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 29 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AntihistamineDIPHENHYDRAMINE HCLGendose Pharmaceuticals, LLC847cdee8-410f-4ff3-9245-976ed6f4c7762026-05-15WarningsExact identifier
application number: M012
AntihistamineDIPHENHYDRAMINE HCLGendose Pharmaceuticals, LLCd3b2f300-d919-44cd-ab71-b74b5bdfd9772026-05-15WarningsExact identifier
application number: M012
ONESSIP DAY TIME KIDS COLD AND COUGH PLUS FEVERACETAMINOPHEN 325 MG AND DEXTROMETHORPHAN HBR 10 MG ORAL LIQUID DAY TIME KIDSMEDWISE LIFESCIENCES INC.51d52ce4-98c4-2b9b-e063-6294a90ade442026-05-15WarningsExact identifier
application number: M012
Curewell Tussin DMDEXTROMETHORPHAN, GUAIFENESINRMT HEALTH LLC4fe9ad93-cdc4-b4df-e063-6294a90a90ae2026-05-15WarningsExact identifier
application number: M012
CounterAct Cough Drops Orchard CherryMENTHOLMelaleuca, Inc.6049842c-d763-4a91-a225-976ed74e16932026-05-15WarningsExact identifier
application number: M012
CounterAct Cough Drops Honey LemonMENTHOLMelaleuca, Inc.84ac3489-9d64-401f-ab78-715af4de54402026-05-15WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold Flu and Congestion Maximum Strength Day Night Fast GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATEBayer HealthCare LLC.51e03b5b-b05a-07c1-e063-6394a90ab2012026-05-15WarningsExact identifier
application number: M012
Sinus Congestion and Pain Relief Non-Drowsy/DaytimeACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCLRite Aid Corporation38d73a1e-ac78-4f67-9291-bb48ab80306e2026-05-15WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBRWALMART INC.071615ba-f50a-4d2a-a358-43140bccce722026-05-14WarningsExact identifier
application number: M012
Severe Cold and Flu Nighttime DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLHyVee Incd4bcfabb-a054-4f53-8dc9-d361a03558b82026-05-14WarningsExact identifier
application number: M012
Cough and Chest Congestion DM AdultDEXTROMETHORPHAN HBR, GUAIFENESINCVS Pharmacy4444c05a-eba6-4633-b86f-34f455699fa92026-05-14WarningsExact identifier
application number: M012
Topcare Day Time Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLTopco Associates LLCa88e5b8e-e6dd-4a1c-9628-5861d3205bdb2026-05-14WarningsExact identifier
application number: M012
equate daytime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores Inc69b24c67-cf4b-46d7-a44b-d1917cc876b12026-05-14WarningsExact identifier
application number: M012
GILTUSS DIABETIC EXGILTUSS DIABETIC EXGil Pharmaceutical Corpab7915e7-323a-4fe1-887a-a3bd3f0aac982026-05-13WarningsExact identifier
application number: M012
Giltuss EX Maximum Strength ExpectorantGILTUSS EX MAXIMUM STRENGTH EXPECTORANTGil Pharmaceutical Corp950db1ca-6936-47f8-a112-e3594d4c922c2026-05-13WarningsExact identifier
application number: M012
Giltuss EX ExpectorantGILTUSS EX EXPECTORANTGil Pharmaceutical Corp3b363fb9-c4d3-446f-927c-f705ffc715b52026-05-13WarningsExact identifier
application number: M012
Giltuss HBP EX ExpectorantGILTUSS HBP EX EXPECTORANTGil Pharmaceutical Corp31bd6356-27cf-4188-8fd5-9cd9392021ca2026-05-13WarningsExact identifier
application number: M012
Halls Honey LemonMENTHOLMondelez Global LLCaec46410-ffb1-4db4-b232-82110c562f692026-05-13WarningsExact identifier
application number: M012
Mucinex Fast-Max Chest Congestion Honey and Berry FlavorGUAIFENESINReckitt Benckiser LLC8ec74cf2-88f5-40be-87e2-b756ab8417542026-05-13WarningsExact identifier
application number: M012
Mucinex Fast-Max Cold and FluACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLCc16253d3-3824-458c-8840-e3a2fbe7682c2026-05-13WarningsExact 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