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 |
|---|---|---|---|---|---|---|
| Childrens Tussnex | ACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Guardian Drug Company | 19e9678d-ac34-4af8-a80f-d08fce0a5f0e | 2024-12-19 | Warnings | M012 |
| Vaporising Chest Rub | CAMPHOR, MENTHOL, EUCALYPTUS OIL | New Pride Corp | f66476d5-036b-0b1c-e053-2a95a90a0a07 | 2024-12-19 | Warnings | M012 |
| Chest Rub Vaporizing Action | MENTHOL AND CAMPHOR AND EUCALYPTUS OIL | Singhfam Corporation | c6ea663a-9c4f-4d1a-a937-002806a8530a | 2024-12-19 | Warnings | M012 |
| ELIZABETH HEALTH STYLE CHESTRUB VAPORIZING ACTION | CAMPHOR (SYNTHETIC), LEVOMENTHOL, EUCALYPTUS | Singhfam Corporation | f1e4caee-b50e-a0a6-e053-2a95a90aadce | 2024-12-19 | Warnings | M012 |
| Leader Vapor Steam camphor (synthetic) | CAMPHOR (SYNTHETIC) | LEADER/Cardinal Health 110, Inc. | ae580e6c-2efd-c788-e053-2995a90a3360 | 2024-12-19 | Warnings | M012 |
| Tussin DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Strategic Sourcing Service, LLC | 0b6689db-ea34-9a06-e063-6394a90abaf7 | 2024-12-19 | Warnings | M012 |
| Medicated Chest Rub | CAMPHOR, MENTHOL, EUCALYPTUS OIL | Jell Pharmaceuticals Pvt Ltd. | d80b9cc1-55f5-76d5-e053-2995a90aa967 | 2024-12-19 | Warnings | M012 |
| Health Smart Vaporizing Chest Rub | MENTHOL AND CAMPHOR AND EUCALYPTUS OIL | Home Smart Products | acab200e-48bd-69e1-e053-2995a90afde0 | 2024-12-19 | Warnings | M012 |
| Halls MENTHO-LYPTUS | MENTHOL | Mondelez Global LLC | ff21cf0e-9811-4819-bdfc-17a950e9b114 | 2024-12-19 | Warnings | M012 |
| Tussnex FM Cold, Flu and Sore Throat | ACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Guardian Drug Company | 7bddce11-c227-4d95-94c1-6f41ecd7285b | 2024-12-19 | Warnings | M012 |
| Childrens Tussnex Multi-symptom cold | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Guardian Drug Company | 9028676e-d725-4afe-aa14-72235825aa17 | 2024-12-19 | Warnings | M012 |
| Tussnex FM Cold and Sinus | ACTEAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | Guardian Drug Company | 04c6bb6a-d2f8-4322-afba-e240e8090176 | 2024-12-19 | Warnings | M012 |
| Tussnex FM Severe cough and congestion | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Guardian Drug Company | 387df403-7803-4031-915e-8de9b103a162 | 2024-12-19 | Warnings | M012 |
| Maximum strength Tussnex FM DM Max | DEXTROMETHORPHAN HBR, GUAIFENESIN | Guardian Drug Company | 0bae53e3-9661-4bc6-9fcc-da7fa131b034 | 2024-12-19 | Warnings | M012 |
| Vicks Vaposteam Lavender | CAMPHOR, (-)- | Kaz USA, Inc | 03bf6b78-cf8e-44c6-bae0-5bd0a85f8aa9 | 2024-12-19 | Warnings | M012 |
| Refenesen Mucus Relief DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | Reese Pharmaceutical Co | 6046dc50-f162-4e2d-aa3c-7d27efad477d | 2024-12-18 | Warnings | M012 |
| Sunmark Chest Congestion Relief PE PE | GUAIFENESIN/PHENYLEPHRINE | Strategic Sourcing Services LLC | f94ae469-4c79-4ce9-9a3d-3bdc645be6d9 | 2024-12-18 | Warnings | M012 |
| Quality Choice Mucus Relief DM DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | Chain Drug Marketing Association | 1c33a01f-1186-4a19-b639-a9cd49245220 | 2024-12-18 | Warnings | M012 |
| HealthMart Chest Congestion Relief | GUAIFENESIN | Strategic Sourcing Services LLC | a5d1a8e8-10ba-4fff-b6f7-18c0fde5155c | 2024-12-18 | Warnings | M012 |
| DG Health Immediate Release Mucus Relief | GUAIFENESIN | Reese Pharmaceutical Co | f60a9d1b-7a63-43d3-b843-e1f31cf78873 | 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 |