Robitussin Elderberry Maximum Strength Cough plus Chest Congestion DM

Product NDC
0031-2097
11-digit product format
000312097
Labeler code
0031
Product ID
0031-2097_446ee4e3-9b08-b5a1-e063-6394a90a0a4e
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan HBr, guaifenesin
Dosage form
SOLUTION
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-06-14
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
20; 400 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 Elderberry Maximum Strength Cough plus Chest Congestion DM
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, 495W7451VQ
Rxcui1020138

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0031-2097-01Robitussin Elderberry Maximum Strength Cough plus Chest Congestion DM1 in 1 CARTONSOLUTION15
0031-2097-01Robitussin Elderberry Maximum Strength Cough plus Chest Congestion DM118 mL in 1 BOTTLESOLUTION1185
0031-2097-02Robitussin Elderberry Maximum Strength Cough plus Chest Congestion DM237 mL in 1 BOTTLESOLUTION2375
0031-2097-02Robitussin Elderberry Maximum Strength Cough plus Chest Congestion DM1 in 1 CARTONSOLUTION15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0031-2097ROBITUSSIN ELDERBERRY MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [HALEON US HOLDINGS LLC]4Current NDC, Legacy NDC, 4 package rows20240217_d13efbcd-1277-45d0-8389-1ba0337f7a24.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020138dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral SolutionPSNd13efbcd-1277-45d0-8389-1ba0337f7a245
1020138dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCDd13efbcd-1277-45d0-8389-1ba0337f7a245
1020138dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral SolutionSYd13efbcd-1277-45d0-8389-1ba0337f7a245
1020138dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral SolutionSYd13efbcd-1277-45d0-8389-1ba0337f7a245

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0031-2097-01000312097011 BOTTLE in 1 CARTON (0031-2097-01) / 118 mL in 1 BOTTLE1 bottle2021-06-140000-00-00NoNoCurrent
0031-2097-02000312097021 BOTTLE in 1 CARTON (0031-2097-02) / 237 mL in 1 BOTTLE1 bottle2021-06-140000-00-00NoNoCurrent