Nighttime Cold and Flu
- Product NDC
- 55910-460
- 11-digit product format
- 559100460
- Labeler code
- 55910
- Product ID
- 55910-460_eee9692c-a80b-42f7-b4f9-6dc805077099
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Diphenhydramine HCI, Phenylephrine HCI
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2018-03-31
- Marketing end
- 2027-03-31
- Substance
- ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 650; 25; 10 mg/20mL; mg/20mL; mg/20mL
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- 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 Cold and Flu
- Brand name suffix
- Maximum Strength
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 650 mg/20mL |
| DIPHENHYDRAMINE HYDROCHLORIDE | 25 mg/20mL |
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/20mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| TC2D6JAD40 | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1375932 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 776b7c67-56c7-420c-82b2-9a176d998396 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55910-460-06 | Nighttime Cold and FluMaximum Strength | 177 mL in 1 BOTTLE, PLASTIC | LIQUID | 177 | 6 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55910-460 | NIGHTTIME COLD AND FLU MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCI) LIQUID [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)] | 5 | Current NDC, Legacy NDC, 1 package rows | 20231011_776b7c67-56c7-420c-82b2-9a176d998396.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 |
|---|---|---|---|---|---|---|
| Daytime Nighttime Childrens Multi-symptom Cold | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Wal-Mart Stores, Inc. | 177e3247-402d-98e4-e063-6294a90ae068 | 2024-11-26 | Warnings | M012 |
| Alka-Seltzer Plus Cold and Flu, CVP | CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE TABLET | Lil' Drug Store Products, Inc. | e7a27773-69d6-9e07-e053-2a95a90af8ea | 2024-11-25 | Warnings | M012 |
| DayTime Sinus Relief | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | 4361912e-4b56-4743-b11d-acfb94482a2e | 2024-11-25 | Warnings | M012 |
| NightTime Sinus Relief | ACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | 413d82d3-a896-4f15-9fca-c1b7b9a1ee63 | 2024-11-25 | Warnings | M012 |
| Night Cold Flu Cough and Allergy | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | 590f4f0d-c8b0-412d-be1e-3eb2ccb29ac0 | 2024-11-25 | Warnings | M012 |
| Daytime Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | cbd3a905-1c41-4cb0-8df6-36784430d627 | 2024-11-25 | Warnings | M012 |
| Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | 7a28d0fe-0e0a-453a-b604-1cc784dd153c | 2024-11-25 | Warnings | M012 |
| Cough and Cold plus | ACETAMINOPHEN, PHENYLEPHRINE HCL, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd | c483d88f-cb0a-4dd6-b3ae-559521782ba6 | 2024-11-25 | Warnings | M012 |
| DayTime Sinus | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd. | a0b01aef-4248-4d41-862c-0c8884dfca5e | 2024-11-25 | Warnings | M012 |
| DayTime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | 3af20739-6794-42e0-b404-3f0401d10a6d | 2024-11-25 | Warnings | M012 |
| Dextromethorphan HBr 15 mg | DEXTROMETHORPHAN HBR | Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd. | ffc7e1e2-b664-461b-963d-764bad2f983f | 2024-11-25 | Warnings | M012 |
| NightTime Sinus | ACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd. | 0f3b1404-9252-470a-aa8c-b360c85731f3 | 2024-11-25 | Warnings | M012 |
| Maximum Strength-Cough and Chest Congestion DM | MAXIMUM STRENGTH-COUGH AND CHEST CONGESTION DM | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd. | d1830989-fe82-4f08-8618-78979fcef568 | 2024-11-25 | Warnings | M012 |
| ASP Daytime PE | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | b84f2392-0b24-4af0-80f7-c45454093f51 | 2024-11-25 | Warnings | M012 |
| ASP Nighttime Max | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | d8756d1f-baf5-412d-a493-a1c051eae302 | 2024-11-25 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | FOODHOLD U.S.A., LLC | 508a65ee-42fa-4c0b-b24d-9faac6b0eba7 | 2024-11-24 | Warnings | M012 |
| DG Day Time Cold and Flu Formula and Night Time Cold and Flu Formula | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | PuraCap Pharmaceutical LLC | cb68eef0-b027-4bf1-b78f-f31844a8c06c | 2024-11-22 | Warnings | M012 |
| Benadryl | DIPHENHYDRAMINE HYDROCHLORIDE | Lil' Drug Store Products, Inc. | de2a64ce-c169-4162-b79e-d3809bea2147 | 2024-11-22 | Warnings | M012 |
| 12 Hour Nasal Decongestant Extra Moisturizing | NASAL SPRAY | WinCo Foods LLC | 13fbde45-958c-455f-b766-f6a34342ee95 | 2024-11-21 | Warnings | M012 |
| Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | a01abac3-c13e-40f2-ae98-34bd6c9b7504 | 2024-11-21 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2637728 | {1 (acetaminophen 32.5 MG/ML / diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution) / 1 (dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution) } Pack | GPCK | 0d65c4a9-938c-4a89-b1f1-d9ada8a8c587 | 7 |
| 2637728 | 1 daytime (dextromethorphan HBr 5 MG / guaiFENesin 100 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution) / 1 nighttime (acetaminophen 325 MG / diphenhydrAMINE HCl 12.5 MG / phenylephrine HCl 5 MG in 10 mL Oral Solution) Pack | PSN | 0d65c4a9-938c-4a89-b1f1-d9ada8a8c587 | 7 |
| 1375932 | acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG in 20 mL Oral Solution | PSN | 0d65c4a9-938c-4a89-b1f1-d9ada8a8c587 | 7 |
| 1043543 | dextromethorphan HBr 5 MG / guaiFENesin 100 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution | PSN | 0d65c4a9-938c-4a89-b1f1-d9ada8a8c587 | 7 |
| 1375932 | acetaminophen 32.5 MG/ML / diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution | SCD | 0d65c4a9-938c-4a89-b1f1-d9ada8a8c587 | 7 |
| 1043543 | dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution | SCD | 0d65c4a9-938c-4a89-b1f1-d9ada8a8c587 | 7 |
| 2637728 | 1 daytime (dextromethorphan HBr 5 MG / guaifenesin 100 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Solution) / 1 nighttime (acetaminophen 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution) Pack | SY | 0d65c4a9-938c-4a89-b1f1-d9ada8a8c587 | 7 |
| 1375932 | acetaminophen 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution | SY | 0d65c4a9-938c-4a89-b1f1-d9ada8a8c587 | 7 |
| 1375932 | acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG per 20 ML Oral Solution | SY | 0d65c4a9-938c-4a89-b1f1-d9ada8a8c587 | 7 |
| 1375932 | APAP 32.5 MG/ML / Diphenhydramine Hydrochloride 1.25 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral Solution | SY | 0d65c4a9-938c-4a89-b1f1-d9ada8a8c587 | 7 |
| 1375932 | APAP 325 MG / diphenhydramine hydrochloride 12.5 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral Solution | SY | 0d65c4a9-938c-4a89-b1f1-d9ada8a8c587 | 7 |
| 1375932 | APAP 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG per 20 ML Oral Solution | SY | 0d65c4a9-938c-4a89-b1f1-d9ada8a8c587 | 7 |
| 1043543 | dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral Solution | SY | 0d65c4a9-938c-4a89-b1f1-d9ada8a8c587 | 7 |
| 1043543 | dextromethorphan HBr 5 MG / guaifenesin 100 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Solution | SY | 0d65c4a9-938c-4a89-b1f1-d9ada8a8c587 | 7 |
| 1375932 | acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG in 20 mL Oral Solution | PSN | 776b7c67-56c7-420c-82b2-9a176d998396 | 6 |
| 1375932 | acetaminophen 32.5 MG/ML / diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution | SCD | 776b7c67-56c7-420c-82b2-9a176d998396 | 6 |
| 1375932 | acetaminophen 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution | SY | 776b7c67-56c7-420c-82b2-9a176d998396 | 6 |
| 1375932 | acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG per 20 ML Oral Solution | SY | 776b7c67-56c7-420c-82b2-9a176d998396 | 6 |
| 1375932 | APAP 32.5 MG/ML / Diphenhydramine Hydrochloride 1.25 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral Solution | SY | 776b7c67-56c7-420c-82b2-9a176d998396 | 6 |
| 1375932 | APAP 325 MG / diphenhydramine hydrochloride 12.5 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral Solution | SY | 776b7c67-56c7-420c-82b2-9a176d998396 | 6 |
| 1375932 | APAP 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG per 20 ML Oral Solution | SY | 776b7c67-56c7-420c-82b2-9a176d998396 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 55910-460-06 | 55910046006 | 177 mL in 1 BOTTLE, PLASTIC (55910-460-06) | 177 ml | 2018-03-31 | 2027-03-31 | No | No | Current |