Severe Cold and Flu Relief
- Product NDC
- 55910-515
- 11-digit product format
- 559100515
- Labeler code
- 55910
- Product ID
- 55910-515_4d50ad4f-b21f-4500-8560-d81273a592fe
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2018-03-31
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 325; 10; 200; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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 Cold and Flu Relief
- Brand name suffix
- Daytime
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/15mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/15mL |
| GUAIFENESIN | 200 mg/15mL |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/15mL |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55910-515-08 | Severe Cold and Flu ReliefDaytime | 237 mL in 1 BOTTLE, PLASTIC | LIQUID | 237 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55910-515 | SEVERE COLD AND FLU RELIEF DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)] | 5 | Current NDC, Legacy NDC, 1 package rows | 20240906_91cd42fb-0aaf-4e83-b99c-9c521f93e874.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 | fb3809b1-4b10-4027-9cae-d97f121410cf | 6 |
| 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 | fb3809b1-4b10-4027-9cae-d97f121410cf | 6 |
| 1369842 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution | PSN | fb3809b1-4b10-4027-9cae-d97f121410cf | 6 |
| 1431245 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG in 30 mL Oral Solution | PSN | fb3809b1-4b10-4027-9cae-d97f121410cf | 6 |
| 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 | fb3809b1-4b10-4027-9cae-d97f121410cf | 6 |
| 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 | fb3809b1-4b10-4027-9cae-d97f121410cf | 6 |
| 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 | fb3809b1-4b10-4027-9cae-d97f121410cf | 6 |
| 1431245 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | fb3809b1-4b10-4027-9cae-d97f121410cf | 6 |
| 1369842 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | fb3809b1-4b10-4027-9cae-d97f121410cf | 6 |
| 1431245 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | fb3809b1-4b10-4027-9cae-d97f121410cf | 6 |
| 1369842 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | fb3809b1-4b10-4027-9cae-d97f121410cf | 6 |
| 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 | fb3809b1-4b10-4027-9cae-d97f121410cf | 6 |
| 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 | fb3809b1-4b10-4027-9cae-d97f121410cf | 6 |
| 1369842 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution | PSN | 91cd42fb-0aaf-4e83-b99c-9c521f93e874 | 5 |
| 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 | 91cd42fb-0aaf-4e83-b99c-9c521f93e874 | 5 |
| 1369842 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | 91cd42fb-0aaf-4e83-b99c-9c521f93e874 | 5 |
| 1369842 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | 91cd42fb-0aaf-4e83-b99c-9c521f93e874 | 5 |
| 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 | 91cd42fb-0aaf-4e83-b99c-9c521f93e874 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 55910-515-08 | 55910051508 | 237 mL in 1 BOTTLE, PLASTIC (55910-515-08) | 237 ml | 2018-03-31 | 0000-00-00 | No | No | Current |