FDA.reportPublic FDA data

APRODINE

Product NDC
50090-7085
11-digit product format
500907085
Labeler code
50090
Product ID
50090-7085_776706de-0208-42eb-8d93-5223b46440a9
Type
HUMAN OTC DRUG
Nonproprietary name
Pseudoephedrine HCl, Triprolidine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-11-11
Substance
PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE
Active strength
60; 2.5 mg/1; mg/1
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
APRODINE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PSEUDOEPHEDRINE HYDROCHLORIDE60 mg/1
TRIPROLIDINE HYDROCHLORIDE2.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6V9V2RYJ8NInternal UNII lookup
YAN7R5L890Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1099446Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
bbc268b8-fa66-4dc5-b935-f77ae39d28c8Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-7085-2APRODINE24 in 1 BLISTER PACKTABLET, FILM COATED243
50090-7085-2APRODINE1 in 1 CARTONTABLET, FILM COATED13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7085-2EA - Each50090-7085aaaec6c4-b0b2-44f6-a5bc-f30ec33d9a3712024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7085APRODINE (PSEUDOEPHEDRINE HCL, TRIPROLIDINE HCL) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]3Current NDC, 2 package rows20240301_bbc268b8-fa66-4dc5-b935-f77ae39d28c8.zip

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 60 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alka-Seltzer Plus Maximum Strength Sinus, Congestion and Pain Power Max GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.e07931fc-f753-1aeb-e053-2a95a90ada3f2026-01-08WarningsExact identifier
application number: M012
Alka-Seltzer Plus Severe Cold PowerFast Fizz Day and NightASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.fc60af2f-83cb-99ea-e053-6394a90a0b3b2026-01-08WarningsExact identifier
application number: M012
Alka Seltzer Plus Maximum Strength Sinus, Allergy And Cough Power Max GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.e17eb929-209d-a2d1-e053-2a95a90a4cf32026-01-08WarningsExact identifier
application number: M012
Alka-Seltzer Plus Severe Cold Night PowerFast FizzASPIRIN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.c1fae6c7-bbac-1320-e053-2a95a90aac5a2026-01-08WarningsExact identifier
application number: M012
Alka-Seltzer Plus Night Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.f4c60ca1-ba59-4a92-84a5-6ba65faa56ab2026-01-08WarningsExact identifier
application number: M012
Alka-Seltzer Plus Day Severe Cold Plus FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.cec51eab-cce3-4965-a14e-a46d953050c42026-01-08WarningsExact identifier
application number: M012
VanaCof 2CHLOPHEDIANOL HCL, DEXCHLORPHENIRAMINE MALEATEGM Pharmaceuticals, INC0c7c6756-abb2-c10c-e063-6394a90a98632026-01-08WarningsExact identifier
application number: M012
VANACOF XP Cough / Chest CongestionDEXTROMETHORPHAN HBR, GUAIFENESINGM Pharmaceuticals, INC0b3a8cc1-a49f-e1e5-e063-6394a90a1c062026-01-08WarningsExact identifier
application number: M012
Diphenhydramine HClDIPHENHYDRAMINE HCLINVAHEALTH INCe4e4004f-77e3-569d-e053-2a95a90a73fe2026-01-08WarningsExact identifier
application number: M012
Robitussin Maximum Strength Cough Plus Chest Congestion DMDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINHaleon US Holdings LLC868ac65a-63e2-46ac-b87d-66b2890867562026-01-08WarningsExact identifier
application number: M012
Theraflu Flu Relief Max Strength DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBRHaleon US Holdings LLC0324195f-506d-4747-990e-ad44e2a117d92026-01-07WarningsExact identifier
application number: M012
Sambrosa NightDOXYLAMINE SUCCINATESambrosa Care, Inc.acdc8740-6231-d1e8-e053-2995a90a3b8d2026-01-07WarningsExact identifier
application number: M012
VAPOREXCAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOLDLC Laboratories, Inc.971943b1-4199-4f75-9d2d-61242d346b5f2026-01-07WarningsExact identifier
application number: M012
BACTIMICINA COUGH AND COLDDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEDLC Laboratories, Inc.2e612c62-9bbb-45f2-a253-aa2bfaeaac702026-01-07WarningsExact identifier
application number: M012
Earths Care Chest RubCAMPHOR, EUCALYPTUS OI, MENTHOLDLC Laboratories, Inc2424f5d5-1772-96f1-e063-6294a90a89ee2026-01-07WarningsExact identifier
application number: M012
Bactimicina Vapor RubVAPOR RUBDLC Laboratories, Inc.176b617a-faf6-7893-e063-6294a90a046b2026-01-07WarningsExact identifier
application number: M012
Sinus Pressure and PainACETAMINOPHEN, PHENYLEPHRINE HCLFamily Dollar Services Inc0d3e4ceb-5059-4aac-8aa2-bf714ca9deb22026-01-07WarningsExact identifier
application number: M012
Tussin Multi Symptom Cold CFDEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCLQUALITY CHOICE (Chain Drug Marketing Association)b225e897-5728-4519-b727-c0f361c759762026-01-07WarningsExact identifier
application number: M012
Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWalgreen Company80b218f7-66bb-4e15-a0dc-ec9b6af1b0562026-01-07WarningsExact identifier
application number: M012
tussin cough and chest congestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINRite Aid Corporation13618054-d0c5-4190-b626-e7e91b8557382026-01-06WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099446pseudoephedrine HCl 60 MG / triprolidine HCl 2.5 MG Oral TabletPSNbbc268b8-fa66-4dc5-b935-f77ae39d28c83
1099446pseudoephedrine hydrochloride 60 MG / triprolidine hydrochloride 2.5 MG Oral TabletSCDbbc268b8-fa66-4dc5-b935-f77ae39d28c83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7085-2500907085021 BLISTER PACK in 1 CARTON (50090-7085-2) / 24 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2024-02-05NoNoCurrent