FDA.reportPublic FDA data

CALCAREA PHOSPHORICA

Manufacturer
Rxhomeo Private Limited d.b.a. Rxhomeo, Inc | Rxhomeo, Inc
Effective date
2015-12-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:07:01

Label at a glance#

ProductCALCAREA PHOSPHORICA
Active ingredientTRIBASIC CALCIUM PHOSPHATE
Label structure9 sections

Indications and uses

Tardy Dentition

Storage and handling

Store in a cool dark place

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

CALCAREA PHOSPHORICA HPUS 1X and Higher

USES

OTC - PURPOSE SECTION

Tardy Dentition

INDICATIONS

INDICATIONS & USAGE SECTION

Condition listed above or as directed by the physician

DOSAGE

DOSAGE & ADMINISTRATION SECTION

Adults- Take 4 or 6 Tablets by mouth, three times daily or as suggested by physician. Children 2 years and older- take 1/2 the adult dose.

WARNINGS

WARNINGS SECTION

This product is to be used for self-limiting conditions

OTC - STOP USE SECTION

If symptoms do not improve in 4 days, or worsen, discontinue use and seek assistance of health professional

OTC - PREGNANCY OR BREAST FEEDING SECTION

As with any drug, if you are pregnant, or nursing a baby, seek professional advice before taking this product

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medication out of reach of children

OTC - DO NOT USE SECTION

Do not use if capseal is broken or missing.

Close the cap tightly after use.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Lactose

STORAGE

STORAGE AND HANDLING SECTION

Store in a cool dark place

QUESTIONS OR COMMENTS

OTC - QUESTIONS SECTION

www.Rxhomeo.com | 1.888.2796642 | info@rxhomeo.com

Rxhomeo, Inc 9415 Burnet Road, Suite 312, Austin, TX 78758

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-138907460005526GTIN-13: 8907460005526
EAN-13: 8907460005526
GTIN storage (14 digits): 08907460005526		15631-0549.jpg
QR code linkQR Codewww.rxhomeo.com/15631-0549.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
15631-0549-02020-01-31C16284748780-19d75b9d0-d735-f424-e053-dadaa90a57ce1e9f1667-711c-4e1d-b70a-e03217c4a8ff
15631-0549-12020-01-31C16284748780-19d75b9d0-d735-f424-e053-dadaa90a57ce1e9f1667-711c-4e1d-b70a-e03217c4a8ff
15631-0549-22020-01-31C16284748780-19d75b9d0-d735-f424-e053-dadaa90a57ce1e9f1667-711c-4e1d-b70a-e03217c4a8ff
15631-0549-32020-01-31C16284748780-19d75b9d0-d735-f424-e053-dadaa90a57ce1e9f1667-711c-4e1d-b70a-e03217c4a8ff
15631-0549-42020-01-31C16284748780-19d75b9d0-d735-f424-e053-dadaa90a57ce1e9f1667-711c-4e1d-b70a-e03217c4a8ff
15631-0549-52020-01-31C16284748780-19d75b9d0-d735-f424-e053-dadaa90a57ce1e9f1667-711c-4e1d-b70a-e03217c4a8ff
15631-0549-62020-01-31C16284748780-19d75b9d0-d735-f424-e053-dadaa90a57ce1e9f1667-711c-4e1d-b70a-e03217c4a8ff
15631-0549-72020-01-31C16284748780-19d75b9d0-d735-f424-e053-dadaa90a57ce1e9f1667-711c-4e1d-b70a-e03217c4a8ff

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
15631-0549-0CALCAREA PHOSPHORICA1 in 1 BLISTER PACKTABLET12
15631-0549-1CALCAREA PHOSPHORICA4 in 1 BLISTER PACKTABLET42
15631-0549-2CALCAREA PHOSPHORICA50 in 1 CONTAINERTABLET502
15631-0549-3CALCAREA PHOSPHORICA100 in 1 CONTAINERTABLET1002
15631-0549-4CALCAREA PHOSPHORICA250 in 1 CONTAINERTABLET2502
15631-0549-5CALCAREA PHOSPHORICA500 in 1 CONTAINERTABLET5002
15631-0549-6CALCAREA PHOSPHORICA1000 in 1 CONTAINERTABLET10002
15631-0549-7CALCAREA PHOSPHORICA10000 in 1 CONTAINERTABLET100002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
15631-0549CALCAREA PHOSPHORICA TABLET [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC]2Legacy NDC, 8 package rows20151216_1e9f1667-711c-4e1d-b70a-e03217c4a8ff.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
15631-054915631-0549-0, 15631-0549-1, 15631-0549-2, 15631-0549-3, 15631-0549-4, 15631-0549-5, 15631-0549-6, 15631-0549-7

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28ACTIM
LACTOSEJ2B2A4N98GIACT

Source Document#

Source XML

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
fa02de0f-10a6-4811-a949-3648897916731e9f1667-711c-4e1d-b70a-e03217c4a8ff2015-12-16WarningsExact identifier
spl id: fa02de0f-10a6-4811-a949-364889791673
spl set id: 1e9f1667-711c-4e1d-b70a-e03217c4a8ff

Reported adverse events (FAERS/openFDA)#

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