Home DailyMed a2bc62f8-2ddd-4f07-a749-e7bd2ce51bcc National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2012-07-24
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 02:22:36 Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
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 N202236-001 DYMISTA AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD 2012-05-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N202236-001 AB
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N202236-001 8168620 2026-02-24 Drug product 2012-05-11 N202236-001 8168620*PED 2026-08-24 Pediatric extension
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 Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N202236-001 DYMISTA 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD 2012-05-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N202236-001 DYMISTA 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD 2012-05-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202236-001 DYMISTA 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD 2012-05-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202236-001 DYMISTA 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD 2012-05-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202236-001 DYMISTA 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD 2012-05-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202236-001 DYMISTA 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD 2012-05-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202236-001 DYMISTA 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD 2012-05-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202236-001 DYMISTA 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD 2012-05-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202236-001 DYMISTA 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD 2012-05-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202236-001 DYMISTA 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD 2012-05-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N202236-001 DYMISTA 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD 2012-05-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202236-001 DYMISTA 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD 2012-05-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N202236-001 DYMISTA 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD 2012-05-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N202236-001 DYMISTA 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD 2012-05-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N202236-001 DYMISTA 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD 2012-05-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N202236-001 DYMISTA 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 2012-05-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N202236-001 DYMISTA 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 2012-05-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N202236-001 DYMISTA 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 2012-05-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N202236-001 DYMISTA EQ 0.125MG BASE/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2012-05-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N202236-001 DYMISTA 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 2012-05-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N202236-001 DYMISTA 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 2012-05-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N202236-001 DYMISTA EQ 0.125MG BASE/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 2012-05-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N202236-001 DYMISTA EQ 0.125MG BASE/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 2012-05-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N202236-001 DYMISTA EQ 0.125MG BASE/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 2012-05-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N202236-001 DYMISTA EQ 0.125MG BASE/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 2012-05-01 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N202236-001 DYMISTA EQ 0.125MG BASE/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2012-05-01 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N202236-001 DYMISTA EQ 0.125MG BASE/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2012-05-01 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N202236-001 DYMISTA EQ 0.125MG BASE/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2012-05-01 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N202236-001 DYMISTA 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD 2012-05-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N202236-001 DYMISTA 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD 2012-05-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N202236-001 DYMISTA 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 2012-05-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N202236-001 DYMISTA 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 2012-05-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N202236-001 DYMISTA 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 2012-05-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N202236-001 DYMISTA 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 2012-05-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N202236-001 DYMISTA 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 2012-05-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N202236-001 DYMISTA 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 2012-05-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N202236-001 DYMISTA 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 2012-05-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N202236-001 DYMISTA 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 2012-05-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N202236-001 DYMISTA 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 2012-05-01 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N202236-001 DYMISTA 0.137MG/SPRAY;0.05MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 2012-05-01 e64feba35796…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 8 · 311 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N202236-001 8168620 2026-02-24 Drug product 2012-05-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202236-001 8168620*PED 2026-08-24 Pediatric extension caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N202236-001 8168620 2026-02-24 Drug product 2012-05-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202236-001 8168620*PED 2026-08-24 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202236-001 8168620 2026-02-24 Drug product 2012-05-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202236-001 8168620*PED 2026-08-24 Pediatric extension 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202236-001 8168620 2026-02-24 Drug product 2012-05-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202236-001 8168620*PED 2026-08-24 Pediatric extension 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202236-001 8168620 2026-02-24 Drug product 2012-05-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202236-001 8168620*PED 2026-08-24 Pediatric extension fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202236-001 8168620 2026-02-24 Drug product 2012-05-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202236-001 8168620*PED 2026-08-24 Pediatric extension b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202236-001 8163723*PED 2024-02-29 Pediatric extension 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202236-001 8168620 2026-02-24 Drug product 2012-05-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202236-001 8168620*PED 2026-08-24 Pediatric extension 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202236-001 8163723*PED 2024-02-29 Pediatric extension 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202236-001 8168620 2026-02-24 Drug product 2012-05-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202236-001 8168620*PED 2026-08-24 Pediatric extension 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202236-001 8163723*PED 2024-02-29 Pediatric extension 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202236-001 8168620 2026-02-24 Drug product 2012-05-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202236-001 8168620*PED 2026-08-24 Pediatric extension 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202236-001 8163723*PED 2024-02-29 Pediatric extension d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202236-001 8168620 2026-02-24 Drug product 2012-05-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202236-001 8168620*PED 2026-08-24 Pediatric extension d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N202236-001 8163723*PED 2024-02-29 Pediatric extension d06236e962d9…2024-10-29 15:01 UTC 2024-10 N202236-001 8168620 2026-02-24 Drug product 2012-05-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N202236-001 8168620*PED 2026-08-24 Pediatric extension d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202236-001 8163723*PED 2024-02-29 Pediatric extension 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202236-001 8168620 2026-02-24 Drug product 2012-05-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202236-001 8168620*PED 2026-08-24 Pediatric extension 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N202236-001 8163723*PED 2024-02-29 Pediatric extension 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N202236-001 8168620 2026-02-24 Drug product 2012-05-11 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N202236-001 8168620*PED 2026-08-24 Pediatric extension 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N202236-001 8163723*PED 2024-02-29 Pediatric extension 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N202236-001 8168620 2026-02-24 Drug product 2012-05-11 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N202236-001 8168620*PED 2026-08-24 Pediatric extension 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N202236-001 8163723*PED 2024-02-29 Pediatric extension 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N202236-001 8168620 2026-02-24 Drug product 2012-05-11 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N202236-001 8168620*PED 2026-08-24 Pediatric extension 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N202236-001 9259428 2023-06-13 U-644 2016-03-09 5c6f7cd8ea54…
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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join DYMISTA AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE Viatris Specialty LLC 4c557ec4-c4cf-11df-851a-0800200c9a66 2024-12-04 Warnings, Adverse reactions Exact identifier ndc (package): 0037-0245-23 ndc11 (package): 00037024523