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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N205434-001FLONASE ALLERGY RELIEFFLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALRLD2014-07-23

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD2014-07-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD2014-07-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD2014-07-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD2014-07-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD2014-07-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD2014-07-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD2014-07-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD2014-07-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD2014-07-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD2014-07-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD2014-07-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD2014-07-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD2014-07-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD2014-07-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD2014-07-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD2014-07-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD2014-07-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD, RS2014-07-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD2014-07-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD2014-07-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD, RS2014-07-2387673890dc5c…
2021-03-12 10:30 UTC2021-03N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD, RS2014-07-235aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD, RS2014-07-238869cabd3fbd…
2020-11-12 02:37 UTC2020-11N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD, RS2014-07-23c0c555d07b60…
2019-12-14 00:12 UTC2019-12N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD, RS2014-07-233f01610625f2…
2019-09-15 20:21 UTC2019-09N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD, RS2014-07-23b00525d2431f…
2019-07-19 19:46 UTC2019-07N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD, RS2014-07-23ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD2014-07-236a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD2014-07-231c564ffb4f44…
2023-12-20 04:57 UTC2023-12N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD2014-07-23ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD2014-07-23a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD2014-07-239b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD2014-07-23a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD2014-07-233f0d92c62455…
2023-05-13 08:27 UTC2023-05N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD2014-07-23053a50430f4f…
2023-01-26 05:58 UTC2023-01N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD2014-07-233bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD2014-07-233a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD2014-07-23f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD2014-07-23e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N205434-001FLONASE ALLERGY RELIEF0.05MG/SPRAYSPRAY, METERED / NASALRLD2014-07-23cb3db0bc1861…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
O2GMZ0LF5WInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1797907Internal RxNorm lookup
1797933Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b6134ba0-b70a-4eac-9a82-cef64b242c1dAvailable on FDA.report

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#

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FLONASE ALLERGY RELIEFFLUTICASONE PROPIONATEHaleon US Holdings LLCb6134ba0-b70a-4eac-9a82-cef64b242c1d2024-12-19WarningsExact identifier
application applno (NDA): 205434
application number: NDA205434
ndc (product): 0135-0576
CHILDRENS FLONASE ALLERGY RELIEFFLUTICASONE PROPIONATEHaleon US Holdings LLCfab7a1f4-75e0-416f-9644-07aff08e6ab02024-03-05WarningsExact identifier
application applno (NDA): 205434
application number: NDA205434
CHILDRENS FLONASE ALLERGY RELIEFFLUTICASONE PROPIONATEHaleon US Holdings LLC3adff80f-fca7-4cc5-b106-0f68f71c85b02024-02-08WarningsExact identifier
application applno (NDA): 205434
application number: NDA205434

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