FDA.reportPublic FDA data

diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Oral Tablet

RxCUI
1052928
RxNorm name
diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Oral Tablet
Display name
diphenhydrAMINE/Phenylephrine (Oral Pill)
Full name
diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Oral Tablet
Term type
SCD
Status
Active
Strength
25-10 mg
Dose form
Tab
Route
Oral Pill
Updated
2026-07-25 06:53:29

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
diphenhydramine hydrochloride25 MG / 1 EACHdiphenhydraminediphenhydramine hydrochloride
phenylephrine hydrochloride10 MG / 1 EACHphenylephrinephenylephrine hydrochloride

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Oral Tablet317541

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
diphenhydramine3498
phenylephrine8163

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRdiphenhydrAMINE hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Oral Tablet1NAMES
RxNorm Namediphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Oral Tablet1NAMES
TTYSCD1ATTRIBUTES
SPL_SET_ID
7 linked values
7CODES
RxCUI10529281CODES
MMSL_CODECD379931CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
0363-4851-080363-4851Allergy Relief Diphenhydramine HCl, Phenylephrine HClWalgreen CompanyM012
11822-0485-811822-0485Allergy Plus Sinus Relief Diphenhydramine HCl and Phenylephrine HClRite Aid CorporationM012
51316-485-0851316-485Allergy Plus Congestion Relief Diphenhydramine HCl, Phenylephrine HClCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDM012

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M0120363-4851Allergy Relief Diphenhydramine HCl, Phenylephrine HClOTC MONOGRAPH DRUGWalgreen Company

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 12 matching rows.

NDC11, Source, Active table
NDC11SourceActive
00363485108rxnav_ndcsyes
00363748540rxnav_ndcsyes
11822048508rxnav_ndcsyes
49035048508rxnav_ndcsyes
51316048508rxnav_ndcsyes
79481748503rxnav_ndcsyes
00363048508rxnav_historical_indirect
00501291412rxnav_historical_indirect
11822350850rxnav_historical
36800098508rxnav_historical
50428382286rxnav_historical
59779098508rxnav_historical

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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sinus Pressure and Congestion ReliefDIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLRite Aid Corporation35bcf263-3296-4d9c-84c0-146a173d6e872026-07-13WarningsExact identifier
rxcui: 1052928
Allergy Plus Sinus ReliefDIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCLRite Aid Corporation54623e2e-5f9a-426e-8f7e-ea755ff8b3f82026-04-06WarningsExact identifier
ndc (package): 11822-0485-8
ndc (product): 11822-0485
ndc11 (package): 11822048508
rxcui: 1052928
Allergy Plus Congestion ReliefDIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED0d2cf481-622f-4262-b0bd-c38fe5de67212026-02-11WarningsExact identifier
ndc (package): 51316-485-08
ndc (product): 51316-485
ndc11 (package): 51316048508
rxcui: 1052928
Allergy Relief Plus CongestionDIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLWalgreen Company38d91107-d95c-40f2-a27e-561f951e519d2026-02-02WarningsExact identifier
ndc (package): 0363-4851-08
ndc (product): 0363-4851
ndc11 (package): 00363485108
rxcui: 1052928
Sinus PE CongestionDIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLWalgreen Company5b9151b7-3e40-4f37-b3e0-4c0fa0115b712025-12-10WarningsExact identifier
ndc11 (package): 00363748540
rxcui: 1052928
Sinus PE Congestion Daytime NighttimeDIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLMeijer Distribution, Inc.9da77306-5098-4c79-845c-97ead849c84a2025-12-08WarningsExact identifier
ndc11 (package): 79481748503
rxcui: 1052928
SUDAFED PE SINUS CONGESTIONDIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLCa38fdfb8-db89-487f-9b68-aa9152b91f5f2024-11-08WarningsExact identifier
rxcui: 1052928
Benadryl Allergy Plus CongestionDIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC685b51d3-cc25-47b2-ac8a-368924f431372024-11-08WarningsExact identifier
rxcui: 1052928

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 8 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
35bcf263-3296-4d9c-84c0-146a173d6e87diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG Oral Tablet [PSN] · diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Oral Tablet [SCD]210Rite Aid 44-45348520250721
54623e2e-5f9a-426e-8f7e-ea755ff8b3f8diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG Oral Tablet [PSN] · diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Oral Tablet [SCD]29Rite Aid 44-48520260406
5b9151b7-3e40-4f37-b3e0-4c0fa0115b71diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG Oral Tablet [PSN] · diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Oral Tablet [SCD]29Walgreens 44-453485-Sinus PE Congestion20251210
38d91107-d95c-40f2-a27e-561f951e519ddiphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG Oral Tablet [PSN] · diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Oral Tablet [SCD]27Walgreens 44-485-Allergy Relief Plus Congestion20260202
685b51d3-cc25-47b2-ac8a-368924f43137diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG Oral Tablet [PSN] · diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Oral Tablet [SCD]27Benadryl Allergy Plus Congestion20241108
0d2cf481-622f-4262-b0bd-c38fe5de6721diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG Oral Tablet [PSN] · diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Oral Tablet [SCD]26CVS 44-485 Allergy Plus20260211
9da77306-5098-4c79-845c-97ead849c84adiphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG Oral Tablet [PSN] · diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Oral Tablet [SCD]25Meijer 44-45348520251208
a38fdfb8-db89-487f-9b68-aa9152b91f5fdiphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG Oral Tablet [PSN] · diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Oral Tablet [SCD]25SUDAFED PE SINUS CONGESTION20241108

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
54623e2e-5f9a-426e-8f7e-ea755ff8b3f8Rite Aid 44-485Rite Aid Corporation | LNK International, Inc.20260406
0d2cf481-622f-4262-b0bd-c38fe5de6721CVS 44-485 Allergy PlusCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | LNK International, Inc.20260211
38d91107-d95c-40f2-a27e-561f951e519dWalgreens 44-485-Allergy Relief Plus CongestionWalgreen Company | LNK International, Inc.20260202
5b9151b7-3e40-4f37-b3e0-4c0fa0115b71Walgreens 44-453485-Sinus PE CongestionWalgreen Company | LNK International, Inc.20251210
9da77306-5098-4c79-845c-97ead849c84aMeijer 44-453485Meijer Distribution, Inc. | LNK International, Inc.20251208
bf30d477-dec6-49a3-87f0-ea7299a23c69CVS 44-485CVS Pharmacy | LNK International, Inc.20190514
a1767b69-bf64-4ae7-ab99-d687c9b71e2aTopCare 44-485Topco Associates, LLC | LNK International, Inc.20190424
936d9d63-b60e-421d-95ff-74f954e9a9efNational Council for Prescription Drug Programs20130401

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCC01CAAdrenergic and dopaminergic agentsATC1-4phenylephrine
ATCR06AAAminoalkyl ethersATC1-4diphenhydramine
ATCD04AAAntihistamines for topical useATC1-4diphenhydramine
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
FDASPLN0000175587Histamine-1 Receptor AntagonistEPChas_epcdiphenhydramine
FDASPLN0000000190Histamine H1 Receptor AntagonistsMOAhas_moadiphenhydramine
MEDRTD004155DiphenhydramineCHEMhas_ingredientdiphenhydramine
MEDRTD004155DiphenhydramineCHEMhas_ingredientdiphenhydramine hydrochloride
MEDRTD010656PhenylephrineCHEMhas_ingredientphenylephrine hydrochloride
MEDRTD010656PhenylephrineCHEMhas_ingredientphenylephrine
MEDRTD013447SulfitesCHEMci_chemclassphenylephrine hydrochloride
MEDRTD013447SulfitesCHEMci_chemclassphenylephrine
MEDRTD001008Anxiety DisordersDISEASEmay_treatdiphenhydramine
MEDRTD001008Anxiety DisordersDISEASEmay_treatdiphenhydramine hydrochloride
MEDRTD004342Drug HypersensitivityDISEASEci_withphenylephrine
MEDRTD004342Drug HypersensitivityDISEASEci_withdiphenhydramine
MEDRTD004342Drug HypersensitivityDISEASEci_withdiphenhydramine hydrochloride
MEDRTD004342Drug HypersensitivityDISEASEci_withphenylephrine hydrochloride
MEDRTD005401Fissure in AnoDISEASEmay_treatphenylephrine hydrochloride
MEDRTD005401Fissure in AnoDISEASEmay_treatphenylephrine
MEDRTD005902Glaucoma, Open-AngleDISEASEmay_treatphenylephrine
MEDRTD005902Glaucoma, Open-AngleDISEASEmay_treatphenylephrine hydrochloride
MEDRTD006484HemorrhoidsDISEASEmay_treatphenylephrine hydrochloride
MEDRTD006484HemorrhoidsDISEASEmay_treatphenylephrine
MEDRTD006973HypertensionDISEASEci_withphenylephrine hydrochloride
MEDRTD006973HypertensionDISEASEci_withphenylephrine
MEDRTD007022HypotensionDISEASEmay_treatphenylephrine hydrochloride
MEDRTD007022HypotensionDISEASEmay_treatphenylephrine
MEDRTD007231Infant, NewbornDISEASEci_withdiphenhydramine hydrochloride
MEDRTD007231Infant, NewbornDISEASEci_withdiphenhydramine
MEDRTD007234Infant, PrematureDISEASEci_withdiphenhydramine hydrochloride
MEDRTD007234Infant, PrematureDISEASEci_withdiphenhydramine
MEDRTD007774LactationDISEASEci_withdiphenhydramine hydrochloride
MEDRTD007774LactationDISEASEci_withdiphenhydramine
MEDRTD009041Motion SicknessDISEASEmay_treatdiphenhydramine
MEDRTD009041Motion SicknessDISEASEmay_treatdiphenhydramine hydrochloride
MEDRTD015878MydriasisDISEASEinducesphenylephrine hydrochloride
MEDRTD015878MydriasisDISEASEinducesphenylephrine
MEDRTD009325NauseaDISEASEmay_treatdiphenhydramine
MEDRTD009325NauseaDISEASEmay_treatdiphenhydramine hydrochloride
MEDRTD011538Pruritus AniDISEASEmay_treatphenylephrine hydrochloride
MEDRTD011538Pruritus AniDISEASEmay_treatphenylephrine
MEDRTD012221Rhinitis, Allergic, PerennialDISEASEmay_treatdiphenhydramine
MEDRTD012221Rhinitis, Allergic, PerennialDISEASEmay_treatdiphenhydramine hydrochloride
MEDRTD012223Rhinitis, VasomotorDISEASEmay_treatphenylephrine
MEDRTD012223Rhinitis, VasomotorDISEASEmay_treatphenylephrine hydrochloride
MEDRTD012772Shock, SepticDISEASEmay_treatphenylephrine
MEDRTD012772Shock, SepticDISEASEmay_treatphenylephrine hydrochloride
MEDRTD007319Sleep Initiation and Maintenance DisordersDISEASEmay_treatdiphenhydramine
MEDRTD007319Sleep Initiation and Maintenance DisordersDISEASEmay_treatdiphenhydramine hydrochloride
MEDRTD012912SneezingDISEASEmay_treatdiphenhydramine hydrochloride
MEDRTD012912SneezingDISEASEmay_treatdiphenhydramine
MEDRTD013224Status AsthmaticusDISEASEci_withdiphenhydramine hydrochloride
MEDRTD013224Status AsthmaticusDISEASEci_withdiphenhydramine
MEDRTD013617Tachycardia, SupraventricularDISEASEmay_treatphenylephrine hydrochloride
MEDRTD013617Tachycardia, SupraventricularDISEASEmay_treatphenylephrine
MEDRTD017180Tachycardia, VentricularDISEASEci_withphenylephrine hydrochloride
MEDRTD017180Tachycardia, VentricularDISEASEci_withphenylephrine
MEDRTD014581UrticariaDISEASEmay_treatdiphenhydramine
MEDRTD014581UrticariaDISEASEmay_treatdiphenhydramine hydrochloride
MEDRTN0000000209Adrenergic alpha-AgonistsMOAhas_moaphenylephrine hydrochloride
MEDRTN0000000209Adrenergic alpha-AgonistsMOAhas_moaphenylephrine
MEDRTN0000000190Histamine H1 Receptor AntagonistsMOAhas_moadiphenhydramine hydrochloride
MEDRTN0000000190Histamine H1 Receptor AntagonistsMOAhas_moadiphenhydramine
MEDRTN0000008371Conjunctival Arterial VasoconstrictionPEhas_pephenylephrine
MEDRTN0000008371Conjunctival Arterial VasoconstrictionPEhas_pephenylephrine hydrochloride
MEDRTN0000008896Decreased Nasal and Sinus SecretionsPEhas_pephenylephrine
MEDRTN0000008896Decreased Nasal and Sinus SecretionsPEhas_pephenylephrine hydrochloride

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH25 MG / 10 MG
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESVUID4039671
NAMESPrescribable SynonymdiphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG Oral Tablet
NAMESTallman SynonymdiphenhydrAMINE hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Oral Tablet
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon
SOURCESSourceNational Drug Data File Plus Source Vocabulary
SOURCESSourceVeterans Health Administration National Drug File