Fluticasone Propionate

Product NDC: 49035-362
Requested package NDC: 49035-362-01
11-digit product format: 490350362
Labeler code: 49035
Product ID: 49035-362_5a0d9074-0bd2-e7b4-d816-399454e9aa37
Type: HUMAN OTC DRUG
Nonproprietary name: Fluticasone Propionate
Dosage form: SPRAY, METERED
Route: NASAL
Labeler: Walmart
Application: ANDA208150
Marketing category: ANDA
Marketing start: 2017-10-23
Marketing end: 2026-10-31
Substance: FLUTICASONE PROPIONATE
Active strength: 50 ug/1
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	49035-362	49035-362-01	D	Discontinued by firm		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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-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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
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…`
2022-09-29 23:25 UTC	2022-09	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208150-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	2016-02-29	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Fluticasone Propionate

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
8616944c-a684-085a-7106-cf034e3f6f4d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f4fb2f5a-dadb-40e3-a4b1-a2a58f5d9a33	Product name	3	20260126
343e8617-eb68-1e10-cfa9-8c30af285764	Product name	3	20240513
a31ad3df-8021-2ea1-94eb-0fe2f49b7729	Product name	4	20220719
813fe018-3e3c-40e4-8f71-7ab50f3dfe81	Product name	2	20180723
3bcd721e-0555-4bc3-96c6-690471ff9d94	Product name	1	20171113
9f9452df-fa34-43d4-97fe-c6605344c5a8	Product name	1	20171113
0e5a25a6-9f05-44b5-8449-aa63e59f7202	Product name	1	20170426
f3c5232f-03de-44f5-996a-90cd9c08bc60	Product name	1	20170426
1cb17fbb-0da4-2841-37bc-e7079783e1a2	Product name	1	20140508
667f427a-8698-a508-767a-53ed61b4c2e9	Product name	1	20140508
6a97ffc8-1d4d-a971-4978-85ba3a22eac9	Product name	1	20140508
6df84e13-2223-fa46-1e26-17e2f58a1e1c	Product name	1	20140508
90fec588-984c-4375-cfd4-7e40114bdf80	Product name	1	20140508
9c1d3c48-b162-204b-f55b-e0f25c31c52e	Product name	1	20140508
9fdb6139-394b-1510-4baf-bde68c419789	Product name	1	20140508
aef26912-037b-9a4e-db49-225ef6dfd8f1	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
49035-362-01	Fluticasone Propionate	1 in 1 CARTON	SPRAY, METERED	1	11
49035-362-01	Fluticasone Propionate	60 in 1 BOTTLE, SPRAY	SPRAY, METERED	60	11
49035-362-02	Fluticasone Propionate	1 in 1 CARTON	SPRAY, METERED	1	11
49035-362-03	Fluticasone Propionate	120 in 1 BOTTLE, SPRAY	SPRAY, METERED	120	11
49035-362-04	Fluticasone Propionate	1 in 1 CARTON	SPRAY, METERED	1	11
49035-362-04	Fluticasone Propionate	72 in 1 BOTTLE, SPRAY	SPRAY, METERED	72	11
49035-362-05	Fluticasone Propionate	144 in 1 BOTTLE, SPRAY	SPRAY, METERED	144	11
49035-362-05	Fluticasone Propionate	1 in 1 CARTON	SPRAY, METERED	1	11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49035-362-04	ML - Milliliter	49035-362	8b5bcd0d-4e0d-4fc0-9279-a0743e06d0a1	1	2024-09-09
49035-362-05	ML - Milliliter	49035-362	74c90abe-5ed6-4227-87c8-e0cbe57e462e	1	2024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49035-362	FLUTICASONE PROPIONATE SPRAY, METERED [WALMART]	10	Current NDC, Legacy NDC, 8 package rows	20241004_8616944c-a684-085a-7106-cf034e3f6f4d.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluticasone Propionate	FLUTICASONE PROPIONATE	Walgreens	16756136-e813-8a91-3351-7e759d1b4b94	2026-07-30	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	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	FLUTICASONE PROPIONATE	Discount Drug Mart	9b6791d9-f8e8-5ae6-fbdd-c96561c0976a	2025-09-22	Warnings	Exact identifier application applno (ANDA): 208150 application number: ANDA208150
Fluticasone Propionate	FLUTICASONE PROPIONATE	Sam's West Inc.	0370ef12-9199-e2ef-ef85-7d2c7d413bc9	2025-09-22	Warnings	Exact identifier application applno (ANDA): 208150 application number: ANDA208150
Allergy Relief	FLUTICASONE PROPIONATE	Quality Home Products	7c81d4d6-d688-72ab-9e43-9b2278d1e057	2025-09-22	Warnings	Exact identifier application applno (ANDA): 208150 application number: ANDA208150
Fluticasone Propionate	FLUTICASONE PROPIONATE	Apotex Corp.	1252da79-70c1-c46e-e92b-a4edba76b178	2025-09-22	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 ndc (package): 49035-362-01 ndc (product): 49035-362 ndc11 (package): 49035036201
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	Target Corporation	cee73f84-40fb-7143-0f11-4d119de6a905	2025-02-13	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

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1797907	fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal Spray	PSN	8616944c-a684-085a-7106-cf034e3f6f4d	11
1797907	fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal Spray	SCD	8616944c-a684-085a-7106-cf034e3f6f4d	11
1797907	fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal Spray	SY	8616944c-a684-085a-7106-cf034e3f6f4d	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
49035-362-01	49035036201	1 BOTTLE, SPRAY in 1 CARTON (49035-362-01) > 60 SPRAY, METERED in 1 BOTTLE, SPRAY	2017-10-23	2024-04-28	No	No	Current