FDA.reportPublic FDA data

HEB Enamel Protection

Product NDC
37808-336
11-digit product format
378080336
Labeler code
37808
Product ID
37808-336_441c1004-fd5d-d250-e063-6294a90aae44
Type
HUMAN OTC DRUG
Nonproprietary name
Potassium nitrate, sodium fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
HEB
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-02-20
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

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 Enamel Protection
Brand name suffix
Multi Action
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
1038841Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8255de83-aa60-b081-e053-2a91aa0afcdcAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-336-19HEB Enamel ProtectionMulti Action113 g in 1 TUBEPASTE, DENTIFRICE11314
37808-336-19HEB Enamel ProtectionMulti Action1 in 1 CARTONPASTE, DENTIFRICE114

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-336HEB ENAMEL PROTECTION MULTI ACTION (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE, DENTIFRICE [HEB]12Current NDC, Legacy NDC, 2 package rows20250119_8255de83-aa60-b081-e053-2a91aa0afcdc.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 16 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GuruNanda OxyfusionHYDROGEN PEROXIDEGURUNANDA, LLC3be317b9-a5d8-b198-e063-6394a90af9852025-11-11WarningsExact identifier
application number: M022
GuruNanda Oral Pain ReliefMENTHOLGURUNANDA, LLC3b8f3562-0e46-bea4-e063-6294a90adb712025-11-11WarningsExact identifier
application number: M022
TopCare Cherry FlavorPHENOLTOPCO ASSOCIATES, LLC5d3f0610-deb4-4180-ae19-2c65ed2f368b2025-11-10WarningsExact identifier
application number: M022
Topcare Sore Throat Menthol FlavorPHENOLTOPCO ASSOCIATES LLCfb1f2c11-2508-4985-bae5-7d547bd6aa232025-11-10WarningsExact identifier
application number: M022
Zilactin-BBENZOCAINEASCENT CONSUMER PRODUCTS, INC42eeb3d4-bac6-4e29-e063-6294a90a644d2025-11-06WarningsExact identifier
application number: M022
Zilactin Early Relief Cold SoreBENZYL ALCOHOLASCENT CONSUMER PRODUCTS, INC42ef8bfa-c4d9-01cf-e063-6394a90ac88a2025-11-06WarningsExact identifier
application number: M022
HurriCaine Topical Anesthetic GelBENZOCAINEBeutlich Pharmaceuticals, LLC106b6115-d043-4050-80c6-1d82456dea022025-11-06WarningsExact identifier
application number: M022
HurriCaine Topical Anesthetic GelBENZOCAINEBeutlich Pharmaceuticals, LLC4c278122-2643-46bf-9e44-11985210a16e2025-11-06WarningsExact identifier
application number: M022
HurriCaine Topical Anesthetic LiquidBENZOCAINEBeutlich Pharmaceuticals, LLCfee9969d-ad1a-4f44-9741-a0a44c9e11282025-11-06WarningsExact identifier
application number: M022
Ear Wax Removal Aid DropsCARBAMIDE PEROXIDETarget Corporation0ddf9945-147d-4b25-98a6-4e9f12a4656f2025-11-05WarningsExact identifier
application number: M022
Alpha-Caine Topical AnestheticBENZOCAINEDental Technologies, Inc.e6a312e5-17ac-46f0-8723-4e40eeecd69f2025-11-04WarningsExact identifier
application number: M022
PEROXY SHIELD MOUTH SORE1.5% HYDROGEN PEROXIDEDental Technologies, Inc.a72e433b-1b7d-4a0c-e053-2995a90a30c42025-11-04WarningsExact identifier
application number: M022
Alpha-Caine Topical AnestheticBENZOCAINEDental Technologies, Inc.ae628766-25b7-4b4f-abb8-a43faf2f44b92025-11-04WarningsExact identifier
application number: M022
Alpha-Caine Topical AnestheticBENZOCAINEDental Technologies, Inc.719743f9-21fc-4568-b879-acdfa46394642025-11-04WarningsExact identifier
application number: M022
Alpha-Caine Topical AnestheticBENZOCAINEDental Technologies, Inc.ff0695a1-1d7d-4b51-97fd-689e56d914fe2025-11-04WarningsExact identifier
application number: M022
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLFamily Dollar (FAMILY WELLNESS)f7edf75c-cdba-4dde-bfc5-a04af34759d32025-11-03WarningsExact identifier
application number: M022
7 Select Oral Pain Maximum Strength ReliefBENZOCAINE7-ELEVEN, INC.f170a570-1c50-4b9a-be16-9b01bf5eaa742025-10-31WarningsExact identifier
application number: M022
Oral Pain ReliefBENZOCAINE AND BENZALKONIUM CHLORIDEUniversal Distribution Center LLC18520f9b-4d35-1e9c-e063-6294a90aaa392025-10-30WarningsExact identifier
application number: M022
Iodent Oral AnalgesicBENZOCAINEUnited Exchange Corp.63902125-f8dc-0ada-e053-2991aa0a7ce52025-10-30WarningsExact identifier
application number: M022
Ear Wax Removal Aid DropsCARBAMIDE PEROXIDEBETTER LIVING BRANDS, LLC3bded237-4d2c-4b38-bedc-267fdc3741942025-10-29WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038841potassium nitrate 5 % / sodium fluoride 0.15 % ToothpastePSN8255de83-aa60-b081-e053-2a91aa0afcdc14
1038841potassium nitrate 0.05 MG/MG / sodium fluoride 0.0015 MG/MG ToothpasteSCD8255de83-aa60-b081-e053-2a91aa0afcdc14
1038841K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0015 MG/MG ToothpasteSY8255de83-aa60-b081-e053-2a91aa0afcdc14
1038841pot nitrate 0.05 MG/MG / sodium fluoride 0.0015 MG/MG gel ToothpasteSY8255de83-aa60-b081-e053-2a91aa0afcdc14
1038841Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0015 MG/MG ToothpasteSY8255de83-aa60-b081-e053-2a91aa0afcdc14
1038841potassium nitrate 5 % / sodium fluoride 0.15 % ToothpasteSY8255de83-aa60-b081-e053-2a91aa0afcdc14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-336-19378080336191 TUBE in 1 CARTON (37808-336-19) / 113 g in 1 TUBE1 tube2019-02-200000-00-00NoNoCurrent