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 |
|---|---|---|---|---|---|---|
| Quantum Health Bing Cherry Flavor | MENTHOL, UNSPECIFIED FORM | Quantum, Inc. | 94d40c95-fa2b-42cf-b9f5-a5027d86401d | 2025-10-20 | Warnings | M012 |
| Quantum Health Meyer Lemon and Honey Flavor | MENTHOL, UNSPECIFIED FORM | Quantum, Inc. | fe780067-5a20-4d55-a108-91237cd9e5f4 | 2025-10-20 | Warnings | M012 |
| OneSsip Diphenhydramine HCl 12.5 mg/ 5 mL Oral Solution (Cherry) | DIPHENHYDRAMINE HCL | MEDWISE LIFESCIENCES INC. | 4157e680-37ac-eb4c-e063-6394a90a2a99 | 2025-10-17 | Warnings | M012 |
| Norel AD | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HCL | U.S. PHARMACEUTICAL CORPORATION | 53d9ed3c-212d-4b12-ac35-8bd49382b49d | 2025-10-17 | Warnings | M012 |
| Severe Congestion, Cough, Cold and Flu Relief Maximum Strength, Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, TRIPROLIDINE HCL | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 92c570ff-139f-49ff-a7bd-8a540ecc07c7 | 2025-10-17 | Warnings | M012 |
| NoHist DM | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE | Larken Laboratories, Inc. | 6aafe912-28ff-442f-8e07-b3c5993ac943 | 2025-10-16 | Warnings | M012 |
| Signature Care Original | OXYMETAZOLINE HYDROCHLORIDE | SAFEWAY, INC. | f7ad687b-dcaf-928c-e053-6294a90a6abe | 2025-10-16 | Warnings | M012 |
| Daytime Nighttime Cold Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Care One (Retail Business Services, LLC.) | 90ccb29c-9967-46cb-a409-e440344e1a1a | 2025-10-15 | Warnings | M012 |
| Robitussin Childrens Honey Day Night DM Value Pack | DEXTROMETHORPHAN HBR, GUAIFENESIN, DOXYLAMINE SUCCINATE | Haleon US Holdings LLC | f9999875-3433-4052-a628-39539d373216 | 2025-10-15 | Warnings | M012 |
| Robitussin Day and Night Cough Relief Value Pack | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, CHLORPHENIRAMINE MALEATE | Haleon US Holdings LLC | 4029eccd-5443-4ae2-9232-2a1d922798f8 | 2025-10-15 | Warnings | M012 |
| EndaCof DM | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE | Larken Laboratories, Inc. | c68ea55a-8b9a-4a70-8b5c-1a2736651813 | 2025-10-15 | Warnings | M012 |
| DURATUSS DM | DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | Poly Pharmaceuticals, Inc. | 413a3951-d704-f14b-e063-6394a90a06dc | 2025-10-15 | Warnings | M012 |
| LoHist DM | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE | Larken Laboratories, Inc. | 29730dab-fa09-4351-9b36-0359ba4f7744 | 2025-10-15 | Warnings | M012 |
| M-END DMX | DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE | R. A. McNeil Company | ee1fae2e-3a21-4487-9989-c7620a4a7056 | 2025-10-15 | Warnings | M012 |
| Chlo Tuss | CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE | R.A. McNeil Company | 43610aaa-8b94-40d5-ae09-3d75bd2317c8 | 2025-10-15 | Warnings | M012 |
| Chlo Hist | CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE | R. A. McNeil Company | d046f4ba-5753-4ed5-a924-0b66fd116781 | 2025-10-15 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Care One (Retail Business Services, LLC.) | 6ca7372b-50c4-4b15-b133-fefa35525ade | 2025-10-15 | Warnings | M012 |
| Extra Strength Sinus Relief Nasal Decongestant | PHENYLEPHRINE HYDROCHLORIDE | CARDINAL HEALTH | 0d8a009c-30b5-4f12-90bd-f8aa1110243f | 2025-10-14 | Warnings | M012 |
| Tussin DM Cough plus Chest Congestion | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | Cardinal Health 110, Inc. DBA LEADER | 9d11f443-c93d-44e8-b5a3-2677b7b11212 | 2025-10-14 | Warnings | M012 |
| Rompe Pecho SF | GUAIFENESIN | Efficient Laboratories, Inc. | 31ff48fc-9603-413c-ab7c-2598b3e08f9c | 2025-10-14 | 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 |