Fluticasone

Product NDC: 73581-535
11-digit product format: 735810535
Labeler code: 73581
Product ID: 73581-535_535b1604-a2a0-612c-e063-6394a90a53c2
Type: HUMAN OTC DRUG
Nonproprietary name: Fluticasone propionate
Dosage form: SPRAY, METERED
Route: NASAL
Labeler: YYBA CORP
Application: ANDA207957
Marketing category: ANDA
Marketing start: 2026-09-01
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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A207957-001	FLUTICASONE PROPIONATE	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL		RS	2016-05-26

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	RS	2016-05-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	RS	2016-05-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	RS	2016-05-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	RS	2016-05-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	RS	2016-05-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	RS	2016-05-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	RS	2016-05-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	RS	2016-05-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	RS	2016-05-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	RS	2016-05-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	RS	2016-05-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	RS	2016-05-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	RS	2016-05-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	RS	2016-05-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	RS	2016-05-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	RS	2016-05-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	RS	2016-05-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	RS	2016-05-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	RS	2016-05-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL		2016-05-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	RS	2016-05-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	RS	2016-05-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL		2016-05-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL		2016-05-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL		2016-05-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL		2016-05-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL		2016-05-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL		2016-05-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL		2016-05-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	RS	2016-05-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	RS	2016-05-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	RS	2016-05-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	RS	2016-05-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	RS	2016-05-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	RS	2016-05-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	RS	2016-05-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	RS	2016-05-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	RS	2016-05-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	RS	2016-05-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	RS	2016-05-26	`f41ea6bd6efb…`

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
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FLUTICASONE PROPIONATE	50 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
O2GMZ0LF5W	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
535b2575-8af8-d951-e063-6394a90ac72d	Available 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 2 of 3 · 41 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
exchange select allergy relief	FLUTICASONE PROPIONATE	Army & Air Force Exchange Service	f15d5c04-e308-4540-8c0a-d66a44c3d4fd	2026-02-10	Warnings	Exact identifier application applno (ANDA): 207957 application number: ANDA207957
RUGBY FLUTICASONE PROPIONATE NASAL	FLUTICASONE PROPIONATE	Sportpharm LLC	95765842-415e-438b-8105-f6d93cddbdd0	2026-02-09	Warnings	Exact identifier application applno (ANDA): 207957 application number: ANDA207957
24 Hour Allergy Nasal	FLUTICASONE PROPIONATE	Walgreen Company	7698b73f-16f4-4b99-a3be-9453e8c35469	2026-02-05	Warnings	Exact identifier application applno (ANDA): 207957 application number: ANDA207957
leader fluticasone propionate	FLUTICASONE PROPIONATE	Cardinal Health 110, LLC. dba Leader	14bb5d74-0384-417e-a06b-8868d85234dd	2026-01-21	Warnings	Exact identifier application applno (ANDA): 207957 application number: ANDA207957
DG Health Allergy Relief Nasal	FLUTICASONE PROPIONATE	Dolgencorp Inc	5f0514bd-7893-4602-a17b-716fb9947572	2026-01-21	Warnings	Exact identifier application applno (ANDA): 207957 application number: ANDA207957
Foster and Thrive Allergy Relief	FLUTICASONE PROPIONATE	Strategic Sourcing Services LLC	67899c15-e5e5-4fe6-a639-71832969a761	2026-01-21	Warnings	Exact identifier application applno (ANDA): 207957 application number: ANDA207957
allergy relief nasal	FLUTICASONE PROPIONATE	Publix Super Markets Inc	a70e26c8-2f50-49ac-8278-fc06e4c63e6a	2026-01-08	Warnings	Exact identifier application applno (ANDA): 207957 application number: ANDA207957
RUGBY FLUTICASONE PROPIONATE NASAL	FLUTICASONE PROPIONATE	Rugby Laboratories	5227df05-f2c2-4bc4-91ee-da0fd03d1095	2026-01-08	Warnings	Exact identifier application applno (ANDA): 207957 application number: ANDA207957
good neighbor pharmacy fluticasone propionate	FLUTICASONE PROPIONATE	Amerisource Bergen	b12ddc59-b689-48ac-9a40-2b9ae04a1312	2026-01-08	Warnings	Exact identifier application applno (ANDA): 207957 application number: ANDA207957
Kirkland Signature Aller Flo	FLUTICASONE PROPIONATE	Costco Wholesale Company	bf120a48-cc29-4f40-b70d-415868ac9d3e	2026-01-06	Warnings	Exact identifier application applno (ANDA): 207957 application number: ANDA207957
Allergy Relief	FLUTICASONE PROPIONATE	Meijer Distribution Inc	b69241d8-f019-43fe-b12b-25edcf01df40	2025-12-12	Warnings	Exact identifier application applno (ANDA): 207957 application number: ANDA207957
basic care allergy relief nasal	FLUTICASONE PROPIONATE	Amazon.com Services LLC	6e0628f6-bfdc-4c9d-8800-ffcdb93459f1	2025-11-25	Warnings	Exact identifier application applno (ANDA): 207957 application number: ANDA207957
Equaline Fluticasone Propionate	FLUTICASONE PROPIONATE	United Natural Foods, Inc. dba UNFI	dbaa5264-bbc9-411c-89bb-4aef3ee96459	2025-11-16	Warnings	Exact identifier application applno (ANDA): 207957 application number: ANDA207957
Childrens Nasopro	FLUTICASONE PROPIONATE	H E B	607d0a22-72d1-440f-9dac-e088b68dde09	2025-08-11	Warnings	Exact identifier application applno (ANDA): 207957 application number: ANDA207957
DG Health childrens allergy relief nasal	FLUTICASONE PROPIONATE	Dolgencorp Inc	4dc4b47a-233c-4bb8-b08b-c07561c415ff	2025-06-03	Warnings	Exact identifier application applno (ANDA): 207957 application number: ANDA207957
basic care childrens allergy relief nasal	FLUTICASONE PROPIONATE	Amazon.com Services LLC	cb4cb80a-9bc5-4e7b-a33b-fb462abf96c5	2025-05-23	Warnings	Exact identifier application applno (ANDA): 207957 application number: ANDA207957
Good Sense 24 hour allergy nasal	FLUTICASONE PROPIONATE	RedPharm Drug, Inc	f4c26992-c988-e20f-e053-2a95a90afb65	2025-01-23	Warnings	Exact identifier application applno (ANDA): 207957 application number: ANDA207957
allergy nasal	FLUTICASONE PROPIONATE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	2aee623c-602a-407c-b7a3-e29928d7dfed	2024-12-18	Warnings	Exact identifier application applno (ANDA): 207957 application number: ANDA207957
CHILDRENS ALLERGY	FLUTICASONE PROPIONATE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	b9b3efe4-2f5c-4d22-80a4-d15fb266fb23	2024-06-12	Warnings	Exact identifier application applno (ANDA): 207957 application number: ANDA207957
topcare fluticasone propionate nasal	FLUTICASONE PROPIONATE	Topco Associates LLC	f7c425d2-4afb-478f-83bc-eb336910233b	2022-11-01	Warnings	Exact identifier application applno (ANDA): 207957 application number: ANDA207957

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
O2GMZ0LF5W	FLUTICASONE PROPIONATE	80474-14-2	FLUTICASONE PROPIONATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
73581-535-01	73581053501	1 BOTTLE, SPRAY in 1 CARTON (73581-535-01) / 144 SPRAY, METERED in 1 BOTTLE, SPRAY	2026-09-01	No	No	Current
73581-535-03	73581053503	3 BOTTLE, SPRAY in 1 CARTON (73581-535-03) / 144 SPRAY, METERED in 1 BOTTLE, SPRAY	2026-09-01	No	No	Current