FDA.reportPublic FDA data

Coricidin HBP Maximum Strength Cold Flu And Chest Congestion

Product NDC
11523-0094
11-digit product format
115230094
Labeler code
11523
Product ID
11523-0094_4526d3e1-16f9-f68e-e063-6294a90a029b
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Guaifenesin
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
Bayer HealthCare LLC.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-05-01
Substance
ACETAMINOPHEN; GUAIFENESIN
Active strength
325; 200 mg/1; mg/1
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
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 Flu And Chest Congestion
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
GUAIFENESIN200 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
495W7451VQInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
de95d2dd-e766-f7ec-e053-2995a90afc5fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-0094-1Coricidin HBP Maximum Strength Cold Flu And Chest Congestion12 in 1 BLISTER PACKCAPSULE, GELATIN COATED128
11523-0094-1Coricidin HBP Maximum Strength Cold Flu And Chest Congestion2 in 1 CARTONCAPSULE, GELATIN COATED28

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-0094CORICIDIN HBP MAXIMUM STRENGTH COLD FLU AND CHEST CONGESTION (ACETAMINOPHEN, GUAIFENESIN) CAPSULE, GELATIN COATED [BAYER HEALTHCARE LLC.]7Current NDC, Legacy NDC, 2 package rows20241208_de95d2dd-e766-f7ec-e053-2995a90afc5f.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 30 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Halls Honey LemonMENTHOLMondelez Global LLCaec46410-ffb1-4db4-b232-82110c562f692026-05-13WarningsExact identifier
application number: M012
Mucinex Fast-Max DM MaxDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINReckitt Benckiser LLC6a8cdcad-4881-49b8-a3f1-2c1574300d182026-05-13WarningsExact 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
Mucinex Fast-Max Severe Congestion and CoughGUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC1991d5ee-fc90-4070-8965-cd6f4abc45cf2026-05-13WarningsExact identifier
application number: M012
Mucinex Fast-Max Severe Congestion and Cough and Mucinex Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC3b2bb6d0-c5fa-3bfa-e063-6294a90a7afc2026-05-13WarningsExact identifier
application number: M012
Mucinex Fast-Max Severe Congestion and CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCa25278bd-c3b9-4db3-b4f7-b395eb5f91772026-05-13WarningsExact identifier
application number: M012
Mucinex Fast-Max DM Max and Mucinex Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC3ba2cc08-acad-79a8-e063-6394a90af17f2026-05-13WarningsExact identifier
application number: M012
Mucinex Fast-Max Cold, Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCa3523aa3-9ed1-472d-9986-438440d0a3eb2026-05-13WarningsExact identifier
application number: M012
Mucinex Fast-Max DM Max and Mucinex Nightshift Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC2ed3c844-0532-40d9-beba-738d196de34d2026-05-13WarningsExact identifier
application number: M012
Mucinex Nightshift SinusACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC6189fb89-a7d7-4ae6-a9e8-d9512acc0f552026-05-13WarningsExact identifier
application number: M012
Mucinex Nightshift Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLCa51b6312-598e-4a25-a873-6b59bc87d9002026-05-13WarningsExact identifier
application number: M012
Mucinex Sinus-Max Severe Congestion and PainACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC1e243dbe-138f-4346-ba22-ceea01e970522026-05-13WarningsExact identifier
application number: M012
Mucinex Nightshift Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLCa14bc0d1-9b05-4a21-aaa8-95d4d073b9ed2026-05-13WarningsExact identifier
application number: M012
Mucinex Sinus-Max Severe Congestion ReliefACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC128f3442-9802-4303-80be-aead092379362026-05-13WarningsExact identifier
application number: M012
MUCINEX SINUS-MAX SEVERE CONGESTION RELIEF SINUS and ALLERGYOXYMETAZOLINE HYDROCHLORIDEReckitt Benckiser LLC41b8cead-92a0-47d8-8079-4fb5d18bf2492026-05-13WarningsExact identifier
application number: M012
Mucinex Rapid Clear Pain, Headache, and Mucus Congestion and Sinus Max Clear and CoolOXYMETAZOLINE HYDROCHLORIDE, ACETAMINOPHEN AND GUAIFENESINReckitt Benckiser LLC33f0d9bb-c67d-92ba-e063-6294a90a99432026-05-13WarningsExact identifier
application number: M012
Mucinex Sinus-Max Severe Congestion and Pain, Maximum StrengthACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC2c01962d-74e3-4dfa-b7cb-a91a687711d52026-05-13WarningsExact identifier
application number: M012
Mucinex Sinus-Max Pressure, Pain and CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCf5365c6d-9296-41a5-953a-d1008954e67f2026-05-13WarningsExact identifier
application number: M012
Mucinex Sinus-Max Pressure, Pain and CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC8905706b-b9da-4520-8cf2-87d7c125edf32026-05-13WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
707195acetaminophen 325 MG / guaiFENesin 200 MG Oral CapsulePSNde95d2dd-e766-f7ec-e053-2995a90afc5f8
707195acetaminophen 325 MG / guaifenesin 200 MG Oral CapsuleSCDde95d2dd-e766-f7ec-e053-2995a90afc5f8
707195APAP 325 MG / Guaifenesin 200 MG Oral CapsuleSYde95d2dd-e766-f7ec-e053-2995a90afc5f8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11523-0094-1115230094012 BLISTER PACK in 1 CARTON (11523-0094-1) / 12 CAPSULE, GELATIN COATED in 1 BLISTER PACK2 blister pack2022-05-020000-00-00NoNoCurrent