FDA.reportPublic FDA data

naphazoline hydrochloride 0.5 MG/ML Nasal Solution

RxCUI
1046602
RxNorm name
naphazoline hydrochloride 0.5 MG/ML Nasal Solution
Display name
Naphazoline (Nasal)
Full name
naphazoline hydrochloride 0.5 MG/ML Nasal Solution
Term type
SCD
Status
Active
Strength
0.05%
Dose form
Sol
Route
Nasal
Updated
2026-06-15 06:59:35

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 Solution316962

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 SolutionNAMES
RxNorm Namenaphazoline hydrochloride 0.5 MG/ML Nasal SolutionNAMES
RxNorm Synonymnaphazoline hydrochloride 0.05 % Nasal SolutionNAMES
TTYSCDATTRIBUTES
SPL_SET_ID30cade3d-208f-8594-e063-6394a90ad2a0CODES
SPL_SET_ID4d4043f8-5ed3-4027-beb6-687db1308202CODES
RxCUI1046602CODES
MMSL_CODECD6057CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
12539-146-0212539-146NAFASOLINA Naphazoline hydrochlorideDoral Pharmamedics Inc DBA AG Marin PharmaceuticalsM012
49873-057-0149873-057Nazal Naphazoline hydrochlorideSato Pharmaceutical Co., Ltd.M012

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M01212539-146NAFASOLINA Naphazoline hydrochlorideOTC MONOGRAPH DRUGDoral Pharmamedics Inc DBA AG Marin Pharmaceuticals

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 9 matching rows.

NDC11, Source, Active table
NDC11SourceActive
12539014601rxnav_ndcsyes
12539014602rxnav_ndcsyes
49873005701rxnav_ndcsyes
00083651158rxnav_historical
00083651176rxnav_historical
00083661158rxnav_historical_indirect
00083662071rxnav_historical_indirect
00083662076rxnav_historical_indirect
63736066207rxnav_historical_indirect

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
NAFASOLINANAPHAZOLINE HYDROCHLORIDEDoral Pharmamedics Inc DBA AG Marin Pharmaceuticals30cade3d-208f-8594-e063-6394a90ad2a02025-12-18WarningsExact identifier
ndc (package): 12539-146-02
ndc (product): 12539-146
ndc11 (package): 12539014602
ndc11 (package): 12539014601
rxcui: 1046602
NazalNAPHAZOLINE HYDROCHLORIDESato Pharmaceutical Co., Ltd.4d4043f8-5ed3-4027-beb6-687db13082022023-12-06WarningsExact identifier
ndc (package): 49873-057-01
ndc (product): 49873-057
ndc11 (package): 49873005701
rxcui: 1046602

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
4d4043f8-5ed3-4027-beb6-687db1308202naphazoline HCl 0.05 % Nasal SolutionPSN7Nazal20231206
4d4043f8-5ed3-4027-beb6-687db1308202naphazoline hydrochloride 0.05 % Nasal SolutionSY7Nazal20231206
4d4043f8-5ed3-4027-beb6-687db1308202naphazoline hydrochloride 0.5 MG/ML Nasal SolutionSCD7Nazal20231206
30cade3d-208f-8594-e063-6394a90ad2a0naphazoline HCl 0.05 % Nasal SolutionPSN2Naphazoline hydrochloride 0.05%20251218
30cade3d-208f-8594-e063-6394a90ad2a0naphazoline hydrochloride 0.5 MG/ML Nasal SolutionSCD2Naphazoline hydrochloride 0.05%20251218
30cade3d-208f-8594-e063-6394a90ad2a0naphazoline hydrochloride 0.05 % Nasal SolutionSY2Naphazoline hydrochloride 0.05%20251218

DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
30cade3d-208f-8594-e063-6394a90ad2a0Naphazoline hydrochloride 0.05%Doral Pharmamedics Inc DBA AG Marin Pharmaceuticals | DEXTRUM LABORATORIES INC.20251218
4d4043f8-5ed3-4027-beb6-687db1308202NazalSato Pharmaceutical Co., Ltd.20231206

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
ATTRIBUTESTTYSCD
CODESMMSL_CODECD6057
CODESRxCUI1046602
CODESSPL_SET_ID30cade3d-208f-8594-e063-6394a90ad2a0
CODESSPL_SET_ID4d4043f8-5ed3-4027-beb6-687db1308202
CODESVUID4005501
NAMESPrescribable Synonymnaphazoline HCl 0.05 % Nasal Solution
NAMESRXNAV_STRnaphazoline hydrochloride 0.5 MG/ML Nasal Solution
NAMESRxNorm Namenaphazoline hydrochloride 0.5 MG/ML Nasal Solution
NAMESRxNorm Synonymnaphazoline hydrochloride 0.05 % Nasal Solution
SOURCESSourceMetathesaurus FDA Structured Product Labels