FDA.reportPublic FDA data

Oralone

openFDA label record#

Cross-check layer: This is openFDA JSON-derived label data. Use the corresponding DailyMed SPL as the canonical label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name
Oralone
Generic name
TRIAMCINOLONE ACETONIDE
Manufacturer
Sun Pharmaceutical Industries, Inc.
Product type
HUMAN PRESCRIPTION DRUG
SPL set ID
ac1e2116-795e-4c20-974d-11fa07cf0fa7
SPL ID
3961db48-e5fb-c2d8-e063-6294a90ab8ba
Version
4
Effective date
2025-07-07
Source export date
2026-08-01
Source partition
7
Source file
https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/29baabee7fa6726d72190670d84f1571113181a958a8119cbe97e8f0d1d955b2/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:15:43
Harmonized routes table
Harmonized routes
DENTAL

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS The following local adverse reactions may occur with corticosteroid-containing dental pastes: burning, itching, irritation, dryness, blistering or peeling not present prior to therapy, perioral dermatitis, allergic contact dermatitis, maceration of the oral mucosa, secondary infection, and atrophy of the oral mucosa. Also, see PRECAUTIONS for potential effects of systemic absorption.