Saline

NASAL NASAL HUMAN OTC DRUG

Saline is an FDA drug label for the active ingredient NASAL manufactured by Raritan Pharmaceuiticals Inc administered by NASAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260909.

Generic name
NASAL
Manufacturer
Raritan Pharmaceuiticals Inc
Product type
HUMAN OTC DRUG
Route
NASAL
Dosage form
N/A
NDC
68163-704
Application
M022
Label effective
20260909

About this product

Saline is an FDA-registered drug product whose active ingredient is NASAL. It is labelled by Raritan Pharmaceuiticals Inc taken by nasal and marketed as a human otc drug product. Identifiers on file: NDC 68163-704, application M022, label effective 20260909. It is one of 5 FDA drug label records sharing the active ingredient NASAL. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

What it is used for

Across FDA labelling, products containing NASAL are most often described in connection with: naturally provides, instant soothing, relief dry, irritated nasal, passages due, colds allergies, air pollution, decongestants steroidal. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active Ingredients Sodium Chloride 0.65%

Indications & Usage

Uses Naturally provides instant, soothing relief dry irritated nasal passages due to colds, allergies, dry air, pollution, smoke, air travel and use of decongestants/steroidal sprays.

Dosage & Administration

Directions For children and adults, squeeze bottle twice in each nostril as often as needed or as directed by physician. For infants, use drop application. Hold bottle upright for spray, horizontally for stream, and upside down for drop. The use of this dispenser by more than one person may spread infection.

Warnings

Warnings If pregnant or breast-feeding, ask a healthcare professional before use. Use of this container by more than one person may spread infection.

More products with the same ingredient

NASAL

CVS Saline

CVS PHARMACY View label

KROGER Saline

KROGER COMPANY View label

How products containing NASAL compare

FDA lists 5 drug label records with NASAL as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

Dosage formProductsManufacturerProducts
— — BEST CHOICE (VALU MERCHANDISERS COMPANY) 1
— — CVS PHARMACY 1
— — GERI-CARE PHARMACEUTICAL CORP 1
— — KROGER COMPANY 1
— — Raritan Pharmaceuiticals Inc 1

Recall and safety notices

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

RecallProductFirmClassStatusReported
D-0620-2026 BEEKEEPER'S NATURALS Saline Nasal Spray, Sinus Congestion Rinse, Made with Propolis + Xylitol, 1 FL OZ (30 mL) per bottle, Manufactured For: Beekeeper's Naturals USA Inc., Covina, CA 91789. BEEKEEPER'S NATURALS USA INC. Class I Ongoing 20260617
D-0179-2026 Walgreens Saline Nasal Spray WITH XYLITOL, 1.5 oz (45mL) bottle, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL 60015, NDC 0363-3114-01 Medical Products Laboratories, Inc. Class II Ongoing 20251203
D-0082-2026 Sterile Saline Reconstitution Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. GenoGenix LLC Class II Ongoing 20251015
D-0300-2025 SinuCleanse Premixed SALINE PACKETS (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg) for Nasal Wash System, 60-count All Natural USP Grade Saline Packets, Net WT 0.1OZ (3g) each, Distributed by Ascent Consumer Products Inc., Melville, NY 11747, UPC 6 46011 00103 4 Ascent Consumer Products Inc. Class I Ongoing 20250402
D-0299-2025 SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg), 30-count All Natural USP Grade Saline Packets and 1 Soft tip Squeeze Bottle, Net WT 0.1OZ (3g) each, Distributed by Ascent Consumer Products Inc., Melville, NY 11747, UPC 6 46011 00104 1 Ascent Consumer Products Inc. Class I Ongoing 20250402

Frequently asked questions

What is Saline used for?
Uses Naturally provides instant, soothing relief dry irritated nasal passages due to colds, allergies, dry air, pollution, smoke, air travel and use of decongestants/steroidal sprays.

Who makes Saline?
Raritan Pharmaceuiticals Inc is the labeler of record for Saline. 5 FDA label records share the active ingredient NASAL, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Saline come in?
administered by nasal. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Saline prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing NASAL?
Yes. 5 FDA drug label records list NASAL as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Saline been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.

This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.