FDA.reportPublic FDA data

Masood Biogen 21 Oracure

Manufacturer
Dr. Masood Homeopathic Pharmaceuticals Private Limited
Effective date
2024-01-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:25:34

Label at a glance#

ProductMasood Biogen 21 Oracure
Active ingredientFERROSOFERRIC PHOSPHATE, TRIBASIC CALCIUM PHOSPHATE
Label structure8 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

Directions:

As directed by a Licensed Homoeopathic Practitioner.

  • Infants up to 5 to 6 months: 1 Tablet after every 4 hours.
  • Infants above 6 months: 2 Tablets after every 4 hours.

INDICATIONS & USAGE SECTION

Uses:

Temporarily relieves running colic due to delayed teething. *

*The uses for this product is based on traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

  • Calcarea Phosphoricum
  • Ferrum Phosphoricum

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTC - PURPOSE SECTION

Purpose

  • Temporary Relief - Running Colic Due to Delayed teething*
  • To be used for acute self-limiting conditions according to standard homeopathic indications

INACTIVE INGREDIENT SECTION

Inactive ingredients

Sodium Starch Glycolate, Starch, Gelatin, Magnesium Stearate

WARNINGS SECTION

Warnings:

Do not:

  • use if you have an allergy or hypersensitivity to components of the formula
  • If pregnant or breast feeding, ask a licensed homeopathic practitioner before use

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Masood Biogen 21Masood Biogen 21

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
82797-321-212026-01-29C16284748780-149896155-ae08-586f-e063-e6dba90add90Masood Biogen 21 Oracure

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82797-321-20Masood Biogen 21 Oracure190 in 1 BOTTLETABLET1902
82797-321-21Masood Biogen 21 Oracure1 in 1 BOXTABLET12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82797-321MASOOD BIOGEN 21 ORACURE (CALCAREA PHOSPHORICUM) TABLET [DR. MASOOD HOMEOPATHIC PHARMACEUTICALS PRIVATE LIMITED]2Legacy NDC, 2 package rows20240110_e65b6062-68b5-3326-e053-2a95a90abb66.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82797-32182797-321-20, 82797-321-21

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
FERROSOFERRIC PHOSPHATE91GQH8I5F7ACTIB
MAGNESIUM STEARATE70097M6I30IACT
SODIUM STARCH GLYCOLATE TYPE A CORNAG9B65PV6BIACT
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28ACTIM
HYDROXYPROPYL CORN STARCH (5% SUBSTITUTION BY WEIGHT)9M44R3409AIACT
GELATIN2G86QN327LIACT

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
0e7dde08-86e1-06a8-e063-6294a90af62ae65b6062-68b5-3326-e053-2a95a90abb662024-01-09WarningsExact identifier
spl id: 0e7dde08-86e1-06a8-e063-6294a90af62a
spl set id: e65b6062-68b5-3326-e053-2a95a90abb66

Reported adverse events (FAERS/openFDA)#

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