Daytime Severe Cold and Flu
- Product NDC
- 69676-0093
- 11-digit product format
- 696760093
- Labeler code
- 69676
- Product ID
- 69676-0093_2d9857c2-f02a-1a24-e063-6394a90ae1b8
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Genexa Inc.
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-07-03
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
- Active strength
- 650; 20 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
- Daytime Severe Cold and Flu
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 650 mg/20mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 20 mg/20mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 362O9ITL9D, 9D2RTI9KYH |
| Rxcui | 2693772 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69676-0093-9 | Daytime and Nighttime Severe Cold and Flu combo pack | 177 mL in 1 BOTTLE | SUSPENSION | 177 mL | 650 mg in 20mL | 2 |
| 69676-0093-9 | Daytime Severe Cold and Flu | 177 mL in 1 BOTTLE | SUSPENSION | 177 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 69676-0093 | DAYTIME SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR) SUSPENSION [GENEXA INC.] | 2 | Current NDC, 1 package rows | 20250210_22f23aeb-f874-6e54-e063-6394a90a9565.zip |
| 69676-0093 | DAYTIME AND NIGHTTIME SEVERE COLD AND FLU COMBO PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) KIT [GENEXA INC.] | 1 | Current NDC | 20240927_190c7eaf-dcd4-d314-e063-6294a90a6f33.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2693777 | {1 (acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Suspension) / 1 (acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral Suspension) } Pack | GPCK | 190c7eaf-dcd4-d314-e063-6294a90a6f33 | 2 |
| 2693777 | 1 daytime (acetaminophen 650 MG / dextromethorphan HBr 20 MG in 20 mL Oral Suspension) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 20 mL Oral Suspension) Pack | PSN | 190c7eaf-dcd4-d314-e063-6294a90a6f33 | 2 |
| 2693772 | acetaminophen 650 MG / dextromethorphan HBr 20 MG in 20 mL Oral Suspension | PSN | 190c7eaf-dcd4-d314-e063-6294a90a6f33 | 2 |
| 2693772 | acetaminophen 650 MG / dextromethorphan HBr 20 MG in 20 mL Oral Suspension | PSN | 22f23aeb-f874-6e54-e063-6394a90a9565 | 2 |
| 2692302 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 20 mL Oral Suspension | PSN | 190c7eaf-dcd4-d314-e063-6294a90a6f33 | 2 |
| 2693772 | acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Suspension | SCD | 22f23aeb-f874-6e54-e063-6394a90a9565 | 2 |
| 2693772 | acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Suspension | SCD | 190c7eaf-dcd4-d314-e063-6294a90a6f33 | 2 |
| 2692302 | acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral Suspension | SCD | 190c7eaf-dcd4-d314-e063-6294a90a6f33 | 2 |
| 2693777 | 1 daytime (acetaminophen 650 MG / dextromethorphan HBr 20 MG per 20 mL Oral Suspension) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 20 ML Oral Suspension) Pack | SY | 190c7eaf-dcd4-d314-e063-6294a90a6f33 | 2 |
| 2693772 | acetaminophen 325 MG / dextromethorphan HBr 10 MG per 10 mL Oral Suspension | SY | 190c7eaf-dcd4-d314-e063-6294a90a6f33 | 2 |
| 2693772 | acetaminophen 325 MG / dextromethorphan HBr 10 MG per 10 mL Oral Suspension | SY | 22f23aeb-f874-6e54-e063-6394a90a9565 | 2 |
| 2693772 | acetaminophen 650 MG / dextromethorphan HBr 20 MG per 20 mL Oral Suspension | SY | 22f23aeb-f874-6e54-e063-6394a90a9565 | 2 |
| 2693772 | acetaminophen 650 MG / dextromethorphan HBr 20 MG per 20 mL Oral Suspension | SY | 190c7eaf-dcd4-d314-e063-6294a90a6f33 | 2 |
| 2692302 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 20 ML Oral Suspension | SY | 190c7eaf-dcd4-d314-e063-6294a90a6f33 | 2 |
| 2693772 | APAP 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Suspension | SY | 190c7eaf-dcd4-d314-e063-6294a90a6f33 | 2 |
| 2693772 | APAP 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Suspension | SY | 22f23aeb-f874-6e54-e063-6394a90a9565 | 2 |
| 2692302 | APAP 32.5 MG/ML / dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral Suspension | SY | 190c7eaf-dcd4-d314-e063-6294a90a6f33 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 69676-0093-9 | 69676009309 | 177 mL in 1 BOTTLE (69676-0093-9) | 177 ml | 2024-07-03 | No | No | Current |