Fluticasone Propionate

Product NDC
85828-448
11-digit product format
858280448
Labeler code
85828
Product ID
85828-448_279f4af7-2826-499c-9955-afc81de00832
Type
HUMAN OTC DRUG
Nonproprietary name
Fluticasone Propionate
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Grocery Outlet
Application
ANDA208150
Marketing category
ANDA
Marketing start
2026-03-16
Substance
FLUTICASONE PROPIONATE
Active strength
50 ug/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 PROPIONATEGrocery Outlet838bbb29-0aa3-4c88-a10d-81be71c202112026-03-16WarningsExact 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 ingredient 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 breastfeeding, 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.

Additional Listing Data#

Finished product
Yes
Brand name base
Fluticasone Propionate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUTICASONE PROPIONATE50 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO2GMZ0LF5W
Rxcui1797907

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f4fb2f5a-dadb-40e3-a4b1-a2a58f5d9a33Product name320260126
343e8617-eb68-1e10-cfa9-8c30af285764Product name320240513
a31ad3df-8021-2ea1-94eb-0fe2f49b7729Product name420220719
813fe018-3e3c-40e4-8f71-7ab50f3dfe81Product name220180723
3bcd721e-0555-4bc3-96c6-690471ff9d94Product name120171113
9f9452df-fa34-43d4-97fe-c6605344c5a8Product name120171113
0e5a25a6-9f05-44b5-8449-aa63e59f7202Product name120170426
f3c5232f-03de-44f5-996a-90cd9c08bc60Product name120170426
1cb17fbb-0da4-2841-37bc-e7079783e1a2Product name120140508
667f427a-8698-a508-767a-53ed61b4c2e9Product name120140508
6a97ffc8-1d4d-a971-4978-85ba3a22eac9Product name120140508
6df84e13-2223-fa46-1e26-17e2f58a1e1cProduct name120140508
90fec588-984c-4375-cfd4-7e40114bdf80Product name120140508
9c1d3c48-b162-204b-f55b-e0f25c31c52eProduct name120140508
9fdb6139-394b-1510-4baf-bde68c419789Product name120140508
aef26912-037b-9a4e-db49-225ef6dfd8f1Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85828-448-01Fluticasone Propionate1 in 1 CARTONSPRAY, METERED15
85828-448-01Fluticasone Propionate72 in 1 BOTTLE, SPRAYSPRAY, METERED725

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSN838bbb29-0aa3-4c88-a10d-81be71c202115
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCD838bbb29-0aa3-4c88-a10d-81be71c202115
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySY838bbb29-0aa3-4c88-a10d-81be71c202115

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
85828-448-01858280448011 BOTTLE, SPRAY in 1 CARTON (85828-448-01) / 72 SPRAY, METERED in 1 BOTTLE, SPRAY2026-03-16NoNoCurrent