ONESSIP ADULT DAYTIME SEVERE COLD AND FLU
- Product NDC
- 87078-972
- 11-digit product format
- 870780972
- Labeler code
- 87078
- Product ID
- 87078-972_45fa9159-d74d-063a-e063-6294a90a3ed0
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCI
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- MEDWISE LIFESCIENCES INC.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-12-15
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 650; 20; 400; 10 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ONESSIP ADULT DAYTIME SEVERE COLD AND FLU
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 650 mg/15mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 20 mg/15mL |
| GUAIFENESIN | 400 mg/15mL |
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/15mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, 9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 87078-972-03 | ONESSIP ADULT DAYTIME SEVERE COLD AND FLU | 15 mL in 1 POUCH | SOLUTION | 15 | | 1 |
| 87078-972-32 | ONESSIP ADULT DAYTIME SEVERE COLD AND FLU | 12 in 1 CARTON | SOLUTION | 12 | | 1 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 87078-972-03 | 87078097203 | 15 mL in 1 POUCH | 15 ml | | | | Historical |
| 87078-972-32 | 87078097232 | 12 POUCH in 1 CARTON (87078-972-32) / 15 mL in 1 POUCH (87078-972-03) | 12 pouch | 2025-12-15 | No | No | Current |