Nighttime Cold and Flu
- Product NDC
- 53345-006
- 11-digit product format
- 533450006
- Labeler code
- 53345
- Product ID
- 53345-006_276790ce-21a1-7191-e063-6294a90adb7e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2013-04-15
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
- Active strength
- 325; 15; 6.25 mg/1; mg/1; mg/1
- 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
- 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 Cold and Flu
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 15 mg/1 |
| DOXYLAMINE SUCCINATE | 6.25 mg/1 |
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 |
|---|---|
| 1094549 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| a01abac3-c13e-40f2-ae98-34bd6c9b7504 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 59361619-24d9-b610-eca6-5a7f25ed5e03 | Product name | 5 | 20240909 |
| f4368033-af8c-41bf-a84b-ff77392b8522 | Product name | 1 | 20161229 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53345-006-01 | Nighttime Cold and Flu | 1 in 1 BOX | CAPSULE, LIQUID FILLED | 1 | 4 | |
| 53345-006-01 | Nighttime Cold and Flu | 4000 in 1 BAG | CAPSULE, LIQUID FILLED | 4000 | 4 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53345-006 | NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20241122_a01abac3-c13e-40f2-ae98-34bd6c9b7504.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 |
|---|---|---|---|---|
| 1094549 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule | PSN | a01abac3-c13e-40f2-ae98-34bd6c9b7504 | 4 |
| 1094549 | acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SCD | a01abac3-c13e-40f2-ae98-34bd6c9b7504 | 4 |
| 1094549 | APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SY | a01abac3-c13e-40f2-ae98-34bd6c9b7504 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53345-006-01 | 53345000601 | 1 BAG in 1 BOX (53345-006-01) / 4000 CAPSULE, LIQUID FILLED in 1 BAG | 1 bag | 2013-04-15 | 0000-00-00 | No | No | Current |