FDA.reportPublic FDA data

naphazoline hydrochloride 0.5 MG/ML Nasal Spray

RxCUI
1046610
RxNorm name
naphazoline hydrochloride 0.5 MG/ML Nasal Spray
Display name
Naphazoline (Nasal)
Full name
naphazoline hydrochloride 0.5 MG/ML Nasal Spray
Term type
SCD
Status
Active
Strength
0.05%
Dose form
Spray
Route
Nasal
Updated
2026-06-15 06:59:38

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
122010
Active start
122010
Multiple ingredient
NO
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
naphazoline hydrochloride0.5 MG / 1 MLnaphazolinenaphazoline hydrochloride

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Nasal Spray126542

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
naphazoline7247

Source Vocabulary Codes#

Code type, Value, Category table
Code typeValueCategory
PRESCRIBABLEYATTRIBUTES
RXNAV_STRnaphazoline hydrochloride 0.5 MG/ML Nasal SprayNAMES
RxNorm Namenaphazoline hydrochloride 0.5 MG/ML Nasal SprayNAMES
RxNorm Synonymnaphazoline HCl 0.05 % Nasal SprayNAMES
TTYSCDATTRIBUTES
SPL_SET_ID4a208a1f-f6e8-0b4a-e063-6294a90a10c8CODES
SPL_SET_ID4a470b9e-c83f-fb20-e063-6294a90a2f13CODES
SPL_SET_ID4a4abdc0-aded-1b8a-e063-6394a90a9b56CODES
SPL_SET_ID4a4d0c03-7d8f-76cb-e063-6394a90a938cCODES
SPL_SET_ID4a4d3a2b-a4ed-c736-e063-6394a90a96dfCODES
RxCUI1046610CODES
MMSL_CODECD6058CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
85248-053-0185248-053SKAPEMED ORIGINAL NASAL Naphazoline HCL 0.05% ORIGINAL NASALJiangxi Yudexi Pharmaceutical Co., LTDM012
85248-083-0185248-083NATUHEAL ORIGINAL NASAL Naphazoline HCL 0.05% ORIGINAL NASALJiangxi Yudexi Pharmaceutical Co., LTDM012
85248-099-0185248-099SERYNTH FAST RELIEF NASAL Naphazoline HCL 0.05% FAST RELIEF NASALJiangxi Yudexi Pharmaceutical Co., LTDM012
85248-111-0185248-111DERMFREE ORIGINAL NASAL Naphazoline HCL0.05%ORIGINAL NASALJiangxi Yudexi Pharmaceutical Co., LTDM012
85248-112-0185248-112DERMFREE ORIGINAL NASAL Naphazoline HCL 0.05%ORIGINAL NASALJiangxi Yudexi Pharmaceutical Co., LTDM012

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M01285248-053SKAPEMED ORIGINAL NASAL Naphazoline HCL 0.05% ORIGINAL NASALOTC MONOGRAPH DRUGJiangxi Yudexi Pharmaceutical Co., LTD

RxNav Current And Historical NDCs#

NDC11, Source, Active table
NDC11SourceActive
85248005301rxnav_ndcsyes
85248008301rxnav_ndcsyes
85248009901rxnav_ndcsyes
85248011101rxnav_ndcsyes
85248011201rxnav_ndcsyes
63736066255rxnav_historical_indirect
84010005501rxnav_historical
84010005601rxnav_historical
84010005701rxnav_historical
84010005801rxnav_historical
84010011701rxnav_historical
84010014501rxnav_historical
85248000601rxnav_historical

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
4a4abdc0-aded-1b8a-e063-6394a90a9b56naphazoline HCl 0.05 % Nasal SpraySY185248-09920260208
4a4abdc0-aded-1b8a-e063-6394a90a9b56naphazoline hydrochloride 0.5 MG/ML Nasal SpraySCD185248-09920260208
4a4abdc0-aded-1b8a-e063-6394a90a9b56naphazoline HCl 0.05 % Nasal SprayPSN185248-09920260208
4a4d0c03-7d8f-76cb-e063-6394a90a938cnaphazoline HCl 0.05 % Nasal SpraySY185248-11120260208
4a4d0c03-7d8f-76cb-e063-6394a90a938cnaphazoline HCl 0.05 % Nasal SprayPSN185248-11120260208
4a4d0c03-7d8f-76cb-e063-6394a90a938cnaphazoline hydrochloride 0.5 MG/ML Nasal SpraySCD185248-11120260208
4a4d3a2b-a4ed-c736-e063-6394a90a96dfnaphazoline hydrochloride 0.5 MG/ML Nasal SpraySCD185248-11220260208
4a4d3a2b-a4ed-c736-e063-6394a90a96dfnaphazoline HCl 0.05 % Nasal SprayPSN185248-11220260208
4a4d3a2b-a4ed-c736-e063-6394a90a96dfnaphazoline HCl 0.05 % Nasal SpraySY185248-11220260208
4a470b9e-c83f-fb20-e063-6294a90a2f13naphazoline HCl 0.05 % Nasal SpraySY185248-08320260207
4a470b9e-c83f-fb20-e063-6294a90a2f13naphazoline HCl 0.05 % Nasal SprayPSN185248-08320260207
4a470b9e-c83f-fb20-e063-6294a90a2f13naphazoline hydrochloride 0.5 MG/ML Nasal SpraySCD185248-08320260207
4a208a1f-f6e8-0b4a-e063-6294a90a10c8naphazoline HCl 0.05 % Nasal SpraySY185248-05320260205
4a208a1f-f6e8-0b4a-e063-6294a90a10c8naphazoline hydrochloride 0.5 MG/ML Nasal SpraySCD185248-05320260205
4a208a1f-f6e8-0b4a-e063-6294a90a10c8naphazoline HCl 0.05 % Nasal SprayPSN185248-05320260205
ec2bb7d7-d014-46ed-a836-453e921da4c5naphazoline HCl 0.05 % Nasal SprayPSN1Privine ® nasal spray20090731
ec2bb7d7-d014-46ed-a836-453e921da4c5naphazoline HCl 0.05 % Nasal SpraySY1Privine ® nasal spray20090731
ec2bb7d7-d014-46ed-a836-453e921da4c5naphazoline hydrochloride 0.5 MG/ML Nasal SpraySCD1Privine ® nasal spray20090731

DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
4a4abdc0-aded-1b8a-e063-6394a90a9b5685248-099Jiangxi Yudexi Pharmaceutical Co., LTD20260208
4a4d0c03-7d8f-76cb-e063-6394a90a938c85248-111Jiangxi Yudexi Pharmaceutical Co., LTD20260208
4a4d3a2b-a4ed-c736-e063-6394a90a96df85248-112Jiangxi Yudexi Pharmaceutical Co., LTD20260208
4a470b9e-c83f-fb20-e063-6294a90a2f1385248-083Jiangxi Yudexi Pharmaceutical Co., LTD20260207
4a208a1f-f6e8-0b4a-e063-6294a90a10c885248-053Jiangxi Yudexi Pharmaceutical Co., LTD20260205

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCS01GASympathomimetics used as decongestantsATC1-4naphazoline
ATCR01ABSympathomimetics, combinations excl. corticosteroidsATC1-4naphazoline
ATCR01AASympathomimetics, plainATC1-4naphazoline
MEDRTD009278NaphazolineCHEMhas_ingredientnaphazoline
MEDRTD009278NaphazolineCHEMhas_ingredientnaphazoline hydrochloride
MEDRTD004342Drug HypersensitivityDISEASEci_withnaphazoline
MEDRTD004342Drug HypersensitivityDISEASEci_withnaphazoline hydrochloride
MEDRTD015812Glaucoma, Angle-ClosureDISEASEci_withnaphazoline hydrochloride
MEDRTD015812Glaucoma, Angle-ClosureDISEASEci_withnaphazoline
MEDRTD006940HyperemiaDISEASEmay_treatnaphazoline
MEDRTD006940HyperemiaDISEASEmay_treatnaphazoline hydrochloride
MEDRTD012220RhinitisDISEASEmay_treatnaphazoline hydrochloride
MEDRTD012220RhinitisDISEASEmay_treatnaphazoline
MEDRTD012852SinusitisDISEASEmay_treatnaphazoline
MEDRTD012852SinusitisDISEASEmay_treatnaphazoline hydrochloride
MEDRTN0000000209Adrenergic alpha-AgonistsMOAhas_moanaphazoline
MEDRTN0000000209Adrenergic alpha-AgonistsMOAhas_moanaphazoline hydrochloride
MEDRTN0000008371Conjunctival Arterial VasoconstrictionPEhas_penaphazoline
MEDRTN0000008371Conjunctival Arterial VasoconstrictionPEhas_penaphazoline hydrochloride
MEDRTN0000008896Decreased Nasal and Sinus SecretionsPEhas_penaphazoline
MEDRTN0000008896Decreased Nasal and Sinus SecretionsPEhas_penaphazoline hydrochloride

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH0.5 MG/ML
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESPRESCRIBABLEY
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
ATTRIBUTESTTYSCD
CODESMMSL_CODECD6058
CODESRxCUI1046610
CODESSPL_SET_ID4a208a1f-f6e8-0b4a-e063-6294a90a10c8
CODESSPL_SET_ID4a470b9e-c83f-fb20-e063-6294a90a2f13
CODESSPL_SET_ID4a4abdc0-aded-1b8a-e063-6394a90a9b56
CODESSPL_SET_ID4a4d0c03-7d8f-76cb-e063-6394a90a938c
CODESSPL_SET_ID4a4d3a2b-a4ed-c736-e063-6394a90a96df
NAMESPrescribable Synonymnaphazoline HCl 0.05 % Nasal Spray
NAMESRXNAV_STRnaphazoline hydrochloride 0.5 MG/ML Nasal Spray
NAMESRxNorm Namenaphazoline hydrochloride 0.5 MG/ML Nasal Spray
NAMESRxNorm Synonymnaphazoline HCl 0.05 % Nasal Spray
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMultum MediSource Lexicon