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 |
|---|---|---|---|---|---|---|
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Cabinet Health, Inc | 26a55d74-f772-5d17-e063-6394a90a5583 | 2025-08-07 | Warnings | M012 |
| Daytime Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | H E B | b7434978-44a8-4c51-979d-0bc446461e43 | 2025-08-06 | Warnings | M012 |
| Tussin DM | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | CVS Pharmacy | fc1e224c-5c57-43fc-ae6e-36aa0a4ae439 | 2025-08-06 | Warnings | M012 |
| childrens cold cough dm | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | Publix Super Markets Inc | 6efe7097-2a99-4654-9d94-b47f2e64d19d | 2025-08-05 | Warnings | M012 |
| Quality Choice Throat Soothing Drops Creamy Strawberry | PECTIN | Chain Drug Marketing Association, Inc. | 3b7548ee-7cd3-62c3-e063-6294a90a0612 | 2025-08-03 | Warnings | M012 |
| Vaporizing chest rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | LJ Pharma | 065bb666-e482-4e96-ac75-c6577dcc5b48 | 2025-08-01 | Warnings | M012 |
| Nighttime Cough-Kids | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Genexa | 024bb864-4214-1d8b-e063-6394a90aa573 | 2025-08-01 | Warnings | M012 |
| Antigrip Cough and Cold | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Pharmadel LLC | 3b53e5fc-f258-c2b9-e063-6394a90ab500 | 2025-08-01 | Warnings | M012 |
| Diphenhydramine HCl | DIPHENHYDRAMINE HYDROCHLORIDE | Major Pharmaceuticals | 1b591e27-b00b-41c8-9fe9-c633aba09134 | 2025-08-01 | Warnings | M012 |
| meijer Nighttime Cold and Flu SOFTGEL | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Meijer, Inc. | 377248b6-d64d-8dff-e063-6394a90a43f6 | 2025-07-31 | Warnings | M012 |
| meijer Daytime Cold and Flu SOFTGEL | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Meijer, Inc. | 3771f778-7ac9-7108-e063-6394a90a1105 | 2025-07-31 | Warnings | M012 |
| tussin dm | DEXTROMETHORPHAN HBR, GUAIFENESIN | CVS Pharmacy | 087d7774-9b0f-44f6-bc1b-4dfbd2f2f6ca | 2025-07-31 | Warnings | M012 |
| Equate Nasal | OXYMETAZOLINE HCL | Wal-Mart Stores Inc | c38a2783-aed9-466d-8976-59d03a792c04 | 2025-07-30 | Warnings | M012 |
| Quality Choice Throat Soothing Drops Creamy Strawberry | PECTIN | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 3b15d2ea-f784-275d-e063-6394a90a800c | 2025-07-29 | Warnings | M012 |
| Respiratory Relief | GUAIFENESIN | Schwabe North America, Inc | f683041a-4ff9-42a5-9047-a9a3140a8758 | 2025-07-29 | Warnings | M012 |
| Childrens Robitussin Honey Cough and Chest Congestion DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Haleon US Holdings LLC | b87f700e-3414-463c-80d4-c3dbca89a488 | 2025-07-29 | Warnings | M012 |
| Tussin DM | TUSSIN DM | Allegiant Health | 7a2f8d48-3123-4c37-b238-bd7cc4242bb7 | 2025-07-23 | Warnings | M012 |
| Dr. SANA COUGH AND CHEST CONGESTION DM SUGAR FREE | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | GADAL Laboratories, Inc | 5fb2438b-8f2d-4af2-9981-42d278d26800 | 2025-07-23 | Warnings | M012 |
| DR. SANA COUGH AND CHEST CONGESTION DM | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | GADAL Laboratories, Inc | baca0580-4c30-4b94-89fa-a7cf06d4ff25 | 2025-07-22 | Warnings | M012 |
| Defensol D | ACETAMINOPHEN, CHLORPHERINAMINE MALEATE, PHENYLEPHRINE HCI | Menper Distributors, Inc. | f466c660-69eb-4581-81ff-1499fa421d8b | 2025-07-22 | 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 |