Severe Congestion and Cough, Cold and Flu
- Product NDC
- 0363-4063
- 11-digit product format
- 003634063
- Labeler code
- 0363
- Product ID
- 0363-4063_b364fa5a-99ee-4738-a880-852a90c33e04
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl, Triprolidine HCl
- Dosage form
- KIT
- Labeler
- Walgreen Company
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-10-23
- 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
- Severe Congestion and Cough, Cold and Flu
- Brand name suffix
- Nighttime
- Listing expiration
- 2026-12-31
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| b75af815-9bd4-4a7a-bc68-f42f4af50699 | Available on FDA.report |
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 |
|---|---|---|---|---|---|---|
| 0363-4063-45 | Severe Congestion and Cough, Cold and FluNighttime | 1 in 1 PACKAGE | KIT | 1 | 4 | |
| 0363-8004-45 | Severe Congestion and Cough, Cold and FluNighttime | 177 mL in 1 BOTTLE, PLASTIC | SOLUTION | 177 mL | 400 mg in 20mL | 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 |
|---|---|---|---|---|
| 0363-4063 | SEVERE CONGESTION AND COUGH, COLD AND FLU NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, TRIPROLIDINE HCL) KIT [WALGREEN COMPANY] | 2 | Current NDC, 3 package rows | 20241017_b75af815-9bd4-4a7a-bc68-f42f4af50699.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.
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 |
|---|---|---|---|---|---|---|---|
| 0363-4063-45 | 00363406345 | 1 KIT in 1 PACKAGE (0363-4063-45) * 177 mL in 1 BOTTLE, PLASTIC (0363-8004-45) * 177 mL in 1 BOTTLE, PLASTIC (0363-8063-45) | 1 kit | 2023-10-23 | No | No | Current |
| 0363-8004-45 | 00363800445 | 177 mL in 1 BOTTLE, PLASTIC | 177 ml | Historical | |||
| 0363-8063-45 | 00363806345 | 177 mL in 1 BOTTLE, PLASTIC | 177 ml | Historical |