Severe Congestion and Cough

Product NDC
0363-6048
11-digit product format
003636048
Labeler code
0363
Product ID
0363-6048_031f54cf-3ac7-49b0-b8fd-b0a7a0975084
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Walgreen Company
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
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
0363-6048-09Severe Congestion and Cough10 in 1 BLISTER PACKTABLET, FILM COATED1012
0363-6048-09Severe Congestion and Cough2 in 1 PACKAGETABLET, FILM COATED212
0363-6048-19Severe Congestion and Cough2 in 1 CARTONTABLET, FILM COATED212
0363-6048-19Severe Congestion and Cough10 in 1 BLISTER PACKTABLET, FILM COATED1012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-6048SEVERE CONGESTION AND COUGH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WALGREEN COMPANY]11Current NDC, Legacy NDC, 4 package rows20240704_1ddc04fb-069c-44fe-814b-ba4f503c4be0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1372652dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral TabletPSN1ddc04fb-069c-44fe-814b-ba4f503c4be012
1372652dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD1ddc04fb-069c-44fe-814b-ba4f503c4be012
1372652dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG Oral TabletSY1ddc04fb-069c-44fe-814b-ba4f503c4be012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-6048-09003636048092 BLISTER PACK in 1 PACKAGE (0363-6048-09) > 10 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2015-07-200000-00-00NoNoCurrent
0363-6048-19003636048192 BLISTER PACK in 1 CARTON (0363-6048-19) / 10 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2023-07-18NoNoCurrent