Fluticasone Propionate

Product NDC
59726-350
11-digit product format
597260350
Labeler code
59726
Product ID
59726-350_643792c9-892a-4e0c-91a5-8186c78ed5ac
Type
HUMAN OTC DRUG
Nonproprietary name
Fluticasone Propionate
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
P & L Development, LLC
Application
ANDA208150
Marketing category
ANDA
Marketing start
2026-08-15
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A208150-001FLUTICASONE PROPIONATEFLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-29

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-2984e616aacf4f…
2026-08-18 06:07:402026-07A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-2987673890dc5c…
2021-03-12 10:30 UTC2021-03A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-293f01610625f2…
2019-09-15 20:21 UTC2019-09A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-29b00525d2431f…
2019-07-19 19:46 UTC2019-07A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-29ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-293f0d92c62455…
2023-05-13 08:27 UTC2023-05A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-29053a50430f4f…
2023-01-26 05:58 UTC2023-01A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-29f41ea6bd6efb…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e3347976-facd-49b6-9ae1-7ed3cd02ba96Available on FDA.report

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 · 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fluticasone PropionateFLUTICASONE PROPIONATEWalgreens16756136-e813-8a91-3351-7e759d1b4b942026-08-17WarningsExact identifier
application applno (ANDA): 208150
application number: ANDA208150
Fluticasone PropionateFLUTICASONE PROPIONATEThe Kroger Co.f05689fa-7ff3-0846-c647-bdbe79cb2ff82026-07-29WarningsExact identifier
application applno (ANDA): 208150
application number: ANDA208150
Fluticasone PropionateFLUTICASONE PROPIONATEP & L Development, LLCe3347976-facd-49b6-9ae1-7ed3cd02ba962026-07-02WarningsExact identifier
application applno (ANDA): 208150
application number: ANDA208150
ndc (product): 59726-350
Fluticasone PropionateFLUTICASONE PROPIONATEChain Drug Marketing Association, Inc.0d7f6823-a7ef-a6a3-3f4e-3c8618ebccc72026-07-02WarningsExact identifier
application applno (ANDA): 208150
application number: ANDA208150
Allergy ReliefFLUTICASONE PROPIONATEP & L Development, LLCf83fabaa-1c6c-4a19-9f30-2f06df6d48f42026-05-26WarningsExact identifier
application applno (ANDA): 208150
application number: ANDA208150
Fluticasone PropionateFLUTICASONE PROPIONATEAllegiant Healthf4b9fcfc-f3f7-4ce0-8f97-3d475081aa672026-04-29WarningsExact identifier
application applno (ANDA): 208150
application number: ANDA208150
Fluticasone PropionateFLUTICASONE PROPIONATEGrocery Outlet838bbb29-0aa3-4c88-a10d-81be71c202112026-03-16WarningsExact identifier
application applno (ANDA): 208150
application number: ANDA208150
Fluticasone PropionateFLUTICASONE PROPIONATEApotex Corp.e3c861e3-2507-9758-fcd0-8e82d721b5b42026-03-06WarningsExact identifier
application applno (ANDA): 208150
application number: ANDA208150
Fluticasone PropionateFLUTICASONE PROPIONATESam's West, Incd2a6e22c-1159-c86a-b927-e7ace1d7023f2025-10-24WarningsExact identifier
application applno (ANDA): 208150
application number: ANDA208150
Allergy Relief NasalALLERGY RELIEF NASALMarc Glassman, Inc.bf100c3f-b1f4-4efa-af88-b51ed2a217712025-08-08WarningsExact identifier
application applno (ANDA): 208150
application number: ANDA208150
Fluticasone PropionateFLUTICASONE PROPIONATEWalmart8616944c-a684-085a-7106-cf034e3f6f4d2025-07-01WarningsExact identifier
application applno (ANDA): 208150
application number: ANDA208150
Fluticasone PropionateFLUTICASONE PROPIONATEBi-Mart3e4ff2eb-0d99-4ce7-910e-81f878b2231e2025-05-22WarningsExact identifier
application applno (ANDA): 208150
application number: ANDA208150
Fluticasone PropionateFLUTICASONE PROPIONATETWIN MED LLC9337aa4b-382d-4ab9-b312-60417cdd40cf2025-05-01WarningsExact identifier
application applno (ANDA): 208150
application number: ANDA208150
Fluticasone PropionateFLUTICASONE PROPIONATEAllegiant Health4250d331-17b0-46be-a779-fb4f09bade162024-04-11WarningsExact identifier
application applno (ANDA): 208150
application number: ANDA208150
Fluticasone PropionateFLUTICASONE PROPIONATEAllegiant Healtha4e1c265-5205-4089-8190-0755ede838962023-11-28WarningsExact identifier
application applno (ANDA): 208150
application number: ANDA208150
Fluticasone PropionateFLUTICASONE PROPIONATESelder, S.A. de C.V.2da4ba91-c356-473d-b20c-5bb9265767df2017-11-29WarningsExact identifier
application applno (ANDA): 208150
application number: ANDA208150
Fluticasone PropionateFLUTICASONE PROPIONATEAllegiant Health4e1cd546-4598-115b-0357-5d0c22731faa2017-11-17WarningsExact identifier
application applno (ANDA): 208150
application number: ANDA208150

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
59726-350-38597260350381 BOTTLE, SPRAY in 1 CARTON (59726-350-38) / 72 SPRAY, METERED in 1 BOTTLE, SPRAY2026-08-15NoNoCurrent
59726-350-54597260350541 BOTTLE, SPRAY in 1 CARTON (59726-350-54) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY2026-08-15NoNoCurrent