Drugplain

Nasal 12 [hp_X]/mL

Arsenicum Album, Euphorbium Officinarum, Hepar Sulphuris Calcareum, Histaminum, Iodium, Lycopodium, Pulsatilla · LIQUID · Natural Creations, Inc

10 Recalls on Record
Plain English

This is an over-the-counter homeopathic nasal spray containing multiple herbal and mineral ingredients intended to help relieve nasal symptoms. It is applied as a liquid oral preparation and is available without a prescription.

Key Facts

Brand Name
Nasal
Generic Name
Arsenicum Album, Euphorbium Officinarum, Hepar Sulphuris Calcareum, Histaminum, Iodium, Lycopodium, Pulsatilla
NDC Code (Product)
43406-0102
Manufacturer
Natural Creations, Inc
Strength
12 [hp_X]/mL
Dosage Form
LIQUID
Route
ORAL
Marketing Status
Marketing Start
09/21/2011

Recall History

10 Recalls on Record
Class II10/26/2021

Perrigo Company PLC

CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

TerminatedVoluntary: Firm initiated
Class II01/30/2013

TG United, Inc.

CGMP Deviations: Products are underdosed or have an incorrect dosage regime.

TerminatedVoluntary: Firm initiated
Class II08/03/2018

Product Quest Manufacturing LLC

CGMP Deviations: products manufactured under conditions that could impact its product quality.

TerminatedVoluntary: Firm initiated
Class II02/27/2015

Akorn, Inc.

Failed Stability Specifications: Out of specification for preservative, benazalkonium chloride.

TerminatedVoluntary: Firm initiated
Class II01/30/2013

TG United, Inc.

CGMP Deviations: Products are underdosed or have an incorrect dosage regime.

TerminatedVoluntary: Firm initiated
Class II10/26/2021

Perrigo Company PLC

CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

TerminatedVoluntary: Firm initiated
Class II05/21/2019

Torrent Pharma Inc

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

TerminatedVoluntary: Firm initiated
Class I12/12/2025

Medinatura New Mexico, inc.

Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.

OngoingVoluntary: Firm initiated
Class III02/05/2018

Sun Pharmaceutical Industries, Inc.

Sun Pharmaceutical is recalling Azelastine HCl Nasal Solution, 0.1% (30 mL Bottle) following a failure to meet the % RSD requirement in the test for Droplet Size during the 6 month long term stability test station

TerminatedVoluntary: Firm initiated
Class II08/03/2018

Product Quest Manufacturing LLC

CGMP Deviations: products manufactured under conditions that could impact its product quality.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective15,571 reports
off label use14,163 reports
fatigue13,873 reports
pain12,571 reports
nausea11,667 reports
headache11,257 reports
dyspnoea10,934 reports
rash10,051 reports
vomiting9,028 reports
diarrhoea8,936 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses temporarily relieves sinus congestion and pressure temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies

Dosage & Administration

Directions adults and children 12 years and over: take 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours. children under 12 years: ask a doctor

Warnings

Warnings Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have heart disease diabetes thyroid disease high blood pressure difficulty in urination due to enlargement of the prostate gland When using this product do not exceed recommended dosage. Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with fever If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Frequently Asked Questions

What is Nasal used for?

This is an over-the-counter homeopathic nasal spray containing multiple herbal and mineral ingredients intended to help relieve nasal symptoms. It is applied as a liquid oral preparation and is available without a prescription.

Is Nasal a controlled substance?

Nasal is not classified as a controlled substance by the DEA.

What is the generic name for Nasal?

The generic name for Nasal is Arsenicum Album, Euphorbium Officinarum, Hepar Sulphuris Calcareum, Histaminum, Iodium, Lycopodium, Pulsatilla. There are no other listed brand versions of Arsenicum Album, Euphorbium Officinarum, Hepar Sulphuris Calcareum, Histaminum, Iodium, Lycopodium, Pulsatilla.

What is the NDC code for Nasal 12 [hp_X]/mL?

The NDC (National Drug Code) for Nasal 12 [hp_X]/mL is 43406-0102, listed by Natural Creations, Inc.

Product NDC

43406-0102

Package NDC

43406-0102-1

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)