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
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 Identifiers#
| Field | Values |
|---|---|
| Unii | 362O9ITL9D, 9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ |
| Rxcui | 1116572 |
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 |
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 |