FDA.reportPublic FDA data

Sound Body Sensitive

Manufacturer
Big Lots Stores, Inc. | Lornamead Products
Effective date
2025-11-14
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:16:07

Label at a glance#

ProductSound Body Sensitive Maximum Strength
Active ingredientSODIUM FLUORIDE, POTASSIUM NITRATE
Label structure10 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Potassium nitrate 5%

Sodium fluoride 0.24% (0.15% w/v fluoride ion)

OTC - PURPOSE SECTION

Purpose

Antihypersensitivity

Anticavity

INDICATIONS & USAGE SECTION

Uses

  • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
  • aids in the prevention of dental cavities

WARNINGS SECTION

Warnings

OTC - WHEN USING SECTION

When using this productdo not use longer than 4 weeks unless recommended by a dentist or physician.

OTC - STOP USE SECTION

See your dentistif the problem worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

Adults and children 12 years of age and older:Apply at least a 1-inch strip of the product onto a soft bristle toothbrush.

  • Brush teeth thoroughly for at least one minute, preferably after each meal or at least twice a day (morning and evening) or as recommended by a dentist or physican. Make sure to brush all sensitive areas of the teeth.
  • Children under 12 years of age:consult a dentist or physician.

INACTIVE INGREDIENT SECTION

Inactive ingredientscocamidopropyl betaine, flavor, glycerin, hydrated silica, PEG-8, sodium hydroxide, sodium methyl cocoyl taurate, sodium saccharin, sodium tripolyphosphate, sorbitol, titanium dioxide, water, xanthan gum

OTC - QUESTIONS SECTION

Comments/Questions:1-877-777-2743

SPL UNCLASSIFIED SECTION

MANUFACTURED BY:

Lornamead, Inc.

175 Cooper Avenue

Tonawanda, NY 14150

MADE IN USA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SOUND BODY

MAXIMUM STRENGTH

SENSITIVE TOOTHPASTE WITH FLUORIDE

  • For sensitive teeth & cavity protection
  • Relieves painful sensitivity

EXTRA WHITENING

NET WT 4 OZ (113 g)

MM1MM1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpastePSN5
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCD5
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY5
1038929Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY5
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY5
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY5
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSY5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50594-214-192024-02-23C16284748780-1ab0e2407-265d-f274-e053-dbdaa90a64715820214 Sound Body Max Str Sensitive Toothpaste with Fluoride (8015201)
50594-214-192020-09-27C16284748780-1ab0e2407-265d-f274-e053-dbdaa90a64715820214 Sound Body Max Str Sensitive Toothpaste with Fluoride (8015201)
50594-214-192020-09-25C16284748780-1ab0e2407-265d-f274-e053-dbdaa90a64715820214 Sound Body Max Str Sensitive Toothpaste with Fluoride (8015201)
50594-214-192020-07-22C16284748780-1ab0e2407-265d-f274-e053-dbdaa90a64715820214 Sound Body Max Str Sensitive Toothpaste with Fluoride (8015201)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50594-214-19Sound Body SensitiveMaximum Strength113 g in 1 TUBEPASTE, DENTIFRICE1135
50594-214-19Sound Body SensitiveMaximum Strength1 in 1 CARTONPASTE, DENTIFRICE15

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50594-21450594-214-19

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM TRIPOLYPHOSPHATE5HK03SA80JIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
SORBITOL506T60A25RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SODIUM HYDROXIDE55X04QC32IIACT
GLYCERINPDC6A3C0OXIACT
XANTHAN GUMTTV12P4NEEIACT
HYDRATED SILICAY6O7T4G8P9IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SODIUM METHYL COCOYL TAURATEJVL98CG53GIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
POTASSIUM NITRATERU45X2JN0ZACTIB

Source Document#

Source XML

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sound Body Sensitive Maximum StrengthPOTASSIUM NITRATE, SODIUM FLUORIDEBig Lots Stores, Inc.81a0a712-76e1-133f-e053-2a91aa0a001a2025-11-14WarningsExact identifier
ndc (package): 50594-214-19
ndc (product): 50594-214
ndc11 (package): 50594021419
spl id: 43958162-cac7-a219-e063-6294a90ac0aa
spl set id: 81a0a712-76e1-133f-e053-2a91aa0a001a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.