Core Values Allergy Relief

Product NDC: 63940-501
11-digit product format: 639400501
Labeler code: 63940
Product ID: 63940-501_b0fc5a85-8595-410c-bb39-67d23d6ebc95
Type: HUMAN OTC DRUG
Nonproprietary name: Fluticasone propionate
Dosage form: SPRAY, METERED
Route: NASAL
Labeler: Harmon Stores Inc.
Application: ANDA207957
Marketing category: ANDA
Marketing start: 2017-01-05
Marketing end: 2023-01-01
Substance: FLUTICASONE PROPIONATE
Active strength: 50 ug/1
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 0000-00-00
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	63940-501		D	Discontinued by firm		2026-08-17
excluded package	package	63940-501	63940-501-01	D	Discontinued by firm		2026-08-17

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63940-501-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63940-501-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63940-501-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63940-501-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63940-501-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63940-501-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63940-501-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63940-501-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63940-501-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63940-501-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63940-501-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63940-501-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 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…`
2022-09-29 23:25 UTC	2022-09	A207957-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	RS	2016-05-26	`e64feba35796…`

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 3 · 43 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TopCare Childrens Allergy Relief Nasal 24 Hour	FLUTICASONE PROPIONATE	Topco Associates LLC	3eeab9c9-82db-4d03-b4ba-34c1d6f1b1a9	2026-08-11	Warnings	Exact identifier application applno (ANDA): 207957 application number: ANDA207957
Good Sense 24 hour allergy nasal	FLUTICASONE PROPIONATE	L. Perrigo Company	6f3f64e6-d1f8-40d7-bb25-f6f279db9987	2026-08-11	Warnings	Exact identifier application applno (ANDA): 207957 application number: ANDA207957
ALLERGY RELIEF NASAL	FLUTICASONE PROPIONATE	Amazon.com Services LLC	dc552613-5cfe-4de3-b2c0-79703316758a	2026-07-30	Warnings	Exact identifier application applno (ANDA): 207957 application number: ANDA207957
allergy relief nasal	FLUTICASONE PROPIONATE	HyVee Inc	c3327be1-e4a9-4b02-968d-eff5e18cbc84	2026-06-03	Warnings	Exact identifier application applno (ANDA): 207957 application number: ANDA207957
allergy nasal	FLUTICASONE PROPIONATE	Rite Aid Corporation	e471dacd-9b6e-4783-9a14-aa95d00cbc9c	2026-06-03	Warnings	Exact identifier application applno (ANDA): 207957 application number: ANDA207957
Equate Childrens Allergy Relief	FLUTICASONE PROPIONATE	WALMART INC.	7e6949aa-66a7-4288-9990-3ad2ece1df3d	2026-05-19	Warnings	Exact identifier application applno (ANDA): 207957 application number: ANDA207957
Fluticasone Propionate Nasal	FLUTICASONE PROPIONATE	CVS Pharmacy	cf2e16be-0126-412e-9ddd-013f97a7a742	2026-05-08	Warnings	Exact identifier application applno (ANDA): 207957 application number: ANDA207957
childrens allergy relief	FLUTICASONE PROPIONATE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	4b1d223a-723b-4569-9505-da727691bc56	2026-04-29	Warnings	Exact identifier application applno (ANDA): 207957 application number: ANDA207957
CareOne Allergy Relief	FLUTICASONE PROPIONATE	American Sales Company	587d7c72-a70e-4ada-945d-14989b96350c	2026-04-23	Warnings	Exact identifier application applno (ANDA): 207957 application number: ANDA207957
careone childrens allergy relief	FLUTICASONE PROPIONATE	American Sales Company	45ffaf45-8b88-44ba-804b-c2b563589898	2026-04-23	Warnings	Exact identifier application applno (ANDA): 207957 application number: ANDA207957
Up and Up Allergy Relief Nasal	FLUTICASONE PROPIONATE	Target Corporation	51c0a953-93cb-4d0a-b51c-02d9482d1746	2026-04-20	Warnings	Exact identifier application applno (ANDA): 207957 application number: ANDA207957
Good Sense 24 hour allergy nasal	FLUTICASONE PROPIONATE	L. Perrigo Company	783ce1b9-27e4-428a-9f5e-04e70b234ac9	2026-04-09	Warnings	Exact identifier application applno (ANDA): 207957 application number: ANDA207957
allergy relief	FLUTICASONE PROPIONATE	Safeway	7b5547e1-af4d-4ba9-bd92-524aa11a0ecf	2026-04-01	Warnings	Exact identifier application applno (ANDA): 207957 application number: ANDA207957
Nasopro 24	FLUTICASONE PROPIONATE	H E B	8416eb8f-e7fc-4cae-9aa1-84b2321ad67e	2026-03-10	Warnings	Exact identifier application applno (ANDA): 207957 application number: ANDA207957
RUGBY FLUTICASONE PROPIONATE NASAL	FLUTICASONE PROPIONATE	A-S Medication Solutions	0c4eb6cb-abc9-4945-8f30-cfa8b9eb579c	2026-02-24	Warnings	Exact identifier application applno (ANDA): 207957 application number: ANDA207957
Topcare Allergy Relief Nasal	FLUTICASONE PROPIONATE	Topco Associates LLC	4586256c-cc86-4792-92ef-5a65a35d6377	2026-02-19	Warnings	Exact identifier application applno (ANDA): 207957 application number: ANDA207957
ALLERGY RELIEF	FLUTICASONE PROPIONATE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	1a4f4449-a8d3-4c5b-8ba1-21223574545b	2026-02-17	Warnings	Exact identifier application applno (ANDA): 207957 application number: ANDA207957
RUGBY FLUTICASONE PROPIONATE NASAL	FLUTICASONE PROPIONATE	ASCLEMED USA INC.	e38d8796-b08c-49a8-94b8-0c2fdeb52a81	2026-02-10	Warnings	Exact identifier application applno (ANDA): 207957 application number: ANDA207957
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

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	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63940-501-01	63940050101	1 BOTTLE in 1 CARTON (63940-501-01) > 60 SPRAY, METERED in 1 BOTTLE	1 bottle	2017-01-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Harmon Stores Inc. Allergy Relief Drug Facts	Harmon Stores Inc.	2022-11-30	HUMAN OTC DRUG LABEL	5