TYLENOL Cold Plus Mucus Severe
- Product NDC
- 50580-511
- 11-digit product format
- 505800511
- Labeler code
- 50580
- Product ID
- 50580-511_22c7e800-a49a-73b9-e063-6394a90aebd9
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Kenvue Brands LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2015-06-22
- 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
- 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
- TYLENOL Cold Plus Mucus Severe
- Listing expiration
- 2026-12-31
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 |
|---|---|
| 24ac94e8-b223-424e-bcd2-9c027c8ff9ed | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50580-511-01 | TYLENOL Cold Plus Mucus Severe | 240 mL in 1 BOTTLE, PLASTIC | SOLUTION | 240 | 10 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50580-511-01 | ML - Milliliter | 50580-511 | b233327b-c679-4c9f-89e2-f7b465a49862 | 1 | 2020-09-14 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50580-511 | TYLENOL COLD PLUS MUCUS SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [KENVUE BRANDS LLC] | 10 | Current NDC, Legacy NDC, 1 package rows | 20241109_24ac94e8-b223-424e-bcd2-9c027c8ff9ed.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 |
|---|---|---|---|---|---|---|
| Childrens Cold and Cough Nighttime | DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Safeway, Inc. | cbbec807-f882-4c6a-b1cd-c7fd5ce70cad | 2024-05-15 | Warnings | M012 |
| Cold and Flu Relief Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Safeway, Inc. | d6ac0d70-0511-4ec8-bb35-8b2e0e3d7742 | 2024-05-15 | Warnings | M012 |
| Night Time Cough | DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Safeway, Inc. | f658a03b-6fc2-4b63-b3ab-7e886fbf20b4 | 2024-05-15 | Warnings | M012 |
| AXIV DM Max | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | VIVUNT PHARMA LLC | 18704e66-ee8f-315d-e063-6294a90a5282 | 2024-05-14 | Warnings | M012 |
| Menthol Cough Drops | MENTHOL | Target Corporation Inc. | 187622dc-ecde-181d-e063-6294a90a4e8f | 2024-05-14 | Warnings | M012 |
| Lemon Mint Drops | MENTHOL | Target Corporation Inc. | 1876df19-398a-23d8-e063-6394a90ae7e8 | 2024-05-14 | Warnings | M012 |
| Cold Flu and Sore Throat Relief Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Safeway, Inc. | 6c952c81-c8b6-4e74-abd8-781f6f44736b | 2024-05-14 | Warnings | M012 |
| Pain and Sinus Reliever | ACETAMINOPHEN AND PHENYLEPHRINE | JHK DBA American Safety & First Aid | 249373c6-f56f-4bd3-9cef-98b7ee73457d | 2024-05-14 | Warnings | M012 |
| Nasal | PHENYLEPHRINE HYDROCHLORIDE | Meijer, Inc. | fea71cb9-e044-4729-ad26-1db0cdb9dd11 | 2024-05-14 | Warnings | M012 |
| Nighttime Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Safeway, Inc. | a70ead03-6d2c-44c1-9ae5-f6c4094821ec | 2024-05-14 | Warnings | M012 |
| Day Time Cold and Flu Relief non drowsy | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Safeway, Inc. | cc450f89-a156-48e0-82ae-19782f13c2ca | 2024-05-13 | Warnings | M012 |
| Daytime Nighttime Cold Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Safeway, Inc. | a8df5c04-0f92-4013-b3e5-2b45009a7b8d | 2024-05-13 | Warnings | M012 |
| Daytime Nighttime Cold and Flu | ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCI DOXYLAMINESUCINATE | Safeway, Inc. | f762600a-f4b1-4869-a04b-8431c3d8a3e3 | 2024-05-13 | Warnings | M012 |
| Cold and Flu DayTime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Safeway, Inc. | ef0cd436-5e81-47a7-92d6-58495283ab28 | 2024-05-13 | Warnings | M012 |
| Tussin Cough Sugar Free | DEXTROMETHORPHAN HBR GUAIFENESIN | P & L Development, LLC | 7ed2fe86-3346-4308-a9b6-6a264f879b02 | 2024-05-09 | Warnings | M012 |
| Severe Cold and Flu Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | KROGER COMPANY | 10106c90-f2f0-508e-e063-6294a90a544b | 2024-05-08 | Warnings | M012 |
| Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATE | Kroger | 1013ce02-7b12-335e-e063-6394a90af3e6 | 2024-05-08 | Warnings | M012 |
| Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATE | Kroger | 10b08ea8-693e-eb18-e063-6394a90af548 | 2024-05-08 | Warnings | M012 |
| Nighttime Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Kroger | 10b0bcff-d3bc-f70c-e063-6394a90a35ed | 2024-05-08 | Warnings | M012 |
| Daytime Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Kroger | 10b0e0a0-b878-0a9a-e063-6394a90a20e0 | 2024-05-08 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1369842 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution | PSN | 24ac94e8-b223-424e-bcd2-9c027c8ff9ed | 10 |
| 1369842 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.3 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SCD | 24ac94e8-b223-424e-bcd2-9c027c8ff9ed | 10 |
| 1369842 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | 24ac94e8-b223-424e-bcd2-9c027c8ff9ed | 10 |
| 1369842 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | 24ac94e8-b223-424e-bcd2-9c027c8ff9ed | 10 |
| 1369842 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / Guaifenesin 13.3 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral Solution | SY | 24ac94e8-b223-424e-bcd2-9c027c8ff9ed | 10 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50580-511-01 | 50580051101 | 240 mL in 1 BOTTLE, PLASTIC (50580-511-01) | 240 ml | 2015-06-22 | 0000-00-00 | No | No | Current |