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 |
|---|---|---|---|---|---|---|
| Health Smart Vaporizing Chest Rub | MENTHOL AND CAMPHOR AND EUCALYPTUS OIL | Jell Pharmaceuticals Pvt Ltd. | d80cad8d-da4c-049d-e053-2a95a90ac20e | 2024-12-18 | Warnings | M012 |
| Afrin Original | OXYMETAZOLINE HYDROCHLORIDE | Lil' Drug Store Products, Inc. | 8a97c012-6a47-4607-9389-58a4eed17b08 | 2024-12-18 | Warnings | M012 |
| Medicated Chest Rub | CAMPHOR, MENTHOL, EUCALYPTUS OIL | Orazen Inc | ecddaa3b-e18f-1c74-e053-2995a90ad86a | 2024-12-18 | Warnings | M012 |
| Rite Aid Chest Rub | CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL | Rite Aid | dfedbef1-8062-432d-e053-2a95a90a09e9 | 2024-12-18 | Warnings | M012 |
| TheraCare Medicated Chest Rub | CAMPHOR, MENTHOL, EUCALYPTUS OIL | Veridian Healthcare | f7801843-f96c-710e-e053-6294a90a5086 | 2024-12-18 | Warnings | M012 |
| Rugby Chest Congestion Relief G450 | GUAIFENESIN | Rugby Laboratories | a6aa8cbd-21ff-4f84-b338-c05c2d46e6df | 2024-12-18 | Warnings | M012 |
| Refenesen Mucus Relief | GUAIFENESIN | Reese Pharmaceutical Co | 861dffb7-8bf4-4f03-bcc2-ed8a35bc341d | 2024-12-18 | Warnings | M012 |
| Marcs Chest Congestion Relief DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | Marc Glassman Inc | be3ad54f-522c-440d-b8c7-9664f6015566 | 2024-12-18 | Warnings | M012 |
| Chest Congestion Relief | GUAIFENESIN | Strategic Sourcing Services LLC | da6bd9df-aebe-4fe5-b20b-01bda3b9e7ee | 2024-12-18 | Warnings | M012 |
| Family Wellness Chest Congestion Relief | GUAIFENESIN | Family Dollar Services Inc | 412f3459-4c22-4822-86bd-011fc3e91ca6 | 2024-12-18 | Warnings | M012 |
| Marcs Mucus Relief | GUAIFENESIN | Marc Glassman Inc | 455b9f01-206c-4534-a006-292d2bd48f47 | 2024-12-18 | Warnings | M012 |
| Leader Chest Congestion Relief G450 | GUAIFENESIN | Cardinal Health | 4586a83f-077c-4fb3-adfe-7a9497a78d97 | 2024-12-18 | Warnings | M012 |
| Foster and Thrive Chest Congestion Relief DM DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | Strategic Sourcing Services LLC | 5372f764-985e-4a42-bc97-cb0dc90fcd9c | 2024-12-18 | Warnings | M012 |
| TopCare Chest Congestion and Cough Relief DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | TOPCO ASSOCIATES LLC | 5a2d0464-038d-4c3f-b39e-ee9984fb383e | 2024-12-18 | Warnings | M012 |
| Always Save Chest Congestion Relief DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | Valu Merch | a72b6a97-f97f-44bb-8d55-ac48b8ba45c5 | 2024-12-18 | Warnings | M012 |
| Harris Teeter Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Harris Teeter | 4ebe1d94-bb15-4250-a4c2-8cd45743c7dd | 2024-12-18 | Warnings | M012 |
| Care One Chest Congestion Relief DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | RETAIL BUSINESS SERVICES , LLC | f6657dee-9f32-45b1-8e44-1ad67a4a68bd | 2024-12-18 | Warnings | M012 |
| Childrens Metapp Daytime | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Guardian Drug Company | 40565500-944b-47f2-8563-5df05469e418 | 2024-12-18 | Warnings | M012 |
| CVS Chest Congestion Relief DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | CVS Pharmacy, Inc. | 884abed2-e355-4134-92f1-591f3a18f71d | 2024-12-18 | Warnings | M012 |
| CVS Health Chest Congestion Relief PE | GUAIFENESIN/PHENYLEPHRINE | CVS Pharmacy, Inc. | a49020e8-739e-47ec-8141-e866479a3ab3 | 2024-12-18 | 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 |