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 |
|---|---|---|---|---|---|---|
| Right Remedies Adult Long Lasting Cough Relief Softgel | DEXTROMETHORPHAN HYDROBROMIDE | Strive Pharmaceuticals Inc. | e3ea468e-4e12-4dae-b222-8e32456b77b8 | 2025-01-02 | Warnings | M012 |
| AVON HeXashield Congestion Relief Original | OXYMETAZOLINE HYDROCHLORIDE | Tai Guk Pharm. Co., Ltd. | 8f2c152c-c564-0cba-e053-2a95a90ab3c7 | 2025-01-01 | Warnings | M012 |
| Multi-Symptom Nighttime Cold and Flu Relief | ACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HBR | Advanced Rx LLC | a75553bd-f3f0-47bd-b3c3-aeeb0d1a81b4 | 2025-01-01 | Warnings | M012 |
| Cough Relief | DEXTROMETHORPHAN HYDROBROMIDE | Advanced Rx LLC | 297e10e3-e740-4434-91a2-2e5c54985d33 | 2025-01-01 | Warnings | M012 |
| MUCUS RELIEF DM | GUAIFENESIN, DEXTROMETHORPHAN HBR | Advanced Rx LLC | 64620186-a45b-4c35-a3b9-a347348f93f7 | 2025-01-01 | Warnings | M012 |
| DM Max | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Best Choice | 57a44bbf-a304-47b9-8adc-4442c7787853 | 2025-01-01 | Warnings | M012 |
| Long Acting Cough Softgels | DEXTROMETHORPHAN HYDROBROMIDE | CVS PHARMACY, INC | 322daee6-c61d-43d3-a54d-a354fd3df242 | 2025-01-01 | Warnings | M012 |
| Adult Tussin DM Lil Drug Store Products | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | Lil' Drug Store Products, Inc | 1915cf2a-ebaa-4c47-8991-5b741fa01be2 | 2024-12-31 | Warnings | M012 |
| Congestion Relief Lil Drug Store Products | OXYMETAZOLINE HYDROCHLORIDE | Lil' Drug Store Products, Inc | 8fca348c-ecb6-4a91-89dd-8bd4c05ac745 | 2024-12-31 | Warnings | M012 |
| DAYTIME COLD AND FLU MULTI SYMPTOM | DAYTIME COLD AND FLU MULTI SYMPTOM | TARGET CORP | 9dea350d-2f09-b944-e053-2995a90a2b63 | 2024-12-30 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Walgreens | 2b7aa3f5-3bc9-471f-8ff7-3c52719f0acb | 2024-12-30 | Warnings | M012 |
| Pediacare Childrens Cough and Cold Grape | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH | fabafdc1-9dd8-4258-af49-bab1e29ad109 | 2024-12-30 | Warnings | M012 |
| Pediacare Childrens Cough and Congestion Grape | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH | 9576723b-748c-45e7-bc0d-cc109b9f6735 | 2024-12-30 | Warnings | M012 |
| Cold and Flu Nighttime Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Lil' Drug Store Products, Inc. | ef6836fa-d104-d7b3-e053-2a95a90af2b8 | 2024-12-30 | Warnings | M012 |
| Circle K Congestion Relief | OXYMETAZOLINE HYDROCHLORIDE | Lil' Drug Store Products, Inc | 7e02fe57-f42f-4d3c-9002-4c4c0b1fafd6 | 2024-12-30 | Warnings | M012 |
| SDA Laboratories Tussin | GUAIFENESIN | SDA Laboratories, Inc. | 2a444cc8-96be-9432-e063-6394a90a1b63 | 2024-12-27 | Warnings | M012 |
| SDA Laboratories Tussin DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | SDA Laboratories, Inc. | 2a445f31-818d-11b1-e063-6294a90a8cb1 | 2024-12-27 | Warnings | M012 |
| Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | Richmond Pharmaceuticals Inc. | f184b2aa-91a4-44f9-b688-d4e318181984 | 2024-12-26 | Warnings | M012 |
| Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | Richmond Pharmaceuticals, Inc. | 2792032a-ff0f-4d5f-a8e3-b8b8c54f4e99 | 2024-12-26 | Warnings | M012 |
| OXYMETAZOLINE HYDROCHLORIDE | OXYMETAZOLINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION INC. | c7b1f980-9b0d-4f63-a70d-fd366658f863 | 2024-12-26 | 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 |