Home NDC 0135-0582 CHILDRENS FLONASE
Product NDC 0135-0582
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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Dataset, Scope, Package NDC table Dataset Scope Package NDC excluded product product excluded package package 0135-0582-03 excluded package package 0135-0582-02 excluded package package 0135-0582-01
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 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 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 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…2022-09-29 23:25 UTC 2022-09 N205434-001 FLONASE ALLERGY RELIEF 0.05MG/SPRAY SPRAY, METERED / NASAL RLD 2014-07-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N205434-001 FLONASE ALLERGY RELIEF 0.05MG/SPRAY SPRAY, METERED / NASAL RLD 2014-07-23 cb3db0bc1861…
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.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength 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 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.
DailyMed RxNorm Mappings# 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 0135-0582-02 00135058202 2 BOTTLE in 1 PACKAGE (0135-0582-02) / 60 SPRAY, METERED in 1 BOTTLE 2 bottle 2016-02-29 0000-00-00 No No Current 0135-0582-03 00135058203 1 BOTTLE in 1 CARTON (0135-0582-03) / 30 SPRAY, METERED in 1 BOTTLE 1 bottle 2016-06-30 0000-00-00 No No Current 0135-0582-04 00135058204 1 BOTTLE in 1 PACKAGE (0135-0582-04) / 72 SPRAY, METERED in 1 BOTTLE 1 bottle 2016-02-29 0000-00-00 No No Current 0135-0582-05 00135058205 1 BOTTLE in 1 PACKAGE (0135-0582-05) / 90 SPRAY, METERED in 1 BOTTLE 1 bottle 2021-07-01 0000-00-00 No No Current