FDA.reportPublic FDA data

acetaminophen 325 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule

RxCUI
1052647
RxNorm name
acetaminophen 325 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule
Display name
Acetaminophen/Doxylamine/Phenylephrine (Oral Pill)
Full name
acetaminophen 325 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule
Term type
SCD
Status
Active
Strength
325-6.25-5 mg
Dose form
Cap
Route
Oral Pill
Updated
2026-06-13 07:09:28

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
022011
Active start
022011
Multiple ingredient
YES
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
acetaminophen325 MG / 1 EACHacetaminophenacetaminophen
doxylamine succinate6.25 MG / 1 EACHdoxylaminedoxylamine succinate
phenylephrine hydrochloride5 MG / 1 EACHphenylephrinephenylephrine hydrochloride

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Oral Capsule316965

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
acetaminophen161
doxylamine3642
phenylephrine8163

Source Vocabulary Codes#

Code type, Value, Category table
Code typeValueCategory
PRESCRIBABLEYATTRIBUTES
RXNAV_STRacetaminophen 325 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral CapsuleNAMES
RxNorm Nameacetaminophen 325 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral CapsuleNAMES
RxNorm SynonymAPAP 325 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral CapsuleNAMES
TTYSCDATTRIBUTES
SPL_SET_ID0f3b1404-9252-470a-aa8c-b360c85731f3CODES
SPL_SET_ID413d82d3-a896-4f15-9fca-c1b7b9a1ee63CODES
SPL_SET_IDd538445e-a47d-4983-844f-38aa303d11fdCODES
RxCUI1052647CODES
MMSL_CODEBD28700CODES
MMSL_CODECD28700CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
53345-013-0153345-013NightTime Sinus Relief Acetaminophen, Doxylamine succinate, Phenylephrine hydrochlorideHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.M012
53345-031-0153345-031NightTime Sinus Acetaminophen, Doxylamine succinate, Phenylephrine hydrochlorideHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.M012

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M01253345-013NightTime Sinus Relief Acetaminophen, Doxylamine succinate, Phenylephrine hydrochlorideOTC MONOGRAPH DRUGHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.

RxNav Current And Historical NDCs#

NDC11, Source, Active table
NDC11SourceActive
23900002328rxnav_ndcsyes
51013011314rxnav_ndcsyes
53345001301rxnav_ndcsyes
53345003101rxnav_ndcsyes
68016020116rxnav_ndcsyes
68016063116rxnav_ndcsyes
00280119820rxnav_historical
23900001448rxnav_historical
23900001983rxnav_historical
36800010116rxnav_historical
36800010124rxnav_historical
36800040862rxnav_historical
37000040824rxnav_historical
37000050824rxnav_historical
37000080620rxnav_historical_indirect
37000080624rxnav_historical
41250010124rxnav_historical
41250024762rxnav_historical
41520010116rxnav_historical
42507030562rxnav_historical
46122000660rxnav_historical
49035024760rxnav_historical
50804010124rxnav_historical
51013015604rxnav_historical
51013016004rxnav_historical
51013018614rxnav_historical
55312010112rxnav_historical
55312010116rxnav_historical
55315010216rxnav_historical
59726010108rxnav_historical
59779010116rxnav_historical
59995000700rxnav_historical
63868038812rxnav_historical
63868038820rxnav_historical
68016010112rxnav_historical
68016073316rxnav_historical
68210148005rxnav_historical
68210148006rxnav_historical
76270011408rxnav_historical

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
0f3b1404-9252-470a-aa8c-b360c85731f3acetaminophen 325 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral CapsulePSN3NightTime Sinus Capsule, liquid filled20241125
0f3b1404-9252-470a-aa8c-b360c85731f3acetaminophen 325 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD3NightTime Sinus Capsule, liquid filled20241125
0f3b1404-9252-470a-aa8c-b360c85731f3APAP 325 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral CapsuleSY3NightTime Sinus Capsule, liquid filled20241125
413d82d3-a896-4f15-9fca-c1b7b9a1ee63APAP 325 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral CapsuleSY3NightTime Sinus Relief capsule, liquid filled20241125
413d82d3-a896-4f15-9fca-c1b7b9a1ee63acetaminophen 325 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral CapsulePSN3NightTime Sinus Relief capsule, liquid filled20241125
413d82d3-a896-4f15-9fca-c1b7b9a1ee63acetaminophen 325 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD3NightTime Sinus Relief capsule, liquid filled20241125
649f429a-ba62-4ef0-9c7f-940bbf18dbf0acetaminophen 325 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD2Night Time Sinus Relief20200103
649f429a-ba62-4ef0-9c7f-940bbf18dbf0APAP 325 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral CapsuleSY2Night Time Sinus Relief20200103
649f429a-ba62-4ef0-9c7f-940bbf18dbf0acetaminophen 325 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral CapsulePSN2Night Time Sinus Relief20200103
d538445e-a47d-4983-844f-38aa303d11fdAPAP 325 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral CapsuleSY2Daytime Sinus Relief and Nighttime Sinus Relief20191230
d538445e-a47d-4983-844f-38aa303d11fdacetaminophen 325 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral CapsulePSN2Daytime Sinus Relief and Nighttime Sinus Relief20191230
d538445e-a47d-4983-844f-38aa303d11fdacetaminophen 325 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD2Daytime Sinus Relief and Nighttime Sinus Relief20191230
4f1ceec0-1273-4cfd-8263-f4247b5e7ee6acetaminophen 325 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral CapsulePSN2Nighttime Sinus & Congestion Relief20191220
4f1ceec0-1273-4cfd-8263-f4247b5e7ee6APAP 325 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral CapsuleSY2Nighttime Sinus & Congestion Relief20191220
4f1ceec0-1273-4cfd-8263-f4247b5e7ee6acetaminophen 325 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD2Nighttime Sinus & Congestion Relief20191220
cd1ec9c1-54da-4b73-8d2c-6b727234142cAPAP 325 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral CapsuleSY2NiteTime Sinus Relief20191220
cd1ec9c1-54da-4b73-8d2c-6b727234142cacetaminophen 325 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral CapsulePSN2NiteTime Sinus Relief20191220
cd1ec9c1-54da-4b73-8d2c-6b727234142cacetaminophen 325 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD2NiteTime Sinus Relief20191220
e3be9ee0-b9bb-4a09-a40a-dbe2f08325adAPAP 325 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral CapsuleSY2N-Time Sinus Soft Gelatin Capsules20100726
e3be9ee0-b9bb-4a09-a40a-dbe2f08325adacetaminophen 325 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral CapsulePSN2N-Time Sinus Soft Gelatin Capsules20100726
e3be9ee0-b9bb-4a09-a40a-dbe2f08325adacetaminophen 325 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD2N-Time Sinus Soft Gelatin Capsules20100726
842706f9-eedf-1783-49ed-e6b7ae7d650eacetaminophen 325 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral CapsulePSN1Drug Facts20151012
842706f9-eedf-1783-49ed-e6b7ae7d650eacetaminophen 325 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD1Drug Facts20151012
842706f9-eedf-1783-49ed-e6b7ae7d650eAPAP 325 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral CapsuleSY1Drug Facts20151012

DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
0f3b1404-9252-470a-aa8c-b360c85731f3NightTime Sinus Capsule, liquid filledHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.20241125
413d82d3-a896-4f15-9fca-c1b7b9a1ee63NightTime Sinus Relief capsule, liquid filledHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.20241125
649f429a-ba62-4ef0-9c7f-940bbf18dbf0Night Time Sinus ReliefPuraCap Pharmaceutical LLC | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd20200103
4f1ceec0-1273-4cfd-8263-f4247b5e7ee6Nighttime Sinus & Congestion ReliefPuraCap Pharmaceutical LLC | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd20191220
cd1ec9c1-54da-4b73-8d2c-6b727234142cNiteTime Sinus ReliefPuraCap Pharmaceutical LLC | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd20191220
842706f9-eedf-1783-49ed-e6b7ae7d650eDrug FactsChain Drug Consortium, LLC | Accucaps Industries Limited | Accucaps Industries Limited Strathroy | Legacy Pharmaceutical Packaging20151012
e3be9ee0-b9bb-4a09-a40a-dbe2f08325adN-Time Sinus Soft Gelatin CapsulesSPIRIT PHARMACEUTICALS,LLC20100726

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCC01CAAdrenergic and dopaminergic agentsATC1-4phenylephrine
ATCR06AAAminoalkyl ethersATC1-4doxylamine
ATCN02BEAnilidesATC1-4acetaminophen
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
FDASPLN0000175750AntihistamineEPChas_epcdoxylamine
FDASPLN0000000207Histamine Receptor AntagonistsMOAhas_moadoxylamine
MEDRTD000082AcetaminophenCHEMhas_ingredientacetaminophen
MEDRTD004319DoxylamineCHEMhas_ingredientdoxylamine succinate
MEDRTD004319DoxylamineCHEMhas_ingredientdoxylamine
MEDRTD010656PhenylephrineCHEMhas_ingredientphenylephrine hydrochloride
MEDRTD010656PhenylephrineCHEMhas_ingredientphenylephrine
MEDRTD013447SulfitesCHEMci_chemclassphenylephrine
MEDRTD013447SulfitesCHEMci_chemclassphenylephrine hydrochloride
MEDRTD004342Drug HypersensitivityDISEASEci_withphenylephrine hydrochloride
MEDRTD004342Drug HypersensitivityDISEASEci_withacetaminophen
MEDRTD004342Drug HypersensitivityDISEASEci_withdoxylamine succinate
MEDRTD004342Drug HypersensitivityDISEASEci_withphenylephrine
MEDRTD004342Drug HypersensitivityDISEASEci_withdoxylamine
MEDRTD005334FeverDISEASEmay_preventacetaminophen
MEDRTD005334FeverDISEASEmay_treatacetaminophen
MEDRTD005401Fissure in AnoDISEASEmay_treatphenylephrine hydrochloride
MEDRTD005401Fissure in AnoDISEASEmay_treatphenylephrine
MEDRTD005902Glaucoma, Open-AngleDISEASEmay_treatphenylephrine hydrochloride
MEDRTD005902Glaucoma, Open-AngleDISEASEmay_treatphenylephrine
MEDRTD005955Glucosephosphate Dehydrogenase DeficiencyDISEASEci_withacetaminophen
MEDRTD006261HeadacheDISEASEmay_treatdoxylamine
MEDRTD006261HeadacheDISEASEmay_treatdoxylamine succinate
MEDRTD006484HemorrhoidsDISEASEmay_treatphenylephrine hydrochloride
MEDRTD006484HemorrhoidsDISEASEmay_treatphenylephrine
MEDRTD006973HypertensionDISEASEci_withphenylephrine hydrochloride
MEDRTD006973HypertensionDISEASEci_withphenylephrine
MEDRTD007022HypotensionDISEASEmay_treatphenylephrine
MEDRTD007022HypotensionDISEASEmay_treatphenylephrine hydrochloride
MEDRTD008107Liver DiseasesDISEASEci_withacetaminophen
MEDRTD015878MydriasisDISEASEinducesphenylephrine hydrochloride
MEDRTD015878MydriasisDISEASEinducesphenylephrine
MEDRTD010146PainDISEASEmay_preventacetaminophen
MEDRTD010146PainDISEASEmay_treatacetaminophen
MEDRTD011538Pruritus AniDISEASEmay_treatphenylephrine
MEDRTD011538Pruritus AniDISEASEmay_treatphenylephrine hydrochloride
MEDRTD012221Rhinitis, Allergic, PerennialDISEASEmay_treatdoxylamine succinate
MEDRTD012221Rhinitis, Allergic, PerennialDISEASEmay_treatdoxylamine
MEDRTD012223Rhinitis, VasomotorDISEASEmay_treatphenylephrine
MEDRTD012223Rhinitis, VasomotorDISEASEmay_treatphenylephrine hydrochloride
MEDRTD012772Shock, SepticDISEASEmay_treatphenylephrine
MEDRTD012772Shock, SepticDISEASEmay_treatphenylephrine hydrochloride
MEDRTD007319Sleep Initiation and Maintenance DisordersDISEASEmay_treatdoxylamine succinate
MEDRTD007319Sleep Initiation and Maintenance DisordersDISEASEmay_treatdoxylamine
MEDRTD013617Tachycardia, SupraventricularDISEASEmay_treatphenylephrine
MEDRTD013617Tachycardia, SupraventricularDISEASEmay_treatphenylephrine hydrochloride
MEDRTD017180Tachycardia, VentricularDISEASEci_withphenylephrine
MEDRTD017180Tachycardia, VentricularDISEASEci_withphenylephrine hydrochloride
MEDRTN0000000209Adrenergic alpha-AgonistsMOAhas_moaphenylephrine
MEDRTN0000000209Adrenergic alpha-AgonistsMOAhas_moaphenylephrine hydrochloride
MEDRTN0000000190Histamine H1 Receptor AntagonistsMOAhas_moadoxylamine succinate
MEDRTN0000000190Histamine H1 Receptor AntagonistsMOAhas_moadoxylamine
MEDRTN0000000108Prostaglandin Receptor AntagonistsMOAhas_moaacetaminophen
MEDRTN0000175724Central Nervous System Activity AlterationPEhas_peacetaminophen
MEDRTN0000008371Conjunctival Arterial VasoconstrictionPEhas_pephenylephrine hydrochloride
MEDRTN0000008371Conjunctival Arterial VasoconstrictionPEhas_pephenylephrine
MEDRTN0000008657Decreased Histamine ActivityPEhas_pedoxylamine
MEDRTN0000008657Decreased Histamine ActivityPEhas_pedoxylamine succinate
MEDRTN0000008896Decreased Nasal and Sinus SecretionsPEhas_pephenylephrine hydrochloride
MEDRTN0000008896Decreased Nasal and Sinus SecretionsPEhas_pephenylephrine
MEDRTN0000008836Decreased Prostaglandin ProductionPEhas_peacetaminophen
MEDRTN0000009072Hypothalamic Endocrine Activity AlterationPEhas_peacetaminophen
MEDRTN0000175725Peripheral Nervous System Activity AlterationPEhas_peacetaminophen
MEDRTN0000000026Hepatic MetabolismPKhas_pkacetaminophen
MEDRTN0000000042Renal ExcretionPKhas_pkacetaminophen

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH325 MG / 6.25 MG (expressed as doxylamine succinate) / 5 MG
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESPRESCRIBABLEY
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESTTYSCD
CODESMMSL_CODEBD28700
CODESMMSL_CODECD28700
CODESRxCUI1052647
CODESSPL_SET_ID0f3b1404-9252-470a-aa8c-b360c85731f3
CODESSPL_SET_ID413d82d3-a896-4f15-9fca-c1b7b9a1ee63
CODESSPL_SET_IDd538445e-a47d-4983-844f-38aa303d11fd
NAMESPrescribable Synonymacetaminophen 325 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule
NAMESRXNAV_STRacetaminophen 325 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule
NAMESRxNorm Nameacetaminophen 325 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule
NAMESRxNorm SynonymAPAP 325 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels