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 | DIPHENHYDRAMINE HCL | CVS Pharmacy | eafd9823-c0ad-454a-b725-562d88ebec92 | 2026-03-23 | Warnings | M012 |
| Daytime Severe Cold and Flu | ACETAMINOPHEN,DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Grocery Outlet, Inc. | 4db0470b-1bf0-9137-e063-6394a90a1d54 | 2026-03-23 | Warnings | M012 |
| Nighttime Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Grocery Outlet, Inc. | 4db066d4-ddbe-ddce-e063-6394a90ac5f8 | 2026-03-23 | Warnings | M012 |
| Throat Comfort Orange Mint Cinnamon Drops | MENTHOL | Ricola Ag | 27487e5c-044c-41eb-865f-2f34351afd52 | 2026-03-23 | Warnings | M012 |
| Daytime Nighttime Cold Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | f288eeca-9803-4962-a802-fe34f5983c7a | 2026-03-23 | Warnings | M012 |
| Throat Comfort Lemon Mint Ginger Drops | MENTHOL | Ricola Ag | d63b4d24-e926-418c-bb17-420aeaad5a62 | 2026-03-23 | Warnings | M012 |
| Mucus Relief Congestion Cough Maximum Strength Severe Congestion and Cough | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 6e7dfee1-3de9-46c8-9b58-83fcf8ee72e0 | 2026-03-23 | Warnings | M012 |
| Maximum Strength Mucus Relief | DEXTROMETHORPHAN HBR, GUAIFENESIN | Hyvee Inc | 44eafc83-8e7b-89b8-e063-6394a90ab0bc | 2026-03-23 | Warnings | M012 |
| Throat Comfort Lemon Mint Ginger Drops | MENTHOL | Ricola USA Inc. | 5d7889b1-3866-49b0-97e1-1e883a52d3cb | 2026-03-23 | Warnings | M012 |
| Throat Comfort Orange Mint Cinnamon Drops | MENTHOL | Ricola USA Inc. | 1487652c-dbc1-40f4-9d59-891ec74cc363 | 2026-03-23 | Warnings | M012 |
| Mucus Relief Cold Flu and Sore Throat Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 4e2a8b53-0074-42fd-8357-a39cc6afe608 | 2026-03-23 | Warnings | M012 |
| Mucus Relief Severe Cold Daytime Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | TARGET Corporation | 5ccaf3b0-096a-4644-9c6e-9f251c167b3c | 2026-03-23 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCL | Grocery Outlet, Inc. | 4d88180f-610c-d9ab-e063-6394a90a09f0 | 2026-03-21 | Warnings | M012 |
| Cold Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | HyVee Inc | cc371bc3-ba7a-430d-9ee4-22e9c50935f1 | 2026-03-20 | Warnings | M012 |
| Daytime Nighttime Multi Symptom Cold Childrens | DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL,ACETAMINOPHEN,DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Walgreens | da4c36f5-ec79-4489-bb18-8ddab79c34bd | 2026-03-20 | Warnings | M012 |
| Sanatos Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE | Pharmadel LLC | 3bddcd5a-7776-49ff-e063-6294a90a5dd1 | 2026-03-20 | Warnings | M012 |
| Vaporizing | CAMPHOR | Amazon.com Services LLC | 21cfe9cb-5ff5-4331-8358-4d1d9646d6ac | 2026-03-19 | Warnings, Adverse reactions | M012 |
| Equate Wild Cherry Throat Drop | PECTIN | Walmart | 4d66547a-b72a-a0ac-e063-6394a90adc71 | 2026-03-19 | Warnings | M012 |
| Nighttime Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Safeway, Inc. | 45d44cd2-5187-4a5c-983a-edb1e8eba0b2 | 2026-03-19 | Warnings | M012 |
| Sedalmex XL Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Belmora LLC | f2edfedf-e06e-4d1b-8c2d-732e08ec113c | 2026-03-19 | 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 |