Oralone

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product 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: 2026-09-28
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/2026-09-28/bb1af06e95bcf9567b07e56fcf3a03c0cac3c7c82ff89d4c970881174949e5b7/drug-label-0007-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:49:09

Harmonized routes table
Harmonized routes
DENTAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 15 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	070730	derived:openfda.application_number
application number		ANDA070730	openfda.application_number
brand name		Oralone	openfda.brand_name
generic name		TRIAMCINOLONE ACETONIDE	openfda.generic_name
manufacturer name		Sun Pharmaceutical Industries, Inc.	openfda.manufacturer_name
ndc	package	51672-1335-8	openfda.package_ndc
ndc	package	51672-1335-5	openfda.package_ndc
ndc	product	51672-1335	openfda.product_ndc
ndc11	package	51672133508	derived:openfda.package_ndc
ndc11	package	51672133505	derived:openfda.package_ndc
rxcui		1085728	openfda.rxcui
rxcui		1085767	openfda.rxcui
spl id		3961db48-e5fb-c2d8-e063-6294a90ab8ba	id
spl set id		ac1e2116-795e-4c20-974d-11fa07cf0fa7	set_id
unii		F446C597KA	openfda.unii

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

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.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.