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BIO COM 21

BM HOMEOPATHIC REMEDY BIO COM 21 TEETHING TROUBLES/ BIO21

Approved
Approval ID

3b2bcf6c-6b7c-6279-e063-6394a90ab48f

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jul 30, 2025

Manufacturers
FDA

BM Private Limited

DUNS: 645599762

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

CALC PHOS, FERR PHOS

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code85816-3021
Product Classification
G
Generic Name
CALC PHOS, FERR PHOS
Product Specifications
Route of AdministrationORAL
Effective DateJuly 30, 2025
FDA Product Classification

INGREDIENTS (4)

MAGNESIUM STEARATEInactive
Quantity: 0.0208 g in 1 g
Code: 70097M6I30
Classification: IACT
TRIBASIC CALCIUM PHOSPHATEActive
Quantity: 6 [hp_X] in 1 g
Code: 91D9GV0Z28
Classification: ACTIB
LACTOSE, UNSPECIFIED FORMInactive
Quantity: 0.978 g in 1 g
Code: J2B2A4N98G
Classification: IACT
FERROSOFERRIC PHOSPHATEActive
Quantity: 6 [hp_X] in 1 g
Code: 91GQH8I5F7
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 1/1/2015

BIO 21

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 1/1/2015

See the enclosed detail for detail

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 1/1/2015

Dosage:
Adults: Four tablets three times a day.
Children: half of the same or as advised by a homeopathic physician.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 1/1/2015

Calc phos

Ferr phos

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 1/1/2015

LACTOSE, MAGNESIUM STEARATE

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 1/1/2015

See the enclosed detail for detail

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 1/1/2015

Precautions/storage:
Keep away from children and store at cool and dry place.

WARNINGS SECTION

LOINC: 34071-1Updated: 1/1/2015

Precautions/storage:
Keep away from children and store at cool and dry place.

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BIO COM 21 - FDA Drug Approval Details