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RUGBY FLUTICASONE PROPIONATE NASAL

Fluticasone propionate · Spray, Metered

Over-the-counter ANDA Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
RUGBY FLUTICASONE PROPIONATE NASAL
Generic name
Fluticasone propionate
Dosage form
Spray, Metered
Route
Nasal
Marketing category
ANDA · ANDA
Labeler
Rugby Laboratories
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
4
Packages
13
Data completeness
76% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Fluticasone Propionate 50 ug/1 1797907 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Spray, Metered
Route of administration
Nasal
Presentations
17

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Corticosteroid Hormone Receptor Agonists [MoA] MoA All 215 members
Corticosteroid [EPC] EPC All 215 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
207957
Application type
ANDA · Abbreviated New Drug Application
Approval date
May 26, 2016
Sponsor
HIKMA
Products on application
1
Submissions recorded
4
Products approved under application 207957.
Product Trade name Form Strength Ingredient Status TE Flags
207957-001 FLUTICASONE PROPIONATE SPRAY, METERED FLUTICASONE PROPIONATE Over-the-counter — RS

Therapeutic equivalence

Source: Orange Book
TE code
—
Reference Listed Drug
No
Reference Standard
Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA
Most recent submissions on application 207957.
Type No. Action Status Date Review
Supplement 4 Labeling Approved November 27, 2019 Standard
Supplement 2 Manufacturing (CMC) Approved December 29, 2016 Unknown
Supplement 1 Manufacturing (CMC) Approved August 2, 2016 Unknown
Original application 1 Approved May 26, 2016 Standard

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260224). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260224 HUMAN OTC DRUG · 20260108

Indications and Usage

openFDA Drug Labeling

Uses Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: • nasal congestion • itchy nose • runny nose • itchy, watery eyes • sneezing

Purpose Allergy symptom reliever

Dosage and Administration

openFDA Drug Labeling

Directions • read the Quick Start Guide for how to: • prime the bottle • use the spray • 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 Only for use in the nose. Do not spray into your eyes or mouth. Do 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 Stop 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 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).

Do 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

openFDA Drug Labeling

Ask a doctor before use if you have or had glaucoma or cataracts

Stop 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

Active Ingredient

openFDA Drug Labeling

Active ingredient (in each spray) Fluticasone propionate (glucocorticoid)* 50 mcg *read the Question & Answer leaflet

How Supplied / Storage and Handling

openFDA Drug Labeling

HOW SUPPLIED Product: 50090-6823 NDC: 50090-6823-0 120 SPRAY, METERED in a BOTTLE / 1 in a CARTON

Adverse event reports

Source: openFDA FAERS
224,191
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed 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
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
50090-6823-0 50090-6823 A-S Medication Solutions 1 BOTTLE in 1 CARTON (50090-6823-0) / 120 SPRAY, METERED in 1 BOTTLE November 16, 2023
87063-114-12 87063-114 ASCLEMED USA INC. 1 BOTTLE in 1 CARTON (87063-114-12) / 120 SPRAY, METERED in 1 BOTTLE February 9, 2026
87063-114-14 87063-114 ASCLEMED USA INC. 1 BOTTLE in 1 CARTON (87063-114-14) / 144 SPRAY, METERED in 1 BOTTLE August 5, 2024
87063-114-60 87063-114 ASCLEMED USA INC. 1 BOTTLE in 1 CARTON (87063-114-60) / 60 SPRAY, METERED in 1 BOTTLE February 9, 2026
87063-114-72 87063-114 ASCLEMED USA INC. 1 BOTTLE in 1 CARTON (87063-114-72) / 72 SPRAY, METERED in 1 BOTTLE February 9, 2026
0536-1183-13 0536-1183 Rugby Laboratories 1 BOTTLE, SPRAY in 1 CARTON (0536-1183-13) / 72 SPRAY, METERED in 1 BOTTLE, SPRAY August 5, 2024
0536-1183-21 0536-1183 Rugby Laboratories 1 BOTTLE, SPRAY in 1 CARTON (0536-1183-21) / 144 SPRAY, METERED in 1 BOTTLE, SPRAY August 5, 2024
0536-1183-65 0536-1183 Rugby Laboratories 1 BOTTLE, SPRAY in 1 CARTON (0536-1183-65) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY December 18, 2018
0536-1183-99 0536-1183 Rugby Laboratories 1 BOTTLE, SPRAY in 1 CARTON (0536-1183-99) / 60 SPRAY, METERED in 1 BOTTLE, SPRAY December 18, 2018
85766-161-12 85766-161 Sportpharm LLC 1 BOTTLE in 1 CARTON (85766-161-12) / 120 SPRAY, METERED in 1 BOTTLE February 9, 2026
85766-161-14 85766-161 Sportpharm LLC 1 BOTTLE in 1 CARTON (85766-161-14) / 144 SPRAY, METERED in 1 BOTTLE August 5, 2024
85766-161-60 85766-161 Sportpharm LLC 1 BOTTLE in 1 CARTON (85766-161-60) / 60 SPRAY, METERED in 1 BOTTLE February 9, 2026
85766-161-72 85766-161 Sportpharm LLC 1 BOTTLE in 1 CARTON (85766-161-72) / 72 SPRAY, METERED in 1 BOTTLE February 9, 2026
50090-6823 50090-6823 A-S Medication Solutions — December 18, 2018
87063-114 87063-114 ASCLEMED USA INC. — December 18, 2018
0536-1183 0536-1183 Rugby Laboratories — December 18, 2018
85766-161 85766-161 Sportpharm LLC — December 18, 2018

Sources for this page

Every dataset that contributed a fact to 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 · 11 sections on this page.