Children Afrin Extra Moisturizing Stuffy Nose Pump Mist Stuffy Nose Pump Mist Oxymetazoline hydrochloride .025 g/100mL Spray, Metered — NDC 11523-0091-1 (Billing 11523-0091-01)
by Bayer HealthCare LLC. · 1 BOTTLE, PUMP in 1 CARTON / 15 mL in 1 BOTTLE, PUMP
This is a package of Children Afrin Extra Moisturizing Stuffy Nose Pump Mist Stuffy Nose Pump Mist Oxymetazoline hydrochloride .025 g/100mL Spray, Metered from Bayer HealthCare LLC., marketed since Jul 2022 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.
NDC 11523-0091-01
🏷️ FDA NDC (as labeled)
11523-0091-1
billing pads the package segment with a zero
This package
Contains15 mL in 1 bottle, pump
Pack sizes2 compare ↓
Main listing for product 11523-0091 · Also comes in:
2 bottles 11523-0091-2
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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 Oxymetazoline Hydrochloride (different manufacturers) — 3 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Dec 28, 2023 — CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products. (Seaway Pharma Inc.) · FDA recall D-0216-2024
Class II · Dec 28, 2023 — CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products. (Seaway Pharma Inc.) · FDA recall D-0214-2024
Class II · Dec 28, 2023 — CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products. (Seaway Pharma Inc.) · FDA recall D-0217-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
11523-0091-1
Product NDC
11523-0091
11-digit billing NDC
11523009101
NCPDP billing unit
ML — per mL (volume)
UNII
K89MJ0S5VY
Application #
M012
SPL Set ID
e3b239bd-ffc7-600c-e053-2a95a90a3b3b
Established class (EPC)
Vasoconstrictor
Physiologic effect
Increased Sympathetic Activity; Vasoconstriction
Chemical class
Imidazolines
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2022-07-03
Route
NASAL
Dosage form
SPRAY, METERED
Substance
OXYMETAZOLINE HYDROCHLORIDE
Quick answers
- RxCUI (RxNorm): 2606550
Why two NDCs?
The FDA registers this code as 11523-0091-1 — a 5-4-1 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 package segment → 11523-0091-01. 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Vasoconstrictor class.
Pharmacologic class
Vasoconstrictor
Drug family (ATC)
Other dermatologicals, Sympathomimetics, plain, Sympathomimetics used as decongestants
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.
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
📖 What it is MedlinePlus · NLM
Oxymetazoline nasal spray is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Oxymetazoline nasal spray should not be used to treat children younger than 6 years of age unless it is recommended by a doctor. Children 6 to 12 years of age should use oxymetazoline nasal spray carefully and under adult supervision. Oxymetazoline is in a class of medications called nasal decongestants. It works by narrowing the blood vessels in the nasal passages.
Read the full MedlinePlus article ↗📗 Our plain-language guide HelloPharmacist
- It's really important not to use the nasal spray for more than 3 days in a row. If you keep using it longer, your nose can actually become dependent on it — and when you stop, the...
- Can I use the nasal spray every day for my chronic stuffiness?
- You should check with your doctor or pharmacist first. Oxymetazoline can affect blood pressure on its own, and it can interact with antihypertensive drugs like beta-blockers. This...
- I take blood pressure medication. Is it okay to use oxymetazoline?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Oxymetazoline Hydrochloride — tap one for details:
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.
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
💬 Questions about Oxymetazoline hydrochloride?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per mL | Per 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:
2 bottles
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.
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 2, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 11523-0091-01 You're viewing this Main listing | 1 BOTTLE, PUMP in 1 CARTON / 15 mL in 1 BOTTLE, PUMP | 2022-07-14 | — | Active |
| 11523-0091-02 11523-0091-2 | 2 BOTTLE, PUMP in 1 CARTON / 15 mL in 1 BOTTLE, PUMP | 2022-12-02 | — | Active |
Pack size FAQ
What quantity is in this package?
This package is listed by the FDA — 1 bottle, pump in 1 carton / 15 ml in 1 bottle, pump.
What NDC number is used to bill for this package of Children Afrin Extra Moisturizing Stuffy Nose Pump Mist Stuffy Nose Pump Mist Oxymetazoline hydrochloride .025 g/100mL Spray, Metered?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Children Afrin Extra Moisturizing Stuffy Nose Pump Mist Stuffy Nose Pump Mist .025 g/100mLthis 11523-0091-01 | Bayer | 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file
Availability & generic status
🏛️
2022
On the market since
Jul 2022
📍
2026
Currently FDA-listed
4 years 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.
- FDA Orange Book · refreshed Sep 3, 2026
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.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII F5UM2KM3W7
Benzalkonium chloride is a chemical compound that works as a preservative and antimicrobial agent in medications. It prevents bacterial and fungal growth in liquid formulations to keep the product safe during storage and use.
-
UNII 7FLD91C86K
Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
-
UNII PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
-
UNII 3WJQ0SDW1A
Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
-
UNII FZ989GH94E
Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
-
UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
-
UNII GR686LBA74
Sodium phosphate, dibasic is a salt derived from phosphoric acid. It acts as a buffer to help maintain the medicine's pH balance and may serve as a binder or filler in tablets and capsules.
-
UNII 3980JIH2SW
A salt form of phosphoric acid that acts as a buffer and pH adjuster in medicines. It helps keep the product at the correct acidity level for stability and effectiveness.
-
UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
9 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesbenzalkonium chloride, dibasic sodium phosphate, edetate disodium, glycerin, monobasic sodium phosphate, polyethylene glycol, povidone, propylene glycol, purified water
Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.
Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed —
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
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.
Manufacturer & labeler
LabelerBayer HealthCare LLC.
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code11523
First marketedJul 2022
Product typeHuman Otc Drug
Portfolio240 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
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
⏱️ Dosage and Administration
⚠️ Warnings
📦 Storage and Handling
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
🎯 Indications and Usage ▾
Uses temporarily relieves nasal congestion due to: common cold hay fever upper respiratory allergies temporarily relieves sinus congestion and pressure shrinks swollen nasal membranes so you can breathe more freely
⏱️ Dosage and Administration ▾
Directions children 2 to under 6 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours. Use only recommended amount. Do not exceed 2 doses in any 24-hour period. children under 2 years of age: consult a doctor To Use: Shake well before use.
Hold white tabs, press grooved area of cap firmly and turn counter clockwise. Before using the first time, prime metered pump by depressing pump firmly up to 10 times. To spray, hold bottle with thumb at base and nozzle between first and second fingers.
Without tilting head, insert nozzle into nostril. Fully depress rim with a firm, even stroke. Wipe nozzle clean after use.
Secure cap after use.
⚠️ Warnings ▾
Warnings Ask a doctor before use if you or a child has heart disease high blood pressure thyroid disease diabetes When using this product do not use more than directed do not use for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen. temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge may occur use of this container by more than one person may spread infection Stop use and ask a doctor if symptoms persist Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
📦 Storage and Handling ▾
Other information store between 20° to 25°C (68° to 77°F) retain carton for future reference on full labeling
🧪 Active Ingredient ▾
Active ingredient Oxymetazoline hydrochloride 0.025%
🧪 Inactive Ingredients ▾
Inactive ingredients benzalkonium chloride, dibasic sodium phosphate, edetate disodium, glycerin, monobasic sodium phosphate, polyethylene glycol, povidone, propylene glycol, purified water
🎯 Purpose ▾
Purpose Nasal decongestant
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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 Children Afrin Extra Moisturizing Stuffy Nose Pump Mist Stuffy Nose Pump Mist (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 39%
Female · 60%
Unknown · 1%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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.
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) | ✓ 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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Bayer HealthCare LLC.. 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 2 bottles (11523-0091-02). 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?
Bayer HealthCare LLC. 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.
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.