Daytime Severe Cold and Flu
- Product NDC
- 53345-021
- 11-digit product format
- 533450021
- Labeler code
- 53345
- Product ID
- 53345-021_27c7750e-5d1b-f49a-e063-6394a90a06ae
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- acetaminophen, dextromethorphan hydrobromide, Guaifenesin, phenylephrine hydrochloride
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2014-07-11
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
- 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
- Daytime Severe Cold and Flu
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/1 |
| GUAIFENESIN | 200 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
| 495W7451VQ | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1656815 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| cbd3a905-1c41-4cb0-8df6-36784430d627 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 4fe95224-f543-4dbb-9445-8cca122b48c8 | Product name | 1 | 20150609 |
| e8718272-64cb-4436-969b-176c3067c8f4 | Product name | 1 | 20150609 |
| 106ff02a-57e1-4c4c-a307-fd582ff4e311 | Product name | 1 | 20150212 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53345-021-01 | Daytime Severe Cold and Flu | 1 in 1 BOX | CAPSULE, LIQUID FILLED | 1 | 4 | |
| 53345-021-01 | Daytime Severe Cold and Flu | 3000 in 1 BAG | CAPSULE, LIQUID FILLED | 3000 | 4 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53345-021 | DAYTIME SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20241127_cbd3a905-1c41-4cb0-8df6-36784430d627.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 |
|---|---|---|---|---|---|---|
| Vicks NyQuil Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE | The Procter & Gamble Manufacturing Company | d1657403-b953-4db1-9a86-343e9e769a1a | 2026-06-22 | Warnings | M012 |
| Vicks DayQuil and Vicks NyQuil Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE | The Procter & Gamble Manufacturing Company | 04dc3835-64be-d9e4-e063-6394a90a8599 | 2026-06-22 | Warnings | M012 |
| Vicks DayQuil Kids COLD and COUGH plus FEVER | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | The Procter & Gamble Manufacturing Company | 1a01b294-a5ee-ab35-e063-6394a90a4a1a | 2026-06-22 | Warnings | M012 |
| Vicks NyQuil ALLERGY | DOXYLAMINE SUCCINATE | The Procter & Gamble Manufacturing Company | 2f9b3bbb-4494-065d-e063-6294a90afcd2 | 2026-06-22 | Warnings | M012 |
| Vicks NyQuil Kids ALLERGY | DOXYLAMINE SUCCINATE | The Procter & Gamble Manufacturing Company | 2f9a6d65-f849-af0a-e063-6394a90ae435 | 2026-06-22 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | BIONPHARMA INC. | 3c1953a1-32e9-6c81-e063-6294a90a9fa2 | 2026-06-22 | Warnings | M012 |
| Vicks NyQuil Kids COLD and COUGH plus FEVER | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | The Procter & Gamble Manufacturing Company | 1a01d4f7-37ed-bb92-e063-6294a90a208c | 2026-06-22 | Warnings | M012 |
| Vicks DayQuil INTENSE FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | The Procter & Gamble Manufacturing Company | 326ed27d-cbfa-5513-e063-6394a90a41bf | 2026-06-22 | Warnings | M012 |
| Vicks DayQuil Kids and Vicks NyQuil Kids COLD and COUGH plus FEVER | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | The Procter & Gamble Manufacturing Company | 2d430264-074d-fb22-e063-6294a90a57f6 | 2026-06-22 | Warnings | M012 |
| DayQuil VapoCOOL SEVERE COLD and FLU plus CONGESTION | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESIN | The Procter & Gamble Manufacturing Company | ef6e8503-d268-291b-e053-2995a90aec8f | 2026-06-22 | Warnings | M012 |
| Vicks DayQuil and Vicks NyQuil Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE | The Procter & Gamble Manufacturing Company | 4147ff00-8e21-7335-e054-00144ff88e88 | 2026-06-22 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | AMERISOURCE BERGEN | 51021c69-d92b-0504-e063-6294a90a94e7 | 2026-06-22 | Warnings | M012 |
| Vicks NyQuil SINUS PAIN and HEADACHE | ACETAMINOPHEN, DOXYLAMINE SUCCINATE | The Procter & Gamble Manufacturing Company | 4c4ca296-ea6c-1f19-e063-6294a90a8161 | 2026-06-22 | Warnings | M012 |
| Vicks DayQuil and Vicks NyQuil INTENSE FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | The Procter & Gamble Manufacturing Company | 32bea3dc-9889-22dd-e063-6394a90afa1b | 2026-06-22 | Warnings | M012 |
| DAYTIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 59db2573-7ebb-4cf9-bfe3-428929bb4eeb | 2026-06-22 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Best Choice (Valu Merchandisers Company) | bfec14d5-d9ce-4b9c-a803-3d01cb00b56c | 2026-06-22 | Warnings | M012 |
| Sinus and Congestion Non-Drowsy | PSEUDOEPHEDRINE HCL | Wal-Mart Stores Inc | cbdac7ad-3904-4a85-91a9-863f6f06503d | 2026-06-22 | Warnings | M012 |
| Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | WinCo Foods, LLC | 5f1aaa8e-c65f-43b3-9850-c60c1663d78f | 2026-06-22 | Warnings | M012 |
| DAY TIME INTENSE FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Meijer, Inc. | e5a64d5a-c1ff-453d-b0c1-fe265b9e2c8a | 2026-06-22 | Warnings | M012 |
| NO DRIP NASAL | PHENYLEPHRINE HYDROCHLORIDE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 7a866cdf-1c0c-403a-afc8-0e99e0ce81aa | 2026-06-22 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1656815 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Capsule | PSN | cbd3a905-1c41-4cb0-8df6-36784430d627 | 4 |
| 1656815 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SCD | cbd3a905-1c41-4cb0-8df6-36784430d627 | 4 |
| 1656815 | APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule | SY | cbd3a905-1c41-4cb0-8df6-36784430d627 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53345-021-01 | 53345002101 | 1 BAG in 1 BOX (53345-021-01) / 3000 CAPSULE, LIQUID FILLED in 1 BAG | 1 bag | 2014-07-11 | 0000-00-00 | No | No | Current |