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 |
|---|---|---|---|---|---|---|
| DISCOUNT DRUG MART | COUGH DROPS VITAMIN C SUGAR-FREE | DISCOUNT DRUG MART | 06673358-1afc-4d75-e063-6394a90a6ab1 | 2025-09-03 | Warnings | M012 |
| ValuMeds Cough Relief, Dextromethorphan Hbr | DEXTROMETHORPHAN HYDROBROMIDE | Cabinet Health P.B.C. | b16a81db-d9bc-4cce-8ec2-dc189184931e | 2025-09-03 | Warnings | M012 |
| topcare day time cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Topco Associates LLC | 256d96f0-67bf-42d2-85ef-f49625c5910f | 2025-09-02 | Warnings | M012 |
| TOPCARE HONEY FLAVOR COLD AND FLU RELIEF | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Topco Associates LLC | 2256623c-7642-4c39-b022-bfaecc861f1c | 2025-09-02 | Warnings | M012 |
| topcare nite time cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Topco Associates LLC | ef574f18-e28d-46bb-87fd-2f3b4df6dc68 | 2025-09-02 | Warnings | M012 |
| Cold Multi-Symptom | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Kroger Company | f4429475-47f9-451a-bfcc-24b5ef333923 | 2025-09-02 | Warnings | M012 |
| dg health night time cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Dolgencorp Inc | dc8cc7a3-60a9-42f0-babd-d3c7d0276dd1 | 2025-08-29 | Warnings | M012 |
| MGC Health Cough Drops Original Herb | MENTHOL | Medical Group Care LLC | 3d70ba70-eb11-f148-e063-6294a90a4c7c | 2025-08-28 | Warnings | M012 |
| Exchange Select Cough Drops Original Herb | MENTHOL | Army & Air Force Exchange Service | 3d7109a5-4fe1-039b-e063-6394a90a1392 | 2025-08-28 | Warnings | M012 |
| MGC Health Cough Drops Honey Herb | MENTHOL | Medical Group Care LLC | 3d710deb-e42d-13eb-e063-6394a90a56e1 | 2025-08-28 | Warnings | M012 |
| Sinus Relief Pressure and Pain | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | Kroger Company | 98de5cff-3ff5-49b0-bef9-5b9ebb86491e | 2025-08-27 | Warnings | M012 |
| Nighttime SEVERE | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | H E B | 0a178114-0748-4a92-9b60-a7a0a8b72287 | 2025-08-26 | Warnings | M012 |
| Adult Bisolvine Adult | GUAIFENESIN, DEXTROMETHORPHAN | MENPER DISTRIBUTORS INC. | 8cde5e39-a338-45af-b847-3823627f29c5 | 2025-08-25 | Warnings | M012 |
| Pain Reliever PM Extra Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Strategic Sourcing Services LLC | 997eb228-09cb-47ad-acbb-363b05c67635 | 2025-08-25 | Warnings | M012 |
| QUALITY CHOICE Childrens Allergy Relief DYE FREE | DIPHENHYDRAMINE HYDROCHLORIDE | QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION) | 644f39d8-7cd6-43dd-9265-546d01d32e8c | 2025-08-22 | Warnings | M012 |
| SanaTos Multi Symptom | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI | Pharmadel LLC | df260190-89e7-b338-e053-2995a90a32cb | 2025-08-22 | Warnings | M012 |
| Geri-Dryl allergy relief | DIPHENHYDRAMINE HCL | VerityRx | 9ca6c0f8-71d1-4953-8e98-3311c4664011 | 2025-08-22 | Warnings | M012 |
| SU PHEDRINE PE Non-Drowsy, Maximum Strength | PHENYLEPHRINE HCL | Salado Sales, Inc. | 9056fa58-d6aa-4df5-97e0-9be3f2332f86 | 2025-08-22 | Warnings | M012 |
| Chest Rub | CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL | MY IMPORTS USA LLC | 3cde0c23-5c5c-9715-e063-6294a90a9462 | 2025-08-21 | Warnings | M012 |
| Severe Cold Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | CVS Pharmacy | 258d27a9-fea6-4076-8dfa-77c7e982d250 | 2025-08-20 | 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 |