Severe Cold and Flu
- Product NDC
- 42507-763
- 11-digit product format
- 425070763
- Labeler code
- 42507
- Product ID
- 42507-763_1f9bfa6c-334a-4aa1-be3b-cb0b793beef0
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- HyVee Inc
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2014-01-12
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Severe Cold and Flu
- Brand name suffix
- Night time
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 650 mg/30mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 20 mg/30mL |
| DOXYLAMINE SUCCINATE | 12.5 mg/30mL |
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/30mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, 9D2RTI9KYH, V9BI9B5YI2, 04JA59TNSJ |
| Rxcui | 1431245 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42507-763-34 | Severe Cold and FluNight time | 237 mL in 1 BOTTLE | SOLUTION | 237 | | 5 |
| 42507-763-40 | Severe Cold and FluNight time | 355 mL in 1 BOTTLE | SOLUTION | 355 | | 5 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | SEVERE COLD AND FLU NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [HYVEE INC] | 2 | |
| DEXTROMETHORPHAN HYDROBROMIDE | ACTIVE INGREDIENT | 9D2RTI9KYH | SEVERE COLD AND FLU NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [HYVEE INC] | 2 | |
| DOXYLAMINE SUCCINATE | ACTIVE INGREDIENT | V9BI9B5YI2 | SEVERE COLD AND FLU NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [HYVEE INC] | 2 | |
| PHENYLEPHRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 04JA59TNSJ | SEVERE COLD AND FLU NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [HYVEE INC] | 2 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | SEVERE COLD AND FLU NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [HYVEE INC] | 2 | |
| DEXTROMETHORPHAN | ACTIVE MOIETY | 7355X3ROTS | SEVERE COLD AND FLU NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [HYVEE INC] | 2 | |
| DOXYLAMINE | ACTIVE MOIETY | 95QB77JKPL | SEVERE COLD AND FLU NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [HYVEE INC] | 2 | |
| PHENYLEPHRINE | ACTIVE MOIETY | 1WS297W6MV | SEVERE COLD AND FLU NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [HYVEE INC] | 2 | |
| BUTYLATED HYDROXYANISOLE | INACTIVE INGREDIENT | REK4960K2U | SEVERE COLD AND FLU NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [HYVEE INC] | 2 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | SEVERE COLD AND FLU NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [HYVEE INC] | 2 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | SEVERE COLD AND FLU NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [HYVEE INC] | 2 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | SEVERE COLD AND FLU NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [HYVEE INC] | 2 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | SEVERE COLD AND FLU NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [HYVEE INC] | 2 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | SEVERE COLD AND FLU NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [HYVEE INC] | 2 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | SEVERE COLD AND FLU NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [HYVEE INC] | 2 | |
| SACCHARIN SODIUM | INACTIVE INGREDIENT | SB8ZUX40TY | SEVERE COLD AND FLU NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [HYVEE INC] | 2 | |
| SODIUM PHOSPHATE, MONOBASIC | INACTIVE INGREDIENT | 3980JIH2SW | SEVERE COLD AND FLU NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [HYVEE INC] | 2 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | SEVERE COLD AND FLU NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [HYVEE INC] | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | SEVERE COLD AND FLU NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [HYVEE INC] | 2 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | SEVERE COLD AND FLU NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) SOLUTION [HYVEE INC] | 2 | |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 42507-763-34 | 42507076334 | 237 mL in 1 BOTTLE | 237 ml | | | | Historical |
| 42507-763-40 | 42507076340 | 355 mL in 1 BOTTLE (42507-763-40) | 355 ml | 2014-01-12 | No | No | Current |