CHILDRENS FLONASE

Product NDC: 0135-0582
Requested package NDC: 0135-0582-01
11-digit product format: 001350582
Labeler code: 0135
Product ID: 0135-0582_19c67359-3ee5-440b-82c3-efa11b775cdb
Type: HUMAN OTC DRUG
Nonproprietary name: fluticasone propionate
Dosage form: SPRAY, METERED
Route: NASAL
Labeler: Haleon US Holdings LLC
Application: NDA205434
Marketing category: NDA
Marketing start: 2016-02-29
Substance: FLUTICASONE PROPIONATE
Active strength: 50 ug/1
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	0135-0582	0135-0582-01	I	Inactivated by FDA		excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`

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
N205434-001	FLONASE ALLERGY RELIEF	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL		RLD	2014-07-23

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	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD	2014-07-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD	2014-07-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD	2014-07-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD	2014-07-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD	2014-07-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD	2014-07-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD	2014-07-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD	2014-07-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD	2014-07-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD	2014-07-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD	2014-07-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD	2014-07-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD	2014-07-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD	2014-07-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD	2014-07-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD	2014-07-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD	2014-07-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD	2014-07-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD	2014-07-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2014-07-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD	2014-07-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD	2014-07-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2014-07-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2014-07-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2014-07-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2014-07-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2014-07-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2014-07-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2014-07-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD	2014-07-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD	2014-07-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD	2014-07-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD	2014-07-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD	2014-07-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD	2014-07-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD	2014-07-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD	2014-07-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD	2014-07-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD	2014-07-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N205434-001	FLONASE ALLERGY RELIEF	0.05MG/SPRAY	SPRAY, METERED / NASAL	RLD	2014-07-23	`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: CHILDRENS FLONASE
Brand name suffix: ALLERGY RELIEF
Listing expiration: 2026-12-31

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1797907	Internal RxNorm lookup
1797933	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
fab7a1f4-75e0-416f-9644-07aff08e6ab0	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
0135-0582-01	2020-12-02	Drug Facts
0135-0582-02	2020-12-02	Drug Facts
0135-0582-03	2020-12-02	Drug Facts
0135-0582-01	2020-01-31	Drug Facts
0135-0582-02	2020-01-31	Drug Facts
0135-0582-03	2020-01-31	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0135-0582-01	CHILDRENS FLONASEALLERGY RELIEF	60 in 1 BOTTLE	SPRAY, METERED	60	9
0135-0582-01	CHILDRENS FLONASEALLERGY RELIEF	1 in 1 PACKAGE	SPRAY, METERED	1	9
0135-0582-02	CHILDRENS FLONASEALLERGY RELIEF	60 in 1 BOTTLE	SPRAY, METERED	60	9
0135-0582-02	CHILDRENS FLONASEALLERGY RELIEF	2 in 1 PACKAGE	SPRAY, METERED	2	9
0135-0582-03	CHILDRENS FLONASEALLERGY RELIEF	30 in 1 BOTTLE	SPRAY, METERED	30	9
0135-0582-03	CHILDRENS FLONASEALLERGY RELIEF	1 in 1 CARTON	SPRAY, METERED	1	9
0135-0582-05	CHILDRENS FLONASEALLERGY RELIEF	90 in 1 BOTTLE	SPRAY, METERED	90	9
0135-0582-05	CHILDRENS FLONASEALLERGY RELIEF	1 in 1 PACKAGE	SPRAY, METERED	1	9
0135-0582-04	CHILDRENS FLONASEALLERGY RELIEF	1 in 1 PACKAGE	SPRAY, METERED	1	5
0135-0582-04	CHILDRENS FLONASEALLERGY RELIEF	72 in 1 BOTTLE	SPRAY, METERED	72	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0135-0582-01	ML - Milliliter	0135-0582	470ae558-b239-4ade-9c47-67e894c77f7e	1	2016-03-04
0135-0582-02	ML - Milliliter	0135-0582	37d09e02-34fc-43d1-ab8f-004cb4618ffe	1	2016-05-16
0135-0582-04	ML - Milliliter	0135-0582	95e0d1d6-10b3-4efd-9bd6-9fa08d729558	1	2021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0135-0582	CHILDRENS FLONASE ALLERGY RELIEF (FLUTICASONE PROPIONATE) SPRAY, METERED [HALEON US HOLDINGS LLC]	9	Current NDC, Legacy NDC, 8 package rows	20240209_3adff80f-fca7-4cc5-b106-0f68f71c85b0.zip
0135-0582	CHILDRENS FLONASE ALLERGY RELIEF (FLUTICASONE PROPIONATE) SPRAY, METERED [HALEON US HOLDINGS LLC]	5	Current NDC, Legacy NDC, 2 package rows	20240307_fab7a1f4-75e0-416f-9644-07aff08e6ab0.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FLONASE ALLERGY RELIEF	FLUTICASONE PROPIONATE	Haleon US Holdings LLC	b6134ba0-b70a-4eac-9a82-cef64b242c1d	2024-12-19	Warnings	Exact identifier application applno (NDA): 205434 application number: NDA205434
CHILDRENS FLONASE ALLERGY RELIEF	FLUTICASONE PROPIONATE	Haleon US Holdings LLC	fab7a1f4-75e0-416f-9644-07aff08e6ab0	2024-03-05	Warnings	Exact identifier application applno (NDA): 205434 application number: NDA205434 ndc (product): 0135-0582
CHILDRENS FLONASE ALLERGY RELIEF	FLUTICASONE PROPIONATE	Haleon US Holdings LLC	3adff80f-fca7-4cc5-b106-0f68f71c85b0	2024-02-08	Warnings	Exact identifier application applno (NDA): 205434 application number: NDA205434 ndc (package): 0135-0582-01 ndc (product): 0135-0582 ndc11 (package): 00135058201

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
1797933	FLONASE 50 MCG/ACTUAT Metered Dose Nasal Spray	PSN	3adff80f-fca7-4cc5-b106-0f68f71c85b0	9
1797907	fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal Spray	PSN	3adff80f-fca7-4cc5-b106-0f68f71c85b0	9
1797933	fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal Spray [Flonase]	SBD	3adff80f-fca7-4cc5-b106-0f68f71c85b0	9
1797907	fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal Spray	SCD	3adff80f-fca7-4cc5-b106-0f68f71c85b0	9
1797933	Flonase 0.05 MG/ACTUAT Metered Dose Nasal Spray	SY	3adff80f-fca7-4cc5-b106-0f68f71c85b0	9
1797933	Flonase 50 MCG/ACTUAT Metered Dose Nasal Spray	SY	3adff80f-fca7-4cc5-b106-0f68f71c85b0	9
1797907	fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal Spray	SY	3adff80f-fca7-4cc5-b106-0f68f71c85b0	9
1797933	FLONASE 50 MCG/ACTUAT Metered Dose Nasal Spray	PSN	fab7a1f4-75e0-416f-9644-07aff08e6ab0	5
1797907	fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal Spray	PSN	fab7a1f4-75e0-416f-9644-07aff08e6ab0	5
1797933	fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal Spray [Flonase]	SBD	fab7a1f4-75e0-416f-9644-07aff08e6ab0	5
1797907	fluticasone propionate 0.05 MG/ACTUAT Metered Dose Nasal Spray	SCD	fab7a1f4-75e0-416f-9644-07aff08e6ab0	5
1797933	Flonase 0.05 MG/ACTUAT Metered Dose Nasal Spray	SY	fab7a1f4-75e0-416f-9644-07aff08e6ab0	5
1797933	Flonase 50 MCG/ACTUAT Metered Dose Nasal Spray	SY	fab7a1f4-75e0-416f-9644-07aff08e6ab0	5
1797907	fluticasone propionate 50 MCG/ACTUAT Metered Dose Nasal Spray	SY	fab7a1f4-75e0-416f-9644-07aff08e6ab0	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0135-0582-01	00135058201	1 BOTTLE in 1 PACKAGE (0135-0582-01) / 60 SPRAY, METERED in 1 BOTTLE	1 bottle	2016-02-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	Haleon US Holdings LLC	2024-03-05	HUMAN OTC DRUG LABEL	5
Drug Facts	Haleon US Holdings LLC	2024-02-08	HUMAN OTC DRUG LABEL	9