FDA.reportPublic FDA data

CHILDRENS TRIAMCINOLONE ACETONIDE

Product NDC
58602-037
11-digit product format
586020037
Labeler code
58602
Product ID
58602-037_9e50af36-59f1-4f08-a0d7-7566f0a11034
Type
HUMAN OTC DRUG
Nonproprietary name
triamcinolone acetonide
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Aurohealth LLC
Application
ANDA220110
Marketing category
ANDA
Marketing start
2026-08-11
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 43.

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
A220110-001TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDE0.055MG/SPRAYSPRAY, METERED / NASAL2026-08-11

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
2026-09-14 22:38:342026-08A220110-001TRIAMCINOLONE ACETONIDE0.055MG/SPRAYSPRAY, METERED / NASAL2026-08-1184e616aacf4f…
2026-08-18 06:07:402026-07A220110-001TRIAMCINOLONE ACETONIDE0.055MG/SPRAYSPRAY, METERED / NASAL2026-08-11caaa826d4ba7…

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 TRIAMCINOLONE ACETONIDE
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
9e50af36-59f1-4f08-a0d7-7566f0a11034Available on FDA.report

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CHILDRENS TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEAurohealth LLC9e50af36-59f1-4f08-a0d7-7566f0a110342026-08-13WarningsExact identifier
application applno (ANDA): 220110
application number: ANDA220110
ndc (product): 58602-037
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEAurohealth LLCa74eff58-bce4-4785-b583-3e474f8250702026-08-13WarningsExact identifier
application applno (ANDA): 220110
application number: ANDA220110

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
58602-037-11586020037111 BOTTLE, SPRAY in 1 CARTON (58602-037-11) / 60 SPRAY, METERED in 1 BOTTLE, SPRAY2026-08-11NoNoCurrent