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 |
|---|---|---|---|---|---|---|
| Childrens Allergy Relief | DIPHENHYDRAMINE HCL | WALMART INC. | 321430a5-11c9-4d33-8638-5149f601f1bb | 2026-05-22 | Warnings | M012 |
| dg health cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Dolgencorp Inc | ddcc1e78-4ea8-4489-88e7-86ff46016464 | 2026-05-21 | Warnings | M012 |
| GOOD NEIGHBOR PHARMACY DAYTIME FLU RELIEF MAX STRENGTH | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | AMERISOURCE BERGEN | 45dc9dd7-134a-4e70-a07e-7bfdf0dc1c4e | 2026-05-21 | Warnings | M012 |
| Extra Strength Tylenol Cold plus Flu Multi-Symptom Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Kenvue Brands LLC | 525467fb-510d-0b4b-e063-6294a90acd36 | 2026-05-21 | Warnings | M012 |
| Mucinex Childrens | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL | Reckitt Benckiser LLC | 4cee80e5-e412-e832-e063-6394a90aeb90 | 2026-05-21 | Warnings | M012 |
| Mucinex Childrens Multi-Symptom Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | Reckitt Benckiser LLC | 4a9464cf-0c77-23d0-e063-6394a90a62f1 | 2026-05-21 | Warnings | M012 |
| Mucinex Childrens Night Time Multi-Symptom Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL | Reckitt Benckiser LLC | 4ceda68e-c7ce-eb87-e063-6394a90a8ded | 2026-05-21 | Warnings | M012 |
| ALKA SELTZER COLD Cold and Sinus Maximum Strength Day Night Fast Gels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE | Bayer HealthCare LLC. | 5258ea3f-87f1-7f86-e063-6394a90ab82f | 2026-05-21 | Warnings | M012 |
| RELIABLE-1 ANTI DRIP PUMP MIST | OXYMETAZOLINE HYDROCHLORIDE | Reliable 1 Laboratories LLC | 7df9905d-09aa-4c84-8b6f-6e5ed90df0da | 2026-05-21 | Warnings | M012 |
| daytime nitetime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Publix Super Markets Inc | 80abb6b8-b0d5-4f19-8588-50b8717510bb | 2026-05-21 | Warnings | M012 |
| FAMILY DOLLAR ULTRA FINE MIST SINUS RELIEF | OXYMETAZOLINE HYDROCHLORIDE | FAMILY DOLLAR SERVICES INC | 27163169-54d0-4b6e-94cd-721b29b18249 | 2026-05-20 | Warnings | M012 |
| ALKA SELTZER COLD Cold and Cough Fast | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Bayer HealthCare LLC. | 5241b11a-72c8-5e67-e063-6394a90a4353 | 2026-05-20 | Warnings | M012 |
| Mucinex Fast-Max Cold, Flu and Sore Throat | ACETAMINOPHEN, GUAIFENESIN | Reckitt Benckiser LLC | 50b140ad-aba2-ce6b-e063-6294a90ae2f8 | 2026-05-20 | Warnings | M012 |
| Mucinex Fast-Max Recharge Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | 4bae240c-70ce-e9c2-e063-6394a90a5f3d | 2026-05-20 | Warnings | M012 |
| Childrens Mucinex Multi Symptom Cold and Childrens Mucinex Night Time Multi Symptom Cold | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 85f7d60b-32ec-4ec2-86ec-f677093bce1d | 2026-05-20 | Warnings | M012 |
| Chloraseptic Nighttime Sore Throat Hot Relief | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | Prestige Brands Holdings, Inc. | 9c13c052-a5d1-43d2-8d29-4ea011a971ac | 2026-05-20 | Warnings | M012 |
| Cold and Flu Severe, Daytime, Nighttime | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Rite Aid Corporation | a0bff310-2d35-4a18-815b-8386e44730a2 | 2026-05-19 | Warnings | M012 |
| equate nighttime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | WALMART INC. | 61a1beb3-decf-4c8d-a402-93a02ec40a43 | 2026-05-19 | Warnings | M012 |
| Extra Strength Tylenol Cold plus Flu Multi-Symptom Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Kenvue Brands LLC | 52291746-2bbf-8f3f-e063-6294a90adcfc | 2026-05-19 | Warnings | M012 |
| MUCINEX FAST MAX Liquid Cold and Flu Kickstart and MUCINEX Nightshift Kickstart | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, TRIPROLIDINE HCI | Reckitt Benckiser LLC | fdb70793-5dd1-0455-e053-6394a90ac621 | 2026-05-19 | 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 |