Home NDC 11673-385 Whitening
Product NDC 11673-385
11-digit product format 116730385
Labeler code 11673
Product ID 11673-385_441eb113-64d9-ceeb-e063-6394a90a2f74
Type HUMAN OTC DRUG
Nonproprietary name Monofluorophosphate
Dosage form PASTE, DENTIFRICE
Route DENTAL
Labeler Target
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-02-10
Substance SODIUM MONOFLUOROPHOSPHATE
Active strength .14 g/100g
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 11673-385 11673-385-08 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 11673-385 11673-385-08 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
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 Whitening
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM MONOFLUOROPHOSPHATE .14 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination C810JCZ56Q Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 545626 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 11673-385-08 Whitening 1 in 1 CARTON PASTE, DENTIFRICE 1 6 11673-385-08 Whitening 113 g in 1 TUBE PASTE, DENTIFRICE 113 6 11673-385-09 Whitening 2 in 1 CARTON PASTE, DENTIFRICE 2 6 11673-385-09 Whitening 113 g in 1 TUBE PASTE, DENTIFRICE 113 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11673-385 WHITENING (MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TARGET] 4 Current NDC, 4 package rows 20250523_0074630f-9d8d-9209-e063-6294a90a4f01.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 38 of 50 · 995 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 11673-385-08 11673038508 1 in 1 CARTON Historical 11673-385-09 11673038509 2 TUBE in 1 CARTON (11673-385-09) / 113 g in 1 TUBE 2 tube 2025-01-24 No No Current