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 |
|---|---|---|---|---|---|---|
| CareAll Medicated Chest Rub | CAMPHOR, MENTHOL, EUCALYPTUS | New World Imports, Inc | 4cd2f751-e072-4f4e-b059-ed1dfcc60c6b | 2025-12-01 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | CVS PHARMACY, INC | bbb1b395-48d9-4859-ad52-6650961089d9 | 2025-12-01 | Warnings | M012 |
| Severe Sinus Pain and Congestion | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | fbc541ac-9465-4296-bb1e-811b9d811f40 | 2025-11-26 | Warnings | M012 |
| Daytime Severe and Nighttime Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Grocery Outlet, Inc. | 447951e6-459d-0a52-e063-6294a90a6226 | 2025-11-26 | Warnings | M012 |
| Daytime Cold and Flu Relief | ACETAMINOHPEN, DEXTROMETHORPHAN HBR, GUAIFENESIN PHENYLEPHRINE HCL | WALGREENS CO. | bfc58cd5-9815-43af-895d-ec6cbd10937e | 2025-11-26 | Warnings | M012 |
| Walgreen Cough and Chest Congestion | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | WALGREEN COMPANY | 40c038a3-91c7-4ed0-8210-65d58b82ca2b | 2025-11-26 | Warnings | M012 |
| Mucus Relief DM Maximum Strength | DEXTROMETHORPHAN HBR AND GUAIFENESIN | WALGREENS CO | 724554ab-60b8-46c8-96a8-a98242604e3b | 2025-11-26 | Warnings | M012 |
| Walgreens Grape Flavor | CHILDREN COUGH AND CHEST CONGESTION | WALGREENS | 795cf1af-3847-46bc-b605-64a38e57cca2 | 2025-11-26 | Warnings | M012 |
| Walgreens | CHILDRENS STUFFY NOSE AND COLD | WALGREENS CO. | 7ac3de2d-1d10-49ec-a2da-da46977684ad | 2025-11-26 | Warnings | M012 |
| Childrens Chest Congestion Relief | GUAIFENESIN | WALGREENS COMPANY | c1382512-e6f3-4bdf-a9e6-4f68dd5ea553 | 2025-11-26 | Warnings | M012 |
| Dye Free Wal Sleep Z | DIPHENHYDRAMINE HYDROCHLORIDE | WALGREEN CO. | 96948973-09e3-4c05-8982-0494ebeaac4b | 2025-11-26 | Warnings | M012 |
| WALGREEN ADULT COUGH PLUS CHEST CONGESTION DM | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | WALGREEN COMPANY | 02ad9f98-07ad-4786-a1ab-169b870fec01 | 2025-11-26 | Warnings | M012 |
| Walgreen Cherry | GUAIFENESIN | WALGREEN COMPANY | 1f1cb4a5-1ebd-483c-bf82-16931da00e05 | 2025-11-26 | Warnings | M012 |
| Walgreen Childrens COLD PLUS COUGH PLUS SORE THROAT | ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE | WALGREENS CO. | 801880b2-6116-4d26-a7bf-a669eef6ad8b | 2025-11-26 | Warnings | M012 |
| Walgreen Daytimel Kids Cold Cough plus Mucus | GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | WALGREENS CO. | 452159e0-1204-460c-981f-cace4e815c6f | 2025-11-26 | Warnings | M012 |
| Multi Symptom Wal Flu Severe Cold | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | WALGREEN CO. | 9c0f3f1e-25d1-4d73-9cd7-42708aa66dcb | 2025-11-25 | Warnings | M012 |
| WALGREEN Daytime Multi Symptom Flu Relief Max Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | WALGREENS CO. | c92a0f47-0b7c-4034-83d1-b7d2ed8022fc | 2025-11-25 | Warnings | M012 |
| Mucus Relief DM Honey and Berry Flavor | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | WALGREENS CO. | 428081f5-b7eb-42da-963c-a587a44b2a79 | 2025-11-25 | Warnings | M012 |
| Walgreen NightTime Cold and Flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE | WALGREENS CO. | 6b3766e6-d0d4-49e0-90da-fc893aef3329 | 2025-11-25 | Warnings | M012 |
| Adult Allergy Relief Dye Free | DIPHENHYDRAMINE HYDROCHLORIDE | WALGREEN COMPANY | 586310f3-0014-4cfc-9d86-961b3fb7aa8c | 2025-11-25 | 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 |