FDA.reportPublic FDA data

Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu

Product NDC
0031-0100
11-digit product format
000310100
Labeler code
0031
Product ID
0031-0100_43e64251-a916-1cb7-e063-6294a90a393a
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen, dextromethorphan hydrobromide, guaifenesin
Dosage form
LIQUID
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-02-15
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
650; 20; 400 mg/20mL; mg/20mL; mg/20mL
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

Additional Listing Data#

Finished product
Yes
Brand name base
Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN650 mg/20mL
DEXTROMETHORPHAN HYDROBROMIDE20 mg/20mL
GUAIFENESIN400 mg/20mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, 9D2RTI9KYH, 495W7451VQ
Rxcui2680300

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0031-0100-04Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu1 in 1 CARTONLIQUID14
0031-0100-04Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu118 mL in 1 BOTTLELIQUID1184
0031-0100-08Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu1 in 1 CARTONLIQUID14
0031-0100-08Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu237 mL in 1 BOTTLELIQUID2374

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0031-0100ROBITUSSIN MAXIMUM STRENGTH SEVERE MULTI-SYMPTOM COUGH COLD FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [HALEON US HOLDINGS LLC]3Current NDC, 4 package rows20250515_a6f750c8-8738-4965-a3ad-612c24611056.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2680300acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral SolutionPSNa6f750c8-8738-4965-a3ad-612c246110564
2680300acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCDa6f750c8-8738-4965-a3ad-612c246110564
2680300acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral SolutionSYa6f750c8-8738-4965-a3ad-612c246110564
2680300APAP 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SolutionSYa6f750c8-8738-4965-a3ad-612c246110564

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0031-0100-04000310100041 BOTTLE in 1 CARTON (0031-0100-04) / 118 mL in 1 BOTTLE1 bottle2024-02-15NoNoCurrent
0031-0100-08000310100081 BOTTLE in 1 CARTON (0031-0100-08) / 237 mL in 1 BOTTLE1 bottle2024-02-15NoNoCurrent