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
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Robitussin Maximum Strength Nighttime Cough DM
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 30 mg/20mL |
| DOXYLAMINE SUCCINATE | 12.5 mg/20mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9D2RTI9KYH | Internal UNII lookup |
| V9BI9B5YI2 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1115329 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 44feee2f-25bc-48d4-8e13-db1d9daaaa90 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bf324df6-7127-7deb-def5-2681c136cd03 | Product name | 3 | 20250325 |
| 59361619-24d9-b610-eca6-5a7f25ed5e03 | Product name | 5 | 20240909 |
| 43a1ed49-eae2-4840-8075-cb4b33478540 | Product name | 1 | 20230425 |
| e2db08c6-133f-4f4f-afb4-e90a2418d6f6 | Product name | 1 | 20230320 |
| ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906 | Product name | 7 | 20210625 |
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| 11ed6f83-cdd2-4637-8379-b1a1d3ae3cde | Product name | 1 | 20181101 |
| 86c45a79-b9f0-4476-a27c-6e10db098497 | Product name | 1 | 20180125 |
| f4368033-af8c-41bf-a84b-ff77392b8522 | Product name | 1 | 20161229 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 4fe95224-f543-4dbb-9445-8cca122b48c8 | Product name | 1 | 20150609 |
| e8718272-64cb-4436-969b-176c3067c8f4 | Product name | 1 | 20150609 |
| 106ff02a-57e1-4c4c-a307-fd582ff4e311 | Product name | 1 | 20150212 |
| 76633df9-0d59-4b88-03ed-21dee1b966f8 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0031-8718-13 | Robitussin Maximum Strength Nighttime Cough DM | 1 in 1 CARTON | SOLUTION | 1 | 10 | |
| 0031-8718-13 | Robitussin Maximum Strength Nighttime Cough DM | 118 mL in 1 BOTTLE | SOLUTION | 118 | 10 | |
| 0031-8718-18 | Robitussin Maximum Strength Nighttime Cough DM | 237 mL in 1 BOTTLE | SOLUTION | 237 | 10 | |
| 0031-8718-18 | Robitussin Maximum Strength Nighttime Cough DM | 1 in 1 CARTON | SOLUTION | 1 | 10 | |
| 0031-8718-24 | Robitussin Maximum Strength Nighttime Cough DM | 355 mL in 1 BOTTLE | SOLUTION | 355 | 10 | |
| 0031-8718-24 | Robitussin Maximum Strength Nighttime Cough DM | 1 in 1 CARTON | SOLUTION | 1 | 10 | |
| 0031-8718-18 | RobitussinDay and Night Cough Relief DM Max | 1 in 1 CARTON | SOLUTION | 12.5 mg in 20mL | 4 | |
| 0031-8718-18 | RobitussinDay and Night Cough Relief DM Max | 237 mL in 1 BOTTLE | SOLUTION | 237 mL | 30 mg in 20mL | 4 |
| 0031-8718-13 | RobitussinDay and Night Maximum Strength Cough DM | 1 in 1 CARTON | SOLUTION | 12.5 mg in 20mL | 1 | |
| 0031-8718-13 | RobitussinDay and Night Maximum Strength Cough DM | 118 mL in 1 BOTTLE | SOLUTION | 118 mL | 30 mg in 20mL | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0031-8718-13 | ML - Milliliter | 0031-8718 | 17cf427c-d526-4213-b309-8d0e9c33ec19 | 1 | 2019-02-13 |
| 0031-8718-18 | ML - Milliliter | 0031-8718 | bebdbba5-3b06-4073-8d1c-fa1ffe74fd46 | 1 | 2019-06-19 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0031-8718 | ROBITUSSIN MAXIMUM STRENGTH NIGHTTIME COUGH DM (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) SOLUTION [HALEON US HOLDINGS LLC] | 9 | Current NDC, Legacy NDC, 6 package rows | 20250315_44feee2f-25bc-48d4-8e13-db1d9daaaa90.zip |
| 0031-8718 | ROBITUSSIN DAY AND NIGHT COUGH RELIEF DM MAX (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE) KIT [HALEON US HOLDINGS LLC] | 2 | Current NDC, Legacy NDC | 20250507_b3d02c91-8f79-4eb4-a378-1072474c572c.zip |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Allergy Relief Extra Strength | DIPHENHYDRAMINE HCL | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 4f33c1fb-150b-4083-a9a4-c0fbab4b6133 | 2026-01-27 | Warnings | M012 |
| Cold and Flu Daytime Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Meijer Distribution Inc | 5ca7dc60-af0c-47c6-b453-8b39c744eb5b | 2026-01-27 | Warnings | M012 |
| Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | HyVee Inc | 2ce5f2af-cabc-466f-b0c5-256e6e6d4c88 | 2026-01-27 | Warnings | M012 |
| Sinus Headache and Pain Day, Non-drowsy | ACETAMINOPHEN, PHENYLEPHRINE HCL | ARMY AND AIR FORCE EXCHANGE SERVICE | c33340c0-47d3-45e2-997b-3d9fb148900f | 2026-01-27 | Warnings | M012 |
| Cold and Flu Daytime Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | L.N.K. International, Inc. | b7501b59-d25a-49ec-9cbf-47018bce8397 | 2026-01-27 | Warnings | M012 |
| good sense nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | L. Perrigo Company | f90bd64a-dd1a-4319-87cd-427d57f677ab | 2026-01-26 | Warnings | M012 |
| Equate Health Non Drowsy DAY Cold and Flu Plus and NIGHTTIME Cold and Flu Plus | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Wal-Mart Stores Inc | 547ff880-3d40-4a4a-84ee-cd0d5290a9b9 | 2026-01-26 | Warnings | M012 |
| Maximum Strength Non Drowsy Day and Night Cold and Flu | MAXIMUM STRENGTH NON DROWSY DAY AND NIGHT COLD AND FLU | WAL-MART STORES INC | d6a35fb8-1899-4da2-ad2b-0423e332845d | 2026-01-26 | Warnings | M012 |
| MUCUS RELIEF | GUAIFENESIN | Prodose, Inc. | 7e5de5b0-18f0-4807-8686-da9821f918ce | 2026-01-26 | Warnings | M012 |
| ALLERGY RELIEF | DIPHENHYDRAMINE HYDROCHLORIDE | Wal-Mart Stores Inc | b9fbf917-12b7-770f-e053-2995a90afe93 | 2026-01-26 | Warnings | M012 |
| Maximum Strength Non Drowsy Daytime Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Wal-Mart Stores Inc | b58b2c36-a403-4dae-b3b2-f0ffd28a963b | 2026-01-26 | Warnings | M012 |
| Allergy Relief Dye Free | DIPHENHYDRAMINE HCL | Wal-Mart Stores Inc | 870e6bcb-84ab-45e0-ae57-08a9a182eb0b | 2026-01-26 | Warnings | M012 |
| Allergy Relief Dye Free | DIPHENHYDRAMINE HCL | Wal-Mart Stores Inc | eb8e83a4-981b-48a5-88f4-3a0ba358d3bc | 2026-01-26 | Warnings | M012 |
| NIGHTTIME SEVERE COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE | Wal-Mart Stores Inc | 8d2d765f-a7e3-40e6-b35d-0e8806a7ea59 | 2026-01-26 | Warnings | M012 |
| NIGHTTIME COLD AND FLU CHERRY | PHENYLEPHRINE, DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, DOXYLAMINE SUCCINATE | Walgreen Company | 02a6781c-aa6f-8fb0-e063-6294a90a043d | 2026-01-26 | Warnings | M012 |
| Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN, DOXYLAMINE SUCCINATE | Walgreen Company | 02e5f475-4e9f-2856-e063-6294a90a21fd | 2026-01-26 | Warnings | M012 |
| GNP Vapor Steam camphor (synthetic) | CAMPHOR (SYNTHETIC) | AmerisourceBergen | 0bcc55bf-9654-120b-e063-6394a90a59d1 | 2026-01-26 | Warnings | M012 |
| S2 | RACEPINEPHRINE HYDROCHLORIDE | Nephron Pharmaceuticals Corporation | dd1b35c7-b23b-4b95-8162-df3d263fe32e | 2026-01-26 | Warnings | M012 |
| SEVERE COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 0d97c634-0975-42d5-8ade-2ed2018cfe9d | 2026-01-26 | Warnings | M012 |
| GOOD SENSE NIGHT TIME | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | L. Perrigo Company | cd68289b-3850-40c6-9439-aae0e2d7637d | 2026-01-26 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1115329 | dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 20 mL Oral Solution | PSN | 44feee2f-25bc-48d4-8e13-db1d9daaaa90 | 10 |
| 1115329 | dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral Solution | SCD | 44feee2f-25bc-48d4-8e13-db1d9daaaa90 | 10 |
| 1115329 | dextromethorphan hydrobromide 30 MG / doxylamine succinate 12.5 MG per 20 ML Oral Solution | SY | 44feee2f-25bc-48d4-8e13-db1d9daaaa90 | 10 |
| 1115329 | dextromethorphan hydrobromide 7.5 MG / doxylamine succinate 3.125 MG per 5 ML Oral Solution | SY | 44feee2f-25bc-48d4-8e13-db1d9daaaa90 | 10 |
| 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) } Pack | GPCK | b3d02c91-8f79-4eb4-a378-1072474c572c | 4 |
| 2056073 | 1 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) Pack | PSN | b3d02c91-8f79-4eb4-a378-1072474c572c | 4 |
| 1020138 | dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral Solution | PSN | b3d02c91-8f79-4eb4-a378-1072474c572c | 4 |
| 1115329 | dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 20 mL Oral Solution | PSN | b3d02c91-8f79-4eb4-a378-1072474c572c | 4 |
| 1020138 | dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral Solution | SCD | b3d02c91-8f79-4eb4-a378-1072474c572c | 4 |
| 1115329 | dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral Solution | SCD | b3d02c91-8f79-4eb4-a378-1072474c572c | 4 |
| 2056073 | 1 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) Pack | SY | b3d02c91-8f79-4eb4-a378-1072474c572c | 4 |
| 1020138 | dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral Solution | SY | b3d02c91-8f79-4eb4-a378-1072474c572c | 4 |
| 1020138 | dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral Solution | SY | b3d02c91-8f79-4eb4-a378-1072474c572c | 4 |
| 1115329 | dextromethorphan hydrobromide 30 MG / doxylamine succinate 12.5 MG per 20 ML Oral Solution | SY | b3d02c91-8f79-4eb4-a378-1072474c572c | 4 |
| 1115329 | dextromethorphan hydrobromide 7.5 MG / doxylamine succinate 3.125 MG per 5 ML Oral Solution | SY | b3d02c91-8f79-4eb4-a378-1072474c572c | 4 |
| 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) } Pack | GPCK | b43d8fbd-1977-4465-aa64-79e7b7f54e09 | 1 |
| 2056073 | 1 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) Pack | PSN | b43d8fbd-1977-4465-aa64-79e7b7f54e09 | 1 |
| 1020138 | dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral Solution | PSN | b43d8fbd-1977-4465-aa64-79e7b7f54e09 | 1 |
| 1115329 | dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 20 mL Oral Solution | PSN | b43d8fbd-1977-4465-aa64-79e7b7f54e09 | 1 |
| 1020138 | dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral Solution | SCD | b43d8fbd-1977-4465-aa64-79e7b7f54e09 | 1 |
| 1115329 | dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral Solution | SCD | b43d8fbd-1977-4465-aa64-79e7b7f54e09 | 1 |
| 2056073 | 1 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) Pack | SY | b43d8fbd-1977-4465-aa64-79e7b7f54e09 | 1 |
| 1020138 | dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral Solution | SY | b43d8fbd-1977-4465-aa64-79e7b7f54e09 | 1 |
| 1020138 | dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral Solution | SY | b43d8fbd-1977-4465-aa64-79e7b7f54e09 | 1 |
| 1115329 | dextromethorphan hydrobromide 30 MG / doxylamine succinate 12.5 MG per 20 ML Oral Solution | SY | b43d8fbd-1977-4465-aa64-79e7b7f54e09 | 1 |
| 1115329 | dextromethorphan hydrobromide 7.5 MG / doxylamine succinate 3.125 MG per 5 ML Oral Solution | SY | b43d8fbd-1977-4465-aa64-79e7b7f54e09 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0031-8718-13 | 00031871813 | 1 BOTTLE in 1 CARTON (0031-8718-13) / 118 mL in 1 BOTTLE | 1 bottle | 2016-06-01 | 0000-00-00 | No | No | Current |
| 0031-8718-18 | 00031871818 | 1 BOTTLE in 1 CARTON (0031-8718-18) / 237 mL in 1 BOTTLE | 1 bottle | 2016-06-01 | 0000-00-00 | No | No | Current |
| 0031-8718-24 | 00031871824 | 1 BOTTLE in 1 CARTON (0031-8718-24) / 355 mL in 1 BOTTLE | 1 bottle | 2016-06-01 | 0000-00-00 | No | No | Current |