Cold and Flu
- Product NDC
- 0363-8063
- 11-digit product format
- 003638063
- Labeler code
- 0363
- Product ID
- 0363-8063_003918c4-bfb0-43ee-ab82-f88d00a3d7a4
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr, Triprolidine HCl
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Walgreen Company
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-10-23
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; TRIPROLIDINE HYDROCHLORIDE
- Active strength
- 650; 20; 2.5 mg/20mL; mg/20mL; mg/20mL
- Pharmacologic classes
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cold and Flu
- Brand name suffix
- Nighttime
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 650 mg/20mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 20 mg/20mL |
| TRIPROLIDINE HYDROCHLORIDE | 2.5 mg/20mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 362O9ITL9D, 9D2RTI9KYH, YAN7R5L890 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e4e263da-1c53-440f-bb80-b7a575843b5a | Product name | 1 | 20260313 |
| d2168cac-a261-415a-9c78-3522859fa720 | Product name | 3 | 20251124 |
| 05a8cdd1-eeb8-409e-b938-0778225eca7d | Product name | 4 | 20250221 |
| e5b5c132-b15d-435b-9faa-2f74e5cadcf9 | Product name | 8 | 20250220 |
| f489e8f3-5c9e-4818-b539-a73587edcfc7 | Product name | 2 | 20240229 |
| 0f7ae452-206d-4fc4-868d-56fc47074084 | Product name | 1 | 20231011 |
| b5abe2e3-39a1-43eb-9bff-f3c1653fe3df | Product name | 2 | 20190930 |
| e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814 | Product name | 3 | 20150910 |
| 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 |
| 30c51294-7ae9-8007-7de6-58222684a0be | Product name | 1 | 20140508 |
| 42f3c020-f1b3-89bc-7bdc-e1f10e680485 | Product name | 1 | 20140508 |
| e949165d-714d-e548-2b76-0cb5def16f30 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0363-8063-45 | Cold and FluNighttime | 177 mL in 1 BOTTLE, PLASTIC | SOLUTION | 177 | 4 | |
| 0363-8063-45 | Severe Congestion and Cough, Cold and FluNighttime | 177 mL in 1 BOTTLE, PLASTIC | SOLUTION | 177 mL | 20 mg in 20mL | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0363-8063 | COLD AND FLU NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL) SOLUTION [WALGREEN COMPANY] | 2 | Current NDC, 1 package rows | 20241023_de4e8af4-d3d0-44b3-aea3-79016803ccdc.zip |
| 0363-8063 | SEVERE CONGESTION AND COUGH, COLD AND FLU NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, TRIPROLIDINE HCL) KIT [WALGREEN COMPANY] | 2 | Current NDC | 20241017_b75af815-9bd4-4a7a-bc68-f42f4af50699.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2390630 | {1 (acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / triprolidine hydrochloride 0.125 MG/ML Oral Solution) / 1 (dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution) } Pack | GPCK | b75af815-9bd4-4a7a-bc68-f42f4af50699 | 4 |
| 2390630 | 1 daytime (dextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 20 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / triprolidine HCl 2.5 MG in 20 mL Oral Solution) Pack | PSN | b75af815-9bd4-4a7a-bc68-f42f4af50699 | 4 |
| 2173667 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / triprolidine HCl 2.5 MG in 20 mL Oral Solution | PSN | b75af815-9bd4-4a7a-bc68-f42f4af50699 | 4 |
| 1043543 | dextromethorphan HBr 5 MG / guaiFENesin 100 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution | PSN | b75af815-9bd4-4a7a-bc68-f42f4af50699 | 4 |
| 2173667 | acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / triprolidine hydrochloride 0.125 MG/ML Oral Solution | SCD | b75af815-9bd4-4a7a-bc68-f42f4af50699 | 4 |
| 1043543 | dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution | SCD | b75af815-9bd4-4a7a-bc68-f42f4af50699 | 4 |
| 2390630 | 1 daytime (dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / triprolidine HCl 2.5 MG per 20 ML Oral Solution) Pack | SY | b75af815-9bd4-4a7a-bc68-f42f4af50699 | 4 |
| 2173667 | acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / triprolidine hydrochloride 2.5 MG per 20 mL Oral Solution | SY | b75af815-9bd4-4a7a-bc68-f42f4af50699 | 4 |
| 2173667 | APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Triprolidine Hydrochloride 0.125 MG/ML Oral Solution | SY | b75af815-9bd4-4a7a-bc68-f42f4af50699 | 4 |
| 1043543 | dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral Solution | SY | b75af815-9bd4-4a7a-bc68-f42f4af50699 | 4 |
| 1043543 | dextromethorphan HBr 5 MG / guaifenesin 100 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Solution | SY | b75af815-9bd4-4a7a-bc68-f42f4af50699 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0363-8063-45 | 00363806345 | 177 mL in 1 BOTTLE, PLASTIC (0363-8063-45) | 177 ml | 2023-10-23 | No | No | Historical |