FDA.reportPublic FDA data

acetaminophen 500 MG / phenylephrine hydrochloride 5 MG Oral Tablet

RxCUI
1101534
RxNorm name
acetaminophen 500 MG / phenylephrine hydrochloride 5 MG Oral Tablet
Display name
Acetaminophen/Phenylephrine (Oral Pill)
Full name
acetaminophen 500 MG / phenylephrine hydrochloride 5 MG Oral Tablet
Term type
SCD
Status
Active
Strength
500-5 mg
Dose form
Tab
Route
Oral Pill
Updated
2026-06-15 07:02:52

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
062011
Active start
062011
Multiple ingredient
YES
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
acetaminophen500 MG / 1 EACHacetaminophenacetaminophen
phenylephrine hydrochloride5 MG / 1 EACHphenylephrinephenylephrine hydrochloride

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Oral Tablet317541

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
acetaminophen161
phenylephrine8163

Source Vocabulary Codes#

Code type, Value, Category table
Code typeValueCategory
PRESCRIBABLEYATTRIBUTES
RXNAV_STRacetaminophen 500 MG / phenylephrine hydrochloride 5 MG Oral TabletNAMES
RxNorm Nameacetaminophen 500 MG / phenylephrine hydrochloride 5 MG Oral TabletNAMES
RxNorm SynonymAPAP 500 MG / Phenylephrine Hydrochloride 5 MG Oral TabletNAMES
TTYSCDATTRIBUTES
SPL_SET_ID0cdd028b-8f08-2351-e063-6394a90aa0efCODES
SPL_SET_ID249373c6-f56f-4bd3-9cef-98b7ee73457dCODES
SPL_SET_ID88f86f5a-cc2b-4c75-b7a4-f2021922280bCODES
SPL_SET_IDa518e124-5a96-4a08-9b5f-3eaa8bf944c0CODES
SPL_SET_IDc66e0b52-5531-4a84-ae90-8a26d27df1ecCODES
SPL_SET_IDe0cbb213-4f4f-4045-e053-2a95a90a2a18CODES
SPL_SET_IDe8e5fb21-a7fd-44d1-b9c4-83e949699ca6CODES
SPL_SET_IDf196f2c5-a100-42b1-bd01-0327b223838eCODES
RxCUI1101534CODES
MMSL_CODEBD16637CODES
MMSL_CODECD16637CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
47682-001-3347682-001Green Guard Advanced Sinus Relief ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEUnifirst First Aid CorporationM012
47682-001-4847682-001Green Guard Advanced Sinus Relief ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEUnifirst First Aid CorporationM012
47682-001-9947682-001Green Guard Advanced Sinus Relief ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEUnifirst First Aid CorporationM012
47682-509-0347682-509Otis Clapp Mygrex ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEUnifirst First Aid CorporationM012
47682-509-9947682-509Otis Clapp Mygrex ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEUnifirst First Aid CorporationM012
47682-819-1347682-819Medi First Sinus Pain and Pressure ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEUnifirst First Aid CorporationM012
47682-819-3347682-819Medi First Sinus Pain and Pressure ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEUnifirst First Aid CorporationM012
47682-819-4847682-819Medi First Sinus Pain and Pressure ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEUnifirst First Aid CorporationM012
47682-819-5047682-819Medi First Sinus Pain and Pressure ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEUnifirst First Aid CorporationM012
47682-819-9947682-819Medi First Sinus Pain and Pressure ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEUnifirst First Aid CorporationM012
47682-919-3347682-919Medi First Plus Sinus Pain and Pressure ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEUnifirst First Aid CorporationM012
47682-919-4847682-919Medi First Plus Sinus Pain and Pressure ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEUnifirst First Aid CorporationM012
68599-4751-368599-4751McKesson Sinus Pain and Pressure Relief Acetaminophen, Phenylephrine HClMcKesson Medical-SurgicalM012
73598-1192-173598-1192Pain and Sinus Acetaminophen and PhenylephrineJHK Inc dba American Safety & First AidM012
73598-1194-173598-1194Pain and Sinus Reliever Acetaminophen and PhenylephrineJHK DBA American Safety & First AidM012
84269-2546-184269-2546Sinu-Phen Plus ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEWildman Business GroupM012
84269-2546-284269-2546Sinu-Phen Plus ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEWildman Business GroupM012

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M01247682-001Green Guard Advanced Sinus Relief ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEOTC MONOGRAPH DRUGUnifirst First Aid Corporation

RxNav Current And Historical NDCs#

NDC11, Source, Active table
NDC11SourceActive
42961012601rxnav_ndcsyes
42961012602rxnav_ndcsyes
46017002408rxnav_ndcsyes
46017002424rxnav_ndcsyes
46017002499rxnav_ndcsyes
47682000133rxnav_ndcsyes
47682000148rxnav_ndcsyes
47682000199rxnav_ndcsyes
47682015509rxnav_ndcsyes
47682050903rxnav_ndcsyes
47682050999rxnav_ndcsyes
47682081913rxnav_ndcsyes
47682081933rxnav_ndcsyes
47682081948rxnav_ndcsyes
47682081950rxnav_ndcsyes
47682081999rxnav_ndcsyes
47682091933rxnav_ndcsyes
47682091948rxnav_ndcsyes
68599475103rxnav_ndcsyes
73598119201rxnav_ndcsyes
73598119401rxnav_ndcsyes
84269254601rxnav_ndcsyes
84269254602rxnav_ndcsyes
00135043602rxnav_historical_indirect
00498104001rxnav_historical
00498104010rxnav_historical
00498104025rxnav_historical
00498104050rxnav_historical
00498104101rxnav_historical
00498104110rxnav_historical
00498104125rxnav_historical
00498104150rxnav_historical
10244054863rxnav_historical
45800023817rxnav_historical_indirect
45800023910rxnav_historical_indirect
46017002108rxnav_historical_indirect
46017002124rxnav_historical_indirect
46017002199rxnav_historical_indirect
47682000233rxnav_historical
47682000248rxnav_historical
47682000299rxnav_historical
47682014613rxnav_historical
47682014633rxnav_historical
47682014648rxnav_historical
47682014650rxnav_historical
47682014699rxnav_historical
47682014803rxnav_historical_indirect
47682014899rxnav_historical_indirect
47682015833rxnav_historical
47682015848rxnav_historical
49348071804rxnav_historical
51532014002rxnav_historical
51645026912rxnav_historical_indirect
51645026966rxnav_historical_indirect
55670015013rxnav_historical
55670015099rxnav_historical
55670047513rxnav_historical
55670047599rxnav_historical
62211026199rxnav_historical
67060014067rxnav_historical
67060014068rxnav_historical
67060019467rxnav_historical
67060019468rxnav_historical
69103254605rxnav_historical
69103254606rxnav_historical
69168026199rxnav_historical
71179002408rxnav_historical
71179002424rxnav_historical
81238014001rxnav_historical
81238014002rxnav_historical
81238024001rxnav_historical
81238024002rxnav_historical

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
f196f2c5-a100-42b1-bd01-0327b223838eacetaminophen 500 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD21819R Sinus Pain and Pressure UniFirst MF/MFP OC20250908
f196f2c5-a100-42b1-bd01-0327b223838eAPAP 500 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSY21819R Sinus Pain and Pressure UniFirst MF/MFP OC20250908
f196f2c5-a100-42b1-bd01-0327b223838eacetaminophen 500 MG / phenylephrine HCl 5 MG Oral TabletPSN21819R Sinus Pain and Pressure UniFirst MF/MFP OC20250908
e8e5fb21-a7fd-44d1-b9c4-83e949699ca6acetaminophen 500 MG / phenylephrine HCl 5 MG Oral TabletPSN15819R Green Guard Advanced Sinus Relief20250908
e8e5fb21-a7fd-44d1-b9c4-83e949699ca6acetaminophen 500 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD15819R Green Guard Advanced Sinus Relief20250908
e8e5fb21-a7fd-44d1-b9c4-83e949699ca6APAP 500 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSY15819R Green Guard Advanced Sinus Relief20250908
8aa33e28-f1d4-42f0-a334-bf85a779fe3facetaminophen 500 MG / phenylephrine HCl 5 MG Oral TabletPSN15Medi-First Sinus Pain and Pressure20220316
8aa33e28-f1d4-42f0-a334-bf85a779fe3facetaminophen 500 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD15Medi-First Sinus Pain and Pressure20220316
8aa33e28-f1d4-42f0-a334-bf85a779fe3fAPAP 500 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSY15Medi-First Sinus Pain and Pressure20220316
e0cbb213-4f4f-4045-e053-2a95a90a2a18acetaminophen 500 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD3McKesson Sinus Pain and Pressure Relief20250908
e0cbb213-4f4f-4045-e053-2a95a90a2a18acetaminophen 500 MG / phenylephrine HCl 5 MG Oral TabletPSN3McKesson Sinus Pain and Pressure Relief20250908
e0cbb213-4f4f-4045-e053-2a95a90a2a18APAP 500 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSY3McKesson Sinus Pain and Pressure Relief20250908
c66e0b52-5531-4a84-ae90-8a26d27df1ecAPAP 500 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSY220260112
c66e0b52-5531-4a84-ae90-8a26d27df1ecacetaminophen 500 MG / phenylephrine HCl 5 MG Oral TabletPSN220260112
c66e0b52-5531-4a84-ae90-8a26d27df1ecacetaminophen 500 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD220260112
88f86f5a-cc2b-4c75-b7a4-f2021922280bacetaminophen 500 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD2Pain & Sinus20251216
88f86f5a-cc2b-4c75-b7a4-f2021922280bAPAP 500 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSY2Pain & Sinus20251216
88f86f5a-cc2b-4c75-b7a4-f2021922280bacetaminophen 500 MG / phenylephrine HCl 5 MG Oral TabletPSN2Pain & Sinus20251216
249373c6-f56f-4bd3-9cef-98b7ee73457dacetaminophen 500 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD1Pain and Sinus Reliever20240514
249373c6-f56f-4bd3-9cef-98b7ee73457dAPAP 500 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSY1Pain and Sinus Reliever20240514
249373c6-f56f-4bd3-9cef-98b7ee73457dacetaminophen 500 MG / phenylephrine HCl 5 MG Oral TabletPSN1Pain and Sinus Reliever20240514
0cca624d-6866-2baa-e063-6394a90ac44dacetaminophen 500 MG / phenylephrine HCl 5 MG Oral TabletPSN1CONTAC Cold + Flu Day20240101
0cca624d-6866-2baa-e063-6394a90ac44dAPAP 500 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSY1CONTAC Cold + Flu Day20240101
0cca624d-6866-2baa-e063-6394a90ac44dacetaminophen 500 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD1CONTAC Cold + Flu Day20240101
0cdd028b-8f08-2351-e063-6394a90aa0efAPAP 500 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSY1CONTAC Cold + Flu Day Night20240101
0cdd028b-8f08-2351-e063-6394a90aa0efacetaminophen 500 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD1CONTAC Cold + Flu Day Night20240101
0cdd028b-8f08-2351-e063-6394a90aa0efacetaminophen 500 MG / phenylephrine HCl 5 MG Oral TabletPSN1CONTAC Cold + Flu Day Night20240101
cabd4342-7957-42ad-baa3-1f6c512cdf8cAPAP 500 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSY1Aramark Maximum Allergy Relief20210611
cabd4342-7957-42ad-baa3-1f6c512cdf8cacetaminophen 500 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD1Aramark Maximum Allergy Relief20210611
cabd4342-7957-42ad-baa3-1f6c512cdf8cacetaminophen 500 MG / phenylephrine HCl 5 MG Oral TabletPSN1Aramark Maximum Allergy Relief20210611
a1a8c1b0-1c3d-4d32-b505-e92a19623f65APAP 500 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSY1Drug Facts20140916
a1a8c1b0-1c3d-4d32-b505-e92a19623f65acetaminophen 500 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD1Drug Facts20140916
a1a8c1b0-1c3d-4d32-b505-e92a19623f65acetaminophen 500 MG / phenylephrine HCl 5 MG Oral TabletPSN1Drug Facts20140916

DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
c66e0b52-5531-4a84-ae90-8a26d27df1ecWildman Business Group | Allegiant Health | Medique Products | Prestige Packaging20260112
88f86f5a-cc2b-4c75-b7a4-f2021922280bPain & SinusJHK Inc dba American Safety & First Aid | ALLEGIANT HEALTH20251216
f196f2c5-a100-42b1-bd01-0327b223838e819R Sinus Pain and Pressure UniFirst MF/MFP OCUnifirst First Aid Corporation20250908
e8e5fb21-a7fd-44d1-b9c4-83e949699ca6819R Green Guard Advanced Sinus ReliefUnifirst First Aid Corporation20250908
e0cbb213-4f4f-4045-e053-2a95a90a2a18McKesson Sinus Pain and Pressure ReliefMcKesson Medical-Surgical | Unifirst First Aid Corporation20250908
249373c6-f56f-4bd3-9cef-98b7ee73457dPain and Sinus RelieverJHK DBA American Safety & First Aid | Allegiant Health20240514
0cca624d-6866-2baa-e063-6394a90ac44dCONTAC Cold + Flu DayVespyr Brands, Inc.20240101
8aa33e28-f1d4-42f0-a334-bf85a779fe3fMedi-First Sinus Pain and PressureUnifirst First Aid Corporation20220316
cabd4342-7957-42ad-baa3-1f6c512cdf8cAramark Maximum Allergy ReliefWestern First Aid Safety DBA Aramark | ULTRA SEAL CORPORATION20210611
05d80f93-020c-48a5-b72f-4a91908949b8Drug FactsAfassco Inc.20191218
a1a8c1b0-1c3d-4d32-b505-e92a19623f65Drug FactsAllegiant Health20140916

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_STRENGTH500 MG / 5 MG
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESPRESCRIBABLEY
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
ATTRIBUTESTTYSCD
CODESMMSL_CODEBD16637
CODESMMSL_CODECD16637
CODESRxCUI1101534
CODESSPL_SET_ID0cdd028b-8f08-2351-e063-6394a90aa0ef
CODESSPL_SET_ID249373c6-f56f-4bd3-9cef-98b7ee73457d
CODESSPL_SET_ID88f86f5a-cc2b-4c75-b7a4-f2021922280b
CODESSPL_SET_IDa518e124-5a96-4a08-9b5f-3eaa8bf944c0
CODESSPL_SET_IDc66e0b52-5531-4a84-ae90-8a26d27df1ec
CODESSPL_SET_IDe0cbb213-4f4f-4045-e053-2a95a90a2a18
CODESSPL_SET_IDe8e5fb21-a7fd-44d1-b9c4-83e949699ca6
CODESSPL_SET_IDf196f2c5-a100-42b1-bd01-0327b223838e
NAMESPrescribable Synonymacetaminophen 500 MG / phenylephrine HCl 5 MG Oral Tablet
NAMESRXNAV_STRacetaminophen 500 MG / phenylephrine hydrochloride 5 MG Oral Tablet
NAMESRxNorm Nameacetaminophen 500 MG / phenylephrine hydrochloride 5 MG Oral Tablet
NAMESRxNorm SynonymAPAP 500 MG / Phenylephrine Hydrochloride 5 MG Oral Tablet
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon
SOURCESSourceNational Drug Data File Plus Source Vocabulary