Home NDC 42507-443-01 Nasal Allergy
Product NDC 42507-443
Requested package NDC 42507-443-01
11-digit product format 425070443
Labeler code 42507
Product ID 42507-443_b0e77f97-75d2-4fd9-be43-99c2368e13e6
Type HUMAN OTC DRUG
Nonproprietary name Triamcinolone acetonide
Dosage form SPRAY, METERED
Route NASAL
Labeler HyVee Inc
Application ANDA078104
Marketing category ANDA
Marketing start 2016-12-30
Substance TRIAMCINOLONE ACETONIDE
Active strength 55 ug/1
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078104-001 TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2009-07-30 A078104-002 TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2014-11-14
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 3 · 86 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 2026-09-14 22:38:34 2026-08 A078104-001 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2009-07-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078104-002 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2014-11-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078104-001 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2009-07-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078104-002 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2014-11-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078104-001 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2009-07-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078104-002 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2014-11-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078104-001 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2009-07-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078104-002 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2014-11-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078104-001 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2009-07-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078104-002 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2014-11-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078104-001 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2009-07-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078104-002 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2014-11-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078104-001 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2009-07-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078104-002 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2014-11-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078104-001 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2009-07-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078104-002 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2014-11-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078104-001 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2009-07-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078104-002 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2014-11-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078104-001 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2009-07-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078104-002 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2014-11-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078104-001 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2009-07-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078104-002 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2014-11-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078104-001 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2009-07-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078104-002 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2014-11-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078104-001 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2009-07-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078104-002 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2014-11-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078104-001 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2009-07-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078104-002 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2014-11-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078104-001 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2009-07-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078104-002 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2014-11-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078104-001 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2009-07-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A078104-002 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2014-11-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078104-001 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2009-07-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078104-002 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2014-11-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078104-001 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2009-07-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A078104-002 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2014-11-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078104-001 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2009-07-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A078104-002 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2014-11-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078104-001 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2009-07-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A078104-002 TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED / NASAL 2014-11-14 74a2ff9319b5…
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 Nasal Allergy
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TRIAMCINOLONE ACETONIDE 55 ug/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination F446C597KA Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1797913 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 2 · 21 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 42507-443-01 42507044301 1 BOTTLE, SPRAY in 1 CARTON (42507-443-01) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY (42507-443-00) 2016-12-30 No No Current