AP-24 Whitening

Product NDC
62839-1155
11-digit product format
628391155
Labeler code
62839
Product ID
62839-1155_1621e578-4a1f-4dbe-8cf7-1fce4b978cb3
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Monofluorophosphate
Dosage form
PASTE
Route
DENTAL
Labeler
NSE Products, Inc.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-05-08
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
7.6 mg/g
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
AP-24 Whitening
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM MONOFLUOROPHOSPHATE7.6 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
C810JCZ56QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
545626Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
57e9e68c-41dd-470b-80db-dfaedc0e2a0aAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62839-1155-1AP-24 Whitening110 g in 1 TUBEPASTE1105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62839-1155AP-24 WHITENING (SODIUM MONOFLUOROPHOSPHATE) PASTE [NSE PRODUCTS, INC.]4Current NDC, Legacy NDC, 1 package rows20250108_57e9e68c-41dd-470b-80db-dfaedc0e2a0a.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 48 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EUTHYMOL Extraordinary Pink WhiteningSODIUM FLUORIDELG H&H CO., LTD.13910b55-9b5d-af53-e063-6294a90acf5d2024-03-13WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Quebec Inc. DBA Attitudee3bb60f8-2a06-42d6-a182-8c31bb982a2a2024-03-01WarningsExact identifier
application number: M021
Maximum SecuritySODIUM FLUORIDEBob Barker Company Inc.e29f30ec-72ea-4944-a2c2-b1696d31b6392024-02-27WarningsExact identifier
application number: M021
Made by Dentists For Kids Monster Slime Sour AppleSODIUM FLUORIDEMADE BY DENTISTS INCdfddc67c-3626-48c4-8120-bcc6c455d1192024-02-23WarningsExact identifier
application number: M021
Orajel Gabbys DollhouseSODIUM FLUORIDEChurch & Dwight Co., Inc.cd47bd1e-44ac-465f-8529-6073ade147062024-02-23WarningsExact identifier
application number: M021
Colgate Kids Maximum Cavity ProtectionSODIUM FLUORIDEColgate-Palmolivec44c7a7e-fc3e-a81b-1961-ff89614b678f2024-02-22WarningsExact identifier
application number: M021
TheraBreath Fresh Breath Anticavity Mild MintSODIUM FLUORIDEChurch & Dwight Co., Inc.19ce5324-7d8d-4d70-ad9b-238f7e612eac2024-02-06WarningsExact identifier
application number: M021
Nature Mint AnticavitySODIUM MONOFLUOROPHOSPHATEBob Barker Company Inc.916891d3-5234-46a8-a492-21a31f36a8522024-02-02WarningsExact identifier
application number: M021
Treatment Rinse MintANTICARIESDENTAL ALLIANCE HOLDINGS LLCf1255065-b7c3-4eb6-e053-2995a90afcdb2024-01-31WarningsExact identifier
application number: M021
Maintenance Rinse MintANTICARIESDental Alliance Holdings LLCf1273510-aa83-3ef9-e053-2a95a90aea272024-01-31WarningsExact identifier
application number: M021
ATOMY PROPOLIS TOOTHPAS TE 50GSODIUM MONOFLUOROPHOSPHATE, SODIUM FLUORIDEATOMY CO., LTD.98d839e3-a1aa-c83d-e053-2995a90a7e792024-01-30WarningsExact identifier
application number: M021
ATOMY PROPOLIS TOOTHPAS TE 200GSODIUM MONOFLUOROPHOSPHATE, SODIUM FLUORIDEATOMY CO., LTD.98aebbec-aec0-1478-e053-2a95a90a03ea2024-01-30WarningsExact identifier
application number: M021
Toms Childrens Anticavity Mouthwash Silly StrawberrySODIUM FLUORIDETom's of Maine, Inc.998c6f35-20f4-4cb8-bc48-6aa39e61481a2024-01-18WarningsExact identifier
application number: M021
Gel-Kam Fruit and BerrySTANNOUS FLUORIDEColgate Oral Pharmaceuticals, Inc.8c2c3c5c-ddef-4a4d-8bc3-5a98c577e74c2024-01-18WarningsExact identifier
application number: M021
Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Gushing Grape FluorideSODIUM FLUORIDEColgate Oral Pharmaceuticals, Inc.9a976ac8-d966-4d94-93da-45652f2d24812024-01-12WarningsExact identifier
application number: M021
Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Mint FluorideSODIUM FLUORIDEColgate Oral Pharmaceuticals, Inc.2b4b6f9a-0e31-4891-8721-d1b9a58cca962024-01-12WarningsExact identifier
application number: M021
Colgate MaxFresh with Mini Breath Cool MintSODIUM FLUORIDEColgate-Palmolive Company51abd6bc-7a3d-4b0e-a810-af9e949264382024-01-09WarningsExact identifier
application number: M021
Colgate Enamel Strength MouthwashSODIUM FLUORIDEColgate-Palmolive - do not usef0cca38b-c0a3-4788-8cca-727a5684c16b2024-01-09WarningsExact identifier
application number: M021
PerCara Oral Health Rinse Fresh MintCETYLPYRIDINIUM CHLORIDELEC Custom Products, Incbd98c654-218b-15ac-e053-2a95a90a75d12024-01-01WarningsExact identifier
application number: M021
PerCara Kids Bubble GumSODIUM FLUORIDELEC Custom Products, Inc.be3a7272-acfb-7d14-e053-2995a90a94202024-01-01WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN57e9e68c-41dd-470b-80db-dfaedc0e2a0a5
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD57e9e68c-41dd-470b-80db-dfaedc0e2a0a5
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY57e9e68c-41dd-470b-80db-dfaedc0e2a0a5
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY57e9e68c-41dd-470b-80db-dfaedc0e2a0a5
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY57e9e68c-41dd-470b-80db-dfaedc0e2a0a5
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY57e9e68c-41dd-470b-80db-dfaedc0e2a0a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62839-1155-162839115501110 g in 1 TUBE (62839-1155-1) 110 g2017-05-080000-00-00NoNoCurrent