On this page
Childrens Fluticasone Propionate
fluticasone propionate · Spray, Metered
Overview
Active ingredients
Source: NDC Directory| Ingredient | Strength | RxCUI | Monograph |
|---|---|---|---|
| Fluticasone Propionate | 50 ug/1 | 1797907 | View |
Forms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Corticosteroid Hormone Receptor Agonists [MoA] | MoA | All 215 members |
| Corticosteroid [EPC] | EPC | All 215 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 218742-001 | FLUTICASONE PROPIONATE | SPRAY, METERED | FLUTICASONE PROPIONATE | Over-the-counter | — |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Original application | 1 | Approved | March 16, 2026 | Standard |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260630). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingUses Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: • nasal congestion • itchy nose • runny nose • itchy, watery eyes • sneezing
Purpose
openFDA Drug LabelingPurpose Allergy symptom reliever
Dosage and Administration
openFDA Drug LabelingDirections • read the Quick Start Guide for how to: o prime the bottle o use the spray o clean the spray nozzle • shake gently before each use • use this product only once a day • do not use more than directed ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER • Week 1- use 2 sprays in each nostril once daily • Week 2 through 6 months- use 1 or 2 sprays in each nostril once daily, as needed to treat your symptoms • After 6 months of daily use – ask your doctor if you can keep using CHILDREN 4 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 • use 1 spray in each nostril once daily CHILDREN UNDER 4 YEARS OF AGE • do not use
Warnings
openFDA Drug LabelingWarnings Only for use in the nose. Do not spray into your eyes or mouth.
FLUTICASONE PROPIONATE NASAL SPRAY, USP QUICK START GUIDE HOW TO START GETTING ALLERGY RELIEF RIGHT NOW USE THE RIGHT DOSE Fluticasone Propionate Nasal Spray, USP works best when you use it daily. Here’s how to get started. Children age 4 to 11 An adult should supervise use Use one spray in each nostril once daily. Don’t use more than one spray in each nostril per day. If you miss a dose , just use your regular dose the next day. Don’t add an extra dose. Check with a doctor if a child needs to use Fluticasone Propionate Nasal Spray, USP for longer than two months a year. Users age 12 or older In your first week Use two sprays in each nostril every day. Don’t use more than two sprays in each nostril per day. After your first week If your symptoms are under control, you may reduce to one spray in each nostril every day. If your symptoms get worse, go back to two sprays in each nostril. If you miss a dose, just use your regular dose the next day. Don’t add an extra dose. WARNING: Do not spray in your eyes. Only for use in your nose. KEEP IT CLEAN A clean spray nozzle helps ensure a full dose. Clean it weekly, or if it’s clogged. Don’t try to unblock nozzle with pin or sharp object – that can damage it. Remove spray nozzle by grasping at base and pulling up. Rinse under running tap, and dry at room temperature. Aim away from your face and gently replace spray nozzle until you hear a soft click. If spray nozzle is clogged, soak in warm water. Then repeat steps 2 and 3 . GET THE RELIEF YOU NEED Fluticasone Propionate Nasal Spray, USP can relieve your allergy symptoms. For best results, it’s important to get a full dose. Here’s how, in five easy steps. 1 Shake Gently shake spray bottle. Remove translucent cap. 2 Prime Do this when: • Starting new bottle • Haven’t used it in a week • Just cleaned nozzle Otherwise go to Step 3. Aim away from face. Grasp spray bottle as shown. Pump until fine mist appears. Pumped six times and still no mist? Spray nozzle may be clogged. See KEEP IT CLEAN. 3 Blow Blow nose gently to clear nostrils. 4 Aim Close one nostril and put tip of spray nozzle in other nostril. Put just the tip into your nose. Aim slightly away from center of nose. 5 Breathe and Spray While sniffing gently, press down on spray nozzle once or twice (according to dosing instructions). You’ll feel a light mist in your nose. Breathe out through your mouth. Repeat in other nostril. Wipe spray nozzle with clean tissue and replace cap. Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India Code: AP/DRUGS/04/2016 Revised: 12/2025 Figure 6 Figure 7 Figure 8 Figure 9 Figure 10 Figure 11 Figure 12 Figure 13 Figure 14 Figure 15 Figure 16 Figure 17 Figure 18 Figure 19 Figure 20 Figure 21 Figure 22 Figure 23
Do Not Use
openFDA Drug LabelingDo not use in children under 4 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 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 or sneezing may occur for a few seconds right after 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
Ask a Doctor
openFDA Drug LabelingStop use and ask a doctor if you have, or come into contact with someone who has, chicken pox, measles or tuberculosis your symptoms do not get better within 7 days of starting use or you get new symptoms 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
Stop Use
openFDA Drug LabelingWHAT TO EXPECT What it’s like to use Fluticasone Propionate Nasal Spray, USP. How soon will I get relief? You may start to feel relief the first day you use Fluticasone Propionate Nasal Spray, USP. Keep using it every day, though. It takes several days before Fluticasone Propionate Nasal Spray, USP builds up to full effectiveness. How long will the relief last? Fluticasone Propionate Nasal Spray, USP is meant to control your symptoms every day, all day and all night. To help you get this lasting relief, it’s important to use Fluticasone Propionate Nasal Spray, USP regularly, once a day. Does Fluticasone Propionate Nasal Spray, USP cause a "rebound" effect? No, Fluticasone Propionate Nasal Spray, USP does not cause a rebound effect. Some nasal decongestant sprays may cause your nasal passages to swell up even more when you use them too often or for longer than their label says you should (three days). This is sometimes called a “rebound effect.” Fluticasone Propionate Nasal Spray, USP is a different kind of medicine and does not cause any rebound effect. You can use Fluticasone Propionate Nasal Spray, USP for up to six months if you are age 12 or older or up to two months a year if you are age 4 to 11 before checking with a doctor. Will Fluticasone Propionate Nasal Spray, USP make me drowsy? No, Fluticasone Propionate Nasal Spray, USP does not cause drowsiness. Some allergy medications can cause drowsiness, but Fluticasone Propionate Nasal Spray, USP does not. Why does Fluticasone Propionate Nasal Spray, USP have a smell? The light floral scent you may notice comes from one of the important ingredients in the Fluticasone Propionate Nasal Spray, USP formula. No fragrance is added to Fluticasone Propionate Nasal Spray, USP. What if little or nothing is spraying out? Try priming the spray bottle. It may take a few pumps to get the dispenser spraying again. If that doesn’t work, the spray nozzle may be clogged. You can clean it following the directions in the Quick Start Guide on the other side. What if I feel stinging in my nose, or I sneeze? Some people may feel a slight stinging, or may sneeze, after spraying Fluticasone Propionate Nasal Spray, USP in their nostrils. This feeling should go away in a few seconds. What if I feel or taste the medicine in my throat? Generally, you can avoid this by taking a shallower breath next time you spray Fluticasone Propionate Nasal Spray, USP into your nostrils. For example, take the kind of breath you would use to smell a flower. What if I have chicken pox, measles or tuberculosis or come into contact with someone who does? Stop using Fluticasone Propionate Nasal Spray, USP and ask your doctor. What if I’m having severe sinus pain? If you feel severe pain in your face, have thick nasal discharge, or think you may have a sinus infection, stop using Fluticasone Propionate Nasal Spray, USP and see your doctor. Your doctor may want to consider if other medicines are needed. What if my symptoms aren’t better after one week? If you have used Fluticasone Propionate Nasal Spray, USP for a week and your allergy symptoms are not getting better, stop use and ask your doctor. You may have an infection. Does Fluticasone Propionate Nasal Spray, USP have side effects? Serious side effects are rare with Fluticasone Propionate Nasal Spray, USP because Fluticasone Propionate Nasal Spray, USP works in your nose, and barely any of it travels through your body. However, like all medicines, Fluticasone Propionate Nasal Spray, USP can cause side effects in some people. Here are some side effects that have been reported when using Fluticasone Propionate Nasal Spray, USP. If you have any concerns about side effects, talk with your doctor. Side effect What could happen What to do Allergic reaction to the product • Sudden swelling of face or tongue • A rash • Wheezing or feeling faint If you feel any of these symptoms, stop using Fluticasone Propionate Nasal Spray, USP and see a doctor right away. Nose injury • Severe …
Active Ingredient
openFDA Drug LabelingDrug Facts Active ingredient (in each spray) Fluticasone propionate USP (glucocorticoid) * 50 mcg * read the Question & Answer Leaflet
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: FLUTICASONE PROPIONATE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 58602-018-04 | 58602-018 | Aurohealth LLC | 3 BOTTLE in 1 CARTON (58602-018-04) / 72 SPRAY, METERED in 1 BOTTLE | December 16, 2025 |
| 58602-018-42 | 58602-018 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-018-42) / 60 SPRAY, METERED in 1 BOTTLE | May 10, 2024 |
| 58602-018-45 | 58602-018 | Aurohealth LLC | 2 BOTTLE in 1 CARTON (58602-018-45) / 72 SPRAY, METERED in 1 BOTTLE | December 16, 2025 |
| 58602-018-51 | 58602-018 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-018-51) / 72 SPRAY, METERED in 1 BOTTLE | December 16, 2025 |
| 72657-166-72 | 72657-166 | GLENMARK THERAPEUTICS INC., USA | 1 BOTTLE in 1 CARTON (72657-166-72) / 72 SPRAY, METERED in 1 BOTTLE | June 30, 2026 |
| 58602-018 | 58602-018 | Aurohealth LLC | — | May 10, 2024 |
| 72657-166 | 72657-166 | GLENMARK THERAPEUTICS INC., USA | — | June 30, 2026 |
Sources for this page
| Dataset | Agency | Used for |
|---|---|---|
| NDC Directory | FDA | Identity, ingredients, strengths, forms, routes, labelers, packages |
| Drugs@FDA | FDA | Application, sponsor, submissions, review documents, marketing status |
| Drug Labeling | FDA / NLM | Prescribing information reproduced above |
| FAERS | FDA | Adverse event report counts |
Generated September 25, 2026 · 10 sections on this page.