Fluticasone Propionate

Product NDC
0363-5012
11-digit product format
003635012
Labeler code
0363
Product ID
0363-5012_e5dd5bd2-02bf-6c8b-881e-c8283a9021eb
Type
HUMAN OTC DRUG
Nonproprietary name
Fluticasone Propionate
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Walgreens
Application
ANDA208150
Marketing category
ANDA
Marketing start
2018-07-13
Marketing end
2024-02-10
Substance
FLUTICASONE PROPIONATE
Active strength
50 ug/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0363-5012DDiscontinued by firm2026-07-31
excluded packagepackage0363-50120363-5012-01DDiscontinued by firm2026-07-31
excluded packagepackage0363-50120363-5012-02DDiscontinued by firm2026-07-31
excluded packagepackage0363-50120363-5012-03DDiscontinued by firm2026-07-31
excluded packagepackage0363-50120363-5012-04DDiscontinued by firm2026-07-31

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A208150-001FLUTICASONE PROPIONATEFLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-29

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fluticasone PropionateFLUTICASONE PROPIONATEWalgreens16756136-e813-8a91-3351-7e759d1b4b942026-07-30WarningsExact identifier
Fluticasone PropionateFLUTICASONE PROPIONATEThe Kroger Co.f05689fa-7ff3-0846-c647-bdbe79cb2ff82026-07-29WarningsExact identifier
Fluticasone PropionateFLUTICASONE PROPIONATEChain Drug Marketing Association, Inc.0d7f6823-a7ef-a6a3-3f4e-3c8618ebccc72026-07-02WarningsExact identifier
Allergy ReliefFLUTICASONE PROPIONATEP & L Development, LLCf83fabaa-1c6c-4a19-9f30-2f06df6d48f42026-05-26WarningsExact identifier
Fluticasone PropionateFLUTICASONE PROPIONATEAllegiant Healthf4b9fcfc-f3f7-4ce0-8f97-3d475081aa672026-04-29WarningsExact identifier
Fluticasone PropionateFLUTICASONE PROPIONATEGrocery Outlet838bbb29-0aa3-4c88-a10d-81be71c202112026-03-16WarningsExact identifier
Fluticasone PropionateFLUTICASONE PROPIONATEApotex Corp.e3c861e3-2507-9758-fcd0-8e82d721b5b42026-03-06WarningsExact identifier
Fluticasone PropionateFLUTICASONE PROPIONATESam's West, Incd2a6e22c-1159-c86a-b927-e7ace1d7023f2025-10-24WarningsExact identifier
Allergy ReliefFLUTICASONE PROPIONATEDiscount Drug Mart9b6791d9-f8e8-5ae6-fbdd-c96561c0976a2025-09-22WarningsExact identifier
Fluticasone PropionateFLUTICASONE PROPIONATESam's West Inc.0370ef12-9199-e2ef-ef85-7d2c7d413bc92025-09-22WarningsExact identifier
Allergy ReliefFLUTICASONE PROPIONATEQuality Home Products7c81d4d6-d688-72ab-9e43-9b2278d1e0572025-09-22WarningsExact identifier
Fluticasone PropionateFLUTICASONE PROPIONATEApotex Corp.1252da79-70c1-c46e-e92b-a4edba76b1782025-09-22WarningsExact identifier
Allergy Relief NasalALLERGY RELIEF NASALMarc Glassman, Inc.bf100c3f-b1f4-4efa-af88-b51ed2a217712025-08-08WarningsExact identifier
Fluticasone PropionateFLUTICASONE PROPIONATEWalmart8616944c-a684-085a-7106-cf034e3f6f4d2025-07-01WarningsExact identifier
Fluticasone PropionateFLUTICASONE PROPIONATEBi-Mart3e4ff2eb-0d99-4ce7-910e-81f878b2231e2025-05-22WarningsExact identifier
Fluticasone PropionateFLUTICASONE PROPIONATETWIN MED LLC9337aa4b-382d-4ab9-b312-60417cdd40cf2025-05-01WarningsExact identifier
Fluticasone PropionateFLUTICASONE PROPIONATETarget Corporationcee73f84-40fb-7143-0f11-4d119de6a9052025-02-13WarningsExact identifier
Fluticasone PropionateFLUTICASONE PROPIONATEAllegiant Health4250d331-17b0-46be-a779-fb4f09bade162024-04-11WarningsExact identifier
Fluticasone PropionateFLUTICASONE PROPIONATEAllegiant Healtha4e1c265-5205-4089-8190-0755ede838962023-11-28WarningsExact identifier
Fluticasone PropionateFLUTICASONE PROPIONATESelder, S.A. de C.V.2da4ba91-c356-473d-b20c-5bb9265767df2017-11-29WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

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 (1-800-222-1222) right away.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-5012-01ML - Milliliter0363-50126240fcb9-2e64-4e3c-a4ed-45646ce19e2e12022-06-06
0363-5012-02ML - Milliliter0363-5012998e931b-164f-46a4-aa57-a65dcff7ed0012022-06-06
0363-5012-03ML - Milliliter0363-501230dfd9b9-e2f6-4e5f-85af-91f6777fb2b412022-06-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0363-5012-01003635012011 BOTTLE, SPRAY in 1 CARTON (0363-5012-01) > 120 SPRAY, METERED in 1 BOTTLE, SPRAY2018-07-130000-00-00NoNoCurrent
0363-5012-02003635012022 BOTTLE, SPRAY in 1 CARTON (0363-5012-02) > 120 SPRAY, METERED in 1 BOTTLE, SPRAY2018-07-130000-00-00NoNoCurrent
0363-5012-03003635012033 BOTTLE, SPRAY in 1 CARTON (0363-5012-03) > 120 SPRAY, METERED in 1 BOTTLE, SPRAY2018-07-130000-00-00NoNoCurrent
0363-5012-04003635012041 BOTTLE, SPRAY in 1 CARTON (0363-5012-04) > 60 SPRAY, METERED in 1 BOTTLE, SPRAY2018-07-130000-00-00NoNoCurrent