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 |
|---|---|---|---|---|---|---|
| Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 879a7804-f3d4-4a3d-bc92-b473499d6c95 | 2026-07-17 | Warnings | M012 |
| Best Choice | OXYMETAZOLINE HYDROCHLORIDE | BEST CHOICE (VALU MERCHANDISERS COMPANY) | 95007785-ddf6-4386-af5f-84dac1066b40 | 2026-07-17 | Warnings | M012 |
| BEST CHOICE No Drip | ALLERGY SINUS | BEST CHOICE (VALU MERCHANDISERS COMPANY) | d5f95b56-8201-4d97-82ab-e23761bfe720 | 2026-07-17 | Warnings | M012 |
| Best Choice Ultra Fine Mist | OXYMETAZOLINE HYDROCHLORIDE | BEST CHOICE (VALU MERCHANDISERS COMPANY) | 7d19fdba-35b0-424a-ba11-315521d3256d | 2026-07-17 | Warnings | M012 |
| Best Choice Maximum Strength | OXYMETAZOLINE HYDROCHLORIDE | BEST CHOICE (VALU MERCHANDISERS COMPANY) | badb15ac-91e8-4962-96f5-beb250977560 | 2026-07-17 | Warnings | M012 |
| Cough and Chest Congestion DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 0839c07b-f692-4af1-85b8-da60fb281d49 | 2026-07-17 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | WinCo Foods, LLC | 2cbf27b6-217c-46d8-89c9-e46f3668f002 | 2026-07-17 | Warnings | M012 |
| Best Choice | OXYMETAZOLINE HYDROCHLORIDE | BEST CHOICE (VALU MERCHANDISERS COMPANY) | d86d53cd-75ce-4c40-83cb-ada9b77a76f6 | 2026-07-17 | Warnings | M012 |
| LEADER Multi Symptom Flu Relief Daytime Max Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | CARDINAL HEALTH 110, LLC. DBA LEADER | 2212cf9e-6944-4922-b5b5-1373cf10b2e1 | 2026-07-16 | Warnings | M012 |
| Cold and Flu HBP | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE | CVS PHARMACY | 06756130-1608-4ae6-9772-95a4549853a1 | 2026-07-16 | Warnings | M012 |
| Medicated Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Old East Main Co. | 7855033e-6a12-4cd8-b0a2-c5d69018d117 | 2026-07-16 | Warnings, Adverse reactions | M012 |
| Oxymetazoline Hydrochloride 12-Hour | OXYMETAZOLINE HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | 34a79f8b-32b7-48db-a895-c942cc795292 | 2026-07-16 | Warnings | M012 |
| LoHist D | CHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCL | Larken Laboratories, Inc. | 93c9ad4f-3376-48c2-8276-0375663acd01 | 2026-07-16 | Warnings | M012 |
| Sanatos | MENTHOL | Pharmadel LLC | 522e1e7f-98ed-c475-e063-6294a90a622c | 2026-07-16 | Warnings | M012 |
| LEADER MS Flu Relief Nighttime | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND DEXTROMETHOPHAN HBR | CARDINAL HEALTH 110, LLC. DBA LEADER | 9db7d4e2-f7c1-41a7-8e1c-ef8d3512259d | 2026-07-16 | Warnings | M012 |
| NIGHTTIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Amazon.com Services LLC | 1bf4cd96-5800-434d-a0dc-e84c759ebb33 | 2026-07-16 | Warnings | M012 |
| Mucus Relief Cough Childrens | DEXTROMETHORPHAN HBR, GUAIFENSIN | Walgreens | 2ace231a-94c4-479d-bb26-454bd07b207b | 2026-07-16 | Warnings | M012 |
| LEADER No Drip | ALLERGY SINUS NASAL MIST | CARDINAL HEALTH 110, LLC. DBA LEADER | e7b2c1c1-6250-4af3-b131-22aced2b23d5 | 2026-07-16 | Warnings | M012 |
| Mucus Relief DM Cough | DEXTROMETHORPHAN HBR, GUAIFENESIN | Amerisource Bergen | 639a59b7-ccff-485e-a232-38b680827229 | 2026-07-16 | Warnings | M012 |
| Equate Nighttime Vapor Ice Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | WALMART INC. | 30470a01-4d42-44c6-a017-d68bb74cdef7 | 2026-07-15 | 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 |