Nighttime Cold and Flu
- Product NDC
- 53345-026
- 11-digit product format
- 533450026
- Labeler code
- 53345
- Product ID
- 53345-026_27c79edd-88b5-a290-e063-6394a90a894c
- 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
- 2014-08-11
- 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 |
|---|---|
| 7a28d0fe-0e0a-453a-b604-1cc784dd153c | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bf324df6-7127-7deb-def5-2681c136cd03 | Product name | 3 | 20250325 |
| 59361619-24d9-b610-eca6-5a7f25ed5e03 | Product name | 5 | 20240909 |
| 43a1ed49-eae2-4840-8075-cb4b33478540 | Product name | 1 | 20230425 |
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| f4368033-af8c-41bf-a84b-ff77392b8522 | Product name | 1 | 20161229 |
| 76633df9-0d59-4b88-03ed-21dee1b966f8 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53345-026-01 | Nighttime Cold and Flu | 1 in 1 BOX | CAPSULE, LIQUID FILLED | 1 | 3 | |
| 53345-026-01 | Nighttime Cold and Flu | 4000 in 1 BAG | CAPSULE, LIQUID FILLED | 4000 | 3 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53345-026 | NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20241127_7a28d0fe-0e0a-453a-b604-1cc784dd153c.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 |
|---|---|---|---|---|---|---|
| Medi-First Sinus Decongestant | PHENYLEPHRINE HYDROCHLORIDE | Unifirst First Aid Corporation | 9654f5cd-74d7-44a2-9674-666d1e94ffa7 | 2025-09-08 | Warnings | M012 |
| Otis Clapp Mygrex | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE | Unifirst First Aid Corporation | f196f2c5-a100-42b1-bd01-0327b223838e | 2025-09-08 | Warnings | M012 |
| Medique Diphen | DIPHENHYDRAMINE HYDROCHLORIDE | Unifirst First Aid Corporation | b61ee2e0-2543-447d-9fc4-23363d46ce04 | 2025-09-08 | Warnings | M012 |
| Green Guard Allergy 2 Relief | PHENYLEPHRINE HYDROCHLORIDE | Unifirst First Aid Corporation | 16fddca9-a66b-41e6-9423-eaf091d3971e | 2025-09-08 | Warnings | M012 |
| Medique Medi-Phenyl | PHENYLEPHRINE HYDROCHLORIDE | Unifirst First Aid Corporation | d7d62ac1-1333-4366-884b-26537766ce38 | 2025-09-08 | Warnings | M012 |
| Unishield Sinus Decongestant | PHENYLEPHRINE HCL | Unishield | b8f68d9d-2d38-414a-e053-2a95a90a15ec | 2025-09-08 | Warnings | M012 |
| McKesson Sinus Pain and Pressure Relief | ACETAMINOPHEN, PHENYLEPHRINE HCL | McKesson Medical-Surgical | e0cbb213-4f4f-4045-e053-2a95a90a2a18 | 2025-09-08 | Warnings | M012 |
| Medique Medicidin D | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE | Unifirst First Aid Corporation | 1f172d58-4050-424b-9743-130d8e618fe8 | 2025-09-08 | Warnings | M012 |
| Medique Cold Cough Product | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL , | Unifirst First Aid Corporation | e8059137-efba-398c-e053-2a95a90a21f2 | 2025-09-08 | Warnings | M012 |
| Medique Medi-Mucus | DEXTROMETHORPHAN HBR, GUAIFENESIN | Unifirst First Aid Corporation | f3bb862a-9cb8-f644-e053-2a95a90a5f4f | 2025-09-08 | Warnings | M012 |
| Physicians Care Cough and Sore Throat | MENTHOL | Acme United Corporation | 4e02223d-f34b-333e-e054-00144ff8d46c | 2025-09-08 | Warnings | M012 |
| Physicians Care Non-Drowsy Cold and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Acme United | 186ec543-1f23-75d6-e063-6294a90a46b9 | 2025-09-08 | Warnings | M012 |
| PhysiciansCare Sinus Non-Drowsy | PHENYLEPHRINE HCL | Acme United Corporation | a6daf3ef-f386-4de4-b38e-d0b90c9ae62b | 2025-09-08 | Warnings | M012 |
| PhysiciansCare Allergy Multi-Symptom Relief | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE | Acme United Corporation | fd101c27-6ba9-4cd3-baec-a354504c37a0 | 2025-09-08 | Warnings | M012 |
| Green Guard Honey Lemon Cough Drop | MENTHOL 8.6 MG | Unifirst First Aid Corporation | 8a94f090-61d6-4909-e053-2995a90aee38 | 2025-09-08 | Warnings | M012 |
| Green Guard Cough Drop Relief | MENTHOL | Unifirst First Aid Corporation | 0fc4cb11-8ff9-4eff-9588-c73eef4e0137 | 2025-09-08 | Warnings | M012 |
| Multi-Symptom Cold Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL , GUAIFENESIN, , | Unifirst First Aid Corporation | e6ea6faf-baff-a130-e053-2a95a90a085a | 2025-09-08 | Warnings | M012 |
| MEDIQUE Medikoff Drops | MENTHOL | Unifirst First Aid Corporation | 0d6b4443-16a1-4851-bb03-d7407167551d | 2025-09-08 | Warnings | M012 |
| Medique Sugar Free Medikoff Drops | MENTHOL | Unifirst First Aid Corporation | 92d13e19-4e7b-4565-970e-504abf02579a | 2025-09-08 | Warnings | M012 |
| Medique at Home Diphen | DIPHENHYDRAMINE HCL | Unifirst First Aid Corporation | b56d1966-efd7-56eb-e053-2995a90a89b5 | 2025-09-08 | 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 | 7a28d0fe-0e0a-453a-b604-1cc784dd153c | 3 |
| 1094549 | acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SCD | 7a28d0fe-0e0a-453a-b604-1cc784dd153c | 3 |
| 1094549 | APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SY | 7a28d0fe-0e0a-453a-b604-1cc784dd153c | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53345-026-01 | 53345002601 | 1 BAG in 1 BOX (53345-026-01) / 4000 CAPSULE, LIQUID FILLED in 1 BAG | 1 bag | 2014-08-11 | 0000-00-00 | No | No | Current |