Robitussin Honey Maximum Strength Cough and Chest Congestion DM

Product NDC
0031-8756
11-digit product format
000318756
Labeler code
0031
Product ID
0031-8756_178d098c-514f-d1fe-e063-6294a90af6ca
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
2018-06-25
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 Honey Maximum Strength Cough and 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
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0031-8756-12Robitussin Honey Maximum Strength Cough and Chest Congestion DM118 mL in 1 BOTTLESOLUTION1188
0031-8756-12Robitussin Honey Maximum Strength Cough and Chest Congestion DM1 in 1 CARTONSOLUTION18
0031-8756-18Robitussin Honey Maximum Strength Cough and Chest Congestion DM1 in 1 CARTONSOLUTION18
0031-8756-18Robitussin Honey Maximum Strength Cough and Chest Congestion DM237 mL in 1 BOTTLESOLUTION2378
0031-8756-12RobitussinHoney Cough DM Day Night Value Pack1 in 1 CARTONSOLUTION400 mg in 20mL1
0031-8756-12RobitussinHoney Cough DM Day Night Value Pack118 mL in 1 BOTTLESOLUTION118 mL20 mg in 20mL1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0031-8756-12ML - Milliliter0031-87568416ba12-afa1-4752-97ab-31d20f644e5f12019-07-02
0031-8756-18ML - Milliliter0031-8756913071af-382f-4fe6-ad2d-df68bbb113a912019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0031-8756ROBITUSSIN HONEY MAXIMUM STRENGTH COUGH AND CHEST CONGESTION DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [HALEON US HOLDINGS LLC]8Current NDC, Legacy NDC, 4 package rows20240504_eaa10aed-5b1e-48bf-bc05-7a5638851daf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020138dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral SolutionPSNeaa10aed-5b1e-48bf-bc05-7a5638851daf8
1020138dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCDeaa10aed-5b1e-48bf-bc05-7a5638851daf8
1020138dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral SolutionSYeaa10aed-5b1e-48bf-bc05-7a5638851daf8
1020138dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral SolutionSYeaa10aed-5b1e-48bf-bc05-7a5638851daf8
2056073{1 (dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral Solution) / 1 (dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral Solution) } PackGPCK1bbd0157-06e6-4a3b-bac9-91ac879ba0891
20560731 daytime (dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral Solution) / 1 nighttime (dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 20 mL Oral Solution) PackPSN1bbd0157-06e6-4a3b-bac9-91ac879ba0891
1020138dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral SolutionPSN1bbd0157-06e6-4a3b-bac9-91ac879ba0891
1115329dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 20 mL Oral SolutionPSN1bbd0157-06e6-4a3b-bac9-91ac879ba0891
1020138dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD1bbd0157-06e6-4a3b-bac9-91ac879ba0891
1115329dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral SolutionSCD1bbd0157-06e6-4a3b-bac9-91ac879ba0891
20560731 daytime (dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral Solution) / 1 nighttime (dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 20 ML Oral Solution) PackSY1bbd0157-06e6-4a3b-bac9-91ac879ba0891
1020138dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral SolutionSY1bbd0157-06e6-4a3b-bac9-91ac879ba0891
1020138dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY1bbd0157-06e6-4a3b-bac9-91ac879ba0891
1115329dextromethorphan hydrobromide 30 MG / doxylamine succinate 12.5 MG per 20 ML Oral SolutionSY1bbd0157-06e6-4a3b-bac9-91ac879ba0891
1115329dextromethorphan hydrobromide 7.5 MG / doxylamine succinate 3.125 MG per 5 ML Oral SolutionSY1bbd0157-06e6-4a3b-bac9-91ac879ba0891

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0031-8756-12000318756121 BOTTLE in 1 CARTON (0031-8756-12) / 118 mL in 1 BOTTLE1 bottle2018-06-250000-00-00NoNoCurrent
0031-8756-18000318756181 BOTTLE in 1 CARTON (0031-8756-18) / 237 mL in 1 BOTTLE1 bottle2018-06-250000-00-00NoNoCurrent