Robitussin Severe Multi-Symptom Cough Cold Flu
- Product NDC
- 0031-8751
- 11-digit product format
- 000318751
- Labeler code
- 0031
- Product ID
- 0031-8751_156f7025-ae4f-7de7-e063-6394a90a11bf
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- Haleon US Holdings LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2015-05-01
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 650; 20; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], 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], alpha-1 Adrenergic Agonist [EPC]
- 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 Severe Multi-Symptom Cough Cold Flu
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 650 mg/20mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 20 mg/20mL |
| GUAIFENESIN | 400 mg/20mL |
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/20mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
| 495W7451VQ | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1116572 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 66360295-f364-479a-8b49-c12b21918279 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0031-8751-12 | Robitussin Severe Multi-Symptom Cough Cold Flu | 118 mL in 1 BOTTLE | LIQUID | 118 | 8 | |
| 0031-8751-12 | Robitussin Severe Multi-Symptom Cough Cold Flu | 1 in 1 CARTON | LIQUID | 1 | 8 | |
| 0031-8751-18 | Robitussin Severe Multi-Symptom Cough Cold Flu | 237 mL in 1 BOTTLE | LIQUID | 237 | 8 | |
| 0031-8751-18 | Robitussin Severe Multi-Symptom Cough Cold Flu | 1 in 1 CARTON | LIQUID | 1 | 8 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0031-8751-12 | ML - Milliliter | 0031-8751 | c6be0fec-1cb9-4c0a-88c7-de76b7058449 | 1 | 2019-08-06 |
| 0031-8751-18 | ML - Milliliter | 0031-8751 | e8911c75-b420-4ed9-8eb6-14996ce7c66c | 1 | 2019-08-06 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0031-8751 | ROBITUSSIN SEVERE MULTI-SYMPTOM COUGH COLD FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [HALEON US HOLDINGS LLC] | 8 | Current NDC, Legacy NDC, 4 package rows | 20240408_66360295-f364-479a-8b49-c12b21918279.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 |
|---|---|---|---|---|---|---|
| Daytime Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | SALADO SALES INC. | 8f66f5bc-7c77-420b-9feb-911c980fbfdc | 2025-12-12 | Warnings | M012 |
| Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | WALMART INC. | de55a9fd-53a2-4f3e-82b7-cabcbe287d46 | 2025-12-12 | Warnings | M012 |
| Nighttime Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE | SALADO SALES INC. | cc73b668-cc6a-41d6-800a-4988c59c0449 | 2025-12-12 | Warnings | M012 |
| Allergy Relief | CHLORPHENIRAMINE MALEATE | CHAIN DRUG MARKETING ASSOCIATION INC | 75269bcc-3bb2-49a0-8788-6b7da18796d3 | 2025-12-12 | Warnings | M012 |
| Suphedrine PE Sinus plus Allergy | CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | ARMY AND AIR FORCE EXCHANGE SERVICE | affac07f-d645-4999-98ee-7467902f5adc | 2025-12-12 | Warnings | M012 |
| Sinus Congestion and Pain Relief Non-Drowsy | ACETAMINOPHEN, PHENYLEPHRINE HCL | WinCo Foods, LLC | f7e925f4-7da6-4157-a97f-e6a3e399911f | 2025-12-11 | Warnings | M012 |
| Sinus Relief Severe Congestion and Pain | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | CARDINAL HEALTH | 645f8075-e33f-4e1a-9249-7368261cdcb9 | 2025-12-11 | Warnings | M012 |
| Geri-Tussin | GUAIFENESIN | Geri-Care Pharmaceuticals, Corp | 8fd0071b-c6ca-49e6-b159-45dead71b664 | 2025-12-11 | Warnings | M012 |
| Geri-Tussin DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Geri-Care Pharmaceuticals, Corp | 098582dc-3e12-782f-e063-6394a90aa1a1 | 2025-12-11 | Warnings | M012 |
| GUAIASORB DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Geri-Care Pharmaceuticals, Corp | 09866b9c-aa32-45eb-e063-6394a90a4903 | 2025-12-11 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | VALU MERCHANDISERS COMPANY | d6947661-a6dd-4bc4-a0ca-932db1840f58 | 2025-12-11 | Warnings | M012 |
| Mucus Relief Sinus Severe Congestion Relief | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | VALU MERCHANDISERS COMPANY | 2e751d67-51b4-4b74-a9e8-7f3bc5636984 | 2025-12-11 | Warnings | M012 |
| Pressure and Pain Plus Mucus PE | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | VALU MERCHANDISERS COMPANY | 232acb86-7383-4992-b333-1e47bf7c06ad | 2025-12-11 | Warnings | M012 |
| Sinus Pressure plus Pain PE | ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE | VALU MERCHANDISERS COMPANY | 72847721-9f59-4af1-8f20-dc8449742918 | 2025-12-11 | Warnings | M012 |
| Cold plus Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | VALU MERCHANDISERS COMPANY | f6401317-0295-14b3-e053-2a95a90acbb4 | 2025-12-11 | Warnings | M012 |
| Head Congestion plus Flu Severe PE | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | VALU MERCHANDISERS COMPANY | f6401b58-8cf8-4067-e053-2995a90a68fc | 2025-12-11 | Warnings | M012 |
| Sinus Relief Pressure, Pain and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | VALU MERCHANDISERS COMPANY | b1ba37b8-4558-0808-e053-2995a90a9f5e | 2025-12-11 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | VALU MERCHANDISERS COMPANY | b84f37bc-be37-4f2b-83ee-d7d134184490 | 2025-12-11 | Warnings | M012 |
| Mucus Relief Cold Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | VALU MERCHANDISERS COMPANY | b1b7c7fc-1068-f486-e053-2a95a90a8e8c | 2025-12-11 | Warnings | M012 |
| Mucus Relief Cold and Flu All in One | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | VALU MERCHANDISERS COMPANY | b1b9e0da-2c54-8b31-e053-2995a90a690b | 2025-12-11 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1116572 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 20 mL Oral Solution | PSN | 66360295-f364-479a-8b49-c12b21918279 | 8 |
| 1116572 | acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution | SCD | 66360295-f364-479a-8b49-c12b21918279 | 8 |
| 1116572 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral Solution | SY | 66360295-f364-479a-8b49-c12b21918279 | 8 |
| 1116572 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine hydrochloride 10 MG per 20 ML Oral Solution | SY | 66360295-f364-479a-8b49-c12b21918279 | 8 |
| 1116572 | APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Guaifenesin 20 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral Solution | SY | 66360295-f364-479a-8b49-c12b21918279 | 8 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0031-8751-12 | 00031875112 | 1 BOTTLE in 1 CARTON (0031-8751-12) / 118 mL in 1 BOTTLE | 1 bottle | 2015-05-01 | 0000-00-00 | No | No | Current |
| 0031-8751-18 | 00031875118 | 1 BOTTLE in 1 CARTON (0031-8751-18) / 237 mL in 1 BOTTLE | 1 bottle | 2015-05-01 | 0000-00-00 | No | No | Current |