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topcare allergy mometasone furoate monohydrate 50 ug Spray, Metered — NDC 76162-134-02 (Billing 76162-0134-02)

by Topco Associates LLC · 1 BOTTLE, SPRAY in 1 CARTON / 120 SPRAY in 1 BOTTLE, SPRAY

This is a package of topcare allergy mometasone furoate monohydrate 50 ug Spray, Metered from Topco Associates LLC, marketed since Mar 2023 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 76162-0134-02
🏷️ FDA NDC (as labeled) 76162-134-02 billing pads the product segment with a zero
This package
Contains120 spray in 1 bottle, spray Pack sizes2 compare ↓
Main listing for product 76162-134 · Also comes in: 1 bottle 76162-134-11
OTC Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ 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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 76162-134-02 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
76162 labeler · 134 product · 02 package
Package marketed since
Mar 28, 2023
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 7616213402 1
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 76162-134-02
Product NDC 76162-134
11-digit billing NDC 76162013402
RxCUI 1797865
UNII MTW0WEG809
Application # NDA215712
SPL Set ID 9e7c759e-d2cb-4505-ad9f-38efaaaeefc2
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 2023-03-28
Route NASAL
Dosage form SPRAY, METERED
Substance MOMETASONE FUROATE MONOHYDRATE
Quick answers
  • RxCUI (RxNorm): 1797865
Why two NDCs? The FDA registers this code as 76162-134-02 — 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 → 76162-0134-02. 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.

Clinical

📗 Our plain-language guide HelloPharmacist
  • It depends on the product. The nasal spray treats hay fever symptoms and nasal polyps, Asmanex inhalers treat asthma long term, Sinuva treats nasal polyps after sinus surgery, and...
  • No. Asmanex is for daily control, not quick relief. Use your fast-acting rescue inhaler, and call your doctor if your asthma isn't responding.
  • Can I use my Asmanex inhaler during an asthma attack?
  • Inhaled steroids can cause thrush, a yeast infection in the mouth and throat. Rinse with water and spit it out, without swallowing, after every dose.
📖 Read our full Mometasone guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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.

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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
76162-0134-02 You're viewing this Main listing 1 BOTTLE, SPRAY in 1 CARTON / 120 SPRAY in 1 BOTTLE, SPRAY 2023-03-28 — Active
76162-0134-11 76162-134-11 1 BOTTLE, SPRAY in 1 CARTON / 60 SPRAY, METERED in 1 BOTTLE, SPRAY 2024-03-14 Dec 1, 2026 Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 bottle, spray in 1 carton / 120 spray in 1 bottle, spray.
What NDC number is used to bill for this package of topcare allergy mometasone furoate monohydrate 50 ug 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

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 $1.587 AB Availability likely —
Mometasone Furoate 50 ug 60505-0830-01 Apotex 1 bottle $1.587 AB Availability likely —
Mometasone Furoate 50 ug 65162-0891-29 Amneal 1 bottle $1.587 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 ug 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 ugthis 76162-0134-02 Topco 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
Mar 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.

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.

Manufacturer & labeler

LabelerTopco Associates LLC
Application holderPERRIGO PHARMA INTERNATIONAL DAC
FDA applicationNDA215712 (NDA)
Labeler code76162
First marketedMar 2023
Product typeHuman Otc Drug
Portfolio408 products on file

More NDCs from Topco Associates LLC labeler code 76162

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 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 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 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

📄 Do Not Use 48 words ▾

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 19 words ▾

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 36 words ▾

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 74 words ▾

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 116 words ▾

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 10 words ▾

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

📄 Keep Out of Reach of Children 22 words ▾

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).

📄 Questions or Comments 6 words ▾

Questions or comments? Call toll-free 1-888-423-0139

📄 Package Label / Principal Display Panel 65 words ▾

Package/Label Principal Display Panel TopCare ® health NON-DROWSY COMPARE TO NASONEX ® 24HR ALLERGY FULL PRESCRIPTION STRENGTH Allergy Spray MOMETASONE FUROATE NASAL SPRAY, 50 MCG/SPRAY ALLERGY SYMPTOM RELIEVER (GLUCOCORTICOID)* ALLERGY + CONGESTION SCENT-FREE MIST 24 HOUR RELIEF OF: Nasal Congestion • Runny Nose Sneezing • Itchy Nose 120 SPRAYS

0.57FL OZ (17.0 mL) *Mometasone furoate is a steroid medicine known as a glucocorticoid 1y8-88-allergy-spray.jpg

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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

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 Topco Associates 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 1 bottle (76162-0134-11). 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?
Topco Associates 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.
← 76162-0131-68 · Topco 76162-0142-01 · Topco →
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.