HomeNDC LookupIngredientsMometasone Furoate › 70000-0635-01
Leader Allergy Nasal mometasone furoate 50 ug Spray, Metered — NDC 70000-0635-01 package photo

Leader Allergy Nasal mometasone furoate 50 ug Spray, Metered

by Cardinal Health 110, LLC. dba Leader · 1 BOTTLE, SPRAY in 1 PACKAGE (70000-0635-1) / 60 SPRAY in 1 BOTTLE, SPRAY
NDC 70000-0635-01
🏷️ FDA NDC (as labeled) 70000-0635-1 billing pads the package segment with a zero
This package
Contains60 spray in 1 bottle, spray Pack sizes2 compare ↓
Also comes in: 1 bottle 70000-0635-02
OTC Brand 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 Mometasone Furoate (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class III · May 28, 2024 — Defective Container (Organon Llc) · FDA recall D-0551-2024
Class III · May 28, 2024 — Defective Container (Organon Llc) · FDA recall D-0550-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 70000-0635-1
Product NDC 70000-0635
11-digit billing NDC 70000063501
RxCUI 1797865
UNII MTW0WEG809
Application # NDA215712
SPL Set ID 26f929e8-0759-4584-a0bf-f7709baa6bee
Established class (EPC) Corticosteroid
Mechanism of action Corticosteroid Hormone Receptor Agonists
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-09-22
Route NASAL
Dosage form SPRAY, METERED
Substance MOMETASONE FUROATE MONOHYDRATE
GCN Seq No 083194
GCN 52083
HICL code 003329
Ingredient (HICL) Mometasone Furoate
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q7
Therapeutic class — intermediate (HIC2) Nasal Preparations
HIC3 code Q7P
Therapeutic class — specific (HIC3) Nasal Anti-Inflammatory Steroids
AHFS code 52:08.08.00
AHFS class Corticosteroids (Eent)
FDB label name ALLERGY NASAL 50 MCG SPRAY
FDB brand name Allergy Nasal
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 70000-0635-1 — 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 → 70000-0635-01. 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.

🏷️ RxNorm drug class

This medicine belongs to the Corticosteroid class.

Pharmacologic class Corticosteroid
Drug family (ATC) Corticosteroids, potent (group III), Corticosteroids, Glucocorticoids
How it works Corticosteroid Hormone Receptor Agonists
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

LabelerCardinal Health 110, LLC. dba Leader
Application holderPERRIGO PHARMA INTERNATIONAL DAC
FDA applicationNDA215712 (NDA)
Labeler code70000
First marketedSep 2023
Product typeHuman Otc Drug
Portfolio162 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

Label name ALLERGY NASAL 50 MCG SPRAY Ingredient Mometasone Furoate
📖 What it is MedlinePlus · NLM

Mometasone nasal spray is used to prevent and relieve symptoms of sneezing, runny, stuffy, or itchy nose caused by hay fever or other allergies. It is also used to treat nasal polyps (swelling of the lining of the nose). Mometasone nasal spray should not be used to treat symptoms (e.g., sneezing, stuffy, runny, itchy nose) caused by the common cold. Mometasone nasal spray is in a class of medications called corticosteroids. It works by blocking the release of certain natural substances that cause allergy symptoms.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • For the nasal spray, it can help with allergy symptoms, but it works best as a daily preventive — not a quick-fix spray you grab when symptoms hit suddenly. For the inhalers (Asman...
  • Can I use my mometasone nasal spray or inhaler when I'm having an allergy attack or asthma flare right now?
  • That's actually normal — it can take one to two weeks or even longer to feel the full benefit from an inhaled corticosteroid like Asmanex. These medications work by gradually reduc...
  • I've been using the Asmanex inhaler for a week and I still feel the same. Is it working?
📖 Read our full Mometasone 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.

💡 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 K679OBS311
    Carboxymethylcellulose sodium is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a disintegrant to help the tablet break apart, or a thickener in liquids.
  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • 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 OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • 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.

8 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesbenzalkonium chloride, citric acid, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, polysorbate 80, purified water, sodium citrate

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 DailyMedingredient 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.

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: 1 bottle
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
Nasonex 50 ug 00113-1720-02 L. 1 bottle $1.193 Availability likely
Mometasone Furoate Monohydrate 50 ug 59651-0402-17 Aurobindo 1 bottle $1.590 AB Availability likely
Mometasone Furoate 50 ug 60505-0830-01 Apotex 1 bottle $1.590 AB Availability likely
Mometasone Furoate 50 ug 65162-0891-29 Amneal 1 bottle $1.590 AB Availability likely
Childrens Nasonex 50 ug 00113-1999-01 L. 1 bottle FDA listed
allergy nasal 50 ug 00363-2060-02 Walgreen 1 bottle FDA listed
Rugby mometasone furoate nasal 50 ug 00536-1381-30 Rugby 1 bottle FDA listed
Allergy 50 ug 11822-7099-00 Rite 1 bottle Discontinued
allergy 50 ug 42507-0182-02 HyVee 1 bottle FDA listed
allergy 50 ug 51316-0117-11 CVS 1 bottle FDA listed
Allergy Relief 50 ug 51316-0172-11 CVS 1 bottle FDA listed
Mometasone Furoate 50 ug 58602-0522-44 Aurohealth 1 bottle FDA listed
Mometasone Furoate 50 ug 60429-0664-17 Golden 1 bottle AB FDA listed
Leader Allergy Nasal 50 ugthis 70000-0635-01 Cardinal 1 bottle FDA listed
basic care allergy 50 ug 72288-0610-02 Amazon.com 1 bottle FDA listed
topcare allergy 50 ug 76162-0134-02 Topco 1 bottle FDA listed
Allergy 50 ug 72288-0506-02 Amazon.com 1 bottle FDA listed
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be 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

🏛️
2023
On the market since
Sep 2023
📍
2026
Currently FDA-listed
3 years listed
🔓
·
Generic versions listed
see equivalents
Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 bottle70000-0635-02 45 Rx · $1,434
Drug total (last 4 qtrs): 45 Rx · 799 units · $1,434 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Mometasone Furoate (matched by generic name) — the program that covers self-administered drugs. 9 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 Mometasone Furoate. CMS lists 3 products for this generic; we show the highest-spend one. 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
$8.35M
Claims incl. refills
244.2K
Beneficiaries
188.1K
Spend / beneficiary
$44.41
Spend / claim
$34.22
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.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
70000-0635-01 You're viewing this 1 BOTTLE, SPRAY in 1 PACKAGE (70000-0635-1) / 60 SPRAY in 1 BOTTLE, SPRAY 2023-09-22 Active
70000-0635-02 1 BOTTLE, SPRAY in 1 PACKAGE (70000-0635-2) / 120 SPRAY in 1 BOTTLE, SPRAY $0.7141 / mL 2023-09-22 Active

Pack size FAQ

What quantity is in NDC 70000-0635-01?
NDC 70000-0635-01 is listed by the FDA — 1 bottle, spray in 1 package / 60 spray in 1 bottle, spray.
What NDC number is used to bill for this package of Leader Allergy Nasal mometasone furoate 50 ug Spray, Metered?
Bill NDC 70000-0635-01 — the 11-digit billing format is 70000063501. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

🧭 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 ✓ Available
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

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 70000-0635-1, 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: 70000-0635-01, written without dashes as 70000063501. 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 70000-0635-01, the first segment (70000) is the labeler code FDA assigned to Cardinal Health 110, LLC. dba Leader; the middle segment (0635) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 Cardinal Health 110, LLC. dba Leader. 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 (70000-0635-02). 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?
Cardinal Health 110, LLC. dba Leader 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 temporarily relieves these symptoms of hay fever or other upper respiratory allergies: • nasal congestion • runny nose • sneezing • itchy nose

⏱️ Dosage and Administration 143 words

Directions Read insert (inside package) for how to: • prime the bottle • use the spray • clean the nozzle • shake well before each use • use this product only once a day • do not use more than directed Adults & children 12 years of age and older • 2 sprays in each nostril once daily while sniffing gently Children 2 to 11 years of age • the growth rate of some children may be slower while using this product. Children should use for the shortest amount of time necessary to achieve symptom relief. Talk to your child’s doctor if your child needs to use the spray for longer than two months a year. • an adult should supervise use • 1 spray in each nostril once daily while sniffing gently Children under 2 years of age • do not use

⚠️ Warnings ~2 min read

Warnings Only for use in the nose. Do not spray into your eyes or mouth. Do not use • in children under 2 years of age • to treat asthma • if you have an injury or surgery to your nose that is not fully healed • if you have ever had an allergic reaction to this product or any of the ingredients Ask a doctor before use if you • have an eye infection • have or had glaucoma or cataracts Ask a doctor or pharmacist before use if you are taking • medicine for HIV infection (such as ritonavir) • a steroid medicine for asthma, allergies or skin rash • ketoconazole pills (medicine for fungal infection) When using this product • the growth rate of some children may be slower • stinging may occur for a few seconds right after use • you may start to feel relief within 12 hours and full effect after several days of regular, once-a-day use • do not share this bottle with anyone else as this may spread germs • remember to tell your doctor about all the medicines you take, including this one Stop use and ask a doctor if • you have, or come into contact with someone who has chickenpox, measles or tuberculosis • your symptoms do not get better within 7 days of starting use or you get a new symptom such as severe facial pain or thick nasal discharge.

You may have something more than allergies, such as an infection. • you get a constant whistling sound from your nose. This may be a sign of damage inside your nose. • you get an allergic reaction to this product. Seek medical help right away. • you get new changes to your vision that develop after starting this product • you have severe or frequent nosebleeds 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 (1-800-222-1222).

📦 Storage and Handling 41 words

Other information • do not use if tape printed with “sealed for your protection” on top and bottom carton flaps is not intact • keep package and insert. They contain important information. • store between 20-25 ° C (68-77 ° F)

🧪 Active Ingredient 11 words

Active ingredient (in each spray) Mometasone furoate monohydrate (glucocorticoid) 50 mcg

🧪 Inactive Ingredients 18 words

Inactive ingredients benzalkonium chloride, citric acid, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, polysorbate 80, purified water, sodium citrate

🎯 Purpose 4 words

Purpose Allergy symptom reliever

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.