daytime severe cold and flu
- Product NDC
- 72288-557
- 11-digit product format
- 722880557
- Labeler code
- 72288
- Product ID
- 72288-557_063eb739-87db-4038-9ead-a15e11ba1efc
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Amazon.com Services LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-05-29
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 325; 10; 200; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL
- 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
- 2027-12-31
- 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
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/15mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/15mL |
| GUAIFENESIN | 200 mg/15mL |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/15mL |
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 |
|---|---|
| 1369842 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1a21cbb2-1ba5-414f-a31f-42b7a7bddae5 | Available on FDA.report |
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 |
|---|---|---|---|---|---|---|
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | CVS PHARMACY, INC | 1b8d5494-1fcf-4cd0-acc0-34f17d577bd7 | 2025-03-14 | Warnings | M012 |
| Ultra Concentrated Daytime COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | PuraCap Pharmaceutical LLC | 300b2357-933b-fe9a-e063-6294a90aa4b9 | 2025-03-11 | Warnings | M012 |
| Ultra Concentrated Nighttime COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | PuraCap Pharmaceutical LLC | 300bf27f-744f-7366-e063-6394a90acbcb | 2025-03-11 | Warnings | M012 |
| Daytime COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | PuraCap Pharmaceutical LLC | 300c7c7b-ea0b-3650-e063-6294a90a65e8 | 2025-03-11 | Warnings | M012 |
| Rompe Pecho Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | EFFICIENT LABORATORIES INC | 2ec319a8-92bf-4552-86dd-37cbce18980f | 2025-03-11 | Warnings | M012 |
| HISTEX-DM New Formulation | DEXTROMETHORPHAN HBR, PSEUDOEPHEDRINE HCI, AND TRIPROLIDINE HCI | Allegis Pharmaceuticals, LLC | 30010401-e5b4-2bd9-e063-6394a90a0b0b | 2025-03-10 | Warnings | M012 |
| daytime severe cold multi-symptom | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | United Natural Foods, Inc. dba UNFI | cc7c5f1c-76b7-4278-8e2a-5fbc85e022dd | 2025-03-08 | Warnings | M012 |
| Cold and Head Congestion Relief Severe | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | WinCo Foods, LLC | a39778ba-1f63-4495-8e9b-44b0bdd7f71a | 2025-03-08 | Warnings | M012 |
| Extra Strength TYLENOL Severe Cough Plus Sore Throat Day | ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE | Kenvue Brands LLC | 2e9540e4-bd1d-9370-e063-6294a90affcb | 2025-03-07 | Warnings | M012 |
| Herbal Cough Drops Original Herb | COUGH DROPS | Topco Associates LLC | 2fb22181-aee3-d0bf-e063-6294a90a7865 | 2025-03-06 | Warnings | M012 |
| REVASOL DAYTIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Rnv LLC | 2f9ddcc3-b913-f8b0-e063-6294a90a93ab | 2025-03-05 | Warnings | M012 |
| Herbal Throat Drops Lemon Mint Herb | THROAT DROPS | Topco Associates LLC | 2fa086b4-3b0e-0df8-e063-6294a90a6769 | 2025-03-05 | Warnings | M012 |
| Redicare Nasal and Sinus Decongestant | REDICARE NASAL AND SINUS DECONGESTANT | Redicare LLC | 2f24be68-f30e-d916-e063-6294a90a7e31 | 2025-03-04 | Warnings | M012 |
| Diphenhydramine HCl Oral Solution | DIPHENHYDRAMINE HCL ORAL SOLUTION | Kesin Pharma Corporation | 2f871005-de4d-8b2a-e063-6394a90aa43a | 2025-03-04 | Warnings | M012 |
| CVS Daytime Cough Relief Chews - Citrus Punch | DEXTROMETHORPHAN HBR | CVS | 2f885f1b-7ff5-251b-e063-6394a90a656f | 2025-03-04 | Warnings | M012 |
| CVS Dex-Dox Kids Nighttime Cough Suppressant | DEXTROMETHORPHAN HBR | CVS | 2f8b6f5e-399c-b033-e063-6294a90ac3d1 | 2025-03-04 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL 25 MG | Pioneer Life Sciences, LLC | ff8b096c-8f01-4a8c-a98f-e4aa4d688e95 | 2025-03-04 | Warnings | M012 |
| Menthol Cough Drops Honey Vanilla Flavor | MENTHOL | 7-ELEVEN | 2f3c43dd-175f-722e-e063-6294a90acff9 | 2025-02-28 | Warnings | M012 |
| Menthol Cough Drops Creamy Strawberry Flavor | MENTHOL AND PECTIN | 7-ELEVEN | 2f3c3c65-4178-6304-e063-6294a90a51fa | 2025-02-28 | Warnings | M012 |
| Menthol Cough Drops Creamy Strawberry Flavor | MENTHOL AND PECTIN | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 2efbffd7-bbdd-c5f5-e063-6294a90a15f0 | 2025-02-25 | Warnings | M012 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 72288-557-34 | 72288055734 | 237 mL in 1 BOTTLE (72288-557-34) | 237 ml | 2026-06-04 | No | No | Current |
| 72288-557-40 | 72288055740 | 355 mL in 1 BOTTLE (72288-557-40) | 355 ml | 2026-05-29 | No | No | Current |