Nighttime Severe Cold and Flu
- Product NDC
- 41226-775
- 11-digit product format
- 412260775
- Labeler code
- 41226
- Product ID
- 41226-775_17c2f13d-13cd-ff3c-e063-6294a90a8b10
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- Kroger
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-04-30
- Substance
- DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
- Active strength
- 12.5; 10; 650; 20 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
- 2026-12-31
- 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
- Nighttime Severe Cold and Flu
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DOXYLAMINE SUCCINATE | 12.5 mg/30mL |
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/30mL |
| ACETAMINOPHEN | 650 mg/30mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 20 mg/30mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| V9BI9B5YI2 | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
| 362O9ITL9D | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1431245 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 10b0bcff-d3bc-f70c-e063-6394a90a35ed | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 41226-775-01 | Nighttime Severe Cold and Flu | 354 mL in 1 BOTTLE | LIQUID | 354 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 41226-775 | NIGHTTIME SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) LIQUID [KROGER] | 2 | Current NDC, 1 package rows | 20240509_10b0bcff-d3bc-f70c-e063-6394a90a35ed.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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| AXIV DayTime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | VIVUNT PHARMA LLC | 131b1f17-cd86-f9b3-e063-6294a90a3028 | 2025-02-12 | Warnings | M012 |
| Maximum Strength Mucus Relief DM Max | DEXTROMETHORPHAN HBR, GUAIFENESIN | Topco Associates, LLC | 17d0dbc7-c8c2-7917-e063-6394a90a42af | 2025-02-12 | Warnings | M012 |
| DAYTIME COLD AND FLU | DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE | Kroger Company | bc00bbf8-52bb-fa75-e053-2a95a90a9406 | 2025-02-11 | Warnings | M012 |
| Daytime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCI 325, 10, 5 MG SOFTGELS | TIME CAP LABORATORIES, INC. | fd24653e-c4fa-3c09-e053-6394a90aaa9e | 2025-02-10 | Warnings | M012 |
| Daytime Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCI, DOXYLAMINE SUCCINATE 325, 10/15, 5, 6.25 MG SOFTGELS | TIME CAP LABORATORIES INC. | fd81dd4b-9617-f4c1-e053-6394a90a5e72 | 2025-02-10 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | DOLGENCORP, LLC | be2207b7-b8f8-7fba-e053-2a95a90abd16 | 2025-02-10 | Warnings | M012 |
| NIGHTTIME COLD AND FLU | DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, DOXYLAMINE SUCCINATE | Kroger Company | bc0115a3-5322-855d-e053-2995a90aba27 | 2025-02-10 | Warnings | M012 |
| Day time high blood pressure cold and flu | ACETAMINOPHEN DEXTROMETHORPHAN HBR | Camber Consumer Care | 09fbd872-0970-4864-9308-4a7b85983920 | 2025-02-10 | Warnings | M012 |
| Cough Drops | MENTHOL | The Kroger CO | f05e11ce-c908-acbc-e053-2a95a90a584e | 2025-02-09 | Warnings | M012 |
| Cough Drops | MENTHOL | The Kroger CO | f035c499-cda6-fadf-e053-2995a90af457 | 2025-02-09 | Warnings | M012 |
| Cough Drops | MENTHOL | The Kroger CO | f6d977ce-bbca-f1cc-e053-6394a90acc96 | 2025-02-09 | Warnings | M012 |
| Cough Drops | MENTHOL | The Kroger CO | f6da36d3-496d-2336-e053-6394a90a0f83 | 2025-02-09 | Warnings | M012 |
| Cough Drops | MENTHOL | The Kroger CO | f6da2e02-42c7-1ede-e053-6394a90aff5f | 2025-02-09 | Warnings | M012 |
| MUCOSA DM | GUAIFENESIN DEXTROMETHORPHAN | TIME CAP LABORATORIES, INC. | 62c1f4aa-6571-414c-9a58-31e107b7db97 | 2025-02-08 | Warnings | M012 |
| Childrens Cough and Chest Congestion | DEXTROMETHORPHAN HBR, GUAIFENESIN | Genexa Inc. | 2d95d5a4-34dc-e195-e063-6394a90a39da | 2025-02-07 | Warnings | M012 |
| Halls Sugar Free Honey Lemon | MENTHOL | Mondelez Global LLC | 5d56ccd2-1c28-4750-9454-44809091ad2f | 2025-02-05 | Warnings | M012 |
| SanaTos Mucus Relief Cold Toddlers | DEXTROMETHORPHAN HBR, GUAIFENESIN | Pharmadel LLC | 60672feb-1421-651e-e053-2a91aa0af41d | 2025-02-04 | Warnings | M012 |
| SofSkin Vaporizing Chest Rub and Cough Suppressant | CAMPHOR, MENTHOL, EUCALYPTUS OIL | Viny Health and Beauty Inc | 34626cf5-64fc-15c0-e063-6294a90aa310 | 2025-02-04 | Warnings | M012 |
| Pain Reliever PM | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | CVS PHARMACY, INC | 17922df7-7867-4300-bd99-55aee7b60606 | 2025-02-04 | Warnings | M012 |
| No Drip Nasal Mist | OXYMETAZOLINE SPRAY | CVS Health | f4b8ff54-47b5-4d18-bf4e-b101abb22a24 | 2025-02-03 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1431245 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG in 30 mL Oral Solution | PSN | 10b0bcff-d3bc-f70c-e063-6394a90a35ed | 2 |
| 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 | 10b0bcff-d3bc-f70c-e063-6394a90a35ed | 2 |
| 1431245 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | 10b0bcff-d3bc-f70c-e063-6394a90a35ed | 2 |
| 1431245 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | 10b0bcff-d3bc-f70c-e063-6394a90a35ed | 2 |
| 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 | 10b0bcff-d3bc-f70c-e063-6394a90a35ed | 2 |
| 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 | 49a98411-aa5a-6de3-e063-6294a90a148f | 1 |
| 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 | 49a98411-aa5a-6de3-e063-6294a90a148f | 1 |
| 1369842 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution | PSN | 49a98411-aa5a-6de3-e063-6294a90a148f | 1 |
| 1431245 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG in 30 mL Oral Solution | PSN | 49a98411-aa5a-6de3-e063-6294a90a148f | 1 |
| 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 | 49a98411-aa5a-6de3-e063-6294a90a148f | 1 |
| 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 | 49a98411-aa5a-6de3-e063-6294a90a148f | 1 |
| 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 | 49a98411-aa5a-6de3-e063-6294a90a148f | 1 |
| 1431245 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | 49a98411-aa5a-6de3-e063-6294a90a148f | 1 |
| 1369842 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | 49a98411-aa5a-6de3-e063-6294a90a148f | 1 |
| 1431245 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | 49a98411-aa5a-6de3-e063-6294a90a148f | 1 |
| 1369842 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | 49a98411-aa5a-6de3-e063-6294a90a148f | 1 |
| 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 | 49a98411-aa5a-6de3-e063-6294a90a148f | 1 |
| 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 | 49a98411-aa5a-6de3-e063-6294a90a148f | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 41226-775-01 | 41226077501 | 354 mL in 1 BOTTLE (41226-775-01) | 354 ml | 2024-04-30 | No | No | Current |