MedPath

Bestmade Natural Products BIO28

BNP BIO28

Approved
Approval ID

3e46ee90-2c2c-0a70-e063-6294a90a576a

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 8, 2025

Manufacturers
FDA

Total Operations Management LLC DBA: Bestmade Natural Products Micro

DUNS: 047124582

Products 1

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

CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEA

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code82969-3128
Product Classification
G
Generic Name
CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEA
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 8, 2025
FDA Product Classification

INGREDIENTS (14)

LACTOSE, UNSPECIFIED FORMInactive
Quantity: 0.978 g in 1 g
Code: J2B2A4N98G
Classification: IACT
SODIUM CHLORIDEActive
Quantity: 6 [hp_X] in 1 g
Code: 451W47IQ8X
Classification: ACTIB
SODIUM SULFATEActive
Quantity: 6 [hp_X] in 1 g
Code: 0YPR65R21J
Classification: ACTIB
CALCIUM FLUORIDEActive
Quantity: 6 [hp_X] in 1 g
Code: O3B55K4YKI
Classification: ACTIB
FERROSOFERRIC PHOSPHATEActive
Quantity: 6 [hp_X] in 1 g
Code: 91GQH8I5F7
Classification: ACTIB
MAGNESIUM STEARATEInactive
Quantity: 0.0208 g in 1 g
Code: 70097M6I30
Classification: IACT
CALCIUM SULFATE ANHYDROUSActive
Quantity: 6 [hp_X] in 1 g
Code: E934B3V59H
Classification: ACTIB
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEActive
Quantity: 6 [hp_X] in 1 g
Code: 70WT22SF4B
Classification: ACTIB
POTASSIUM SULFATEActive
Quantity: 6 [hp_X] in 1 g
Code: 1K573LC5TV
Classification: ACTIB
TRIBASIC CALCIUM PHOSPHATEActive
Quantity: 6 [hp_X] in 1 g
Code: 91D9GV0Z28
Classification: ACTIB
SILICON DIOXIDEActive
Quantity: 6 [hp_X] in 1 g
Code: ETJ7Z6XBU4
Classification: ACTIB
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEActive
Quantity: 6 [hp_X] in 1 g
Code: HF539G9L3Q
Classification: ACTIB
POTASSIUM CHLORIDEActive
Quantity: 6 [hp_X] in 1 g
Code: 660YQ98I10
Classification: ACTIB
POTASSIUM PHOSPHATE, DIBASICActive
Quantity: 6 [hp_X] in 1 g
Code: CI71S98N1Z
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

Entire package label

bio28

INDICATIONS & USAGE SECTION

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

Uses: Temporarily relieves sneezing, dry cough, nasal congestion, tiredness, headaches, and nervous tension. This combination of all twelve cell salts temporarily supports energy, wellness, and the health of your immune system.*

OTC - ACTIVE INGREDIENT SECTION

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

Active Ingredients: (Calc Fluor, Calc Phos, Calc Sulph, Ferr Phos, Kali Mur, Kali Phos, Kali Sulph, Mag Phos, Nat Mur, Nat Phos, Nat Sulph, Silicea) 6x potency

INACTIVE INGREDIENT SECTION

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

Ingredients: Inactive: Lactose Pellet Base to Preserve Product

DOSAGE & ADMINISTRATION SECTION

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

How to Use: Take with water 3-4 times a day. Ages 12 or older, 5 Pellets, Ages 12-2, 3 Pellets, Ages below 2, consult your Doctor.

OTC - PURPOSE SECTION

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

Uses: Temporarily relieves sneezing, dry cough, nasal congestion, tiredness, headaches, and nervous tension. This combination of all twelve cell salts temporarily supports energy, wellness, and the health of your immune system.*

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Warnings and Storage: Ask a professional before use if pregnant or breastfeeding or if you have severe symptoms. Keep away from children. If you have a reaction to this product that is not positive, discontinue use. Store in a cool and dry place.

WARNINGS SECTION

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

Warnings and Storage: Ask a professional before use if pregnant or breastfeeding or if you have severe symptoms. Keep away from children. If you have a reaction to this product that is not positive, discontinue use. Store in a cool and dry place.

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE, NOT FDA EVALUATED. This product is not intended to diagnose, treat, cure, or prevent any disease.

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Bestmade Natural Products BIO28 - FDA Drug Approval Details