Fluticasone Propionate

Product NDC: 63868-656
11-digit product format: 638680656
Labeler code: 63868
Product ID: 63868-656_d61b7b22-c5c7-1d36-2d96-6f263162f58c
Type: HUMAN OTC DRUG
Nonproprietary name: Fluticasone Propionate
Dosage form: SPRAY, METERED
Route: NASAL
Labeler: Chain Drug Marketing Association
Application: ANDA208150
Marketing category: ANDA
Marketing start: 2022-02-25
Marketing end: 0000-00-00
Substance: FLUTICASONE PROPIONATE
Active strength: 50 ug/1
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	63868-656		D	Discontinued by firm		2026-10-05
excluded package	package	63868-656	63868-656-01	D	Discontinued by firm		2026-10-05

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
A208150-001	FLUTICASONE PROPIONATE	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL			2016-02-29

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63868-656-01	ML - Milliliter	63868-656	577e64fe-3422-440c-8532-4f352112cfc3	1	2022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63868-656	FLUTICASONE PROPIONATE SPRAY, METERED [CHAIN DRUG MARKETING ASSOCIATION]	4	Legacy NDC	20240619_498458d8-d8ce-3152-be66-7f82e054c3a6.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 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluticasone Propionate	FLUTICASONE PROPIONATE	Walgreens	16756136-e813-8a91-3351-7e759d1b4b94	2026-08-17	Warnings	Exact identifier application applno (ANDA): 208150 application number: ANDA208150
Fluticasone Propionate	FLUTICASONE PROPIONATE	The Kroger Co.	f05689fa-7ff3-0846-c647-bdbe79cb2ff8	2026-07-29	Warnings	Exact identifier application applno (ANDA): 208150 application number: ANDA208150
Fluticasone Propionate	FLUTICASONE PROPIONATE	P & L Development, LLC	e3347976-facd-49b6-9ae1-7ed3cd02ba96	2026-07-02	Warnings	Exact identifier application applno (ANDA): 208150 application number: ANDA208150
Fluticasone Propionate	FLUTICASONE PROPIONATE	Chain Drug Marketing Association, Inc.	0d7f6823-a7ef-a6a3-3f4e-3c8618ebccc7	2026-07-02	Warnings	Exact identifier application applno (ANDA): 208150 application number: ANDA208150
Allergy Relief	FLUTICASONE PROPIONATE	P & L Development, LLC	f83fabaa-1c6c-4a19-9f30-2f06df6d48f4	2026-05-26	Warnings	Exact identifier application applno (ANDA): 208150 application number: ANDA208150
Fluticasone Propionate	FLUTICASONE PROPIONATE	Allegiant Health	f4b9fcfc-f3f7-4ce0-8f97-3d475081aa67	2026-04-29	Warnings	Exact identifier application applno (ANDA): 208150 application number: ANDA208150
Fluticasone Propionate	FLUTICASONE PROPIONATE	Grocery Outlet	838bbb29-0aa3-4c88-a10d-81be71c20211	2026-03-16	Warnings	Exact identifier application applno (ANDA): 208150 application number: ANDA208150
Fluticasone Propionate	FLUTICASONE PROPIONATE	Apotex Corp.	e3c861e3-2507-9758-fcd0-8e82d721b5b4	2026-03-06	Warnings	Exact identifier application applno (ANDA): 208150 application number: ANDA208150
Fluticasone Propionate	FLUTICASONE PROPIONATE	Sam's West, Inc	d2a6e22c-1159-c86a-b927-e7ace1d7023f	2025-10-24	Warnings	Exact identifier application applno (ANDA): 208150 application number: ANDA208150
Allergy Relief Nasal	ALLERGY RELIEF NASAL	Marc Glassman, Inc.	bf100c3f-b1f4-4efa-af88-b51ed2a21771	2025-08-08	Warnings	Exact identifier application applno (ANDA): 208150 application number: ANDA208150
Fluticasone Propionate	FLUTICASONE PROPIONATE	Walmart	8616944c-a684-085a-7106-cf034e3f6f4d	2025-07-01	Warnings	Exact identifier application applno (ANDA): 208150 application number: ANDA208150
Fluticasone Propionate	FLUTICASONE PROPIONATE	Bi-Mart	3e4ff2eb-0d99-4ce7-910e-81f878b2231e	2025-05-22	Warnings	Exact identifier application applno (ANDA): 208150 application number: ANDA208150
Fluticasone Propionate	FLUTICASONE PROPIONATE	TWIN MED LLC	9337aa4b-382d-4ab9-b312-60417cdd40cf	2025-05-01	Warnings	Exact identifier application applno (ANDA): 208150 application number: ANDA208150
Fluticasone Propionate	FLUTICASONE PROPIONATE	Allegiant Health	4250d331-17b0-46be-a779-fb4f09bade16	2024-04-11	Warnings	Exact identifier application applno (ANDA): 208150 application number: ANDA208150
Fluticasone Propionate	FLUTICASONE PROPIONATE	Allegiant Health	a4e1c265-5205-4089-8190-0755ede83896	2023-11-28	Warnings	Exact identifier application applno (ANDA): 208150 application number: ANDA208150
Fluticasone Propionate	FLUTICASONE PROPIONATE	Selder, S.A. de C.V.	2da4ba91-c356-473d-b20c-5bb9265767df	2017-11-29	Warnings	Exact identifier application applno (ANDA): 208150 application number: ANDA208150
Fluticasone Propionate	FLUTICASONE PROPIONATE	Allegiant Health	4e1cd546-4598-115b-0357-5d0c22731faa	2017-11-17	Warnings	Exact identifier application applno (ANDA): 208150 application number: ANDA208150

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	Marketing end	Sample	Exclude flag	Status
63868-656-01	63868065601	1 BOTTLE, SPRAY in 1 CARTON (63868-656-01) > 144 SPRAY, METERED in 1 BOTTLE, SPRAY	2022-02-25	0000-00-00	No	No	Current