FDA.reportPublic FDA data

Quality Choice

Product NDC
63868-172
11-digit product format
638680172
Labeler code
63868
Product ID
63868-172_436bace6-33f8-30cd-e063-6294a90ac22a
Type
HUMAN OTC DRUG
Nonproprietary name
Fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
CHAIN DRUG MARKETING ASSOCIATION INC
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-01-20
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63868-17263868-172-23DDiscontinued by firm2026-10-16
excluded packagepackage63868-17263868-172-29DDiscontinued by firm2026-10-16

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
Quality Choice
Brand name suffix
Natural White
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
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
8d187823-7e56-441b-8bca-8f03e7bb07c7Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-172-22Quality ChoiceNatural White128 g in 1 TUBEPASTE, DENTIFRICE12811
63868-172-23Quality ChoiceNatural White1 in 1 CARTONPASTE, DENTIFRICE111
63868-172-23Quality ChoiceNatural White116 g in 1 TUBEPASTE, DENTIFRICE11611
63868-172-29Quality ChoiceNatural White1 in 1 CARTONPASTE, DENTIFRICE111
63868-172-34Quality ChoiceNatural White1 in 1 CARTONPASTE, DENTIFRICE111
63868-172-34Quality ChoiceNatural White96.4 g in 1 TUBEPASTE, DENTIFRICE96.411

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POTASSIUM NITRATEACTIVE INGREDIENTRU45X2JN0ZQUALITY CHOICE NATURAL WHITE (FLUORIDE) PASTE, DENTIFRICE [CHAIN DRUG MARKETING ASSOCIATION INC]1
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7QUALITY CHOICE NATURAL WHITE (FLUORIDE) PASTE, DENTIFRICE [CHAIN DRUG MARKETING ASSOCIATION INC]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OQUALITY CHOICE NATURAL WHITE (FLUORIDE) PASTE, DENTIFRICE [CHAIN DRUG MARKETING ASSOCIATION INC]1
NITRATE IONACTIVE MOIETYT93E9Y2844QUALITY CHOICE NATURAL WHITE (FLUORIDE) PASTE, DENTIFRICE [CHAIN DRUG MARKETING ASSOCIATION INC]1
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXQUALITY CHOICE NATURAL WHITE (FLUORIDE) PASTE, DENTIFRICE [CHAIN DRUG MARKETING ASSOCIATION INC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXQUALITY CHOICE NATURAL WHITE (FLUORIDE) PASTE, DENTIFRICE [CHAIN DRUG MARKETING ASSOCIATION INC]1
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9QUALITY CHOICE NATURAL WHITE (FLUORIDE) PASTE, DENTIFRICE [CHAIN DRUG MARKETING ASSOCIATION INC]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQQUALITY CHOICE NATURAL WHITE (FLUORIDE) PASTE, DENTIFRICE [CHAIN DRUG MARKETING ASSOCIATION INC]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYQUALITY CHOICE NATURAL WHITE (FLUORIDE) PASTE, DENTIFRICE [CHAIN DRUG MARKETING ASSOCIATION INC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IQUALITY CHOICE NATURAL WHITE (FLUORIDE) PASTE, DENTIFRICE [CHAIN DRUG MARKETING ASSOCIATION INC]1
SODIUM METHYL COCOYL TAURATEINACTIVE INGREDIENTJVL98CG53GQUALITY CHOICE NATURAL WHITE (FLUORIDE) PASTE, DENTIFRICE [CHAIN DRUG MARKETING ASSOCIATION INC]1
SODIUM TRIPOLYPHOSPHATEINACTIVE INGREDIENT5HK03SA80JQUALITY CHOICE NATURAL WHITE (FLUORIDE) PASTE, DENTIFRICE [CHAIN DRUG MARKETING ASSOCIATION INC]1
SORBITOLINACTIVE INGREDIENT506T60A25RQUALITY CHOICE NATURAL WHITE (FLUORIDE) PASTE, DENTIFRICE [CHAIN DRUG MARKETING ASSOCIATION INC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPQUALITY CHOICE NATURAL WHITE (FLUORIDE) PASTE, DENTIFRICE [CHAIN DRUG MARKETING ASSOCIATION INC]1
WATERINACTIVE INGREDIENT059QF0KO0RQUALITY CHOICE NATURAL WHITE (FLUORIDE) PASTE, DENTIFRICE [CHAIN DRUG MARKETING ASSOCIATION INC]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEQUALITY CHOICE NATURAL WHITE (FLUORIDE) PASTE, DENTIFRICE [CHAIN DRUG MARKETING ASSOCIATION INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-172QUALITY CHOICE NATURAL WHITE (FLUORIDE) PASTE, DENTIFRICE [CHAIN DRUG MARKETING ASSOCIATION INC]9Current NDC, Legacy NDC, 6 package rows20250119_8d187823-7e56-441b-8bca-8f03e7bb07c7.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 20 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreens Mouth Sore ReliefBENZOCAINEWalgreens253d7ea2-e48e-c7d7-e063-6394a90ae0012025-08-12WarningsExact identifier
application number: M022
Charm Tex FLUORIDE GelSODIUM FLUORIDEYangzhou Hongshengding Chemical Co.,Ltd.897b0102-1c96-4699-908e-a7b7e26cd29f2025-08-08WarningsExact identifier
application number: M022
Meijer Enamel GuardPOTASSIUM NITRATE, SODIUM FLUORIDEMeijer Distribution Inc82bc95be-0a07-3f00-e053-2a91aa0a74382025-08-08WarningsExact identifier
application number: M022
Topco Associates LLC Maximum StrengthFLUORIDETopco Associates LLCac398ff0-0010-4e13-8b89-dc986fd7f9742025-08-08WarningsExact identifier
application number: M022
QUALITY CHOICE SALINEPLUS SOOTHING ALOEQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)4ae4e88a-aaa5-4195-bedc-622fd5cd93942025-07-30WarningsExact identifier
application number: M022
Aseptil RojoPHENOLMenper Distributors, Inc.62c96dc1-4698-43c1-8e6d-f4062dc5eea22025-07-22WarningsExact identifier
application number: M022
AnestenkaBENZOCAINEMenper Distributors, Inc00a3f1bc-ddfe-47c6-8221-f48f915135032025-07-22WarningsExact identifier
application number: M022
Cureforte Breath ResetMOUTH SPRAYSTEEL CITY HEALTH PRIVATE LIMITED38ddf1a7-29ab-cb8d-e063-6294a90ad34c2025-07-21WarningsExact identifier
application number: M022
SprinJene Natural Sensitivity and GumPOTASSIUM NITRATEHealth and Natural Beauty USA Corp3cb23e36-0e8c-4172-b4ae-859b58a2739f2025-07-07WarningsExact identifier
application number: M022
Normal SaltSODIUM CHLORIDETwin Med LLCdc82ff0f-8600-373a-e053-2995a90a75052025-07-03WarningsExact identifier
application number: M022
Sensodyne Pronamel Kids Berry TwistSODIUM FLUORIDEHaleon US Holdings LLC69c07c36-b5e0-420b-ab29-7d10913863222025-07-03WarningsExact identifier
application number: M022
DenTek Instant Pain Relief Maximum StrengthBENZOCAINEDenTek Oral Care, Inc.ae92b76e-815a-4b4c-8128-bd045098caa52025-06-30WarningsExact identifier
application number: M022
Sensodyne Clinical White Stain ProtectorPOTASSIUM NITRATE, SODIUM FLUORIDEHaleon US Holdings LLC99037e59-53d6-492c-8fce-67641fc8efdd2025-06-25WarningsExact identifier
application number: M022
Iolite-SBENZOCAINEDharma Research, Inc.b3b68914-2adc-4f07-9521-0b18756be5222025-06-14WarningsExact identifier
application number: M022
Red Cross ToothacheEUGENOLThe Mentholatum Company3537e599-65d9-48d6-8a46-d42312f71e842025-06-11WarningsExact identifier
application number: M022
QUALITY CHOICE Sore ThroatPHENOLCHAIN DRUG MARKETING ASSOCIATIONc95ee086-f384-475d-ad0c-75518cb9d2fe2025-06-10WarningsExact identifier
application number: M022
Onral Oral Pain Reliever MouthwashBENZOCAINESyka Pharma Inc.5dd8d933-6f32-4eaf-8eca-9365d7de55a22025-06-03WarningsExact identifier
application number: M022
Orajel Rescue Relief PenORAL PAIN RELIEVERChurch & Dwight Co., Inc.2d68eec5-ae8a-9cdf-e063-6294a90a97992025-06-01WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC9e1f7462-a052-4db4-bc59-cce437b695d02025-05-20WarningsExact identifier
application number: M022
Saline 1.5 FL OZSALINEALAINA HEALTHCARE PRIVATE LIMITEDf1bdbb25-6943-4828-9ae0-7d9783c18b5f2025-05-19WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpastePSN8d187823-7e56-441b-8bca-8f03e7bb07c711
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCD8d187823-7e56-441b-8bca-8f03e7bb07c711
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY8d187823-7e56-441b-8bca-8f03e7bb07c711
1038929Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY8d187823-7e56-441b-8bca-8f03e7bb07c711
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY8d187823-7e56-441b-8bca-8f03e7bb07c711
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY8d187823-7e56-441b-8bca-8f03e7bb07c711
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSY8d187823-7e56-441b-8bca-8f03e7bb07c711

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-172-2263868017222128 g in 1 TUBE128 gHistorical
63868-172-23638680172231 TUBE in 1 CARTON (63868-172-23) > 116 g in 1 TUBE1 tube2012-11-070000-00-00NoNoCurrent
63868-172-29638680172291 TUBE in 1 CARTON (63868-172-29) > 128 g in 1 TUBE (63868-172-22) 1 tube2012-11-070000-00-00NoNoCurrent
63868-172-34638680172341 TUBE in 1 CARTON (63868-172-34) / 96.4 g in 1 TUBE1 tube2023-07-20NoNoCurrent