Nighttime Cold and Flu
- Product NDC
- 49580-0346
- 11-digit product format
- 495800346
- Labeler code
- 49580
- Product ID
- 49580-0346_822c9254-9dc0-40fd-9057-2fc60e0bd248
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- P & L Development, LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2014-11-30
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
- Active strength
- 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL
- Pharmacologic classes
- 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]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- 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 Cold and Flu
- Brand name suffix
- ReadyInCase
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 650 mg/30mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 30 mg/30mL |
| DOXYLAMINE SUCCINATE | 12.5 mg/30mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
| V9BI9B5YI2 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1043400 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 155a7168-b568-41f4-b8a2-214889b4eccf | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49580-0346-2 | Nighttime Cold and FluReadyInCase | 355 mL in 1 BOTTLE, PLASTIC | LIQUID | 355 | 9 | |
| 49580-0346-4 | Nighttime Cold and FluReadyInCase | 118 mL in 1 BOTTLE, PLASTIC | LIQUID | 118 | 9 | |
| 49580-0346-8 | Nighttime Cold and FluReadyInCase | 237 mL in 1 BOTTLE, PLASTIC | LIQUID | 237 | 9 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 49580-0346 | NIGHTTIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [P & L DEVELOPMENT, LLC] | 9 | Current NDC, Legacy NDC, 3 package rows | 20240203_155a7168-b568-41f4-b8a2-214889b4eccf.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 |
|---|---|---|---|---|---|---|
| Cold Max Nighttime | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | DISCOUNT DRUG MART | e3dcf6cf-373c-ea83-e053-2a95a90ae57a | 2024-10-17 | Warnings | M012 |
| Sinus Pressure plus Pain PE | ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE | DISCOUNT DRUG MART | a7e99dad-5918-6a90-e053-2a95a90a8803 | 2024-10-17 | Warnings | M012 |
| SINUS AND HEADACHE | ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE | DISCOUNT DRUG MART | a7e99dad-5916-6a90-e053-2a95a90a8803 | 2024-10-17 | Warnings | M012 |
| ALLERGY MULTISYMPTOM | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE | DISCOUNT DRUG MART | a7e9ab8e-2252-180d-e053-2a95a90a788f | 2024-10-17 | Warnings | M012 |
| COLD PLUS HEAD CONGESTION SEVERE | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | DISCOUNT DRUG MART | 3430c7e4-e142-407e-bed5-358dd6bd10f7 | 2024-10-17 | Warnings | M012 |
| COLD MAX | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | DISCOUNT DRUG MART | a1aba467-c91f-4812-b0b9-ff5fdfa298e3 | 2024-10-17 | Warnings | M012 |
| Head Congestion plus Flu Severe PE | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | DISCOUNT DRUG MART | e3dd12f1-dd63-27ae-e053-2995a90aaaeb | 2024-10-17 | Warnings | M012 |
| COLD and FLU SEVERE | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | DISCOUNT DRUG MART | e44ac549-3e9b-4271-a2b2-ecb124f79832 | 2024-10-17 | Warnings | M012 |
| Mucus Relief Sinus Severe Congestion Relief | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | DISCOUNT DRUG MART | f171a389-8b22-429c-86bc-272156fdc1b7 | 2024-10-17 | Warnings | M012 |
| Daytime Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | DISCOUNT DRUG MART | 6c5b5427-e47a-4eff-928a-c891452facf9 | 2024-10-17 | Warnings | M012 |
| COLD AND FLU SEVERE | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | DISCOUNT DRUG MART | ddeb8978-84b6-4a19-b25e-99d1c29e58d9 | 2024-10-17 | Warnings | M012 |
| Mucus Relief Cold and Flu All in One | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | DISCOUNT DRUG MART | b20baef9-6e68-6679-e053-2a95a90a2b63 | 2024-10-17 | Warnings | M012 |
| Mucus Relief Cold Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | DISCOUNT DRUG MART | b20b71fb-8787-c871-e053-2a95a90a8eb4 | 2024-10-17 | Warnings | M012 |
| Mucus Relief Sinus Pressure Pain and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | DISCOUNT DRUG MART | b20bc492-fed3-bf05-e053-2a95a90ad393 | 2024-10-17 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | United Natural Foods, Inc. dba UNFI | a4d6ecb9-ea67-41ed-917b-9bb4d1e50551 | 2024-10-17 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | United Natural Foods, Inc. dba UNFI | 08fda81a-bedd-4ff3-9c32-2066d2cea3f9 | 2024-10-17 | Warnings | M012 |
| Guaifenesin | GUAIFENESIN | American Health Packaging | 2fd702ea-3069-472c-b99e-c527f1375705 | 2024-10-17 | Warnings | M012 |
| Mucus Relief Xpect | GUAIFENSIN, DEXTROMETHORPHAN | Selder, S.A. de C.V. | c2b49d10-b60f-3072-e053-2a95a90af004 | 2024-10-17 | Warnings | M012 |
| Head Congestion plus Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | United Natural Foods, Inc. dba UNFI | 1db914d3-8bba-405e-9bf9-9b1a5806284c | 2024-10-17 | Warnings | M012 |
| Cold Medicine XL3 | ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE | Selder, S.A. de C.V. | e2c35fae-9dd6-51f2-e053-2995a90a1e9e | 2024-10-17 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution | PSN | 155a7168-b568-41f4-b8a2-214889b4eccf | 9 |
| 1043400 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SCD | 155a7168-b568-41f4-b8a2-214889b4eccf | 9 |
| 1043400 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution | SY | 155a7168-b568-41f4-b8a2-214889b4eccf | 9 |
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution | SY | 155a7168-b568-41f4-b8a2-214889b4eccf | 9 |
| 1043400 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SY | 155a7168-b568-41f4-b8a2-214889b4eccf | 9 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 49580-0346-2 | 49580034602 | 355 mL in 1 BOTTLE, PLASTIC (49580-0346-2) | 355 ml | 2014-11-30 | 0000-00-00 | No | No | Current |
| 49580-0346-4 | 49580034604 | 118 mL in 1 BOTTLE, PLASTIC (49580-0346-4) | 118 ml | 2014-11-30 | 0000-00-00 | No | No | Current |
| 49580-0346-8 | 49580034608 | 237 mL in 1 BOTTLE, PLASTIC (49580-0346-8) | 237 ml | 2014-11-30 | 0000-00-00 | No | No | Current |