVE INGREDIENT506T60A25RHEB EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [HEB]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHEB EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [HEB]2
WATERINACTIVE INGREDIENT059QF0KO0RHEB EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [HEB]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEHEB EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [HEB]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-681HEB EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [HEB]6Current NDC, Legacy NDC, 4 package rows20250119_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 11 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Crest Kids Advanced Color ChangingSODIUM MONOFLUOROPHOSPHATEProcter & Gamble Manufactura, S de R.L. de C.V.fc86b98e-d556-4769-e053-6394a90afc6e2026-01-08WarningsExact identifier
application number: M022
Care One Maximum StrengthFLUORIDEAmerican Sales1b6618ea-6533-41d7-be2c-13bb9e108dc52026-01-08WarningsExact identifier
application number: M022
equate SensitivePOTASSIUM NITRATE, SODIUM FLUORIDEWal-Mart Stores Inc79899b59-3a16-6504-e053-2991aa0a895a2026-01-08WarningsExact identifier
application number: M022
Crest Kids Advanced Color ChangingSODIUM MONOFLUOROPHOSPHATEProcter & Gamble Manufactura, S de R.L. de C.V.451283d3-78b0-8361-e063-6294a90a1fd52026-01-08WarningsExact identifier
application number: M022
CVS Maximum StrengthBENZOCAINECVS Pharmacy8691d6b6-741e-47b2-8332-76742b34715f2026-01-08WarningsExact identifier
application number: M022
4x Medicated Toothache and Gum GelBENZOCAINEPublix Super Markets INC16eb9d15-dba3-36e6-e063-6394a90ab8592026-01-08WarningsExact identifier
application number: M022
Toothache and Gum ReliefBENZOCAINE, MENTHOLCVS Pharmacy814ec7bf-f825-1095-e053-2a91aa0aee592026-01-08WarningsExact identifier
application number: M022
LemonGLYCERINSion Biotext Medical Ltddbd7ed86-1b92-4471-827a-89f3afa1b0dc2026-01-08WarningsExact identifier
application number: M022
Sootheez Organic Wild CherryPECTINBFY LLC47baa2a8-270c-fa07-e063-6394a90a97f62026-01-06WarningsExact identifier
application number: M022
Parodontax Gum Strengthen and ProtectCETYLPYRIDINIUM CHLORIDEHaleon US Holdings LLC3bb378c8-14b2-aa13-e063-6294a90a4db32026-01-05WarningsExact identifier
application number: M022
MySweetSmile Toothpaste.MYSWEETSMILE TOOTHPASTE.Jiangxi Dentalbright Technology Co., Ltd478baf87-9276-7288-e063-6294a90a9e8e2026-01-04WarningsExact identifier
application number: M022
MySweetSmile Mango Toothpaste.MYSWEETSMILE MANGO TOOTHPASTE.Jiangxi Dentalbright Technology Co., Ltd478cbdeb-28e1-fa56-e063-6294a90af1242026-01-04WarningsExact identifier
application number: M022
Smile PaintSODIUM FLUORIDEJABBER JAW KIDS TOOTHPASTE LLCa7463b5c-53b2-4353-a5ea-800fbd7bd17d2026-01-02WarningsExact identifier
application number: M022
Dentek Canker CoverMENTHOLBershtel Enterprises2669183c-7a58-037e-e054-00144ff88e882025-12-31WarningsExact identifier
application number: M022
AutoBrush strawberrySODIUM FLUORIDELander Enterprises, LLC05929148-bffe-439f-a9d4-3170816c0fa22025-12-31WarningsExact identifier
application number: M022
AutoBrush WatermelonSODIUM FLUORIDELander Enterprises, LLC37a4e712-e3b5-42f6-971c-98dea4b8dd062025-12-31WarningsExact identifier
application number: M022
AutoBrush MintSODIUM FLUORIDELander Enterprises, LLC6bcd35f5-18ea-4fc8-84cd-06db73f38a1e2025-12-31WarningsExact identifier
application number: M022
AutoBrush BubblegumSODIUM FLUORIDELander Enterprises, LLCe7bf7e31-650d-4a1c-9100-48722344b2012025-12-31WarningsExact identifier
application number: M022
Normal SaltSODIUM CHLORIDEGRAXCELL PHARMACEUTICAL, LLCf3f09817-8a38-4aa1-956b-69d9cf6950742025-12-25WarningsExact identifier
application number: M022
Sensitive Mint Tooth-pastePOTASSIUM NITRATE, SODIUM FLUORIDEMeijer, Inc.1e5e8b24-8304-482c-ae80-73effcc345da2025-12-23WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpastePSN9bdcbd3f-095b-43d1-8a8e-0ba3eab14e0e9
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCD9bdcbd3f-095b-43d1-8a8e-0ba3eab14e0e9
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY9bdcbd3f-095b-43d1-8a8e-0ba3eab14e0e9
1038929Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY9bdcbd3f-095b-43d1-8a8e-0ba3eab14e0e9
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY9bdcbd3f-095b-43d1-8a8e-0ba3eab14e0e9
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY9bdcbd3f-095b-43d1-8a8e-0ba3eab14e0e9
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSY9bdcbd3f-095b-43d1-8a8e-0ba3eab14e0e9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-681-19378080681191 TUBE in 1 CARTON (37808-681-19) > 113 g in 1 TUBE1 tube2012-11-300000-00-00NoNoCurrent
37808-681-29378080681291 TUBE in 1 CARTON (37808-681-29) / 113 g in 1 TUBE1 tube2025-11-21NoNoCurrent