FDA.reportPublic FDA data

Coricidin HBP Chest Congestion And Cough

Product NDC
11523-7158
Requested package NDC
11523-7158-2
11-digit product format
115237158
Labeler code
11523
Product ID
11523-7158_453714ac-347f-ef85-e063-6394a90a601f
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan hydrobromide and Guaifenesin
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
Bayer HealthCare LLC.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2000-08-31
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
10; 200 mg/1; mg/1
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage11523-715811523-7158-2IInactivated by FDA2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage11523-715811523-7158-2DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage11523-715811523-7158-2DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage11523-715811523-7158-2DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-7158-2Coricidin HBP Chest Congestion And Cough10 in 1 BLISTER PACKCAPSULE, GELATIN COATED1010
11523-7158-2Coricidin HBP Chest Congestion And Cough2 in 1 CARTONCAPSULE, GELATIN COATED210

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11523-7158-2EA - Each11523-715855b7c697-c426-48b3-a28c-44ee29138f1812014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Dextromethorphan hydrobromideACTIVE INGREDIENT9D2RTI9KYHCORICIDIN HBP CHEST CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) CAPSULE, GELATIN COATED [MSD CONSUMER CARE, INC.]1
GuaifenesinACTIVE INGREDIENT495W7451VQCORICIDIN HBP CHEST CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) CAPSULE, GELATIN COATED [MSD CONSUMER CARE, INC.]1
DextromethorphanACTIVE MOIETY7355X3ROTSCORICIDIN HBP CHEST CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) CAPSULE, GELATIN COATED [MSD CONSUMER CARE, INC.]1
GuaifenesinACTIVE MOIETY495W7451VQCORICIDIN HBP CHEST CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) CAPSULE, GELATIN COATED [MSD CONSUMER CARE, INC.]1
FD&C blue no. 1INACTIVE INGREDIENTH3R47K3TBDCORICIDIN HBP CHEST CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) CAPSULE, GELATIN COATED [MSD CONSUMER CARE, INC.]1
FD&C red no. 40INACTIVE INGREDIENTWZB9127XOACORICIDIN HBP CHEST CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) CAPSULE, GELATIN COATED [MSD CONSUMER CARE, INC.]1
gelatinINACTIVE INGREDIENT2G86QN327LCORICIDIN HBP CHEST CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) CAPSULE, GELATIN COATED [MSD CONSUMER CARE, INC.]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXCORICIDIN HBP CHEST CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) CAPSULE, GELATIN COATED [MSD CONSUMER CARE, INC.]1
polyethylene glycol 400INACTIVE INGREDIENTB697894SGQCORICIDIN HBP CHEST CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) CAPSULE, GELATIN COATED [MSD CONSUMER CARE, INC.]1
povidonesINACTIVE INGREDIENTFZ989GH94ECORICIDIN HBP CHEST CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) CAPSULE, GELATIN COATED [MSD CONSUMER CARE, INC.]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3CORICIDIN HBP CHEST CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) CAPSULE, GELATIN COATED [MSD CONSUMER CARE, INC.]1
sorbitolINACTIVE INGREDIENT506T60A25RCORICIDIN HBP CHEST CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) CAPSULE, GELATIN COATED [MSD CONSUMER CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-7158CORICIDIN HBP CHEST CONGESTION AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) CAPSULE, GELATIN COATED [BAYER HEALTHCARE LLC.]9Current NDC, Legacy NDC, 2 package rows20241208_40ad8261-d01d-436b-83b4-1b7c987573db.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 1 of 194 · 3,880 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLFamily Dollar Services Incce590997-3cae-4f22-ac39-2b14d39494bc2026-07-30WarningsExact identifier
application number: M012
Robitussin Direct CoughDEXTROMETHORPHAN HYDROBROMIDEHaleon US Holdings LLC70c9556b-063a-4fb3-96f6-1d4ffa495ed42026-07-30WarningsExact identifier
application number: M012
Major Nasal DecongestantOXYMETAZOLINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.a302e341-1c00-4c3d-b71f-c4c0b307aa672026-07-29WarningsExact identifier
application number: M012
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLWalgreens4c737cd6-fe56-4cef-887c-cd6cf83b254c2026-07-29WarningsExact identifier
application number: M012
ROBITUSSIN LONG-ACTING COUGHGELSDEXTROMETHORPHAN HYDROBROMIDEHaleon US Holdings LLC472c5c1f-eb5a-444b-a17e-f0d71007fb152026-07-29WarningsExact identifier
application number: M012
DAYTIME COLD AND FLU NITETIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEMeijer Distribution Inc3a33c6ce-aada-4099-8c61-49c86c0fc1a82026-07-29WarningsExact identifier
application number: M012
Tussin DM Max NighttimeDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWal-Mart Stores Inc668c92ce-6c1f-4ab3-b0dd-822b0768cb5e2026-07-29WarningsExact identifier
application number: M012
BenadrylDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLC702f9786-7ce9-43e4-921d-e1db096121272026-07-28WarningsExact identifier
application number: M012
LoHist-DCHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCLLarken Laboratories, Inc.efaa354e-c25c-405b-9d30-001c2796978c2026-07-28WarningsExact identifier
application number: M012
NIGHTTIME SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDd1115a55-35cd-4f20-8872-f42983a5ebcd2026-07-28WarningsExact identifier
application number: M012
TUSSINDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINSafewaya5e2bda4-2da6-4c20-855d-2888dadf0c3a2026-07-28WarningsExact identifier
application number: M012
DM MaximumDEXTROMETHORPHAN HBR, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDf6029b04-e681-40fc-be4f-14091b76dd4e2026-07-27WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLCVS PHARMACYe958eef1-8aae-4365-ac64-95a9e8e7e0f22026-07-27WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLDOLGENCORP INC38400854-27fa-e291-e063-6294a90a5c4e2026-07-27WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLBetter Living Brands, LLC65802aa7-64e7-4435-ad6b-65895fba17ce2026-07-27WarningsExact identifier
application number: M012
Cold and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCLWalgreen Company0a48f650-ad2a-4105-9ff4-2bc4d94b46d32026-07-27WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company84202ebe-97b6-4be2-bb09-7f2729303f962026-07-27WarningsExact identifier
application number: M012
Daytime Severe Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRite Aid Corporation8d41defe-8120-4cbb-b42e-c805cc5a794b2026-07-24WarningsExact identifier
application number: M012
Childrens Benadryl ALLERGYDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLCfc9181b9-c92d-493e-8d7c-4a4239c6c0922026-07-24WarningsExact identifier
application number: M012
Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine HydrochlorideACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDEProdose, Inc.3afc88c7-388a-dbd9-e063-6294a90a4faf2026-07-24WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1111663dextromethorphan HBr 10 MG / guaiFENesin 200 MG Oral CapsulePSN40ad8261-d01d-436b-83b4-1b7c987573db10
1111663dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG Oral CapsuleSCD40ad8261-d01d-436b-83b4-1b7c987573db10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11523-7158-2115237158022 BLISTER PACK in 1 CARTON (11523-7158-2) / 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK2 blister pack2000-08-312022-04-30NoNoCurrent