Home NDC 15631-0095-1 CALCAREA FLUORICA
Product NDC 15631-0095
Requested package NDC 15631-0095-1
11-digit product format 156310095
Labeler code 15631
Product ID 15631-0095_ccf9568a-7946-14ee-e053-2995a90a21d3
Type HUMAN OTC DRUG
Nonproprietary name CALCAREA FLUORICA
Dosage form PELLET
Route ORAL
Labeler Rxhomeo Private Limited d.b.a. Rxhomeo, Inc
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2015-10-02
Substance CALCIUM FLUORIDE
Active strength 3 [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 · 1 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 2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 15631-0095 15631-0095-1 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…a55b01930146…
Additional Listing Data#
Finished product Yes
Brand name base CALCAREA FLUORICA
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CALCIUM FLUORIDE 3 [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 15631-0095-0 CALCAREA FLUORICA 100 in 1 PACKAGE PELLET 100 3 15631-0095-1 CALCAREA FLUORICA 200 in 1 PACKAGE PELLET 200 3 15631-0095-2 CALCAREA FLUORICA 400 in 1 PACKAGE PELLET 400 3 15631-0095-3 CALCAREA FLUORICA 750 in 1 PACKAGE PELLET 750 3 15631-0095-4 CALCAREA FLUORICA 2500 in 1 PACKAGE PELLET 2500 3 15631-0095-5 CALCAREA FLUORICA 12500 in 1 PACKAGE PELLET 12500 3 15631-0095-6 CALCAREA FLUORICA 500 in 1 PACKAGE PELLET 500 3 15631-0095-7 CALCAREA FLUORICA 1000 in 1 PACKAGE PELLET 1000 3
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 15631-0095 CALCAREA FLUORICA PELLET [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC] 3 Current NDC, Legacy NDC, 8 package rows 20210928_510eb681-8053-4117-b3c0-99c0ca9b3589.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 Marketing end Sample Exclude flag Status 15631-0095-1 15631009501 200 PELLET in 1 PACKAGE (15631-0095-1) 200 pellet 2018-01-01 0000-00-00 No No Current