FDA.reportPublic FDA data

Coricidin HBP Maximum Strength Cold and Flu Day and Night

Product NDC
11523-0100
11-digit product format
115230100
Labeler code
11523
Product ID
11523-0100_4526d94e-3913-f1e0-e063-6294a90aefc0
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen, dextromethorphan hydrobromide, guaifenesin, doxylamine succinate
Dosage form
KIT
Route
ORAL
Labeler
Bayer HealthCare LLC.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-07-01
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 Maximum Strength Cold and Flu Day and Night
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
707195Internal RxNorm lookup
1426334Internal RxNorm lookup
2612689Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e4f3f906-2252-21d1-e053-2a95a90a85dfAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-0100-1Coricidin HBP Maximum Strength Cold and Flu Day and Night1 in 1 BLISTER PACKKIT15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-0100CORICIDIN HBP MAXIMUM STRENGTH COLD AND FLU DAY AND NIGHT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE) KIT [BAYER HEALTHCARE LLC.]4Current NDC, Legacy NDC, 1 package rows20231201_e4f3f906-2252-21d1-e053-2a95a90a85df.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 11 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ORIGINAL Nasal PUMP MIST No DripOXYMETAZOLINE HYDROCHLORIDEWinCo FOODS, LLCac27fd75-4fe4-433c-a434-2dac16c895c72026-08-07WarningsExact identifier
application number: M012
Winco Foods Childrens Allergy Relief Dye FreeDIPHENHYDRAMINE HYDROCHLORIDEWINCO FOODS, LLCa1367804-37c9-4906-858f-8feeb748d8d32026-08-07WarningsExact identifier
application number: M012
Severe Congestion Nasal Anti-Drip Nasal DecongestantOXYMETAZOLINE HYDROCHLORIDEWinCo FOODS, LLCa09c2d02-334a-4840-b2d0-327121cec9942026-08-07WarningsExact identifier
application number: M012
Daytime Nighttime Intense Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEWalgreen Company03aa43fd-4962-4c2c-9edd-e422a629a0e32026-08-06WarningsExact identifier
application number: M012
Allergy Multi-SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCLARMY AND AIR FORCE EXCHANGE SERVICEf311b56f-b959-4070-9b23-82c642dd98b82026-08-06WarningsExact identifier
application number: M012
Cold Relief Multi-SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLL.N.K. International, Inc.2ed25f69-89ef-4c50-946a-7e7b9df1ca8a2026-08-06WarningsExact identifier
application number: M012
EucamintMENTHOL, CAMPHORIndiana Botanic Gardensd79bc8de-9efb-4996-a55c-accda0f8edb22026-08-06WarningsExact identifier
application number: M012
NICOTINE GUMNICOTINE POLACRILEXGuangzhou Shuimu Jiahe Trading Co., Ltd.4e88dab4-8e13-f074-e063-6394a90a39082026-08-06WarningsExact identifier
application number: M012
Oneoo Nicotine Gum (Mint)NICOTINE POLACRILEXGuangzhou Shuimu Jiahe Trading Co., Ltd.54b1329b-b422-29a5-e063-6294a90a87802026-08-06WarningsExact identifier
application number: M012
Sine Aid PEAK MISERYOXYMETAZOLINE HYDROCHLORIDEInfirst Healthcare Inc.586a2a14-7048-0c8b-e063-6394a90a65b72026-08-06WarningsExact identifier
application number: M012
DRX CHOICE Daytime and Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATERaritan Pharmaceuticals Incb745f45d-2042-4daa-9932-241836d7734b2026-08-06WarningsExact identifier
application number: M012
Acetaminophen, Dextromethorphan HBrACETAMINOPHEN, DEXTROMETHORPHAN HBRNUVICARE LLC6713fdff-0e4e-4a9d-b218-34f786339c572026-08-06WarningsExact identifier
application number: M012
Daytime Cold, Nighttime Cold multi-symptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFI3b462a5d-d48b-4b73-b5d4-d7944730bbdd2026-08-06WarningsExact identifier
application number: M012
TOPCARE DAY TIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDETopco Associates LLCd1b89d17-b3b9-4133-88a3-8cd7c4efafa92026-08-05WarningsExact identifier
application number: M012
Sinufrin Quick Relief DecongestantSINUFRINNeilmed pharmaceuticals Inc.0c36a34e-462d-713c-e063-6294a90a17762026-08-05WarningsExact identifier
application number: M012
No DripOXYMETAZOLINE HYDROCHLORIDENeilMed Pharmaceuticals Ince9b799ad-9164-7f30-e053-2a95a90a00c52026-08-05WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold Flu and Congestion Fast DissolveCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.507284c3-cad9-d65c-e063-6394a90a58a82026-08-05WarningsExact identifier
application number: M012
cough and cold relief HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRUnited Natural Foods, Inc. dba UNFI90482e7a-d7c7-4127-972d-5ee55e55ed1c2026-08-04WarningsExact identifier
application number: M012
DM MaxDEXTROMETHORPHAN HBR, GUAIFENESINWalgreen Company78edeb7a-4712-4f04-9d76-d5b2d20ce76d2026-08-04WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRBetter Living Brands, LLC33f34aa2-3b37-4e51-8428-4a12708aa0642026-08-04WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2612689{1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG Oral Capsule) / 1 (acetaminophen 325 MG / guaifenesin 200 MG Oral Capsule) } PackGPCKe4f3f906-2252-21d1-e053-2a95a90a85df5
26126891 daytime (acetaminophen 325 MG / guaiFENesin 200 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG Oral Capsule) PackPSNe4f3f906-2252-21d1-e053-2a95a90a85df5
1426334acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG Oral CapsulePSNe4f3f906-2252-21d1-e053-2a95a90a85df5
707195acetaminophen 325 MG / guaiFENesin 200 MG Oral CapsulePSNe4f3f906-2252-21d1-e053-2a95a90a85df5
1426334acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG Oral CapsuleSCDe4f3f906-2252-21d1-e053-2a95a90a85df5
707195acetaminophen 325 MG / guaifenesin 200 MG Oral CapsuleSCDe4f3f906-2252-21d1-e053-2a95a90a85df5
26126891 daytime (acetaminophen 325 MG / guaifenesin 200 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG Oral Capsule) PackSYe4f3f906-2252-21d1-e053-2a95a90a85df5
1426334APAP 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG Oral CapsuleSYe4f3f906-2252-21d1-e053-2a95a90a85df5
707195APAP 325 MG / Guaifenesin 200 MG Oral CapsuleSYe4f3f906-2252-21d1-e053-2a95a90a85df5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11523-0100-1115230100011 KIT in 1 BLISTER PACK (11523-0100-1) * 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK1 kit2022-07-010000-00-00NoNoCurrent