FDA.reportPublic FDA data

acetaminophen 325 MG / phenylephrine hydrochloride 5 MG Oral Capsule

RxCUI
1052670
RxNorm name
acetaminophen 325 MG / phenylephrine hydrochloride 5 MG Oral Capsule
Display name
Acetaminophen/Phenylephrine (Oral Pill)
Full name
acetaminophen 325 MG / phenylephrine hydrochloride 5 MG Oral Capsule
Term type
SCD
Status
Active
Strength
325-5 mg
Dose form
Cap
Route
Oral Pill
Updated
2026-06-14 07:03:28

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
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
phenylephrine8163

Source Vocabulary Codes#

Code type, Value, Category table
Code typeValueCategory
PRESCRIBABLEYATTRIBUTES
RXNAV_STRacetaminophen 325 MG / phenylephrine hydrochloride 5 MG Oral CapsuleNAMES
RxNorm Nameacetaminophen 325 MG / phenylephrine hydrochloride 5 MG Oral CapsuleNAMES
RxNorm SynonymAPAP 325 MG / phenylephrine hydrochloride 5 MG Oral CapsuleNAMES
TTYSCDATTRIBUTES
SPL_SET_ID30a07773-bd6f-b9f2-e063-6394a90ab8aaCODES
SPL_SET_ID4361912e-4b56-4743-b11d-acfb94482a2eCODES
SPL_SET_ID9a106398-6d9d-2146-e053-2995a90a3fdfCODES
SPL_SET_IDa0b01aef-4248-4d41-862c-0c8884dfca5eCODES
SPL_SET_IDd538445e-a47d-4983-844f-38aa303d11fdCODES
RxCUI1052670CODES
MMSL_CODEBD16914CODES
MMSL_CODECD16914CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
37000-950-2437000-950Vicks Sinex Severe Acetaminophen, Phenylephrine HClThe Procter & Gamble Manufacturing CompanyM012
53345-012-0153345-012DayTime Sinus Relief acetaminophen, phenylephrine hydrochlorideHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.M012
53345-030-0153345-030DayTime Sinus acetaminophen, phenylephrine hydrochlorideHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.M012
82706-025-0182706-025Sinus Head Congestion Acetaminophen, Phenylephrine HydrochlorideVIVUNT PHARMA LLCM012

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M01237000-950Vicks Sinex Severe Acetaminophen, Phenylephrine HClOTC MONOGRAPH DRUGThe Procter & Gamble Manufacturing Company

RxNav Current And Historical NDCs#

NDC11, Source, Active table
NDC11SourceActive
00363048808rxnav_ndcsyes
23900002327rxnav_ndcsyes
37000050724rxnav_ndcsyes
37000095024rxnav_ndcsyes
51013011214rxnav_ndcsyes
53345001201rxnav_ndcsyes
53345003001rxnav_ndcsyes
59726010012rxnav_ndcsyes
68016020016rxnav_ndcsyes
68016063016rxnav_ndcsyes
82706002501rxnav_ndcsyes
00363055807rxnav_historical
11822058807rxnav_historical
11822058808rxnav_historical
11917007651rxnav_historical
21130035508rxnav_historical
21130055308rxnav_historical
21130066308rxnav_historical
23900001447rxnav_historical_indirect
23900001982rxnav_historical_indirect
33992110008rxnav_historical
36800009816rxnav_historical
36800009824rxnav_historical
36800056562rxnav_historical
37000040724rxnav_historical_indirect
37000052624rxnav_historical
37000080520rxnav_historical_indirect
37000080524rxnav_historical_indirect
41250056562rxnav_historical
41520009916rxnav_historical
42507056562rxnav_historical
46122000460rxnav_historical
46122000462rxnav_historical
46122028862rxnav_historical
49035055308rxnav_historical
49035055822rxnav_historical
49035056560rxnav_historical
49035066308rxnav_historical
50804010024rxnav_historical
50844066300rxnav_historical
50844066302rxnav_historical
50844066308rxnav_historical
51013015704rxnav_historical
51013015904rxnav_historical
51013018514rxnav_historical
51013040804rxnav_historical
55312010012rxnav_historical
55312010016rxnav_historical
55315009916rxnav_historical
55315055808rxnav_historical
55316056560rxnav_historical
55316056562rxnav_historical
55316070762rxnav_historical
59726010008rxnav_historical
59779010016rxnav_historical
59995000600rxnav_historical
63868046324rxnav_historical
63941034151rxnav_historical
63941034186rxnav_historical
68210147005rxnav_historical
68210147006rxnav_historical
69842001804rxnav_historical
70925027262rxnav_historical
76270011308rxnav_historical

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
9a106398-6d9d-2146-e053-2995a90a3fdfacetaminophen 325 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD11VICKS ® Sinex ™ Severe ALL IN ONE™ SINUS LiquiCaps20251120
9a106398-6d9d-2146-e053-2995a90a3fdfacetaminophen 325 MG / phenylephrine HCl 5 MG Oral CapsulePSN11VICKS ® Sinex ™ Severe ALL IN ONE™ SINUS LiquiCaps20251120
9a106398-6d9d-2146-e053-2995a90a3fdfAPAP 325 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSY11VICKS ® Sinex ™ Severe ALL IN ONE™ SINUS LiquiCaps20251120
4361912e-4b56-4743-b11d-acfb94482a2eAPAP 325 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSY3DayTime Sinus Relief capsule, liquid filled20241125
4361912e-4b56-4743-b11d-acfb94482a2eacetaminophen 325 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD3DayTime Sinus Relief capsule, liquid filled20241125
4361912e-4b56-4743-b11d-acfb94482a2eacetaminophen 325 MG / phenylephrine HCl 5 MG Oral CapsulePSN3DayTime Sinus Relief capsule, liquid filled20241125
a0b01aef-4248-4d41-862c-0c8884dfca5eacetaminophen 325 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD3DayTime Sinus Capsules, liquid filled20241125
a0b01aef-4248-4d41-862c-0c8884dfca5eAPAP 325 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSY3DayTime Sinus Capsules, liquid filled20241125
a0b01aef-4248-4d41-862c-0c8884dfca5eacetaminophen 325 MG / phenylephrine HCl 5 MG Oral CapsulePSN3DayTime Sinus Capsules, liquid filled20241125
14c5a143-83ec-45c4-a745-4ed706f58d5cAPAP 325 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSY3Daytime Congestion, Pressure & Pain20191121
14c5a143-83ec-45c4-a745-4ed706f58d5cacetaminophen 325 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD3Daytime Congestion, Pressure & Pain20191121
14c5a143-83ec-45c4-a745-4ed706f58d5cacetaminophen 325 MG / phenylephrine HCl 5 MG Oral CapsulePSN3Daytime Congestion, Pressure & Pain20191121
b273e9d7-c347-48da-8b32-61843ed61c5dAPAP 325 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSY2Daytime Congestion, Pressure & Pain20200103
b273e9d7-c347-48da-8b32-61843ed61c5dacetaminophen 325 MG / phenylephrine HCl 5 MG Oral CapsulePSN2Daytime Congestion, Pressure & Pain20200103
b273e9d7-c347-48da-8b32-61843ed61c5dacetaminophen 325 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD2Daytime Congestion, Pressure & Pain20200103
ffb5d0d5-30a5-4e41-a667-15df0f747ddbAPAP 325 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSY2Day Time Sinus Relief20200103
ffb5d0d5-30a5-4e41-a667-15df0f747ddbacetaminophen 325 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD2Day Time Sinus Relief20200103
ffb5d0d5-30a5-4e41-a667-15df0f747ddbacetaminophen 325 MG / phenylephrine HCl 5 MG Oral CapsulePSN2Day Time Sinus Relief20200103
ca6039af-a148-45e0-b30f-26bd3ac9d276acetaminophen 325 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD2DayTime Sinus20200102
ca6039af-a148-45e0-b30f-26bd3ac9d276APAP 325 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSY2DayTime Sinus20200102
ca6039af-a148-45e0-b30f-26bd3ac9d276acetaminophen 325 MG / phenylephrine HCl 5 MG Oral CapsulePSN2DayTime Sinus20200102
b22e7d6e-a481-46e0-8fcc-c5e9c479e0eeacetaminophen 325 MG / phenylephrine HCl 5 MG Oral CapsulePSN2DayTime Sinus20191230
b22e7d6e-a481-46e0-8fcc-c5e9c479e0eeacetaminophen 325 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD2DayTime Sinus20191230
b22e7d6e-a481-46e0-8fcc-c5e9c479e0eeAPAP 325 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSY2DayTime Sinus20191230
d538445e-a47d-4983-844f-38aa303d11fdacetaminophen 325 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD2Daytime Sinus Relief and Nighttime Sinus Relief20191230
d538445e-a47d-4983-844f-38aa303d11fdacetaminophen 325 MG / phenylephrine HCl 5 MG Oral CapsulePSN2Daytime Sinus Relief and Nighttime Sinus Relief20191230
d538445e-a47d-4983-844f-38aa303d11fdAPAP 325 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSY2Daytime Sinus Relief and Nighttime Sinus Relief20191230
e40c3e2e-2d0b-476d-87d6-9ffe940816ddacetaminophen 325 MG / phenylephrine HCl 5 MG Oral CapsulePSN2Daytime Sinus & Congestion20191220
e40c3e2e-2d0b-476d-87d6-9ffe940816ddacetaminophen 325 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD2Daytime Sinus & Congestion20191220
e40c3e2e-2d0b-476d-87d6-9ffe940816ddAPAP 325 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSY2Daytime Sinus & Congestion20191220
87a8176e-9d32-4a8e-84ab-c81b2f74d46facetaminophen 325 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD2D-Time Sinus Soft Gelatin Capsules20100726
87a8176e-9d32-4a8e-84ab-c81b2f74d46fAPAP 325 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSY2D-Time Sinus Soft Gelatin Capsules20100726
87a8176e-9d32-4a8e-84ab-c81b2f74d46facetaminophen 325 MG / phenylephrine HCl 5 MG Oral CapsulePSN2D-Time Sinus Soft Gelatin Capsules20100726
30a07773-bd6f-b9f2-e063-6394a90ab8aaAPAP 325 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSY1AXIV Sinus Head Congestion20250318
30a07773-bd6f-b9f2-e063-6394a90ab8aaacetaminophen 325 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD1AXIV Sinus Head Congestion20250318
30a07773-bd6f-b9f2-e063-6394a90ab8aaacetaminophen 325 MG / phenylephrine HCl 5 MG Oral CapsulePSN1AXIV Sinus Head Congestion20250318

DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
9a106398-6d9d-2146-e053-2995a90a3fdfVICKS ® Sinex ™ Severe ALL IN ONE™ SINUS LiquiCapsThe Procter & Gamble Manufacturing Company20251120
30a07773-bd6f-b9f2-e063-6394a90ab8aaAXIV Sinus Head CongestionVIVUNT PHARMA LLC | SOFTECH PHARMA PRIVATE LIMITED20250318
8a0a8abf-0a41-44f8-8f4f-aec68a0fa0c5Rite Aid 44-558-DelistedRite Aid Corporation | LNK International, Inc.20250130
4361912e-4b56-4743-b11d-acfb94482a2eDayTime Sinus Relief capsule, liquid filledHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.20241125
a0b01aef-4248-4d41-862c-0c8884dfca5eDayTime Sinus Capsules, liquid filledHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.20241125
b273e9d7-c347-48da-8b32-61843ed61c5dDaytime Congestion, Pressure & PainPuraCap Pharmaceutical LLC | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.20200103
ffb5d0d5-30a5-4e41-a667-15df0f747ddbDay Time Sinus ReliefPuraCap Pharmaceutical LLC | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.20200103
ca6039af-a148-45e0-b30f-26bd3ac9d276DayTime SinusPuraCap Pharmaceutical LLC | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.20200102
b22e7d6e-a481-46e0-8fcc-c5e9c479e0eeDayTime SinusChain Drug Marketing Association Inc. | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.20191230
e40c3e2e-2d0b-476d-87d6-9ffe940816ddDaytime Sinus & CongestionPuraCap Pharmaceutical LLC | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.20191220
14c5a143-83ec-45c4-a745-4ed706f58d5cDaytime Congestion, Pressure & PainCVS PHARMACY, INC. | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.20191121
87a8176e-9d32-4a8e-84ab-c81b2f74d46fD-Time Sinus Soft Gelatin CapsulesSPIRIT PHARMACEUTICALS,LLC20100726

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCC01CAAdrenergic and dopaminergic agentsATC1-4phenylephrine
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
MEDRTD000082AcetaminophenCHEMhas_ingredientacetaminophen
MEDRTD010656PhenylephrineCHEMhas_ingredientphenylephrine
MEDRTD010656PhenylephrineCHEMhas_ingredientphenylephrine hydrochloride
MEDRTD013447SulfitesCHEMci_chemclassphenylephrine hydrochloride
MEDRTD013447SulfitesCHEMci_chemclassphenylephrine
MEDRTD004342Drug HypersensitivityDISEASEci_withphenylephrine hydrochloride
MEDRTD004342Drug HypersensitivityDISEASEci_withphenylephrine
MEDRTD004342Drug HypersensitivityDISEASEci_withacetaminophen
MEDRTD005334FeverDISEASEmay_treatacetaminophen
MEDRTD005334FeverDISEASEmay_preventacetaminophen
MEDRTD005401Fissure in AnoDISEASEmay_treatphenylephrine hydrochloride
MEDRTD005401Fissure in AnoDISEASEmay_treatphenylephrine
MEDRTD005902Glaucoma, Open-AngleDISEASEmay_treatphenylephrine hydrochloride
MEDRTD005902Glaucoma, Open-AngleDISEASEmay_treatphenylephrine
MEDRTD005955Glucosephosphate Dehydrogenase DeficiencyDISEASEci_withacetaminophen
MEDRTD006484HemorrhoidsDISEASEmay_treatphenylephrine
MEDRTD006484HemorrhoidsDISEASEmay_treatphenylephrine hydrochloride
MEDRTD006973HypertensionDISEASEci_withphenylephrine
MEDRTD006973HypertensionDISEASEci_withphenylephrine hydrochloride
MEDRTD007022HypotensionDISEASEmay_treatphenylephrine hydrochloride
MEDRTD007022HypotensionDISEASEmay_treatphenylephrine
MEDRTD008107Liver DiseasesDISEASEci_withacetaminophen
MEDRTD015878MydriasisDISEASEinducesphenylephrine
MEDRTD015878MydriasisDISEASEinducesphenylephrine hydrochloride
MEDRTD010146PainDISEASEmay_treatacetaminophen
MEDRTD010146PainDISEASEmay_preventacetaminophen
MEDRTD011538Pruritus AniDISEASEmay_treatphenylephrine hydrochloride
MEDRTD011538Pruritus AniDISEASEmay_treatphenylephrine
MEDRTD012223Rhinitis, VasomotorDISEASEmay_treatphenylephrine hydrochloride
MEDRTD012223Rhinitis, VasomotorDISEASEmay_treatphenylephrine
MEDRTD012772Shock, SepticDISEASEmay_treatphenylephrine
MEDRTD012772Shock, SepticDISEASEmay_treatphenylephrine hydrochloride
MEDRTD013617Tachycardia, SupraventricularDISEASEmay_treatphenylephrine hydrochloride
MEDRTD013617Tachycardia, SupraventricularDISEASEmay_treatphenylephrine
MEDRTD017180Tachycardia, VentricularDISEASEci_withphenylephrine
MEDRTD017180Tachycardia, VentricularDISEASEci_withphenylephrine hydrochloride
MEDRTN0000000209Adrenergic alpha-AgonistsMOAhas_moaphenylephrine
MEDRTN0000000209Adrenergic alpha-AgonistsMOAhas_moaphenylephrine hydrochloride
MEDRTN0000000108Prostaglandin Receptor AntagonistsMOAhas_moaacetaminophen
MEDRTN0000175724Central Nervous System Activity AlterationPEhas_peacetaminophen
MEDRTN0000008371Conjunctival Arterial VasoconstrictionPEhas_pephenylephrine
MEDRTN0000008371Conjunctival Arterial VasoconstrictionPEhas_pephenylephrine hydrochloride
MEDRTN0000008896Decreased Nasal and Sinus SecretionsPEhas_pephenylephrine
MEDRTN0000008896Decreased Nasal and Sinus SecretionsPEhas_pephenylephrine hydrochloride
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 / 5 MG
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESPRESCRIBABLEY
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
ATTRIBUTESTTYSCD
CODESMMSL_CODEBD16914
CODESMMSL_CODECD16914
CODESRxCUI1052670
CODESSPL_SET_ID30a07773-bd6f-b9f2-e063-6394a90ab8aa
CODESSPL_SET_ID4361912e-4b56-4743-b11d-acfb94482a2e
CODESSPL_SET_ID9a106398-6d9d-2146-e053-2995a90a3fdf
CODESSPL_SET_IDa0b01aef-4248-4d41-862c-0c8884dfca5e
CODESSPL_SET_IDd538445e-a47d-4983-844f-38aa303d11fd
CODESVUID4034506
NAMESPrescribable Synonymacetaminophen 325 MG / phenylephrine HCl 5 MG Oral Capsule
NAMESRXNAV_STRacetaminophen 325 MG / phenylephrine hydrochloride 5 MG Oral Capsule
NAMESRxNorm Nameacetaminophen 325 MG / phenylephrine hydrochloride 5 MG Oral Capsule
NAMESRxNorm SynonymAPAP 325 MG / phenylephrine hydrochloride 5 MG Oral Capsule
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceNational Drug Data File Plus Source Vocabulary
SOURCESSourceVeterans Health Administration National Drug File