FDA.reportPublic FDA data

FLONASE

Product NDC
0135-0576
11-digit product format
001350576
Labeler code
0135
Product ID
0135-0576_fe356980-6a1c-4830-b69c-7adb271b2e20
Type
HUMAN OTC DRUG
Nonproprietary name
fluticasone propionate
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Haleon US Holdings LLC
Application
NDA205434
Marketing category
NDA
Marketing start
2014-12-04
Substance
FLUTICASONE PROPIONATE
Active strength
50 ug/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
FLONASE
Brand name suffix
ALLERGY RELIEF
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUTICASONE PROPIONATE50 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO2GMZ0LF5W
Rxcui1797907, 1797933

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0576-01FLONASEALLERGY RELIEF1 in 1 CARTONSPRAY, METERED121
0135-0576-01FLONASEALLERGY RELIEF30 in 1 BOTTLESPRAY, METERED3021
0135-0576-02FLONASEALLERGY RELIEF60 in 1 BOTTLESPRAY, METERED6021
0135-0576-02FLONASEALLERGY RELIEF1 in 1 PACKAGESPRAY, METERED121
0135-0576-03FLONASEALLERGY RELIEF1 in 1 PACKAGESPRAY, METERED121
0135-0576-03FLONASEALLERGY RELIEF120 in 1 BOTTLESPRAY, METERED12021
0135-0576-04FLONASEALLERGY RELIEF3 in 1 PACKAGESPRAY, METERED321
0135-0576-04FLONASEALLERGY RELIEF120 in 1 BOTTLESPRAY, METERED12021
0135-0576-12FLONASEALLERGY RELIEF120 in 1 BOTTLESPRAY, METERED12021
0135-0576-12FLONASEALLERGY RELIEF2 in 1 PACKAGESPRAY, METERED221
0135-0576-14FLONASEALLERGY RELIEF1 in 1 PACKAGESPRAY, METERED121
0135-0576-14FLONASEALLERGY RELIEF144 in 1 BOTTLESPRAY, METERED14421
0135-0576-15FLONASEALLERGY RELIEF2 in 1 PACKAGESPRAY, METERED221
0135-0576-15FLONASEALLERGY RELIEF144 in 1 BOTTLESPRAY, METERED14421
0135-0576-16FLONASEALLERGY RELIEF144 in 1 BOTTLESPRAY, METERED14421
0135-0576-16FLONASEALLERGY RELIEF3 in 1 PACKAGESPRAY, METERED321
0135-0576-17FLONASEALLERGY RELIEF1 in 1 PACKAGESPRAY, METERED121
0135-0576-17FLONASEALLERGY RELIEF72 in 1 BOTTLESPRAY, METERED7221
0135-0576-18FLONASEALLERGY RELIEF90 in 1 BOTTLESPRAY, METERED9021
0135-0576-18FLONASEALLERGY RELIEF1 in 1 PACKAGESPRAY, METERED121

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0135-0576-02ML - Milliliter0135-0576530d5343-ecd6-4d4c-8c91-009427e86b7d12015-02-02
0135-0576-03ML - Milliliter0135-0576865c93a8-8bed-4d15-9ec7-6d112b4d31e712015-02-02
0135-0576-04ML - Milliliter0135-0576d0a68cc5-b3ef-40cb-98e4-287b6f5a3b0f12015-02-02
0135-0576-14ML - Milliliter0135-0576dd0b22db-120a-4750-9412-a0b7f66f9ffb12018-08-13
0135-0576-15ML - Milliliter0135-05765048df9c-fbbf-4899-880b-a2954d70f8bf12018-03-08
0135-0576-16ML - Milliliter0135-0576f5dd4265-38d2-4dc4-9d1c-e8e9a95a69df12018-03-08
0135-0576-17ML - Milliliter0135-0576cc1b971f-e7c4-4473-adcd-85d87f59cef712020-04-20
0135-0576-18ML - Milliliter0135-05762b27c673-6c75-4a9c-babe-637772aafa2012025-09-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUTICASONE PROPIONATEACTIVE INGREDIENTO2GMZ0LF5WFLONASE ALLERGY RELIEF (FLUTICASONE PROPIONATE) SPRAY, METERED [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
FLUTICASONEACTIVE MOIETYCUT2W21N7UFLONASE ALLERGY RELIEF (FLUTICASONE PROPIONATE) SPRAY, METERED [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7FLONASE ALLERGY RELIEF (FLUTICASONE PROPIONATE) SPRAY, METERED [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311FLONASE ALLERGY RELIEF (FLUTICASONE PROPIONATE) SPRAY, METERED [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFLONASE ALLERGY RELIEF (FLUTICASONE PROPIONATE) SPRAY, METERED [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2FLONASE ALLERGY RELIEF (FLUTICASONE PROPIONATE) SPRAY, METERED [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
PHENYLETHYL ALCOHOLINACTIVE INGREDIENTML9LGA7468FLONASE ALLERGY RELIEF (FLUTICASONE PROPIONATE) SPRAY, METERED [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HFLONASE ALLERGY RELIEF (FLUTICASONE PROPIONATE) SPRAY, METERED [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
WATERINACTIVE INGREDIENT059QF0KO0RFLONASE ALLERGY RELIEF (FLUTICASONE PROPIONATE) SPRAY, METERED [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0576FLONASE ALLERGY RELIEF (FLUTICASONE PROPIONATE) SPRAY, METERED [HALEON US HOLDINGS LLC]21Current NDC, Legacy NDC, 20 package rows20241222_b6134ba0-b70a-4eac-9a82-cef64b242c1d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797933FLONASE 50 MCG/ACTUAT Metered Dose Nasal SprayPSNb6134ba0-b70a-4eac-9a82-cef64b242c1d21
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSNb6134ba0-b70a-4eac-9a82-cef64b242c1d21
1797933fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal Spray [Flonase]SBDb6134ba0-b70a-4eac-9a82-cef64b242c1d21
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCDb6134ba0-b70a-4eac-9a82-cef64b242c1d21
1797933Flonase 0.05 MG/ACTUAT Metered Dose Nasal SpraySYb6134ba0-b70a-4eac-9a82-cef64b242c1d21
1797933Flonase 50 MCG/ACTUAT Metered Dose Nasal SpraySYb6134ba0-b70a-4eac-9a82-cef64b242c1d21
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySYb6134ba0-b70a-4eac-9a82-cef64b242c1d21
1797933FLONASE 50 MCG/ACTUAT Metered Dose Nasal SprayPSN1180fa57-4c68-4dc4-a00f-a1694c6745697
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSN1180fa57-4c68-4dc4-a00f-a1694c6745697
1797933fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal Spray [Flonase]SBD1180fa57-4c68-4dc4-a00f-a1694c6745697
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCD1180fa57-4c68-4dc4-a00f-a1694c6745697
1797933Flonase 0.05 MG/ACTUAT Metered Dose Nasal SpraySY1180fa57-4c68-4dc4-a00f-a1694c6745697
1797933Flonase 50 MCG/ACTUAT Metered Dose Nasal SpraySY1180fa57-4c68-4dc4-a00f-a1694c6745697
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySY1180fa57-4c68-4dc4-a00f-a1694c6745697

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0135-0576-01001350576011 BOTTLE in 1 CARTON (0135-0576-01) / 30 SPRAY, METERED in 1 BOTTLE1 bottle2016-06-300000-00-00NoNoCurrent
0135-0576-02001350576021 BOTTLE in 1 PACKAGE (0135-0576-02) / 60 SPRAY, METERED in 1 BOTTLE1 bottle2014-12-040000-00-00NoNoCurrent
0135-0576-03001350576031 BOTTLE in 1 PACKAGE (0135-0576-03) / 120 SPRAY, METERED in 1 BOTTLE1 bottle2014-12-040000-00-00NoNoCurrent
0135-0576-04001350576043 BOTTLE in 1 PACKAGE (0135-0576-04) / 120 SPRAY, METERED in 1 BOTTLE3 bottle2015-01-070000-00-00NoNoCurrent
0135-0576-12001350576122 BOTTLE in 1 PACKAGE (0135-0576-12) / 120 SPRAY, METERED in 1 BOTTLE2 bottle2016-02-290000-00-00NoNoCurrent
0135-0576-14001350576141 BOTTLE in 1 PACKAGE (0135-0576-14) / 144 SPRAY, METERED in 1 BOTTLE1 bottle2016-11-170000-00-00NoNoCurrent
0135-0576-15001350576152 BOTTLE in 1 PACKAGE (0135-0576-15) / 144 SPRAY, METERED in 1 BOTTLE2 bottle2017-03-200000-00-00NoNoCurrent
0135-0576-16001350576163 BOTTLE in 1 PACKAGE (0135-0576-16) / 144 SPRAY, METERED in 1 BOTTLE3 bottle2017-03-200000-00-00NoNoCurrent
0135-0576-17001350576171 BOTTLE in 1 PACKAGE (0135-0576-17) / 72 SPRAY, METERED in 1 BOTTLE1 bottle2019-01-220000-00-00NoNoCurrent
0135-0576-18001350576181 BOTTLE in 1 PACKAGE (0135-0576-18) / 90 SPRAY, METERED in 1 BOTTLE1 bottle2021-07-010000-00-00NoNoCurrent