FDA.reportPublic FDA data

Lornamead

Product NDC
62721-0470
11-digit product format
627210470
Labeler code
62721
Product ID
62721-0470_3bdd868d-4c10-0942-e063-6294a90a6d15
Type
HUMAN OTC DRUG
Nonproprietary name
Fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Lornamead Products
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-12-01
Substance
POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength
5; .15 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lornamead
Brand name suffix
Natural White
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM NITRATE5 g/100g
SODIUM FLUORIDE.15 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRU45X2JN0Z, 8ZYQ1474W7
Rxcui1038929

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62721-0470-92023-06-13C16284748780-19d75b9d0-bfe0-f424-e053-dadaa90a57ce5010570 Natural White Extreme Sensitive Whitening
62721-0470-92020-01-31C16284748780-19d75b9d0-bfe0-f424-e053-dadaa90a57ce5010570 Natural White Extreme Sensitive Whitening

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62721-0470-2LornameadNatural White128 g in 1 TUBEPASTE, DENTIFRICE1286
62721-0470-3LornameadNatural White96.4 g in 1 TUBEPASTE, DENTIFRICE96.46
62721-0470-7LornameadNatural White1 in 1 CARTONPASTE, DENTIFRICE16
62721-0470-9LornameadNatural White1 in 1 CARTONPASTE, DENTIFRICE16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POTASSIUM NITRATEACTIVE INGREDIENTRU45X2JN0ZLORNAMEAD NATURAL WHITE (FLUORIDE) PASTE, DENTIFRICE [LORNAMEAD]1
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7LORNAMEAD NATURAL WHITE (FLUORIDE) PASTE, DENTIFRICE [LORNAMEAD]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OLORNAMEAD NATURAL WHITE (FLUORIDE) PASTE, DENTIFRICE [LORNAMEAD]1
NITRATE IONACTIVE MOIETYT93E9Y2844LORNAMEAD NATURAL WHITE (FLUORIDE) PASTE, DENTIFRICE [LORNAMEAD]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311LORNAMEAD NATURAL WHITE (FLUORIDE) PASTE, DENTIFRICE [LORNAMEAD]1
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXLORNAMEAD NATURAL WHITE (FLUORIDE) PASTE, DENTIFRICE [LORNAMEAD]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOALORNAMEAD NATURAL WHITE (FLUORIDE) PASTE, DENTIFRICE [LORNAMEAD]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXLORNAMEAD NATURAL WHITE (FLUORIDE) PASTE, DENTIFRICE [LORNAMEAD]1
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9LORNAMEAD NATURAL WHITE (FLUORIDE) PASTE, DENTIFRICE [LORNAMEAD]1
POLYETHYLENE GLYCOL 600INACTIVE INGREDIENTNL4J9F21N9LORNAMEAD NATURAL WHITE (FLUORIDE) PASTE, DENTIFRICE [LORNAMEAD]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYLORNAMEAD NATURAL WHITE (FLUORIDE) PASTE, DENTIFRICE [LORNAMEAD]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EULORNAMEAD NATURAL WHITE (FLUORIDE) PASTE, DENTIFRICE [LORNAMEAD]1
SODIUM TRIPOLYPHOSPHATEINACTIVE INGREDIENT5HK03SA80JLORNAMEAD NATURAL WHITE (FLUORIDE) PASTE, DENTIFRICE [LORNAMEAD]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLORNAMEAD NATURAL WHITE (FLUORIDE) PASTE, DENTIFRICE [LORNAMEAD]1
WATERINACTIVE INGREDIENT059QF0KO0RLORNAMEAD NATURAL WHITE (FLUORIDE) PASTE, DENTIFRICE [LORNAMEAD]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62721-0470LORNAMEAD NATURAL WHITE (FLUORIDE) PASTE, DENTIFRICE [LORNAMEAD]4Current NDC, Legacy NDC, 4 package rows20250119_9d7d08d7-8ca4-4b05-8b74-3bfa372b1608.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpastePSN9d7d08d7-8ca4-4b05-8b74-3bfa372b16086
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCD9d7d08d7-8ca4-4b05-8b74-3bfa372b16086
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY9d7d08d7-8ca4-4b05-8b74-3bfa372b16086
1038929Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY9d7d08d7-8ca4-4b05-8b74-3bfa372b16086
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY9d7d08d7-8ca4-4b05-8b74-3bfa372b16086
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY9d7d08d7-8ca4-4b05-8b74-3bfa372b16086
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSY9d7d08d7-8ca4-4b05-8b74-3bfa372b16086

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62721-0470-262721047002128 g in 1 TUBE128 gHistorical
62721-0470-36272104700396.4 g in 1 TUBE96.4 gHistorical
62721-0470-7627210470071 TUBE in 1 CARTON (62721-0470-7) / 96.4 g in 1 TUBE (62721-0470-3) 1 tube2023-06-12NoNoCurrent
62721-0470-9627210470091 in 1 CARTONHistorical