severe cold and flu relief
- Product NDC
- 11822-3120
- 11-digit product format
- 118223120
- Labeler code
- 11822
- Product ID
- 11822-3120_9143945b-96b6-4a61-af5a-b65f26374229
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Rite Aid Corporation
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-06-30
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 325; 10; 200; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL
- 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
openFDA Listing Details
- Product ID
- 11822-3120_9143945b-96b6-4a61-af5a-b65f26374229
- SPL ID
- 9143945b-96b6-4a61-af5a-b65f26374229
- Product type
- HUMAN OTC DRUG
- Finished product
- Yes
- Brand name base
- severe cold and flu relief
- Generic name
- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Marketing start
- 2023-06-30
- Marketing category
- OTC MONOGRAPH DRUG
- Application number
- M012
- 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]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 325 mg/15mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/15mL |
| GUAIFENESIN | 200 mg/15mL |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/15mL |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | 362O9ITL9D, 9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ |
| Rxcui | 1369842 |
| Spl Set Id | 296f20c0-8b5f-4a08-9329-f93c92e63867 |
| Manufacturer Name | Rite Aid Corporation |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 11822-3120-0 | 1 BOTTLE in 1 CARTON (11822-3120-0) / 355 mL in 1 BOTTLE | 2023-06-30 | No |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 362O9ITL9D | ACETAMINOPHEN | 103-90-2 | ACETAMINOPHEN |
| 9D2RTI9KYH | DEXTROMETHORPHAN HYDROBROMIDE | 6700-34-1 | DEXTROMETHORPHAN HYDROBROMIDE |
| 495W7451VQ | GUAIFENESIN | 93-14-1 | GUAIFENESIN |
| 04JA59TNSJ | PHENYLEPHRINE HYDROCHLORIDE | 61-76-7 | PHENYLEPHRINE HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 11822-3120-0 | 11822312000 | 1 BOTTLE in 1 CARTON (11822-3120-0) / 355 mL in 1 BOTTLE | 1 bottle | 2023-06-30 | No | No | Historical |