FDA.reportPublic FDA data

HEB

Product NDC
37808-961
11-digit product format
378080961
Labeler code
37808
Product ID
37808-961_47e54604-814a-fc9e-e063-6394a90a95f3
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
POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength
5; .15 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
HEB
Brand name suffix
Extra Whitening
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE5 g/100g
POTASSIUM NITRATE.15 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
b76c3591-6383-4661-b3db-7a56b11202f7Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-961-12HEBExtra Whitening113 g in 1 TUBEPASTE, DENTIFRICE11315
37808-961-19HEBExtra Whitening1 in 1 CARTONPASTE, DENTIFRICE115

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POTASSIUM NITRATEACTIVE INGREDIENTRU45X2JN0ZHEB EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [HEB]6
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7HEB EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [HEB]6
FLUORIDE IONACTIVE MOIETYQ80VPU408OHEB EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [HEB]6
NITRATE IONACTIVE MOIETYT93E9Y2844HEB EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [HEB]6
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXHEB EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [HEB]6
GLYCERININACTIVE INGREDIENTPDC6A3C0OXHEB EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [HEB]6
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9HEB EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [HEB]6
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQHEB EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [HEB]6
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYHEB EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [HEB]6
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IHEB EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [HEB]6
SODIUM METHYL COCOYL TAURATEINACTIVE INGREDIENTJVL98CG53GHEB EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [HEB]6
SODIUM TRIPOLYPHOSPHATEINACTIVE INGREDIENT5HK03SA80JHEB EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [HEB]6
SORBITOLINACTIVE INGREDIENT506T60A25RHEB EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [HEB]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHEB EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [HEB]6
WATERINACTIVE INGREDIENT059QF0KO0RHEB EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [HEB]6
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEHEB EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [HEB]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-961HEB EXTRA WHITENING (FLUORIDE) PASTE, DENTIFRICE [HEB]13Current NDC, Legacy NDC, 2 package rows20250316_b76c3591-6383-4661-b3db-7a56b11202f7.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 1 of 41 · 818 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrogen Peroxide 3 Percent ReadyInCaseHYDROGEN PEROXIDEP & L Development, LLCb0866db5-3b0d-4478-9b3b-1f077d2f53932026-08-06WarningsExact identifier
application number: M022
Ollie Fresh MintSODIUM FLUORIDE, POTASSIUM NITRATEBrio Product Group LLC.ebeec44f-3c22-43f2-9256-6ece6025c1052026-08-06WarningsExact identifier
application number: M022
PRO-SYSORAL WOUND CLEANSERForward Science Technologies LLCc357c8f8-6fd6-c2f8-e053-2995a90a40232026-07-30WarningsExact identifier
application number: M022
Lornamead Natural WhiteFLUORIDELornamead Products9d7d08d7-8ca4-4b05-8b74-3bfa372b16082026-07-29WarningsExact identifier
application number: M022
Made by Dentists Enamel 10 Fluoride AnticavityPOTASSIUM NITRATE, SODIUM FLUORIDEMade By Dentists Inc3c62eab1-0cb6-4bdf-bfd4-c5afe734d0362026-07-24WarningsExact identifier
application number: M022
SalineNASALBEST CHOICE (VALU MERCHANDISERS COMPANY)71485e82-bf54-4b8b-8dd2-2a07615345202026-07-17WarningsExact identifier
application number: M022
Good Neighbor Sore Throat Cherry FlavorPHENOLAMERISOURCE BERGENaa8fb8ff-61c7-41ba-9a23-1052e2b6cd7f2026-07-13WarningsExact identifier
application number: M022
ABC Sore Throat Menthol FlavorPHENOLAMERISOURCE BERGEN9d9baf58-4790-4ff4-a462-5eb70c0e80c52026-07-13WarningsExact identifier
application number: M022
Hydrogen PeroxideHYDROGEN PEROXIDEP & L Development, LLC350b5f64-d152-40cb-b22f-98541f0e1b0a2026-07-09WarningsExact identifier
application number: M022
Quality Choice Natural WhiteFLUORIDECHAIN DRUG MARKETING ASSOCIATION INC561a75c2-a40c-ba7c-e063-6294a90aa1192026-07-08WarningsExact identifier
application number: M022
SALINE NASALSODIUM CHLORIDEALAINA HEALTHCARE PRIVATE LIMITEDed30a7f9-7132-42da-9bed-63a9b1c80ab22026-07-07WarningsExact identifier
application number: M022
Tumeez Organic AppleCALCIUM CARBONATEBFY LLCf561685a-5260-59c6-e053-2a95a90ae2062026-07-06WarningsExact identifier
application number: M022
MUCINEX INSTASOOTHE SORE THROAT PLUS PAIN RELIEFHEXYLRESORCINOLReckitt Benckiser LLC4c150222-06ea-4fcf-967f-84e19846bd662026-07-03WarningsExact identifier
application number: M022
Dental system starter kitUS CONVENIENCE KIT (718907)Dyson Technology Limited5355b79b-711f-1a4a-e063-6394a90afc4b2026-06-30WarningsExact identifier
application number: M022
Anticavity and sensitive peppermint907 US VARIANT ANTICAVITY AND SENSITIVE TOOTHPASTE NON FOAMING PEPPERMINTDyson Technology Limited5332ab71-d994-39cf-e063-6294a90a0d982026-06-30WarningsExact identifier
application number: M022
NebuClear MD SalineNEBUCLEAR MD SALINEBlue Echo Care LLC55820ff9-7b4b-2bce-e063-6394a90a8b432026-06-30WarningsExact identifier
application number: M022
NebuClear MD SalineNEBUCLEAR MD SALINEBlue Echo Care LLC55806cb8-cf92-c4e5-e063-6394a90aaa2d2026-06-30WarningsExact identifier
application number: M022
NebuClear MD SalineNEBUCLEAR MD SALINEBlue Echo Care LLC5581d8e5-4105-e9da-e063-6394a90a316e2026-06-30WarningsExact identifier
application number: M022
CorinzCETYLPYRIDINIUM CHLORIDESage Products, LLC685b6023-89c4-417e-af2d-52e831855da12026-06-29WarningsExact identifier
application number: M022
Antiplaque solutionCETYLPYRIDINIUM CHLORIDESage Products LLC881d4d08-4b45-486a-93af-18c0e00a5b0e2026-06-29WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpastePSNb76c3591-6383-4661-b3db-7a56b11202f715
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCDb76c3591-6383-4661-b3db-7a56b11202f715
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSYb76c3591-6383-4661-b3db-7a56b11202f715
1038929Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSYb76c3591-6383-4661-b3db-7a56b11202f715
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSYb76c3591-6383-4661-b3db-7a56b11202f715
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSYb76c3591-6383-4661-b3db-7a56b11202f715
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSYb76c3591-6383-4661-b3db-7a56b11202f715

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-961-1237808096112113 g in 1 TUBE113 gHistorical
37808-961-19378080961191 TUBE in 1 CARTON (37808-961-19) / 113 g in 1 TUBE (37808-961-12) 1 tube2011-01-200000-00-00NoNoCurrent