FDA.reportPublic FDA data

Coricidin HBP Maximum Strength Cold, Cough and Flu

Product NDC
11523-0093
11-digit product format
115230093
Labeler code
11523
Product ID
11523-0093_dda4de27-4247-5d2e-e053-2995a90ac10f
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen, dextromethorphan hydrobromide
Dosage form
LIQUID
Route
ORAL
Labeler
Bayer HealthCare LLC.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-04-27
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
650 mg/30mL; mg/30mL
Pharmacologic classes
Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
79e1734e-f721-4d46-978a-be382f771672Product name220230110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
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06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
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f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
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22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
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332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
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e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-0093-1Coricidin HBP Maximum Strength Cold, Cough and Flu355 mL in 1 BOTTLELIQUID3556
11523-0093-1Coricidin HBP Maximum Strength Cold, Cough and Flu355 mL in 1 BOTTLELIQUID355 mL650 mg in 30mL2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-0093CORICIDIN HBP MAXIMUM STRENGTH COLD, COUGH AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [BAYER HEALTHCARE LLC.]6Legacy NDC, 1 package rows20241208_dda48038-afe0-42fd-e053-2a95a90a836e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2604561acetaminophen 650 MG / dextromethorphan HBr 20 MG in 30 mL Oral SolutionPSNdda48038-afe0-42fd-e053-2a95a90a836e6
2604561acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML Oral SolutionSCDdda48038-afe0-42fd-e053-2a95a90a836e6
2604561acetaminophen 325 MG / dextromethorphan HBr 10 MG per 15 ML Oral SolutionSYdda48038-afe0-42fd-e053-2a95a90a836e6
2604561acetaminophen 650 MG / dextromethorphan HBr 20 MG per 30 ML Oral SolutionSYdda48038-afe0-42fd-e053-2a95a90a836e6
2604561APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML Oral SolutionSYdda48038-afe0-42fd-e053-2a95a90a836e6
2687211{1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution) / 1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML Oral Solution) } PackGPCK351d3c5c-05c8-921a-e063-6394a90abef92
26872111 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG in 15 mL Oral Solution) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG in 15 mL Oral Solution) PackPSN351d3c5c-05c8-921a-e063-6394a90abef92
1042675acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG in 15 mL Oral SolutionPSN351d3c5c-05c8-921a-e063-6394a90abef92
2604561acetaminophen 650 MG / dextromethorphan HBr 20 MG in 30 mL Oral SolutionPSN351d3c5c-05c8-921a-e063-6394a90abef92
1042675acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSCD351d3c5c-05c8-921a-e063-6394a90abef92
2604561acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML Oral SolutionSCD351d3c5c-05c8-921a-e063-6394a90abef92
26872111 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG per 15 mL Oral Solution) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG per 15 mL Oral Solution) PackSY351d3c5c-05c8-921a-e063-6394a90abef92
1042675acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG per 15 ML Oral SolutionSY351d3c5c-05c8-921a-e063-6394a90abef92
2604561acetaminophen 325 MG / dextromethorphan HBr 10 MG per 15 ML Oral SolutionSY351d3c5c-05c8-921a-e063-6394a90abef92
1042675acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG per 30 ML Oral SolutionSY351d3c5c-05c8-921a-e063-6394a90abef92
2604561acetaminophen 650 MG / dextromethorphan HBr 20 MG per 30 ML Oral SolutionSY351d3c5c-05c8-921a-e063-6394a90abef92
1042675APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSY351d3c5c-05c8-921a-e063-6394a90abef92
2604561APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML Oral SolutionSY351d3c5c-05c8-921a-e063-6394a90abef92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11523-0093-111523009301355 mL in 1 BOTTLE (11523-0093-1) 355 ml2022-04-270000-00-00NoNoCurrent