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(from DailyMed)

QUALITY CHOICE SALINE Sodium Chloride 6.5 mg/mL Spray

by QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION) · 1 BOTTLE in 1 CARTON (83324-227-15) / 44 mL in 1 BOTTLE
NDC 83324-0227-15
🏷️ FDA NDC (as labeled) 83324-227-15 billing pads the product segment with a zero
This package
Contains44 mL in 1 bottle Pack sizes2 compare ↓
Also comes in: 88 mL 83324-0227-30
OTC On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
Other active recalls for Sodium Chloride (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class I · Aug 17, 2026 — Presence of particulate matter: Particulates identified as fiberglass (Baxter Healthcare Corporation) · FDA recall D-0849-2026
Class II · Apr 2, 2026 — Lack of Assurance of Sterility (Huons Co., Ltd.) · FDA recall D-0531-2026
Class II · Mar 11, 2026 — Lack of Assurance of Sterility (Fresenius Kabi USA, LLC) · FDA recall D-0433-2026
Class II · Mar 11, 2026 — Lack of Assurance of Sterility (Fresenius Kabi USA, LLC) · FDA recall D-0434-2026
Class II · Mar 11, 2026 — Lack of Assurance of Sterility (Fresenius Kabi USA, LLC) · FDA recall D-0425-2026
Class II · Mar 11, 2026 — Lack of Assurance of Sterility (Fresenius Kabi USA, LLC) · FDA recall D-0429-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 83324-227-15
Product NDC 83324-227
11-digit billing NDC 83324022715
RxCUI 707251
UNII 451W47IQ8X
UPC 0635515988453, 0635515950429
Application # M022
SPL Set ID f51491d8-12ad-4b1b-a171-c621bfdcc341
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-07-07
Route NASAL
Dosage form SPRAY
Substance SODIUM CHLORIDE
Why two NDCs? The FDA registers this code as 83324-227-15 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 83324-0227-15. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Sodium class.

Drug family (ATC) Sodium, Salt solutions, Electrolyte solutions
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)
FDA applicationM022 (OTC MONOGRAPH DRUG)
Labeler code83324
First marketedJul 2025
Product typeHuman Otc Drug
Portfolio91 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📗 Our plain-language guide HelloPharmacist
  • Yes, exactly. Saline is just sodium chloride dissolved in water — it's essentially a sterile salt-water solution. Depending on the concentration and form, it can be used as an IV f...
  • I've heard of saline solution — is that the same thing as sodium chloride?
  • In some situations — like after surgery, during serious illness, or when someone can't take anything by mouth — the body needs fluids and electrolytes delivered directly into the b...
  • Why would someone need sodium chloride through an IV? Can't you just drink water?
📖 Read our full Sodium Chloride guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 88 mL
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Walgreens Saline 6.5 mg/mL 00363-7040-30 WALGREEN 1 bottle — — FDA listed —
Walgreen Saline 6.5 mg/mL 00363-7590-30 WALGREENS 1 bottle — — FDA listed —
HEB Saline 6.5 mg/mL 37808-0845-88 HEB 1 bottle — — FDA listed —
Saline 6.5 mg/mL 37835-0998-01 Bi-Mart 1 bottle — — FDA listed —
KROGER Saline 6.5 mg/mL 41226-0759-30 KROGER 1 bottle — — FDA listed —
MEIJER Saline 6.5 mg/mL 41250-0636-30 MEIJER 1 bottle — — FDA listed —
Saline 6.5 mg/mL 41415-0477-30 PUBLIX 1 bottle — — FDA listed —
Saline 6.5 mg/mL 55319-0047-15 FAMILY 1 bottle — — FDA listed —
Saline 6.5 mg/mL 57896-0333-45 GERI-CARE 44 ml — — FDA listed —
Saline 6.5 mg/mL 63941-0704-15 BEST 1 bottle — — FDA listed —
Family Care Saline 6.5 mg/mL 65923-0493-44 United 44 ml — — FDA listed —
WinCo Foods Saline Nasal Relief .65 g/100mL 67091-0327-46 WinCo 45 ml — — FDA listed —
Saline 6.5 mg/mL 68163-0704-15 Raritan 1 bottle — — FDA listed —
CVS Saline 6.5 mg/mL 69842-0438-30 CVS 1 bottle — — FDA listed —
Saline Nasal 6.5 mg/mL 73492-0281-04 ALAINA 44 ml — — FDA listed —
Equate Premium Saline .65 g/100mL 79903-0275-03 Walmart 88 ml — — FDA listed —
Walmart Saline 6.5 mg/mL 79903-0304-30 WALMART 1 bottle — — FDA listed —
Wild Horse 777 Moisturizing Nasal 6.5 mg/mL 80771-0000-15 Wild 1 bottle — — FDA listed —
Quality Choice Saline 6.5 mg/mLthis 83324-0227-15 QUALITY 1 bottle — — FDA listed —
Quality Choice Saline 6.5 mg/mL 83324-0341-30 QUALITY 1 bottle — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2025
On the market since
Jul 2025
📍
2026
Currently FDA-listed
1 year listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Sodium Chloride (matched by generic name) — the program that covers self-administered drugs. 2 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Sodium Chloride. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$16.2K
Claims incl. refills
266
Beneficiaries
53
Spend / beneficiary
$304.99
Spend / claim
$60.77
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for QUALITY CHOICE SALINE (this brand).

Top reported reactions

Nausea5,254
Myelosuppression5,168
Dyspnoea4,604
Headache4,257
Pyrexia4,195
Fatigue4,058
Vomiting3,745

Age at onset

Neonate122
Infant128
Child819
Adolescent624
Adult8,741
Elderly4,772

Reporter sex

73,152 reports
Male · 42%
Female · 58%
Unknown · 0%

Serious outcomes

Hospitalization33,215
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 9,880 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
83324-0227-15 You're viewing this 1 BOTTLE in 1 CARTON (83324-227-15) / 44 mL in 1 BOTTLE 2025-07-07 Active
83324-0227-30 1 BOTTLE in 1 CARTON (83324-227-30) / 88 mL in 1 BOTTLE 2025-07-07 Active

Pack size FAQ

What quantity is in NDC 83324-0227-15?
NDC 83324-0227-15 is listed by the FDA — 1 bottle in 1 carton / 44 ml in 1 bottle.
What NDC number is used to bill for this package of QUALITY CHOICE SALINE Sodium Chloride 6.5 mg/mL Spray?
Bill NDC 83324-0227-15 — the 11-digit billing format is 83324022715. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 83324-227-15, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 83324-0227-15, written without dashes as 83324022715. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 83324-0227-15, the first segment (83324) is the labeler code FDA assigned to QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION); the middle segment (0227) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (15) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION). Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 bottle (83324-0227-30). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION) is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 24 words ▾

Uses 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 and Administration 51 words ▾

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 11 words ▾

Warnings If pregnant or breast-feeding, ask a healthcare professional before use.

🧪 Active Ingredient 5 words ▾

Active Ingredients Sodium Chloride 0.65%

🧪 Inactive Ingredients 14 words ▾

Inactive Ingredients benzalkonium chloride, benzyl alcohol, purified water, sodium phosphate dibasic, sodium phosphate monobasic

🎯 Purpose 2 words ▾

Purpose Moisturizer

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.