Nighttime Cold and Flu
- Product NDC
- 41226-782
- 11-digit product format
- 412260782
- Labeler code
- 41226
- Product ID
- 41226-782_17a0316a-f751-c6d4-e063-6394a90a6da4
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethrophan HBr, Doxylamine succinate
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- Kroger
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-04-30
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
- Active strength
- 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL
- Pharmacologic classes
- Antihistamine [EPC], Histamine Receptor Antagonists [MoA], 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
- Nighttime Cold and Flu
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 650 mg/30mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 30 mg/30mL |
| DOXYLAMINE SUCCINATE | 12.5 mg/30mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 362O9ITL9D, 9D2RTI9KYH, V9BI9B5YI2 |
| Rxcui | 1043400 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 41226-782-01 | Nighttime Cold and Flu | 354 mL in 1 BOTTLE | LIQUID | 354 | 3 | |
| 41226-782-01 | Daytime NighttimeCold and Flu | 354 mL in 1 BOTTLE | LIQUID | 354 mL | 30 mg in 30mL | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 41226-782 | NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [KROGER] | 3 | Current NDC, 1 package rows | 20240509_10b08ea8-693e-eb18-e063-6394a90af548.zip |
| 41226-782 | DAYTIME NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DEXTROMETHORPHAN HBRDOXYLAMINE SUCCINATE) KIT [KROGER] | 2 | Current NDC | 20240518_10b15337-b9c5-4dc8-e063-6394a90ac056.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution | PSN | 10b08ea8-693e-eb18-e063-6394a90af548 | 3 |
| 1043400 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SCD | 10b08ea8-693e-eb18-e063-6394a90af548 | 3 |
| 1043400 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution | SY | 10b08ea8-693e-eb18-e063-6394a90af548 | 3 |
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution | SY | 10b08ea8-693e-eb18-e063-6394a90af548 | 3 |
| 1043400 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SY | 10b08ea8-693e-eb18-e063-6394a90af548 | 3 |
| 2637726 | {1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution) / 1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution) } Pack | GPCK | 10b15337-b9c5-4dc8-e063-6394a90ac056 | 2 |
| 2637726 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution) Pack | PSN | 10b15337-b9c5-4dc8-e063-6394a90ac056 | 2 |
| 1113705 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution | PSN | 10b15337-b9c5-4dc8-e063-6394a90ac056 | 2 |
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution | PSN | 10b15337-b9c5-4dc8-e063-6394a90ac056 | 2 |
| 1113705 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SCD | 10b15337-b9c5-4dc8-e063-6394a90ac056 | 2 |
| 1043400 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SCD | 10b15337-b9c5-4dc8-e063-6394a90ac056 | 2 |
| 2637726 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 mL Oral Solution) Pack | SY | 10b15337-b9c5-4dc8-e063-6394a90ac056 | 2 |
| 1113705 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | 10b15337-b9c5-4dc8-e063-6394a90ac056 | 2 |
| 1043400 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution | SY | 10b15337-b9c5-4dc8-e063-6394a90ac056 | 2 |
| 1113705 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | 10b15337-b9c5-4dc8-e063-6394a90ac056 | 2 |
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution | SY | 10b15337-b9c5-4dc8-e063-6394a90ac056 | 2 |
| 1113705 | APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SY | 10b15337-b9c5-4dc8-e063-6394a90ac056 | 2 |
| 1043400 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SY | 10b15337-b9c5-4dc8-e063-6394a90ac056 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 41226-782-01 | 41226078201 | 354 mL in 1 BOTTLE (41226-782-01) | 354 ml | 2024-04-30 | No | No | Current |