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 |
|---|---|---|---|---|---|---|
| Severe Congestion and Cough | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Family Dollar Services Inc | b9215a5e-3be8-44fd-9189-50dab760869c | 2026-01-06 | Warnings | M012 |
| Night Time Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Major Pharmaceuticals | f81efbf4-204b-45be-ae32-910d9e4ae4aa | 2026-01-06 | Warnings | M012 |
| SINUS AND NASAL DECONGESTANT | PSEUDOEPHEDRINE HYDROCHLORIDE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | d7646859-f996-46cd-a0b9-56b860f60901 | 2026-01-05 | Warnings | M012 |
| HyVee Cough Drops Honey Lemon | MENTHOL | HY-VEE, INC | 47a71cdf-856d-9ecd-e063-6294a90a70c6 | 2026-01-05 | Warnings | M012 |
| Guaifenesin | GUAIFENESIN | Oncor Pharmaceuticals | fd35036c-b722-48a3-85fd-60471beb6e74 | 2026-01-05 | Warnings | M012 |
| Diphenhydramine HCl | DIPHENHYDRAMINE HCL | NuCare Pharmaceuticals,Inc. | 3c323dc8-f734-b44c-e063-6394a90a6184 | 2026-01-05 | Warnings | M012 |
| Congestion and Cough Childrens | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | CVS PHARMACY | f43d97b1-aeb9-4ca5-8909-b28e7bf764f5 | 2026-01-05 | Warnings | M012 |
| Daytime Nighttime Cold Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | WinCo Foods, LLC | 6bd2b8fd-2023-413b-8988-a47d2058dc85 | 2026-01-05 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | WinCo Foods, LLC | 4c1046df-53a6-4219-83ac-bbf5cf4db9c8 | 2026-01-05 | Warnings | M012 |
| Night Time Cold and Flu Relief Multi Symptom | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | P & L Development, LLC | 80323208-9ba5-432b-a8a0-0c0b51e67145 | 2026-01-05 | Warnings | M012 |
| Sinus Pressure and Pain PE Maximum Strength | ACETAMINOPHEN AND PHENYLEPHRINE HCL | Rite Aid Corporation | 347868e4-0182-4e16-895c-ec269895c57c | 2026-01-02 | Warnings | M012 |
| HyVee Cough Drops Cherry | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | c5b11a9c-6d93-4772-93c2-1ef5c5647016 | 2026-01-02 | Warnings | M012 |
| HyVee Cough Drops Honey Lemon | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | fae96736-1453-42fe-8158-cde770b23165 | 2026-01-02 | Warnings | M012 |
| HyVee Cough Drops Menthol | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 8cac1229-8e8e-4d8c-9f18-c2cd0f6f50bd | 2026-01-02 | Warnings | M012 |
| Reliable-1 Tussin | GUAIFENESIN | RELIABLE 1 LABORATORIES LLC | 2a33ff82-49df-7aaa-e063-6294a90a1281 | 2026-01-02 | Warnings | M012 |
| Tussin DMMax | DEXTROMETHORPHAN HBR, GUAIFENESIN | RELIABLE 1 LABORATORIES LLC | c4bb2e12-e0f6-4cbf-ad24-cfad9326f7fa | 2026-01-02 | Warnings | M012 |
| Severe Sinus Pain and Congestion Daytime | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | CVS Pharmacy | 4af347ce-9745-4a5e-8ce9-e7c97a0a6cc7 | 2026-01-02 | Warnings | M012 |
| NUVALU VAPORIZING CHEST RUB | CAMPHOR, EUCALYPTUS OIL, MENTHOL | JC SALES | 490b2d1e-3a1d-1a52-e063-6394a90a00ba | 2026-01-01 | Warnings | M012 |
| NUVALU VAPORIZING CHEST RUB | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Ningbo Liyuan Daily Chemical Products Co., Ltd. | 4947540b-73c9-d44a-e063-6294a90a9d37 | 2026-01-01 | Warnings | M012 |
| PANCOLD A | ACETAMINOPHEN, GUAIFENESIN, PENTOXYVERINE CITRATE, PHENYLPEHRINE HYDCROCHLORIDE, CHLORPHENIRAMINE MALEATE, CAFFEINE ANHYDROUS | DONGWHA PHARM. CO. LTD. | fc8f1807-d344-ccc2-e053-6294a90a5089 | 2025-12-31 | 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 |