Home NDC 76472-4088-1 CALCAREA FLUORICA
Product NDC 76472-4088
Requested package NDC 76472-4088-1
11-digit product format 764724088
Labeler code 76472
Product ID 76472-4088_2ddc29a1-0636-2e52-e063-6294a90a6428
Type HUMAN OTC DRUG
Nonproprietary name CALCAREA FLUORICA
Dosage form PELLET
Route SUBLINGUAL
Labeler SEVENE USA
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2023-06-26
Substance CALCIUM FLUORIDE
Active strength 6 [hp_X]/1
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 · 3 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 2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 76472-4088 76472-4088-1 U Excluded because listing certification expired excluded / ndc_excluded.zip 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 76472-4088 76472-4088-1 U Excluded because listing certification expired excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 76472-4088 76472-4088-1 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
Additional Listing Data#
Finished product Yes
Brand name base CALCAREA FLUORICA
Brand name suffix 6X
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CALCIUM FLUORIDE 6 [hp_X]/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination O3B55K4YKI Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 76472-4088-1 CALCAREA FLUORICA6X 80 in 1 CYLINDER PELLET 80 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76472-4088 CALCAREA FLUORICA 6X (CALCAREA FLUORICA) PELLET [SEVENE USA] 4 Current NDC, 1 package rows 20250213_ff0e811b-a880-1172-e053-6394a90a01d9.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 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 76472-4088-1 76472408801 80 PELLET in 1 CYLINDER (76472-4088-1) 80 pellet 2023-06-26 No No Current