Welby Fluticasone

Product NDC: 64024-007
Requested package NDC: 64024-007-02
11-digit product format: 640240007
Labeler code: 64024
Product ID: 64024-007_441e9ff4-4e1e-4fb6-89b0-96f998a4f854
Type: HUMAN OTC DRUG
Nonproprietary name: Fluticasone propionate
Dosage form: SPRAY, METERED
Route: NASAL
Labeler: Aldi Inc
Application: ANDA207957
Marketing category: ANDA
Marketing start: 2019-07-10
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	64024-007	64024-007-02	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
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.

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	Strength	SPL version
64024-007-02	Welby Fluticasone	1 in 1 CARTON	SPRAY, METERED	1		3
64024-007-02	Welby Fluticasone	60 in 1 BOTTLE	SPRAY, METERED	60		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64024-007	WELBY FLUTICASONE (FLUTICASONE PROPIONATE) SPRAY, METERED [ALDI INC]	3	Legacy NDC, 2 package rows	20221104_446bfcd9-8f28-4a96-840f-c72ac5970408.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 3 · 43 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluticasone	FLUTICASONE PROPIONATE	YYBA CORP	535b2575-8af8-d951-e063-6394a90ac72d	2026-09-01	Warnings	Exact identifier application applno (ANDA): 207957 application number: ANDA207957
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
CHILDRENS ALLERGY RELIEF	FLUTICASONE PROPIONATE	Walgreen Company	2e81a611-15c2-466e-a111-8ecf939b9560	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
Equate Allergy Relief	FLUTICASONE PROPIONATE	WALMART INC.	bc824143-b876-4c3d-86fd-81fb58673851	2026-08-10	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
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

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	446bfcd9-8f28-4a96-840f-c72ac5970408	3
1797907	fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal Spray	SCD	446bfcd9-8f28-4a96-840f-c72ac5970408	3
1797907	fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal Spray	SY	446bfcd9-8f28-4a96-840f-c72ac5970408	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
64024-007-02	64024000702	1 BOTTLE in 1 CARTON (64024-007-02) > 60 SPRAY, METERED in 1 BOTTLE	1 bottle	2019-07-10	0000-00-00	No	No	Current