Robitussin Maximum Strength Cough Plus Chest Congestion DM

Product NDC
0031-8719
11-digit product format
000318719
Labeler code
0031
Product ID
0031-8719_cb5018d5-8b32-41b8-a393-008d092d4638
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan hydrobromide and guaifenesin
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-05-23
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Robitussin Maximum Strength Cough Plus Chest Congestion DM
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, 495W7451VQ
Rxcui1111663

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
0031-8719-10Robitussin Maximum Strength Cough Plus Chest Congestion DM2 in 1 BLISTER PACKCAPSULE, LIQUID FILLED211
0031-8719-10Robitussin Maximum Strength Cough Plus Chest Congestion DM5 in 1 CARTONCAPSULE, LIQUID FILLED511
0031-8719-20Robitussin Maximum Strength Cough Plus Chest Congestion DM10 in 1 CARTONCAPSULE, LIQUID FILLED1011
0031-8719-20Robitussin Maximum Strength Cough Plus Chest Congestion DM2 in 1 BLISTER PACKCAPSULE, LIQUID FILLED211
0031-8719-31Robitussin Maximum Strength Cough Plus Chest Congestion DM15 in 1 CARTONCAPSULE, LIQUID FILLED1511
0031-8719-31Robitussin Maximum Strength Cough Plus Chest Congestion DM2 in 1 BLISTER PACKCAPSULE, LIQUID FILLED211
0031-8719-70Robitussin Maximum Strength Cough Plus Chest Congestion DM500 in 1 BOXCAPSULE, LIQUID FILLED50011
0031-8719-70Robitussin Maximum Strength Cough Plus Chest Congestion DM2 in 1 POUCHCAPSULE, LIQUID FILLED211

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0031-8719ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) CAPSULE, LIQUID FILLED [HALEON US HOLDINGS LLC]10Current NDC, Legacy NDC, 8 package rows20240316_868ac65a-63e2-46ac-b87d-66b289086756.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1111663dextromethorphan HBr 10 MG / guaiFENesin 200 MG Oral CapsulePSN868ac65a-63e2-46ac-b87d-66b28908675611
1111663dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG Oral CapsuleSCD868ac65a-63e2-46ac-b87d-66b28908675611

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0031-8719-10000318719105 BLISTER PACK in 1 CARTON (0031-8719-10) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK5 blister pack2016-05-020000-00-00NoNoCurrent
0031-8719-200003187192010 BLISTER PACK in 1 CARTON (0031-8719-20) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK10 blister pack2013-05-230000-00-00NoNoCurrent
0031-8719-310003187193115 in 1 CARTONHistorical
0031-8719-7000031871970500 in 1 BOXHistorical