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 |
|---|---|---|---|---|---|---|
| Giltuss D | GILTUSS D | Dextrum Laboratories Inc. | 3f17eefb-b625-b0f2-e063-6294a90afd4d | 2025-09-18 | Warnings | M012 |
| Cold and Flu Relief Daytime | ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Major Pharmaceuticals | 6c11c8c8-b2e1-4b9e-80cf-23247c03dd9b | 2025-09-17 | Warnings | M012 |
| Childrens Giltuss Honey DM Cough | DEXTROMETHORPHAN HBR | Dextrum Laboratories Inc | 3effaf4b-28c3-6131-e063-6294a90a17ff | 2025-09-17 | Warnings | M012 |
| AXIV DayTime - Liquid | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | VIVUNT PHARMA LLC | 1872e1ff-2e08-c404-e063-6294a90afa14 | 2025-09-17 | Warnings | M012 |
| AXIV Allergy | DIPHENHYDRAMINE HYDROCHLORIDE | VIVUNT PHARMA LLC | 1323a67c-b9c5-038c-e063-6394a90a5e6b | 2025-09-17 | Warnings | M012 |
| Giltuss Childrens Cough and Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Dextrum Laboratories Inc. | 3f025ef6-79e7-e833-e063-6294a90ab501 | 2025-09-17 | Warnings | M012 |
| AXIV Night Time - Liquid | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | VIVUNT PHARMA LLC | 186f8519-655d-bd21-e063-6294a90a16a8 | 2025-09-17 | Warnings | M012 |
| AXIV NightTime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | VIVUNT PHARMA LLC | 131f6314-c9a1-7af3-e063-6294a90abe6f | 2025-09-17 | Warnings | M012 |
| AXIV DayTime - NightTime 48 Softgels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | VIVUNT PHARMA LLC | 1320e243-344f-98ed-e063-6294a90a0092 | 2025-09-17 | Warnings | M012 |
| AXIV Sinus Severe Mucus | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCLORIDE | VIVUNT PHARMA LLC | 13245298-8b78-e177-e063-6294a90a6bec | 2025-09-17 | Warnings | M012 |
| GoodSense Tussin CF Multi-Symptom Cold, Raspberry | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Geiss, Destin & Dunn Inc. | 3f05cf84-d485-7688-e063-6394a90ae740 | 2025-09-17 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Family Dollar (FAMILY WELLNESS) | 5d7466b4-fdb7-432b-880d-e7aa4a4acbda | 2025-09-17 | Warnings | M012 |
| allergy relief Childrens | DIPHENHYDRAMINE HCL | United Natural Foods, Inc. dba UNFI | e34d8bf5-e12e-453c-93ea-9c7988c4f13d | 2025-09-16 | Warnings | M012 |
| DayTime Cold Flu Non Drowsy | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Harris Teeter, LLC | 67beb9f6-4e0a-4f7b-b50a-4bcd3a01354f | 2025-09-16 | Warnings | M012 |
| DOMETUSS | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Domel Laboratories | 3ebfc62f-27f6-48b2-9bae-bdefbd1d05fe | 2025-09-16 | Warnings | M012 |
| CareOne Severe Congestion Nasal | OXYMETAZOLINE HYDROCHLORIDE | American Sales Company | d1dba68b-c4e1-4afc-9aee-6a51341b89f5 | 2025-09-16 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | FSA Store Inc. (Caring Mills) | e69ef8dc-09d2-46de-aebf-ba735f4cc7ea | 2025-09-16 | Warnings | M012 |
| Nasal Decongestant | PSEUDOEPHEDRINE HCL | L.N.K. International, Inc. | f12b7f07-0b81-4cab-ae0f-43a7bf9b4bc5 | 2025-09-15 | Warnings | M012 |
| Menthol Cough Drops Honey Lemon Flavor | MENTHOL HONEY LEMON FLAVOR | CVS Pharmacy | 3ea9a1f2-75b3-c67a-e063-6294a90a8caf | 2025-09-13 | Warnings | M012 |
| Menthol Cough Drops Honey Lemon Flavor | MENTHOL HONEY LEMON FLAVOR | CVS Pharmacy | 3eab4cf9-6fdc-a6fb-e063-6394a90a8633 | 2025-09-13 | 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 |