FDA.reportPublic FDA data

Robitussin Maximum Strength Nighttime Cough DM

Product NDC
0031-8718
11-digit product format
000318718
Labeler code
0031
Product ID
0031-8718_42637453-ec82-913e-e063-6294a90af911
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan hydrobromide, doxylamine succinate
Dosage form
SOLUTION
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-06-01
Substance
DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength
30; 12.5 mg/20mL; mg/20mL
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA], 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 Nighttime Cough DM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE30 mg/20mL
DOXYLAMINE SUCCINATE12.5 mg/20mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, V9BI9B5YI2
Rxcui1115329

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
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
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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
0031-8718-13Robitussin Maximum Strength Nighttime Cough DM1 in 1 CARTONSOLUTION110
0031-8718-13Robitussin Maximum Strength Nighttime Cough DM118 mL in 1 BOTTLESOLUTION11810
0031-8718-18Robitussin Maximum Strength Nighttime Cough DM237 mL in 1 BOTTLESOLUTION23710
0031-8718-18Robitussin Maximum Strength Nighttime Cough DM1 in 1 CARTONSOLUTION110
0031-8718-24Robitussin Maximum Strength Nighttime Cough DM355 mL in 1 BOTTLESOLUTION35510
0031-8718-24Robitussin Maximum Strength Nighttime Cough DM1 in 1 CARTONSOLUTION110
0031-8718-18RobitussinDay and Night Cough Relief DM Max1 in 1 CARTONSOLUTION12.5 mg in 20mL4
0031-8718-18RobitussinDay and Night Cough Relief DM Max237 mL in 1 BOTTLESOLUTION237 mL30 mg in 20mL4
0031-8718-13RobitussinDay and Night Maximum Strength Cough DM1 in 1 CARTONSOLUTION12.5 mg in 20mL1
0031-8718-13RobitussinDay and Night Maximum Strength Cough DM118 mL in 1 BOTTLESOLUTION118 mL30 mg in 20mL1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0031-8718-13ML - Milliliter0031-871817cf427c-d526-4213-b309-8d0e9c33ec1912019-02-13
0031-8718-18ML - Milliliter0031-8718bebdbba5-3b06-4073-8d1c-fa1ffe74fd4612019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0031-8718ROBITUSSIN MAXIMUM STRENGTH NIGHTTIME COUGH DM (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) SOLUTION [HALEON US HOLDINGS LLC]9Current NDC, Legacy NDC, 6 package rows20250315_44feee2f-25bc-48d4-8e13-db1d9daaaa90.zip
0031-8718ROBITUSSIN DAY AND NIGHT COUGH RELIEF DM MAX (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE) KIT [HALEON US HOLDINGS LLC]2Current NDC, Legacy NDC20250507_b3d02c91-8f79-4eb4-a378-1072474c572c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115329dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 20 mL Oral SolutionPSN44feee2f-25bc-48d4-8e13-db1d9daaaa9010
1115329dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral SolutionSCD44feee2f-25bc-48d4-8e13-db1d9daaaa9010
1115329dextromethorphan hydrobromide 30 MG / doxylamine succinate 12.5 MG per 20 ML Oral SolutionSY44feee2f-25bc-48d4-8e13-db1d9daaaa9010
1115329dextromethorphan hydrobromide 7.5 MG / doxylamine succinate 3.125 MG per 5 ML Oral SolutionSY44feee2f-25bc-48d4-8e13-db1d9daaaa9010
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) } PackGPCKb3d02c91-8f79-4eb4-a378-1072474c572c4
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) PackPSNb3d02c91-8f79-4eb4-a378-1072474c572c4
1020138dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral SolutionPSNb3d02c91-8f79-4eb4-a378-1072474c572c4
1115329dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 20 mL Oral SolutionPSNb3d02c91-8f79-4eb4-a378-1072474c572c4
1020138dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCDb3d02c91-8f79-4eb4-a378-1072474c572c4
1115329dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral SolutionSCDb3d02c91-8f79-4eb4-a378-1072474c572c4
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) PackSYb3d02c91-8f79-4eb4-a378-1072474c572c4
1020138dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral SolutionSYb3d02c91-8f79-4eb4-a378-1072474c572c4
1020138dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral SolutionSYb3d02c91-8f79-4eb4-a378-1072474c572c4
1115329dextromethorphan hydrobromide 30 MG / doxylamine succinate 12.5 MG per 20 ML Oral SolutionSYb3d02c91-8f79-4eb4-a378-1072474c572c4
1115329dextromethorphan hydrobromide 7.5 MG / doxylamine succinate 3.125 MG per 5 ML Oral SolutionSYb3d02c91-8f79-4eb4-a378-1072474c572c4
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) } PackGPCKb43d8fbd-1977-4465-aa64-79e7b7f54e091
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) PackPSNb43d8fbd-1977-4465-aa64-79e7b7f54e091
1020138dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral SolutionPSNb43d8fbd-1977-4465-aa64-79e7b7f54e091
1115329dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 20 mL Oral SolutionPSNb43d8fbd-1977-4465-aa64-79e7b7f54e091
1020138dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCDb43d8fbd-1977-4465-aa64-79e7b7f54e091
1115329dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral SolutionSCDb43d8fbd-1977-4465-aa64-79e7b7f54e091
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) PackSYb43d8fbd-1977-4465-aa64-79e7b7f54e091
1020138dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral SolutionSYb43d8fbd-1977-4465-aa64-79e7b7f54e091
1020138dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral SolutionSYb43d8fbd-1977-4465-aa64-79e7b7f54e091
1115329dextromethorphan hydrobromide 30 MG / doxylamine succinate 12.5 MG per 20 ML Oral SolutionSYb43d8fbd-1977-4465-aa64-79e7b7f54e091
1115329dextromethorphan hydrobromide 7.5 MG / doxylamine succinate 3.125 MG per 5 ML Oral SolutionSYb43d8fbd-1977-4465-aa64-79e7b7f54e091

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0031-8718-13000318718131 BOTTLE in 1 CARTON (0031-8718-13) / 118 mL in 1 BOTTLE1 bottle2016-06-010000-00-00NoNoCurrent
0031-8718-18000318718181 BOTTLE in 1 CARTON (0031-8718-18) / 237 mL in 1 BOTTLE1 bottle2016-06-010000-00-00NoNoCurrent
0031-8718-24000318718241 BOTTLE in 1 CARTON (0031-8718-24) / 355 mL in 1 BOTTLE1 bottle2016-06-010000-00-00NoNoCurrent