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 |
|---|---|---|---|---|---|---|
| Menthol Cough Drops Honey Vanilla Flavor | MENTHOL | 7-ELEVEN | 2f3c43dd-175f-722e-e063-6294a90acff9 | 2025-02-28 | Warnings | M012 |
| Menthol Cough Drops Creamy Strawberry Flavor | MENTHOL AND PECTIN | 7-ELEVEN | 2f3c3c65-4178-6304-e063-6294a90a51fa | 2025-02-28 | Warnings | M012 |
| Menthol Cough Drops Creamy Strawberry Flavor | MENTHOL AND PECTIN | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 2efbffd7-bbdd-c5f5-e063-6294a90a15f0 | 2025-02-25 | Warnings | M012 |
| Menthol Cough Drops Honey Vanilla Flavor | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 2efc46c9-a421-1998-e063-6394a90aeb64 | 2025-02-25 | Warnings | M012 |
| Redicare Cough Drops Cherry Flavored | CHERRY FLAVORED MENTHOL COUGH DROPS | Redicare LLC | 2efeaafa-ee96-37ee-e063-6394a90a9a4b | 2025-02-25 | Warnings | M012 |
| Childrens Allergy | DIPHENHYDRAMINE HCL | Genexa Inc. | e880b8d7-61c3-41cc-e053-2995a90aaaeb | 2025-02-20 | Warnings | M012 |
| Gencare-Nasal Decongestant PE | PHENYLEPHRINE HYDROCHLORIDE | Pioneer Life Sciences, LLC | 596ec923-56a0-4b6e-a69c-8d740feb75a2 | 2025-02-20 | Warnings | M012 |
| Tylenol Cold Plus Flu Severe Day and Tylenol Cold Plus Flu Plus Cough Night 2-pack | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | 77a2dc96-73ee-4ca2-b1fe-406995802606 | 2025-02-19 | Warnings | M012 |
| nasal decongestant | OXYMETAZOLINE HYDROCHLORIDE | Safeway | f1d0edd5-fe58-4de0-98f4-07fb24bd0ac2 | 2025-02-19 | Warnings | M012 |
| Coricidin HBP Cold and Flu | ACETAMINOPHEN AND CHLORPHENIRAMINE MALEATE | Bayer HealthCare LLC. | 763a5334-a741-4678-9947-603776622450 | 2025-02-18 | Warnings | M012 |
| Sof Skin Vaporizing Chest Rub and Cough Suppressant | MENTHOL AND CAMPHOR AND EUCALYPTUS OIL | Viny Health and Beauty Inc | 46ae16a4-b8a7-44de-ae1a-9bb503c15ea0 | 2025-02-18 | Warnings | M012 |
| Pain Reliever PM | ACETAMINOPHEN DIPHENHYDRAMINE HCL | QUALITY CHOICE (Chain Drug Marketing Association) | 4897d1df-4fb3-46e2-bbf0-847e964dca0a | 2025-02-18 | Warnings | M012 |
| meijer EXTRA STRENGTH Pain Relief PM Caplet | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE | Meijer, Inc. | 1bee7e4f-1813-1bdf-e063-6294a90a6a32 | 2025-02-17 | Warnings | M012 |
| ACETAMINOPHEN, DEXTROMETHORPHAN HBr, GUAILFENESIN,PHENLYEPHRINE HCL | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAILFENESIN,PHENLYEPHRINE HCL | Kroger Company | a24f09d9-60f1-853a-e053-2a95a90ae1fa | 2025-02-15 | Warnings | M012 |
| MAXIMUM STRENGTH COLD AND FLU | ACETAMINOPHEN,DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | FAMILY DOLLAR SERVICES | a7343bea-53cc-4621-e053-2a95a90a2a5f | 2025-02-15 | Warnings | M012 |
| MAXIMUM STRENGTH DAY-NIGHT COLD AND FLU FORMULA | ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE HCL | FAMILY DOLLAR | aa8f6dd0-d19f-0c10-e053-2a95a90a1e8a | 2025-02-15 | Warnings | M012 |
| MAXIMUM STRENGHT DAY COLD AND FLU FORMULA | ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE HCL | FAMILY DOLLAR | aa8ebccf-6813-2dca-e053-2a95a90a032b | 2025-02-15 | Warnings | M012 |
| MAXIMUM STRENTH NIGHT COLD AND FLU FORMULA | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | FAMILY DOLLAR | aa8f0465-1595-0b0f-e053-2a95a90a0081 | 2025-02-15 | Warnings | M012 |
| DAYTIME SEVERE COLD AND FLU | ACETAMINOPHEN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, GUAIFENESIN | KROGER COMPANY | 9bb7aaf0-6698-9a5c-e053-2a95a90a097c | 2025-02-14 | Warnings | M012 |
| Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | H-E-B | db432947-fe02-79b2-e053-2a95a90af4a9 | 2025-02-14 | 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 |