Severe Nighttime Cold and Flu Relief
- Product NDC
- 55319-641
- 11-digit product format
- 553190641
- Labeler code
- 55319
- Product ID
- 55319-641_b135042b-47eb-4018-8fdb-6e1b7d5a214c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen Dextromethorphan HBr Doxylamine Succinate Phenylephrine HCI
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- Family Dollar (FAMILY WELLNESS)
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-07-31
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 650; 20; 12.5; 10 mg/30mL; mg/30mL; mg/30mL; mg/30mL
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], 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], alpha-1 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- 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 Nighttime Cold and Flu Relief
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 650 mg/30mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 20 mg/30mL |
| DOXYLAMINE SUCCINATE | 12.5 mg/30mL |
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/30mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
| V9BI9B5YI2 | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1431245 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| e5c90d6e-70aa-4886-bc81-293e0dcf5638 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55319-641-08 | Daytime Nighttime Severe Cold and Flu Relief | 237 mL in 1 BOTTLE, PLASTIC | LIQUID | 237 mL | 20 mg in 30mL | 7 |
| 55319-641-08 | Severe Nighttime Cold and Flu Relief | 237 mL in 1 BOTTLE, PLASTIC | LIQUID | 237 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55319-641 | DAYTIME NIGHTTIME SEVERE COLD AND FLU RELIEF (ACETAMINOPHEN DEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCI DOXYLAMINE SUCINATE) KIT [FAMILY DOLLAR (FAMILY WELLNESS)] | 6 | Current NDC | 20250417_22918db6-9096-4eb8-a742-aaa2dd5c31da.zip |
| 55319-641 | SEVERE NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE PHENYLEPHRINE HCI) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)] | 2 | Current NDC, 1 package rows | 20240731_e5c90d6e-70aa-4886-bc81-293e0dcf5638.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 |
|---|---|---|---|---|
| 2637731 | {1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution) / 1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.3 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution) } Pack | GPCK | 22918db6-9096-4eb8-a742-aaa2dd5c31da | 7 |
| 2637731 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG in 30 mL Oral Solution) Pack | PSN | 22918db6-9096-4eb8-a742-aaa2dd5c31da | 7 |
| 1369842 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution | PSN | 22918db6-9096-4eb8-a742-aaa2dd5c31da | 7 |
| 1431245 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG in 30 mL Oral Solution | PSN | 22918db6-9096-4eb8-a742-aaa2dd5c31da | 7 |
| 1431245 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SCD | 22918db6-9096-4eb8-a742-aaa2dd5c31da | 7 |
| 1369842 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.3 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SCD | 22918db6-9096-4eb8-a742-aaa2dd5c31da | 7 |
| 2637731 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG per 15 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG per 30 mL Oral Solution) Pack | SY | 22918db6-9096-4eb8-a742-aaa2dd5c31da | 7 |
| 1431245 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | 22918db6-9096-4eb8-a742-aaa2dd5c31da | 7 |
| 1369842 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | 22918db6-9096-4eb8-a742-aaa2dd5c31da | 7 |
| 1431245 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | 22918db6-9096-4eb8-a742-aaa2dd5c31da | 7 |
| 1369842 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | 22918db6-9096-4eb8-a742-aaa2dd5c31da | 7 |
| 1431245 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral Solution | SY | 22918db6-9096-4eb8-a742-aaa2dd5c31da | 7 |
| 1369842 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / Guaifenesin 13.3 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral Solution | SY | 22918db6-9096-4eb8-a742-aaa2dd5c31da | 7 |
| 1431245 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG in 30 mL Oral Solution | PSN | e5c90d6e-70aa-4886-bc81-293e0dcf5638 | 4 |
| 1431245 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SCD | e5c90d6e-70aa-4886-bc81-293e0dcf5638 | 4 |
| 1431245 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | e5c90d6e-70aa-4886-bc81-293e0dcf5638 | 4 |
| 1431245 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | e5c90d6e-70aa-4886-bc81-293e0dcf5638 | 4 |
| 1431245 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral Solution | SY | e5c90d6e-70aa-4886-bc81-293e0dcf5638 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 55319-641-08 | 55319064108 | 237 mL in 1 BOTTLE, PLASTIC (55319-641-08) | 237 ml | 2024-07-31 | No | No | Current |