FDA.reportPublic FDA data

pseudoephedrine hydrochloride 60 MG / triprolidine hydrochloride 2.5 MG Oral Tablet

RxCUI
1099446
RxNorm name
pseudoephedrine hydrochloride 60 MG / triprolidine hydrochloride 2.5 MG Oral Tablet
Display name
Pseudoephedrine/Triprolidine (Oral Pill)
Full name
pseudoephedrine hydrochloride 60 MG / triprolidine hydrochloride 2.5 MG Oral Tablet
Term type
SCD
Status
Active
Strength
60-2.5 mg
Dose form
Tab
Route
Oral Pill
Updated
2026-07-27 06:54:00

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
052011
Active start
052011
Multiple ingredient
YES
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
triprolidine hydrochloride2.5 MG / 1 EACHtriprolidinetriprolidine hydrochloride
pseudoephedrine hydrochloride60 MG / 1 EACHpseudoephedrinepseudoephedrine hydrochloride

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Oral Tablet317541

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
triprolidine10849
pseudoephedrine8896

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRpseudoephedrine hydrochloride 60 MG / triprolidine hydrochloride 2.5 MG Oral Tablet1NAMES
RxNorm Namepseudoephedrine hydrochloride 60 MG / triprolidine hydrochloride 2.5 MG Oral Tablet1NAMES
TTYSCD1ATTRIBUTES
SPL_SET_ID
3 linked values
3CODES
RxCUI10994461CODES
MMSL_CODE
2 linked values
2CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
0363-0287-220363-0287Cold and Allergy D Pseudoephedrine HCl, Triprolidine HClWalgreen CompanyM012
0904-7302-240904-7302Aprodine Pseudoephedrine HCl, Triprolidine HClMajor PharmaceuticalsM012
0904-7302-600904-7302Aprodine Pseudoephedrine HCl, Triprolidine HClMajor PharmaceuticalsM012
50090-7085-250090-7085APRODINE Pseudoephedrine HCl, Triprolidine HClA-S Medication SolutionsM012

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M0120363-0287Cold and Allergy D Pseudoephedrine HCl, Triprolidine HClOTC MONOGRAPH DRUGWalgreen Company

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 3 of 3 · 257 matching rows.

NDC11, Source, Active table
NDC11SourceActive
60814010830rxnav_historical
61073000101rxnav_historical_indirect
61073000110rxnav_historical_indirect
63874001001rxnav_historical
63874001002rxnav_historical
63874001008rxnav_historical
63874001012rxnav_historical
63874001015rxnav_historical
63874001020rxnav_historical
63874001024rxnav_historical
63874001025rxnav_historical
63874001030rxnav_historical
63874001040rxnav_historical
63874001060rxnav_historical
68115034124rxnav_historical_indirect
68115076112rxnav_historical_indirect
71205010024rxnav_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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cold and Allergy DPSEUDOEPHEDRINE HCL, TRIPROLIDINE HCLWalgreen Company832ac849-7f4a-489a-a704-9d4388a75a712026-02-03WarningsExact identifier
ndc (package): 0363-0287-22
ndc (product): 0363-0287
ndc11 (package): 00363028722
rxcui: 1099446
AprodinePSEUDOEPHEDRINE HCL, TRIPROLIDINE HCLMajor Pharmaceuticals6612e514-2690-4f5b-8a82-0e54d362758f2025-11-19WarningsExact identifier
ndc (package): 0904-7302-60
ndc (package): 0904-7302-24
ndc (product): 0904-7302
ndc11 (package): 00904730260
ndc11 (package): 00904730224
rxcui: 1099446
APRODINEPSEUDOEPHEDRINE HCL, TRIPROLIDINE HCLA-S Medication Solutionsbbc268b8-fa66-4dc5-b935-f77ae39d28c82024-02-29WarningsExact identifier
ndc (package): 50090-7085-2
ndc (product): 50090-7085
ndc11 (package): 50090708502
rxcui: 1099446

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 6 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
2b0171a1-3f08-4360-aba3-b13344a52623pseudoephedrine HCl 60 MG / triprolidine HCl 2.5 MG Oral Tablet [PSN] · pseudoephedrine hydrochloride 60 MG / triprolidine hydrochloride 2.5 MG Oral Tablet [SCD]220Major 44-17820230204
6612e514-2690-4f5b-8a82-0e54d362758fpseudoephedrine HCl 60 MG / triprolidine HCl 2.5 MG Oral Tablet [PSN] · pseudoephedrine hydrochloride 60 MG / triprolidine hydrochloride 2.5 MG Oral Tablet [SCD]26Major 44-287A20251119
832ac849-7f4a-489a-a704-9d4388a75a71pseudoephedrine HCl 60 MG / triprolidine HCl 2.5 MG Oral Tablet [PSN] · pseudoephedrine hydrochloride 60 MG / triprolidine hydrochloride 2.5 MG Oral Tablet [SCD]25Walgreens 44-28720260203
b0c6ef78-0f82-4ff7-a988-b11f99094843pseudoephedrine HCl 60 MG / triprolidine HCl 2.5 MG Oral Tablet [PSN] · pseudoephedrine hydrochloride 60 MG / triprolidine hydrochloride 2.5 MG Oral Tablet [SCD]24ED-A-HIST PSE TABLETS20220113
bbc268b8-fa66-4dc5-b935-f77ae39d28c8pseudoephedrine HCl 60 MG / triprolidine HCl 2.5 MG Oral Tablet [PSN] · pseudoephedrine hydrochloride 60 MG / triprolidine hydrochloride 2.5 MG Oral Tablet [SCD]23APRODINE20240229
e5e84aa0-a99d-47ae-983b-fc03f0f2c754pseudoephedrine HCl 60 MG / triprolidine HCl 2.5 MG Oral Tablet [PSN] · pseudoephedrine hydrochloride 60 MG / triprolidine hydrochloride 2.5 MG Oral Tablet [SCD]21Aprodine20110810

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
6612e514-2690-4f5b-8a82-0e54d362758fMajor 44-287AMajor Pharmaceuticals | LNK International, Inc.20261007
832ac849-7f4a-489a-a704-9d4388a75a71Walgreens 44-287Walgreen Company | LNK International, Inc.20260203
6612e514-2690-4f5b-8a82-0e54d362758fMajor 44-287AMajor Pharmaceuticals | LNK International, Inc.20251119
40a29169-dd77-43b1-8887-b91cf98107c6Sunmark 44-327-DelistedStrategic Sourcing Services, LLC (Sunmark) | LNK International, Inc.20250410
bbc268b8-fa66-4dc5-b935-f77ae39d28c8APRODINEA-S Medication Solutions20240229
eb4326b9-4642-4d78-916f-e5d13353d1b4Walgreens 44-178 Cold and Allergy D DelistedWalgreen Company | LNK International, Inc.20240126
2f58a9c3-cf9a-4f2d-a8d1-929c127351ffMajor 44-178-DelistedMajor Pharmaceuticals | LNK International, Inc.20231213
2b0171a1-3f08-4360-aba3-b13344a52623Major 44-178A-S Medication Solutions20230204
b0c6ef78-0f82-4ff7-a988-b11f99094843ED-A-HIST PSE TABLETSEDWARDS PHARMACEUTICALS, INC.20220113
80dec6c1-12fb-94f0-e053-2991aa0ae10aColcol Co Tab.Cho-A Pharm.Co.,Ltd.20210125
dbd8e15e-7bb0-46b5-9d69-3f8ffaf3bfdaMajor 44-178Proficient Rx LP20191001
f081f567-3afd-4a8b-91e8-ec8044671106National Council for Prescription Drug Programs20130401
8951a1cc-f36e-4c88-ac7c-fc31f2235dcfNational Council for Prescription Drug Programs20120724
ceeebd36-eae4-44ff-af24-2f53364e1749National Council for Prescription Drug Programs20120724
d0772455-977b-47b4-9366-6cc86a808681National Council for Prescription Drug Programs20120724
e5e84aa0-a99d-47ae-983b-fc03f0f2c754AprodineRebel Distributors Corp20110810

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCR06AXOther antihistamines for systemic useATC1-4triprolidine
ATCR01BASympathomimeticsATC1-4pseudoephedrine
FDASPLN0000175552alpha-Adrenergic AgonistEPChas_epcpseudoephedrine
MEDRTD054199PseudoephedrineCHEMhas_ingredientpseudoephedrine
MEDRTD054199PseudoephedrineCHEMhas_ingredientpseudoephedrine hydrochloride
MEDRTD014311TriprolidineCHEMhas_ingredienttriprolidine hydrochloride
MEDRTD014311TriprolidineCHEMhas_ingredienttriprolidine
MEDRTD001249AsthmaDISEASEmay_treatpseudoephedrine
MEDRTD001249AsthmaDISEASEmay_treatpseudoephedrine hydrochloride
MEDRTD003139Common ColdDISEASEmay_treatpseudoephedrine hydrochloride
MEDRTD003139Common ColdDISEASEmay_treatpseudoephedrine
MEDRTD003233Conjunctivitis, AllergicDISEASEmay_treattriprolidine hydrochloride
MEDRTD003233Conjunctivitis, AllergicDISEASEmay_treattriprolidine
MEDRTD003327Coronary DiseaseDISEASEci_withtriprolidine hydrochloride
MEDRTD003327Coronary DiseaseDISEASEci_withtriprolidine
MEDRTD003876Dermatitis, AtopicDISEASEmay_treattriprolidine hydrochloride
MEDRTD003876Dermatitis, AtopicDISEASEmay_treattriprolidine
MEDRTD004342Drug HypersensitivityDISEASEci_withpseudoephedrine hydrochloride
MEDRTD004342Drug HypersensitivityDISEASEci_withpseudoephedrine
MEDRTD004342Drug HypersensitivityDISEASEci_withtriprolidine
MEDRTD004342Drug HypersensitivityDISEASEci_withtriprolidine hydrochloride
MEDRTD012220RhinitisDISEASEmay_treattriprolidine hydrochloride
MEDRTD012220RhinitisDISEASEmay_treattriprolidine
MEDRTD012221Rhinitis, Allergic, PerennialDISEASEmay_treatpseudoephedrine
MEDRTD012221Rhinitis, Allergic, PerennialDISEASEmay_treatpseudoephedrine hydrochloride
MEDRTD012852SinusitisDISEASEmay_treatpseudoephedrine
MEDRTD012852SinusitisDISEASEmay_treatpseudoephedrine hydrochloride
MEDRTN0000000209Adrenergic alpha-AgonistsMOAhas_moapseudoephedrine hydrochloride
MEDRTN0000000209Adrenergic alpha-AgonistsMOAhas_moapseudoephedrine
MEDRTN0000000245Adrenergic beta-AgonistsMOAhas_moapseudoephedrine
MEDRTN0000000245Adrenergic beta-AgonistsMOAhas_moapseudoephedrine hydrochloride
MEDRTN0000000190Histamine H1 Receptor AntagonistsMOAhas_moatriprolidine hydrochloride
MEDRTN0000000190Histamine H1 Receptor AntagonistsMOAhas_moatriprolidine
MEDRTN0000000184Monoamine Oxidase InhibitorsMOAci_moatriprolidine
MEDRTN0000000184Monoamine Oxidase InhibitorsMOAci_moapseudoephedrine
MEDRTN0000000184Monoamine Oxidase InhibitorsMOAci_moatriprolidine hydrochloride
MEDRTN0000000184Monoamine Oxidase InhibitorsMOAci_moapseudoephedrine hydrochloride
MEDRTN0000008322BronchodilationPEhas_pepseudoephedrine hydrochloride
MEDRTN0000008322BronchodilationPEhas_pepseudoephedrine
MEDRTN0000008657Decreased Histamine ActivityPEhas_petriprolidine
MEDRTN0000008657Decreased Histamine ActivityPEhas_petriprolidine hydrochloride
MEDRTN0000009908VasoconstrictionPEhas_pepseudoephedrine
MEDRTN0000009908VasoconstrictionPEhas_pepseudoephedrine hydrochloride

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH60 MG / 2.5 MG
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESSNOMEDCT377572005
CODESVUID4005159
CODESVUID4005164
NAMESPrescribable Synonympseudoephedrine HCl 60 MG / triprolidine HCl 2.5 MG Oral Tablet
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon
SOURCESSourceNational Drug Data File Plus Source Vocabulary
SOURCESSourceUS Edition of SNOMED_CT
SOURCESSourceVeterans Health Administration National Drug File