FDA.reportPublic FDA data

Aprodine

Product NDC
0904-7302
11-digit product format
009047302
Labeler code
0904
Product ID
0904-7302_b6cf7f68-5961-42c4-b910-55c43596d013
Type
HUMAN OTC DRUG
Nonproprietary name
Pseudoephedrine HCl, Triprolidine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Major Pharmaceuticals
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
2027-12-31
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
2027-12-31

Active Ingredients#

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

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
0904-7302-24Aprodine1 in 1 CARTONTABLET, FILM COATED16
0904-7302-24Aprodine24 in 1 BLISTER PACKTABLET, FILM COATED246
0904-7302-60Aprodine100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1006
0904-7302-60Aprodine1 in 1 CARTONTABLET, FILM COATED16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7302-24EA - Each0904-730211dcca6e-ea23-41da-a6e2-37516e80fdc012023-01-09
0904-7302-60EA - Each0904-7302cca0caf7-4be9-4c41-a80e-0f1c52bad1fc12023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7302APRODINE (PSEUDOEPHEDRINE HCL, TRIPROLIDINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]5Current NDC, Legacy NDC, 4 package rows20250428_6612e514-2690-4f5b-8a82-0e54d362758f.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 39 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cold Multi-Symptom SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLValu Merchandisers Companyb0d9d869-9f0d-4834-aa2b-1ee21fd8b67b2026-04-16WarningsExact identifier
application number: M012
Rompe Pecho MaxACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESINEfficient Laboratories Inc4f86985c-48f3-2148-e063-6394a90ae2f12026-04-15WarningsExact identifier
application number: M012
Childrens Daytime MucusDEXTROMETHORPHAN HBRWalgreens7a55b7e1-1054-421e-847e-5e4d90d1aebb2026-04-15WarningsExact identifier
application number: M012
Childrens Nighttime MucusDEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATEWalgreensdc69f581-27c7-4030-bb18-39685c7691a12026-04-15WarningsExact identifier
application number: M012
Pseudoephedrine HClPSEUDOEPHEDRINE HCLMajor Pharmaceuticalsda95c643-7122-4025-977f-42205080e56b2026-04-15WarningsExact identifier
application number: M012
Daytime Nighttime ChewableDEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATEWalgreens9ddc0aa7-e7b8-41c5-a2b4-fece0c2e26c62026-04-15WarningsExact identifier
application number: M012
foster and thrive nasalOXYMETAZOLINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.4f7090f4-89c9-c3da-e063-6294a90a47162026-04-14WarningsExact identifier
application number: M012
Sinus and HeadacheACETAMINOPHEN, PHENYLEPHRINE HCLWalgreen Company2115f095-2d75-4e02-a6af-22dd693e08402026-04-14WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLLidl US LLC00f89eee-0edc-40dc-9297-8645afb910042026-04-14WarningsExact identifier
application number: M012
Sinus Pressure and Pain Daytime Nighttime Maximum StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company8647c136-a323-453a-8f57-e66938bbf6392026-04-14WarningsExact identifier
application number: M012
daytime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED5515148f-3e1d-4b03-89fa-40967d5082922026-04-14WarningsExact identifier
application number: M012
Mucus Relief Sinus Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDc70e6506-6c5b-4d3f-ab18-a690840caabc2026-04-13WarningsExact identifier
application number: M012
Nasal Decongestant PEPHENYLEPHRINE HCLWalgreen Company48387b95-8240-4d6e-842b-cc29cc18709c2026-04-13WarningsExact identifier
application number: M012
Sinufrin Plus No Drip DecongestantNASAL CONGESTION RELIEFNeilMed Pharmaceuticals Inc4f06c732-1f9f-bfc6-e063-6394a90a53f52026-04-13WarningsExact identifier
application number: M012
Severe Sinus CongestionACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company8745d9d8-640d-4e3b-96fe-d25032c1e3ce2026-04-13WarningsExact identifier
application number: M012
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDECardinal Health 107, LLC5a5c5f33-5b70-465d-a38b-6f518af097882026-04-13WarningsExact identifier
application number: M012
AllergyDIPHENHYDRAMINE HCLPublix Super Markets Incf2263e38-f686-45ed-bf85-b47f5e1aa9822026-04-13WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCLBETTER LIVING BRANDS, LLC46adbf94-5b93-ee64-e063-6294a90a11442026-04-11WarningsExact identifier
application number: M012
good sense night timeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEL. Perrigo Company0c79357a-b79d-4952-8e6d-ef3d60dde2fa2026-04-10WarningsExact identifier
application number: M012
basic care nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEAmazon.com Services LLC88d27c25-a305-4398-9590-df10d2504b012026-04-09WarningsExact 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 TabletPSN6612e514-2690-4f5b-8a82-0e54d362758f6
1099446pseudoephedrine hydrochloride 60 MG / triprolidine hydrochloride 2.5 MG Oral TabletSCD6612e514-2690-4f5b-8a82-0e54d362758f6
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 startMarketing endSampleExclude flagStatus
0904-7302-24009047302241 BLISTER PACK in 1 CARTON (0904-7302-24) / 24 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2022-11-110000-00-00NoNoCurrent
0904-7302-60009047302601 BOTTLE, PLASTIC in 1 CARTON (0904-7302-60) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2022-11-110000-00-00NoNoCurrent