Neo-Synephrine Severe

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: Neo-Synephrine Severe
Generic name: PHENYLEPHRINE HYDROCHLORIDE
Manufacturer: BF ASCHER AND CO INC
Product type: HUMAN OTC DRUG
SPL set ID: 54edaff7-d241-dc90-e063-6294a90ac64d
SPL ID: 54edb0ef-b9fc-8470-e063-6394a90a5885
Version: 1
Effective date: 2026-06-23
Source export date: 2026-10-27
Source partition: 11
Source file: https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-27/b7a5e61d87a3b8f87f4c3ff7b526bfbf6baf84c840f565574c7d83d4083e2b38/drug-label-0011-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 20:49:44

Harmonized routes table
Harmonized routes
NASAL

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 · 12 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M012	openfda.application_number
brand name		Neo-Synephrine Severe	openfda.brand_name
generic name		PHENYLEPHRINE HYDROCHLORIDE	openfda.generic_name
manufacturer name		BF ASCHER AND CO INC	openfda.manufacturer_name
ndc	package	0225-0811-47	openfda.package_ndc
ndc	product	0225-0811	openfda.product_ndc
ndc11	package	00225081147	derived:openfda.package_ndc
rxcui		1234569	openfda.rxcui
rxcui		1087043	openfda.rxcui
spl id		54edb0ef-b9fc-8470-e063-6394a90a5885	id
spl set id		54edaff7-d241-dc90-e063-6294a90ac64d	set_id
unii		04JA59TNSJ	openfda.unii

Warnings cross-check#

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

Warnings sections page 1 of 1 · 1 matching rows.

warnings

When using this product: temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may occur. use of this container by more than one person may spread infection. use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.

Reported adverse events (FAERS/openFDA)#

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