FDA.reportPublic FDA data

Lornamead

Product NDC
62721-0470
Requested package NDC
62721-0470-7
11-digit product format
627210470
Labeler code
62721
Product ID
62721-0470_57c60feb-2b08-cb25-e063-6294a90a5d92
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
SODIUM FLUORIDE; POTASSIUM NITRATE
Active strength
.15; 5 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
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
Lornamead
Brand name suffix
Natural White
Listing expiration
2027-12-31

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
9d7d08d7-8ca4-4b05-8b74-3bfa372b1608Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-06-135010570 Natural White Extreme Sensitive Whitening
2023-06-135010570 Natural White Extreme Sensitive Whitening
2020-01-315010570 Natural White Extreme Sensitive Whitening
2020-01-315010570 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

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
CrystLCare Regeneration PlusPOTASSIUM NITRATE, SODIUM FLUORIDEGreenMark Biomedical Inc.4f86d0a0-d73e-5605-e063-6394a90adb382026-09-14WarningsExact identifier
application number: M022
Opalescence Whitening Sensitivity ReliefPOTASSIUM NITRATE AND SODIUM FLUORIDEUltradent Products, Inc.44e94663-895b-67da-e063-6394a90a5fe62026-09-09WarningsExact identifier
application number: M022
Opalescence Sensitivity Relief WhiteningPOTASSIUM NITRATE AND SODIUM FLUORIDEUltradent Products, Inc.b5176a84-76a3-4ad0-a2e2-4997a12da9a52026-09-09WarningsExact identifier
application number: M022
Opal by Opalescence SensitivityPOTASSIUM NITRATE AND SODIUM FLUORIDEUltradent Products, Inc.5ffc0d14-0290-47bb-90e5-90a25a5acc282026-09-09WarningsExact identifier
application number: M022
SalineNASALRaritan Pharmaceuiticals Inc4b178e4e-a10f-4b75-8140-1f7548e203ad2026-09-09WarningsExact identifier
application number: M022
SORE THROATPHENOLRaritan Pharmaceuticals Inc43ce374a-824c-4034-bf04-c351b4d8015b2026-09-08WarningsExact identifier
application number: M022
Colgate Optic White Stain Fighter Sens ReliefSODIUM FLUORIDEColgate-Palmolive Company6ec2fff7-df44-4302-be2d-97946c6cd66a2026-09-08WarningsExact identifier
application number: M022
DRx Choice Sore Throat Menthol FlavorPHENOLRARITAN PHARMACEUTICALS INCe3269b12-5c05-45a6-81f2-65d9f016c3aa2026-09-08WarningsExact identifier
application number: M022
Hydrogen PeroxideHYDROGEN PEROXIDEAmerisourceBergen (Good Neighbor Pharmacy) 461220733015b-e81a-4a62-82ad-dacaf3f163cb2026-09-02WarningsExact identifier
application number: M022
KROGER SalineNASALKROGER COMPANYc84b242b-f46e-4ea8-a3c1-109a476446462026-09-02WarningsExact identifier
application number: M022
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWALMART INC. (see also Equate)ceb125d9-8c1b-498c-b0f0-f18756ede4422026-09-01WarningsExact identifier
application number: M022
Orajel 4X Medicated Toothache and Gum CreamBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.5a1c82b4-02b3-d456-e063-6294a90a16bb2026-08-31WarningsExact identifier
application number: M022
Orajel 4X Medicated Toothache and Gum PM CreamBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.5a1cdaf4-3388-280c-e063-6294a90ac70f2026-08-31WarningsExact identifier
application number: M022
MUCINEX INSTASOOTHE SORE THROAT PLUS SOOTHING COMFORTHEXYLRESORCINOLReckitt Benckiser LLC91cd2964-5d83-4e40-bc18-e3e5462f454a2026-08-31WarningsExact identifier
application number: M022
MUCINEX INSTASOOTHE SORE THROAT PLUS PAIN RELIEFHEXYLRESORCINOLReckitt Benckiser LLC4c150222-06ea-4fcf-967f-84e19846bd662026-08-31WarningsExact identifier
application number: M022
Orajel 4X Medicated Toothache and GumBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.5a1b4133-0eac-2f8f-e063-6394a90af8f62026-08-28WarningsExact identifier
application number: M022
LUDENS SUGAR FREE WILD CHERRY THROATPECTINPrestige Brands Holdings, Inc.274fc80c-e5b2-41c7-a119-287d6e8a22582026-08-28WarningsExact identifier
application number: M022
Medline Peroxi Fresh MouthwashHYDROGEN PEROXIDEMedline Industries, LPec7a9240-6c66-4471-b8b6-776e08a14fbc2026-08-27WarningsExact identifier
application number: M022
SalineSALINE NASAL SPRAYDynarex Corporation3247ae7d-554f-baab-e063-6294a90aa3ec2026-08-25WarningsExact identifier
application number: M022
Tumeez Organic AppleCALCIUM CARBONATEBFY LLCf561685a-5260-59c6-e053-2a95a90ae2062026-08-25WarningsExact identifier
application number: M022

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
62721-0470-7627210470071 TUBE in 1 CARTON (62721-0470-7) / 96.4 g in 1 TUBE (62721-0470-3) 1 tube2023-06-12NoNoCurrent