FDA.reportPublic FDA data

Hello Whitening

Product NDC
55882-3477
11-digit product format
558823477
Labeler code
55882
Product ID
55882-3477_6ddc2024-7c8d-4cd3-bdcb-f6d07fcb638f
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM MONOFLUOROPHOSPHATE
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Hello Products LLC
Application
part355
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2020-09-08
Marketing end
0000-00-00
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
1 mg/g
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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 productproduct55882-3477DDiscontinued by firm2026-11-13
excluded packagepackage55882-347755882-3477-1DDiscontinued by firm2026-11-13

Reported adverse events (FAERS/openFDA)#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55882-3477HELLO WHITENING (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [HELLO PRODUCTS LLC]10Legacy NDC20230317_a65a1998-f524-4c56-a7d7-491fe683286d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55882-3477-1558823477011 TUBE in 1 CARTON (55882-3477-1) > 133 g in 1 TUBE1 tube2020-09-080000-00-00NoNoCurrent