Home NDC 69491-043 DELTA COMFORT PLUS AMENITY
Product NDC 69491-043
11-digit product format 694910043
Labeler code 69491
Product ID 69491-043_5036f7a0-ee82-10cf-e063-6394a90a118d
Type HUMAN OTC DRUG
Nonproprietary name SODIUM MONOFLUOROPHOSPHATE
Dosage form KIT
Labeler Buzz Products Inc.
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-04-01
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 DELTA COMFORT PLUS AMENITY
Listing expiration 2027-12-31 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 69491-043-00 DELTA COMFORT PLUS AMENITY 1 in 1 KIT KIT 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69491-043 DELTA COMFORT PLUS AMENITY (SODIUM MONOFLUOROPHOSPHATE) KIT [BUZZ EXPORT SERVICES PTY., LTD.] 1 Current NDC, 1 package rows 20241109_26434794-ae02-0f58-e063-6294a90ad85e.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 44 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 69491-043-00 69491004300 1 KIT in 1 KIT (69491-043-00) * 5 g in 1 TUBE (69491-044-00) 1 kit 2019-04-01 No No Current