Fluticasone Propionate

Product NDC
68196-210
11-digit product format
681960210
Labeler code
68196
Product ID
68196-210_836cdab1-65ae-a9f6-27d4-b1f966b68022
Type
HUMAN OTC DRUG
Nonproprietary name
Fluticasone Propionate
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Sam's West Inc.
Application
ANDA208150
Marketing category
ANDA
Marketing start
2021-01-27
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68196-21068196-210-01DDiscontinued by firm2026-08-03

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
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 · 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 UTC2026-02A208150-001FLUTICASONE 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…
2022-09-29 23:25 UTC2022-09A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-29e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A208150-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-02-29cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Fluticasone Propionate
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 · 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
0370ef12-9199-e2ef-ef85-7d2c7d413bc9Available 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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
68196-210-01Fluticasone Propionate6 in 1 CARTONSPRAY, METERED68
68196-210-01Fluticasone Propionate6 in 1 BOTTLE, SPRAYSPRAY, METERED68
68196-210-02Fluticasone Propionate144 in 1 BOTTLE, SPRAYSPRAY, METERED1448

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68196-210FLUTICASONE PROPIONATE SPRAY, METERED [SAM'S WEST INC.]7Current NDC, Legacy NDC, 3 package rows20240620_0370ef12-9199-e2ef-ef85-7d2c7d413bc9.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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fluticasone PropionateFLUTICASONE PROPIONATEWalgreens16756136-e813-8a91-3351-7e759d1b4b942026-07-30WarningsExact 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 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 ReliefFLUTICASONE PROPIONATEDiscount Drug Mart9b6791d9-f8e8-5ae6-fbdd-c96561c0976a2025-09-22WarningsExact identifier
application applno (ANDA): 208150
application number: ANDA208150
Fluticasone PropionateFLUTICASONE PROPIONATESam's West Inc.0370ef12-9199-e2ef-ef85-7d2c7d413bc92025-09-22WarningsExact identifier
application applno (ANDA): 208150
application number: ANDA208150
ndc (product): 68196-210
Allergy ReliefFLUTICASONE PROPIONATEQuality Home Products7c81d4d6-d688-72ab-9e43-9b2278d1e0572025-09-22WarningsExact identifier
application applno (ANDA): 208150
application number: ANDA208150
Fluticasone PropionateFLUTICASONE PROPIONATEApotex Corp.1252da79-70c1-c46e-e92b-a4edba76b1782025-09-22WarningsExact 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 PROPIONATETarget Corporationcee73f84-40fb-7143-0f11-4d119de6a9052025-02-13WarningsExact 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SprayPSN0370ef12-9199-e2ef-ef85-7d2c7d413bc98
1797907fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal SpraySCD0370ef12-9199-e2ef-ef85-7d2c7d413bc98
1797907fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal SpraySY0370ef12-9199-e2ef-ef85-7d2c7d413bc98

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68196-210-01681960210016 BOTTLE, SPRAY in 1 CARTON (68196-210-01) / 6 SPRAY, METERED in 1 BOTTLE, SPRAY2021-01-272026-06-30NoNoCurrent
68196-210-0268196021002144 SPRAY, METERED in 1 BOTTLE, SPRAY (68196-210-02) 2021-01-270000-00-00NoNoCurrent