FDA.reportPublic FDA data

Nasal Allergy

Product NDC
0536-1457
11-digit product format
005361457
Labeler code
0536
Product ID
0536-1457_7d270581-f118-4e32-9a8b-55796b0cbe0f
Type
HUMAN OTC DRUG
Nonproprietary name
Triamcinolone acetonide
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Rugby Laboratories
Application
ANDA214615
Marketing category
ANDA
Marketing start
2025-11-11
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

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A214615-001TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDE0.055MG/SPRAYSPRAY, METERED / NASAL2023-01-19

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A214615-001TRIAMCINOLONE ACETONIDE0.055MG/SPRAYSPRAY, METERED / NASAL2023-01-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214615-001TRIAMCINOLONE ACETONIDE0.055MG/SPRAYSPRAY, METERED / NASAL2023-01-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A214615-001TRIAMCINOLONE ACETONIDE0.055MG/SPRAYSPRAY, METERED / NASAL2023-01-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214615-001TRIAMCINOLONE ACETONIDE0.055MG/SPRAYSPRAY, METERED / NASAL2023-01-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214615-001TRIAMCINOLONE ACETONIDE0.055MG/SPRAYSPRAY, METERED / NASAL2023-01-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214615-001TRIAMCINOLONE ACETONIDE0.055MG/SPRAYSPRAY, METERED / NASAL2023-01-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214615-001TRIAMCINOLONE ACETONIDE0.055MG/SPRAYSPRAY, METERED / NASAL2023-01-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214615-001TRIAMCINOLONE ACETONIDE0.055MG/SPRAYSPRAY, METERED / NASAL2023-01-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214615-001TRIAMCINOLONE ACETONIDE0.055MG/SPRAYSPRAY, METERED / NASAL2023-01-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214615-001TRIAMCINOLONE ACETONIDE0.055MG/SPRAYSPRAY, METERED / NASAL2023-01-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214615-001TRIAMCINOLONE ACETONIDE0.055MG/SPRAYSPRAY, METERED / NASAL2023-01-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214615-001TRIAMCINOLONE ACETONIDE0.055MG/SPRAYSPRAY, METERED / NASAL2023-01-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214615-001TRIAMCINOLONE ACETONIDE0.055MG/SPRAYSPRAY, METERED / NASAL2023-01-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214615-001TRIAMCINOLONE ACETONIDE0.055MG/SPRAYSPRAY, METERED / NASAL2023-01-198072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214615-001TRIAMCINOLONE ACETONIDE0.055MG/SPRAYSPRAY, METERED / NASAL2023-01-196a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A214615-001TRIAMCINOLONE ACETONIDE0.055MG/SPRAYSPRAY, METERED / NASAL2023-01-191c564ffb4f44…
2023-12-20 04:57 UTC2023-12A214615-001TRIAMCINOLONE ACETONIDE0.055MG/SPRAYSPRAY, METERED / NASAL2023-01-19ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A214615-001TRIAMCINOLONE ACETONIDE0.055MG/SPRAYSPRAY, METERED / NASAL2023-01-19a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A214615-001TRIAMCINOLONE ACETONIDE0.055MG/SPRAYSPRAY, METERED / NASAL2023-01-199b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A214615-001TRIAMCINOLONE ACETONIDE0.055MG/SPRAYSPRAY, METERED / NASAL2023-01-19a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A214615-001TRIAMCINOLONE ACETONIDE0.055MG/SPRAYSPRAY, METERED / NASAL2023-01-193f0d92c62455…
2023-05-13 08:27 UTC2023-05A214615-001TRIAMCINOLONE ACETONIDE0.055MG/SPRAYSPRAY, METERED / NASAL2023-01-19053a50430f4f…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214615-001TRIAMCINOLONE ACETONIDE0.055MG/SPRAYSPRAY, METERED / NASAL2023-01-19a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Nasal Allergy
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRIAMCINOLONE ACETONIDE55 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F446C597KAInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1797913Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0ae25bc9-5d90-4dd8-9620-8684c4fd9d37Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d4d7da1a-7fd4-628e-cdae-89e749b1c534Product name720260127
75f7e47b-8736-a182-fc44-22aca8d79689Product name220251211
62986c8d-91f1-b1ba-b5a3-8b54b75bb8c2Product name620250516
e42f429b-c4e5-0402-e1c5-730154df4060Product name420240205
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
38d4de13-64b3-4057-b91c-4b5126962341Product name120220516
089e0644-1ea8-8654-4113-39f960dd57d5Product name320210115
1629e00f-54fb-4a43-8306-b58442b23902Product name920200430
5331c9c8-f64b-11e6-ccf1-071c477fcb0bProduct name720190612
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
9f64e0dc-109c-9660-8e0e-91ec987b3817Product name620171204
dfa879a3-32de-49f0-a7ba-9b9c3e13002fProduct name120171204
8de20f81-8411-4cf1-a8b2-03404ee56d01Product name320171109
a5f1a68c-0352-4f34-46a3-9b4eed239ed8Product name220160819
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
355b2224-0895-7135-83f5-d099a6a82a0aProduct name120140508
55be6b50-8cc0-f0f1-74a1-3416a91193aaProduct name120140508
7a0092d1-1e8c-0d78-4f8d-d95fa15cc3cfProduct name120140508
89b93c13-4be8-69f3-b33b-63e64feffb9bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0536-1457-69Nasal Allergy120 in 1 BOTTLE, SPRAYSPRAY, METERED1205
0536-1457-69Nasal Allergy1 in 1 CARTONSPRAY, METERED15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1457-69ML - Milliliter0536-14570fc956f5-90ae-42b5-9deb-978b1efe471512026-04-20

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDECARDINAL HEALTH 110, LLC. DBA LEADER 70000444ca70e-fa06-4808-bd9d-d53ee725b7522026-05-21WarningsExact identifier
application applno (ANDA): 214615
application number: ANDA214615
Nasal AllergyTRIAMCINOLONE ACETONIDERugby Laboratories0ae25bc9-5d90-4dd8-9620-8684c4fd9d372026-05-21WarningsExact identifier
application applno (ANDA): 214615
application number: ANDA214615
ndc (product): 0536-1457
Triamcinolone acetonideTRIAMCINOLONE ACETONIDEApotex Corp.a0cde3d7-4934-ed19-78c0-01f21275cba02025-09-22WarningsExact identifier
application applno (ANDA): 214615
application number: ANDA214615
Triamcinolone acetonideTRIAMCINOLONE ACETONIDEAllegiant Health1fd76a49-61ee-4d4d-8abc-e666b2d3c5b02025-07-29WarningsExact identifier
application applno (ANDA): 214615
application number: ANDA214615
Triamcinolone acetonideTRIAMCINOLONE ACETONIDECARDINAL HEALTH 110, LLC. DBA LEADERc8000539-125f-f0dd-2f69-580eea235a772025-06-03WarningsExact identifier
application applno (ANDA): 214615
application number: ANDA214615

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797913triamcinolone acetonide 55 MCG/ACTUAT Metered Dose Nasal SprayPSN0ae25bc9-5d90-4dd8-9620-8684c4fd9d375
1797913triamcinolone acetonide 0.055 MG/ACTUAT Metered Dose Nasal SpraySCD0ae25bc9-5d90-4dd8-9620-8684c4fd9d375
1797913triamcinolone acetonide 55 MCG/ACTUAT Metered Dose Nasal SpraySY0ae25bc9-5d90-4dd8-9620-8684c4fd9d375

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0536-1457-69005361457691 BOTTLE, SPRAY in 1 CARTON (0536-1457-69) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY2025-11-11NoNoCurrent