FDA.reportPublic FDA data

phenylephrine hydrochloride 10 MG/ML Nasal Spray [Neo-Synephrine]

RxCUI
1234569
RxNorm name
phenylephrine hydrochloride 10 MG/ML Nasal Spray [Neo-Synephrine]
Display name
NEO-SYNEPHRINE (Nasal)
Full name
phenylephrine hydrochloride 10 MG/ML Nasal Spray [Neo-Synephrine]
Term type
SBD
Status
Active
Strength
1%
Dose form
Spray
Route
Nasal
Updated
2026-07-18 07:00:36

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
012012
Active start
012012
Multiple ingredient
NO
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
phenylephrine hydrochloride10 MG / 1 MLphenylephrinephenylephrine hydrochloride

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Nasal Spray126542

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
phenylephrine8163

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRNeo-Synephrine 1 % Nasal Spray1NAMES
RxNorm Namephenylephrine hydrochloride 10 MG/ML Nasal Spray [Neo-Synephrine]1NAMES
RxNorm Synonym
2 linked values
2NAMES
TTYSBD1ATTRIBUTES
SPL_SET_ID
2 linked values
2CODES
RxCUI12345691CODES
MMSL_CODEBD182051CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
0225-0810-470225-0810Neo-Synephrine Maximum PHENYLEPHRINE HYDROCHLORIDEBF ASCHER AND CO INCM012
0225-0811-470225-0811Neo-Synephrine Severe PHENYLEPHRINE HYDROCHLORIDEBF ASCHER AND CO INCM012

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M0120225-0810Neo-Synephrine Maximum PHENYLEPHRINE HYDROCHLORIDEOTC MONOGRAPH DRUGBF ASCHER AND CO INC

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 10 matching rows.

NDC11, Source, Active table
NDC11SourceActive
00024135202rxnav_ndcsyes
00225081047rxnav_ndcsyes
00225081147rxnav_ndcsyes
69536017515rxnav_ndcsyes
00280093505rxnav_historical
00295111934rxnav_historical
00295111939rxnav_historical
69536010015rxnav_historical
69536010021rxnav_historical
69536017521rxnav_historical

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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
Neo-Synephrine SeverePHENYLEPHRINE HYDROCHLORIDEBF ASCHER AND CO INC54edaff7-d241-dc90-e063-6294a90ac64d2026-06-23WarningsExact identifier
ndc (package): 0225-0811-47
ndc (product): 0225-0811
ndc11 (package): 00225081147
rxcui: 1234569
Neo-Synephrine MaximumPHENYLEPHRINE HYDROCHLORIDEBF ASCHER AND CO INCab8682a4-1f66-6709-e053-2995a90a8b4a2023-11-16WarningsExact identifier
ndc (package): 0225-0810-47
ndc (product): 0225-0810
ndc11 (package): 00225081047
rxcui: 1234569

Reported adverse events (FAERS/openFDA)#

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

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
ab8682a4-1f66-6709-e053-2995a90a8b4aNeo-Synephrine 1 % Nasal Spray [PSN] · phenylephrine hydrochloride 10 MG/ML Nasal Spray [Neo-Synephrine] [SBD] · Neo-Synephrine 1 % Nasal Spray [SY] · Neo-Synephrine 10 MG/ML Nasal Spray [SY]43Neo-Synephrine Extra20231116

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
54edaff7-d241-dc90-e063-6294a90ac64dNeo-Synephrine SevereBF ASCHER AND CO INC20260623
ab8682a4-1f66-6709-e053-2995a90a8b4aNeo-Synephrine ExtraBF ASCHER AND CO INC20231116
e37c23cf-88d4-4adc-994c-842c44951adcNeo-Synephrine ® Extra StrengthFoundation Consumer Healthcare LLC20200611

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCC01CAAdrenergic and dopaminergic agentsATC1-4phenylephrine
ATCC05AXOther agents for treatment of hemorrhoids and anal fissures for topical useATC1-4phenylephrine
ATCR01BASympathomimeticsATC1-4phenylephrine
ATCS01FBSympathomimetics excl. antiglaucoma preparationsATC1-4phenylephrine
ATCS01GASympathomimetics used as decongestantsATC1-4phenylephrine
ATCR01ABSympathomimetics, combinations excl. corticosteroidsATC1-4phenylephrine
ATCR01AASympathomimetics, plainATC1-4phenylephrine
FDASPLN0000186105alpha-1 Adrenergic AgonistEPChas_epcphenylephrine
MEDRTD010656PhenylephrineCHEMhas_ingredientphenylephrine
MEDRTD010656PhenylephrineCHEMhas_ingredientphenylephrine hydrochloride
MEDRTD013447SulfitesCHEMci_chemclassphenylephrine hydrochloride
MEDRTD013447SulfitesCHEMci_chemclassphenylephrine
MEDRTD004342Drug HypersensitivityDISEASEci_withphenylephrine
MEDRTD004342Drug HypersensitivityDISEASEci_withphenylephrine hydrochloride
MEDRTD005401Fissure in AnoDISEASEmay_treatphenylephrine
MEDRTD005401Fissure in AnoDISEASEmay_treatphenylephrine hydrochloride
MEDRTD005902Glaucoma, Open-AngleDISEASEmay_treatphenylephrine hydrochloride
MEDRTD005902Glaucoma, Open-AngleDISEASEmay_treatphenylephrine
MEDRTD006484HemorrhoidsDISEASEmay_treatphenylephrine hydrochloride
MEDRTD006484HemorrhoidsDISEASEmay_treatphenylephrine
MEDRTD006973HypertensionDISEASEci_withphenylephrine hydrochloride
MEDRTD006973HypertensionDISEASEci_withphenylephrine
MEDRTD007022HypotensionDISEASEmay_treatphenylephrine
MEDRTD007022HypotensionDISEASEmay_treatphenylephrine hydrochloride
MEDRTD015878MydriasisDISEASEinducesphenylephrine
MEDRTD015878MydriasisDISEASEinducesphenylephrine hydrochloride
MEDRTD011538Pruritus AniDISEASEmay_treatphenylephrine hydrochloride
MEDRTD011538Pruritus AniDISEASEmay_treatphenylephrine
MEDRTD012223Rhinitis, VasomotorDISEASEmay_treatphenylephrine
MEDRTD012223Rhinitis, VasomotorDISEASEmay_treatphenylephrine hydrochloride
MEDRTD012772Shock, SepticDISEASEmay_treatphenylephrine
MEDRTD012772Shock, SepticDISEASEmay_treatphenylephrine hydrochloride
MEDRTD013617Tachycardia, SupraventricularDISEASEmay_treatphenylephrine
MEDRTD013617Tachycardia, SupraventricularDISEASEmay_treatphenylephrine hydrochloride
MEDRTD017180Tachycardia, VentricularDISEASEci_withphenylephrine
MEDRTD017180Tachycardia, VentricularDISEASEci_withphenylephrine hydrochloride
MEDRTN0000000209Adrenergic alpha-AgonistsMOAhas_moaphenylephrine
MEDRTN0000000209Adrenergic alpha-AgonistsMOAhas_moaphenylephrine hydrochloride
MEDRTN0000008371Conjunctival Arterial VasoconstrictionPEhas_pephenylephrine
MEDRTN0000008371Conjunctival Arterial VasoconstrictionPEhas_pephenylephrine hydrochloride
MEDRTN0000008896Decreased Nasal and Sinus SecretionsPEhas_pephenylephrine
MEDRTN0000008896Decreased Nasal and Sinus SecretionsPEhas_pephenylephrine hydrochloride

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH10 MG/ML
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
NAMESPrescribable SynonymNeo-Synephrine 1 % Nasal Spray
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon