FDA.reportPublic FDA data

Osteodoron PM Special Formula

Manufacturer
Uriel Pharmacy Inc.
Effective date
2024-01-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:25:42

Label at a glance#

ProductOsteodoron PM Special Formula
Active ingredientCALCIUM FLUORIDE, SILICON DIOXIDE, LEAD CARBONATE, OSTREA EDULIS SHELL, QUERCUS ROBUR WHOLE
Label structure9 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Directions: FOR ORAL USE ONLY.

DOSAGE & ADMINISTRATION SECTION

Take in the evening. Use in combination with Osteodoron AM Special Formula Powder. Ages 12 and older: 1/8 teaspoon. Ages 2-11: 1/16 teaspoon. Under age 2: Consult a doctor.

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: 100 gm contains: 5 gm Conchae (Oyster shell) 1X; Quercus (Oak bark) 4X, Fluorite (Calcium fluoride) 6X, Quartz (Rock crystal) 6X, Cerussite (White lead ore) 8X

INACTIVE INGREDIENT SECTION

Inactive Ingredient: Lactose

OTC - PURPOSE SECTION

Uses: For healthy bone and teeth development.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

WARNINGS SECTION

Warnings: Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Do not use if allergic to any ingredient. Contains lactose. Consult a doctor before use for serious conditions or if conditions worsen or persist. If pregnant or nursing, consult a doctor before use. Do not use if safety seal is broken or missing.

OTC - QUESTIONS SECTION

Questions? Call 866.642.2858
Uriel, East Troy, WI 53120
shopuriel.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Osteodoron PM Special Formula PowderOsteodoron PM Special Formula Powder

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48951-7161-4Osteodoron PM Special Formula50 g in 1 BOTTLE, GLASSPOWDER502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48951-7161OSTEODORON PM SPECIAL FORMULA POWDER [URIEL PHARMACY INC.]2Legacy NDC, 1 package rows20240118_6bb1d864-6348-6b0c-e053-2991aa0ab4c9.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48951-716148951-7161-4

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALCIUM FLUORIDEO3B55K4YKIACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB
LEAD CARBONATE43M0P24L2BACTIB
LACTOSE, UNSPECIFIED FORMJ2B2A4N98GIACT
OSTREA EDULIS SHELL49OY13BE7ZACTIB
QUERCUS ROBUR WHOLER7QMG0BT2WACTIB

Source Document#

Source XML · Source PDF

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0f26f6f3-0a03-1df1-e063-6394a90a4ec26bb1d864-6348-6b0c-e053-2991aa0ab4c92024-01-17WarningsExact identifier
spl id: 0f26f6f3-0a03-1df1-e063-6394a90a4ec2
spl set id: 6bb1d864-6348-6b0c-e053-2991aa0ab4c9

Reported adverse events (FAERS/openFDA)#

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