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 |
|---|---|---|---|---|---|---|
| Foster and Thrive Chest Congestion Relief DM DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | Strategic Sourcing Services LLC | 5372f764-985e-4a42-bc97-cb0dc90fcd9c | 2024-12-18 | Warnings | M012 |
| TopCare Chest Congestion and Cough Relief DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | TOPCO ASSOCIATES LLC | 5a2d0464-038d-4c3f-b39e-ee9984fb383e | 2024-12-18 | Warnings | M012 |
| Always Save Chest Congestion Relief DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | Valu Merch | a72b6a97-f97f-44bb-8d55-ac48b8ba45c5 | 2024-12-18 | Warnings | M012 |
| Harris Teeter Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Harris Teeter | 4ebe1d94-bb15-4250-a4c2-8cd45743c7dd | 2024-12-18 | Warnings | M012 |
| Care One Chest Congestion Relief DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | RETAIL BUSINESS SERVICES , LLC | f6657dee-9f32-45b1-8e44-1ad67a4a68bd | 2024-12-18 | Warnings | M012 |
| Childrens Metapp Daytime | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Guardian Drug Company | 40565500-944b-47f2-8563-5df05469e418 | 2024-12-18 | Warnings | M012 |
| CVS Chest Congestion Relief DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | CVS Pharmacy, Inc. | 884abed2-e355-4134-92f1-591f3a18f71d | 2024-12-18 | Warnings | M012 |
| CVS Health Chest Congestion Relief PE | GUAIFENESIN/PHENYLEPHRINE | CVS Pharmacy, Inc. | a49020e8-739e-47ec-8141-e866479a3ab3 | 2024-12-18 | Warnings | M012 |
| Family Wellness Chest Congestion Relief DM DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | Family Dollar Services Inc | 8aee8108-a4e0-4956-8e37-6b3b1c5dc683 | 2024-12-18 | Warnings | M012 |
| TopCare Chest Congestion Relief | GUAIFENESIN | TOPCO ASSOCIATES LLC | b8339617-17ce-4ad7-af38-399ecc74d864 | 2024-12-18 | Warnings | M012 |
| Kroger Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | THE KROGER CO | 976bfdcf-2110-486c-aa6e-cd2067334cdc | 2024-12-18 | Warnings | M012 |
| Good Neighbor Pharmacy Mucus Relief DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | AmerisourceBergen Drug Corp | 79cefd46-bd19-4a1d-9cb1-e85ff0f12494 | 2024-12-18 | Warnings | M012 |
| Leader Chest Congestion Relief DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | Cardinal Health | 8397e1b9-e83e-4c6a-b858-1663c2365840 | 2024-12-18 | Warnings | M012 |
| GNP Mucus Relief PE | GUAIFENESIN/PHENYLEPHRINE | AmerisourceBergen Drug Corp | 63932e68-b09d-4500-bc1d-cfb2c267df1c | 2024-12-18 | Warnings | M012 |
| Meijer Chest Congestion Relief | GUAIFENESIN | Meijer Distribution Inc. | ae02e0bd-d9e7-495f-b01f-b135b96934a0 | 2024-12-18 | Warnings | M012 |
| Topcare Chest Congestion and Sinus Congestion Relief PE | GUAIFENESIN/PHENYLEPHRINE | TOPCO ASSOCIATES LLC | b6c0362f-86ca-4f08-ba53-800c6df2c025 | 2024-12-18 | Warnings | M012 |
| Sunmark Chest Congestion Relief DM DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | Strategic Sourcing Services LLC | 10cad9a7-1223-470c-9027-807891217d40 | 2024-12-18 | Warnings | M012 |
| Kroger Mucus Relief | GUAIFENESIN | THE KROGER CO | 2b7ad844-4c30-4c0e-aa8e-d7aa6fe4af4e | 2024-12-18 | Warnings | M012 |
| Quality Choice Mucus Relief | GUAIFENESIN | Chain Drug Marketing Association | 41f88b43-3e0a-4650-b167-a72afe6177e8 | 2024-12-18 | Warnings | M012 |
| Rugby Chest Congestion Relief DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | Rugby Laboratories | 5da36516-9f94-49cb-9421-0c310abcd116 | 2024-12-18 | 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 |