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 19 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Burts Bees Charcoal PeppermintSODIUM FLUORIDEProcter & Gamble Manufacturing Companya343853e-4968-2753-e053-2995a90ab1522026-02-02WarningsExact identifier
application number: M021
Burts Bees Complete Multi-CareSODIUM FLUORIDEProcter & Gamble Manufacturing Company12615266-06e8-b891-e063-6394a90ad75d2026-02-02WarningsExact identifier
application number: M021
LIVFRESH GUM PROTECTSTANNOUS FLUORIDELivionex Inc.1da7dcf9-e675-4b4b-8286-bdaa6e59eb0f2026-02-02WarningsExact identifier
application number: M021
Brush Buddies Mouthwash Disney Cars Chow CherrySODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.49d66ad5-cdae-52f4-e063-6294a90a8ee92026-02-01WarningsExact identifier
application number: M021
Crest 3D White Deep Stain Remover Brilliant WhiteSODIUM MONOFLUOROPHOSPHATEThe Procter & Gamble Manufacturing Company4e53a086-6cda-6460-e063-6394a90af1f32026-02-01Exact identifier
application number: M021
ACT Kids Berry BlastSODIUM FLUORIDEChattem, Inc.4f81ea98-5c74-4473-9764-3f11d627cdf12026-02-01WarningsExact identifier
application number: M021
Anticavity RinseSODIUM FLUORIDERite Aid Corporationc1a22692-b955-498a-a7c1-1cd7bfd54bda2026-01-30Warnings, Adverse reactionsExact identifier
application number: M021
ARU GUM HEALTHSTANNOUS FLUORIDEAshtel Studios, Inc.d8e8b92e-d8cb-45ad-8353-7dbe43c3dcd32026-01-30WarningsExact identifier
application number: M021
Colgate AnticavitySODIUM MONOFLUOROPHOSPHATEFORMIA LIMITEDb5eec445-d93a-4abb-a5e3-bfcde6fa20132026-01-28WarningsExact identifier
application number: M021
Supersmile Original MintSODIUM MONOFLUOROPHOSPHATERobell Research, Inc24fee793-57ed-87e9-e063-6394a90ab4ce2026-01-28WarningsExact identifier
application number: M021
Colgate 5g and Toothbrush Dental KitSODIUM MONOFLUOROPHOSPHATEFORMIA LIMITED0b269f9a-aa3f-47b5-b7e8-59a5ed0e2b132026-01-28WarningsExact identifier
application number: M021
Brush Buddies SPIDEY and his AMAZING FRIENDS ANTICAVITY FLUORIDE-Spidey PunchSODIUM FLUORIDEAshtel Studios Inc.023cb63c-52b4-4723-bff6-c25105a53f762026-01-28WarningsExact identifier
application number: M021
Brush Buddies STAR WARS ANTICAVITY FLUORIDE - Saber Strike StrawberrySODIUM FLUORIDEAshtel Studios, Inc.ef4ea4a3-c1ac-447f-a70b-e3a330928cfd2026-01-27WarningsExact identifier
application number: M021
Toms of Maine Tropical IslandALUMINUM CHLOROHYDRATETom's of Maineae6de376-76fd-4609-a2d5-7a902c0d4c5c2026-01-27WarningsExact identifier
application number: M021
Made by Dentists for Kids Fluoride Anticavity Bamboolicious (Bubblegum)SODIUM FLUORIDEMade by Dentists Inc.f3f6b32d-8e47-4f52-bd9a-20bd51c9d0072026-01-27WarningsExact identifier
application number: M021
Brush Buddies DISNEY PRINCESS ANTICAVITY FLUORIDE - Grand GrapeSODIUM FLUORIDEAshtel Studios Inc.6c6d143f-4c2b-4207-bde7-9df8251616a32026-01-27WarningsExact identifier
application number: M021
Brush Buddies TOY STORY ANTICAVITY FLUORIDE - WILD WEST WATERMELONSODIUM FLUORIDEAshtel Studios, Inc.d80d0a87-5d1f-4114-977a-036ffed772052026-01-27WarningsExact identifier
application number: M021
Brush Buddies DISNEY FROZEN ANTICAVITY FLUORIDE - Blizzard BerrySODIUM FLUORIDEAshtel Studios, Inc.ac18dd0a-d476-48a7-8493-594a0293b9262026-01-27WarningsExact identifier
application number: M021
Brush Buddies Cars ANTICAVITY FLUORIDE - KA-CHOW CHERRYSODIUM FLUORIDEAshtel Studios, Inc.2500e14e-6cf4-4ac4-810f-1ef163c5e4742026-01-27WarningsExact identifier
application number: M021
Hello Unicorn SplashSODIUM FLUORIDEAccupac LLC23807810-990a-b723-e063-6394a90aee3e2026-01-22WarningsExact 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