MedPath

Schuessler Tissue Salts Comb 5 Nerve Tonic

Approved
Approval ID

7fd350ec-af99-4eb2-8750-226edc7f24b0

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 13, 2025

Manufacturers
FDA

Martin & Pleasance Pty Ltd

DUNS: 752869859

Products 1

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

Calcarea Phosphorica,Magnesia Phosphorica,Ferrum Phosphoricum ,Natrum Phosphoricum,Kali Phosphoricum

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code84999-027
Product Classification
G
Generic Name
Calcarea Phosphorica,Magnesia Phosphorica,Ferrum Phosphoricum ,Natrum Phosphoricum,Kali Phosphoricum
Product Specifications
Route of AdministrationORAL
Effective DateAugust 13, 2025
FDA Product Classification

INGREDIENTS (8)

GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TRIBASIC CALCIUM PHOSPHATEActive
Quantity: 6 [hp_X] in 30 mL
Code: 91D9GV0Z28
Classification: ACTIM
MAGNESIUM PHOSPHATE, DIBASICActive
Quantity: 6 [hp_X] in 30 mL
Code: A1Y870209Z
Classification: ACTIB
FERROUS PHOSPHATEActive
Quantity: 6 [hp_X] in 30 mL
Code: D07L04MRWI
Classification: ACTIB
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSActive
Quantity: 6 [hp_X] in 30 mL
Code: 22ADO53M6F
Classification: ACTIB
DIBASIC POTASSIUM PHOSPHATEActive
Quantity: 6 [hp_X] in 30 mL
Code: CI71S98N1Z
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/11/2025

Product label

image descriptionimage description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/5/2025

Uses

Temporarily relieves symptoms associated with:

  • Stress
  • Mild anxiety
  • Mild neuralgic pain
  • General debility

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/11/2025

Active ingredient (in each spray) Purpose

Calcarea Phosphorica 6X HPUS .................................................. general debility
Magnesia Phosphorica 6X HPUS .......................................... mild neuralgic pain
Ferrum Phosphoricum 6X HPUS ................................................. general debility
Natrum Phosphoricum 6X HPUS ................................................. general debility
Kali Phosphoricum 6X HPUS ................................................ stress, mild anxiety

"HPUS" is the Homeopathic Pharmacopoeia of the United States

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/5/2025

WARNINGS SECTION

LOINC: 34071-1Updated: 8/5/2025

Warnings

Ask a doctor before use if you have:

  • Symptoms persist for more than 24 hours or worsen
  • New symptoms occur
  • Redness or swelling is present.

If pregnant or breastfeeding, ask a health professional before use.Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 8/5/2025

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/5/2025

Directions

  • Use as directed
  • Take 30 minutes away from food.

Adults

  • Acute dose: Spray into the mouth 4 times every 30 mins until symptoms subside, up to 8 times per day.
  • Maintenance dose: Spray into mouth 4 times, 4 times per day.

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 8/5/2025

**Questions?**www.schuesslertissuesalts.co or + 1-888-464-6775

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/5/2025

Inactive Ingredients

Alcohol, Glycerin, Purified Water

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Schuessler Tissue Salts Comb 5 Nerve Tonic - FDA Drug Approval Details