FDA.reportPublic FDA data

Coricidin HBP

Product NDC
11523-4325
11-digit product format
115234325
Labeler code
11523
Product ID
11523-4325_2e6ded0a-ef75-f06e-e063-6294a90ae4b7
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen and Chlorpheniramine maleate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bayer HealthCare LLC.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-10-01
Substance
ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE
Active strength
325; 2 mg/1; mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [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
Coricidin HBP
Brand name suffix
Cold and Flu
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
CHLORPHENIRAMINE MALEATE2 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
V1Q0O9OJ9ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1112864Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
763a5334-a741-4678-9947-603776622450Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-4325-1Coricidin HBPCold and Flu1 in 1 CARTONTABLET, FILM COATED19
11523-4325-1Coricidin HBPCold and Flu10 in 1 BLISTER PACKTABLET, FILM COATED109
11523-4325-2Coricidin HBPCold and Flu10 in 1 BLISTER PACKTABLET, FILM COATED109
11523-4325-2Coricidin HBPCold and Flu2 in 1 CARTONTABLET, FILM COATED29
11523-4325-3Coricidin HBPCold and Flu4 in 1 CARTONTABLET, FILM COATED49
11523-4325-3Coricidin HBPCold and Flu10 in 1 BLISTER PACKTABLET, FILM COATED109

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11523-4325-1EA - Each11523-4325ec348c21-95b7-4b3e-ba01-1fd2f249a3f712014-06-03
11523-4325-2EA - Each11523-432568512ba5-0809-4b4b-91d8-2245c8154c6912014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9DCORICIDIN HBP COLD AND FLU (ACETAMINOPHEN AND CHLORPHENIRAMINE MALEATE) TABLET, FILM COATED [MSD CONSUMER CARE, INC.]1
Chlorpheniramine maleateACTIVE INGREDIENTV1Q0O9OJ9ZCORICIDIN HBP COLD AND FLU (ACETAMINOPHEN AND CHLORPHENIRAMINE MALEATE) TABLET, FILM COATED [MSD CONSUMER CARE, INC.]1
AcetaminophenACTIVE MOIETY362O9ITL9DCORICIDIN HBP COLD AND FLU (ACETAMINOPHEN AND CHLORPHENIRAMINE MALEATE) TABLET, FILM COATED [MSD CONSUMER CARE, INC.]1
ChlorpheniramineACTIVE MOIETY3U6IO1965UCORICIDIN HBP COLD AND FLU (ACETAMINOPHEN AND CHLORPHENIRAMINE MALEATE) TABLET, FILM COATED [MSD CONSUMER CARE, INC.]1
aluminum oxideINACTIVE INGREDIENTLMI26O6933CORICIDIN HBP COLD AND FLU (ACETAMINOPHEN AND CHLORPHENIRAMINE MALEATE) TABLET, FILM COATED [MSD CONSUMER CARE, INC.]1
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKCORICIDIN HBP COLD AND FLU (ACETAMINOPHEN AND CHLORPHENIRAMINE MALEATE) TABLET, FILM COATED [MSD CONSUMER CARE, INC.]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UCORICIDIN HBP COLD AND FLU (ACETAMINOPHEN AND CHLORPHENIRAMINE MALEATE) TABLET, FILM COATED [MSD CONSUMER CARE, INC.]1
FD&C red no. 40INACTIVE INGREDIENTWZB9127XOACORICIDIN HBP COLD AND FLU (ACETAMINOPHEN AND CHLORPHENIRAMINE MALEATE) TABLET, FILM COATED [MSD CONSUMER CARE, INC.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30CORICIDIN HBP COLD AND FLU (ACETAMINOPHEN AND CHLORPHENIRAMINE MALEATE) TABLET, FILM COATED [MSD CONSUMER CARE, INC.]1
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1ACORICIDIN HBP COLD AND FLU (ACETAMINOPHEN AND CHLORPHENIRAMINE MALEATE) TABLET, FILM COATED [MSD CONSUMER CARE, INC.]1
polyvinyl alcoholINACTIVE INGREDIENT532B59J990CORICIDIN HBP COLD AND FLU (ACETAMINOPHEN AND CHLORPHENIRAMINE MALEATE) TABLET, FILM COATED [MSD CONSUMER CARE, INC.]1
povidonesINACTIVE INGREDIENTFZ989GH94ECORICIDIN HBP COLD AND FLU (ACETAMINOPHEN AND CHLORPHENIRAMINE MALEATE) TABLET, FILM COATED [MSD CONSUMER CARE, INC.]1
starch, cornINACTIVE INGREDIENTO8232NY3SJCORICIDIN HBP COLD AND FLU (ACETAMINOPHEN AND CHLORPHENIRAMINE MALEATE) TABLET, FILM COATED [MSD CONSUMER CARE, INC.]1
talcINACTIVE INGREDIENT7SEV7J4R1UCORICIDIN HBP COLD AND FLU (ACETAMINOPHEN AND CHLORPHENIRAMINE MALEATE) TABLET, FILM COATED [MSD CONSUMER CARE, INC.]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPCORICIDIN HBP COLD AND FLU (ACETAMINOPHEN AND CHLORPHENIRAMINE MALEATE) TABLET, FILM COATED [MSD CONSUMER CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-4325CORICIDIN HBP COLD AND FLU (ACETAMINOPHEN AND CHLORPHENIRAMINE MALEATE) TABLET, FILM COATED [BAYER HEALTHCARE LLC.]9Current NDC, Legacy NDC, 6 package rows20250221_763a5334-a741-4678-9947-603776622450.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 24 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cough and Runny Nose Childrens PlusACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDETOP CARE (Topco Associates LLC)6f04bd51-093c-4624-aef3-0145ac3873862026-06-01WarningsExact identifier
application number: M012
NasalPHENYLEPHRINE HYDROCHLORIDECVS Pharmacy694a3116-1b75-42cd-bbcf-d19831c2d7962026-06-01WarningsExact identifier
application number: M012
night timeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEH E Bcf31538c-9eee-4c81-80cb-66eecabf0aff2026-06-01WarningsExact identifier
application number: M012
Mucinex Childrens Mighty Chews CoughDEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC155e07b3-0a08-3be8-e063-6394a90a76352026-05-31WarningsExact identifier
application number: M012
Mucinex Childrens Mighty Chews Cough NighttimeDEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATEReckitt Benckiser LLC156033ae-b16a-007b-e063-6294a90a74452026-05-31WarningsExact identifier
application number: M012
Cold and Flu DayACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLWalgreen Companyebf8c82d-a653-4c02-893b-61704901acbb2026-05-29WarningsExact identifier
application number: M012
Allergy Relief ChildrensDIPHENHYDRAMINE HCLAmerisource Bergen934c7b91-3cba-47f0-8efa-77216f3f15c42026-05-29WarningsExact identifier
application number: M012
Allergy MedicineDIPHENHYDRAMINE HCLCOSTCO WHOLESALE CORPORATIONd9f03e11-d11f-43ee-8ed0-9e07d1058f662026-05-29WarningsExact identifier
application number: M012
Cold Childrens, Multi SymptomDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS PHARMACYeaa07dd4-cb7e-45ca-abe4-7a3f7a9d928d2026-05-29WarningsExact identifier
application number: M012
NebuClear MDRACEPINEPHRINE HYDROCHLORIDEBlue Echo Care LLC3598ac5b-29f9-f002-e063-6294a90a62cb2026-05-28WarningsExact identifier
application number: M012
NebuClear MDRACEPINEPHRINE HYDROCHLORIDEBlue Echo Care LLC51badd2f-4a43-3dbe-e063-6294a90a4bd12026-05-28WarningsExact identifier
application number: M012
Kids Cough and Chest CongestionDEXTROMETHORPHAN HBR, GUAIFENESINGenexa Inc.a7ab2140-de09-158f-e053-2a95a90a25a02026-05-28WarningsExact identifier
application number: M012
Kids Multi Symptom Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBRGenexa Inc.2d918ec8-3098-1d09-e063-6294a90a9e8f2026-05-28WarningsExact identifier
application number: M012
Daytime and Nighttime Kids Multi-Symptom Cold and Flu combo packACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCLGenexa Inc.213fe898-dace-9a0f-e063-6394a90afd642026-05-28WarningsExact identifier
application number: M012
MGC Health Cough Drops Honey Lemon FlavorMENTHOLMedical Group Care LLC556628ab-e233-92fe-e063-6394a90a00902026-05-28WarningsExact identifier
application number: M012
Sinus Decongestion PEPHENYLEPHRINE HCLKroger Company68eff734-177e-4999-9126-6b92bb2041072026-05-28WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRARMY AND AIR FORCE EXCHANGE SERVICEff39084f-ab2f-48ed-ac62-837f7fff2b652026-05-28WarningsExact identifier
application number: M012
Tylenol Sinus SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDESelect Consumer Group LLC52c5fda0-c358-72e8-e063-6394a90a3f682026-05-27WarningsExact identifier
application number: M012
Mucinex Childrens Mighty Chews Cough Daytime and Nighttime Combo PackDEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATEReckitt Benckiser LLC16637d54-8049-d3ce-e063-6394a90aafc92026-05-27WarningsExact identifier
application number: M012
Childrens Delsym Cough Plus Cold Night TimeACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC00689aa5-ed39-4c9a-92b8-105d2c0e2e152026-05-27WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1112864acetaminophen 325 MG / chlorpheniramine maleate 2 MG Oral TabletPSN763a5334-a741-4678-9947-6037766224509
1112864acetaminophen 325 MG / chlorpheniramine maleate 2 MG Oral TabletSCD763a5334-a741-4678-9947-6037766224509
1112864APAP 325 MG / chlorpheniramine maleate 2 MG Oral TabletSY763a5334-a741-4678-9947-6037766224509
1112864acetaminophen 325 MG / chlorpheniramine maleate 2 MG Oral TabletPSNac79a7dd-c26e-47d2-8fb9-768d2d09e5075
1112864acetaminophen 325 MG / chlorpheniramine maleate 2 MG Oral TabletSCDac79a7dd-c26e-47d2-8fb9-768d2d09e5075
1112864APAP 325 MG / chlorpheniramine maleate 2 MG Oral TabletSYac79a7dd-c26e-47d2-8fb9-768d2d09e5075

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11523-4325-1115234325011 BLISTER PACK in 1 CARTON (11523-4325-1) / 10 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2013-10-010000-00-00NoNoCurrent
11523-4325-2115234325022 BLISTER PACK in 1 CARTON (11523-4325-2) / 10 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2013-10-010000-00-00NoNoCurrent
11523-4325-3115234325034 BLISTER PACK in 1 CARTON (11523-4325-3) / 10 TABLET, FILM COATED in 1 BLISTER PACK4 blister pack2025-02-18NoNoCurrent