Severe Congestion and Cough

Product NDC
59779-648
11-digit product format
597790648
Labeler code
59779
Product ID
59779-648_3aa97af2-b8af-4a71-98fc-3960dbb1f8da
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
CVS Pharmacy
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-07-20
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
10; 200; 5 mg/1; mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], 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], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Severe Congestion and Cough
Brand name suffix
Multi-Symptom Maximum Strength
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE10 mg/1
GUAIFENESIN200 mg/1
PHENYLEPHRINE HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ
Rxcui1372652

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59779-648-01Severe Congestion and CoughMulti-Symptom Maximum Strength3 in 1 PACKAGETABLET, FILM COATED316
59779-648-01Severe Congestion and CoughMulti-Symptom Maximum Strength10 in 1 BLISTER PACKTABLET, FILM COATED1016
59779-648-95Severe Congestion and CoughMulti-Symptom Maximum Strength3 in 1 CARTONTABLET, FILM COATED316
59779-648-95Severe Congestion and CoughMulti-Symptom Maximum Strength10 in 1 BLISTER PACKTABLET, FILM COATED1016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59779-648-01EA - Each59779-64833cbd8ad-b767-419a-a108-092924cd5fcc12022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHSEVERE CONGESTION AND COUGH MULTI-SYMPTOM MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]3
GUAIFENESINACTIVE INGREDIENT495W7451VQSEVERE CONGESTION AND COUGH MULTI-SYMPTOM MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]3
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJSEVERE CONGESTION AND COUGH MULTI-SYMPTOM MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]3
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSSEVERE CONGESTION AND COUGH MULTI-SYMPTOM MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]3
GUAIFENESINACTIVE MOIETY495W7451VQSEVERE CONGESTION AND COUGH MULTI-SYMPTOM MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]3
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVSEVERE CONGESTION AND COUGH MULTI-SYMPTOM MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKSEVERE CONGESTION AND COUGH MULTI-SYMPTOM MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOASEVERE CONGESTION AND COUGH MULTI-SYMPTOM MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SEVERE CONGESTION AND COUGH MULTI-SYMPTOM MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]3
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DSEVERE CONGESTION AND COUGH MULTI-SYMPTOM MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASEVERE CONGESTION AND COUGH MULTI-SYMPTOM MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]3
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990SEVERE CONGESTION AND COUGH MULTI-SYMPTOM MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]3
POVIDONESINACTIVE INGREDIENTFZ989GH94ESEVERE CONGESTION AND COUGH MULTI-SYMPTOM MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SEVERE CONGESTION AND COUGH MULTI-SYMPTOM MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSEVERE CONGESTION AND COUGH MULTI-SYMPTOM MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSEVERE CONGESTION AND COUGH MULTI-SYMPTOM MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]3
TALCINACTIVE INGREDIENT7SEV7J4R1USEVERE CONGESTION AND COUGH MULTI-SYMPTOM MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSEVERE CONGESTION AND COUGH MULTI-SYMPTOM MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-648SEVERE CONGESTION AND COUGH MULTI-SYMPTOM MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [CVS PHARMACY]15Current NDC, Legacy NDC, 4 package rows20240704_707eb066-cdfc-444b-833a-9d6d133d48e4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1372652dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral TabletPSN707eb066-cdfc-444b-833a-9d6d133d48e416
1372652dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD707eb066-cdfc-444b-833a-9d6d133d48e416
1372652dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG Oral TabletSY707eb066-cdfc-444b-833a-9d6d133d48e416

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-648-01597790648013 BLISTER PACK in 1 PACKAGE (59779-648-01) > 10 TABLET, FILM COATED in 1 BLISTER PACK3 blister pack2015-07-200000-00-00NoNoCurrent
59779-648-95597790648953 BLISTER PACK in 1 CARTON (59779-648-95) / 10 TABLET, FILM COATED in 1 BLISTER PACK3 blister pack2023-07-19NoNoHistorical