TYLENOL Cold Plus Flu
- Product NDC
- 50580-402
- 11-digit product format
- 505800402
- Labeler code
- 50580
- Product ID
- 50580-402_5c393efd-40ac-6e38-e063-6394a90ae753
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Kenvue Brands LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2011-09-01
- 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
- 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
- TYLENOL Cold Plus Flu
- Brand name suffix
- Severe
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/1 |
| GUAIFENESIN | 200 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/1 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 50580-402-01 | 2024-02-06 | TYLENOL ® Cold + Flu Severe |
| 50580-402-01 | 2024-02-06 | TYLENOL ® Cold + Flu Severe |
| 50580-402-02 | 2024-02-06 | TYLENOL ® Cold + Flu Severe |
| 50580-402-02 | 2024-02-06 | TYLENOL ® Cold + Flu Severe |
| 50580-402-26 | 2024-02-06 | TYLENOL ® Cold + Flu Severe |
| 50580-402-26 | 2024-02-06 | TYLENOL ® Cold + Flu Severe |
| 50580-402-72 | 2024-02-06 | TYLENOL ® Cold + Flu Severe |
| 50580-402-72 | 2024-02-06 | TYLENOL ® Cold + Flu Severe |
| 50580-402-01 | 2024-01-30 | TYLENOL ® Cold + Flu Severe |
| 50580-402-01 | 2024-01-30 | TYLENOL ® Cold + Flu Severe |
| 50580-402-02 | 2024-01-30 | TYLENOL ® Cold + Flu Severe |
| 50580-402-02 | 2024-01-30 | TYLENOL ® Cold + Flu Severe |
| 50580-402-26 | 2024-01-30 | TYLENOL ® Cold + Flu Severe |
| 50580-402-26 | 2024-01-30 | TYLENOL ® Cold + Flu Severe |
| 50580-402-72 | 2024-01-30 | TYLENOL ® Cold + Flu Severe |
| 50580-402-72 | 2024-01-30 | TYLENOL ® Cold + Flu Severe |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50580-402-01 | TYLENOL Cold Plus FluSevere | 2 in 1 POUCH | TABLET, FILM COATED | 2 | 20 | |
| 50580-402-02 | TYLENOL Cold Plus FluSevere | 2 in 1 POUCH | TABLET, FILM COATED | 2 | 20 | |
| 50580-402-02 | TYLENOL Cold Plus FluSevere | 50 in 1 CARTON | TABLET, FILM COATED | 50 | 20 | |
| 50580-402-26 | TYLENOL Cold Plus FluSevere | 2 in 1 CARTON | TABLET, FILM COATED | 2 | 20 | |
| 50580-402-26 | TYLENOL Cold Plus FluSevere | 12 in 1 BLISTER PACK | TABLET, FILM COATED | 12 | 20 | |
| 50580-402-72 | TYLENOL Cold Plus FluSevere | 3 in 1 PACKAGE | TABLET, FILM COATED | 3 | 20 | |
| 50580-402-72 | TYLENOL Cold Plus FluSevere | 2 in 1 CARTON | TABLET, FILM COATED | 2 | 20 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50580-402-25 | EA - Each | 50580-402 | 0cc3391e-bdb0-4261-8768-843eeb5a7dbd | 1 | 2012-07-24 |
| 50580-402-26 | EA - Each | 50580-402 | 30dba1ec-de87-4165-ada8-eec0bd9a7ef1 | 1 | 2013-03-03 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50580-402 | TYLENOL COLD PLUS FLU SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [KENVUE BRANDS LLC] | 20 | Current NDC, Legacy NDC, 7 package rows | 20241103_efb3bfc5-72e9-4221-8d03-e48f3d8e3821.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 |
|---|---|---|---|---|---|---|
| Vaporizing Rub | CAMPHOR, EUCALYPTUS OIL AND MENTHOL | ALAINA HEALTHCARE PRIVATE LIMITED | 4c6a7ac0-be76-42b0-9a08-b287e70a3460 | 2025-12-09 | Warnings | M012 |
| 24-7 Life BY 7-ELEVEN Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE SOLUTION | Lil' Drug Store products, Inc. | 277363f4-1c00-ddb7-e063-6294a90a4677 | 2025-12-09 | Warnings | M012 |
| Daytime Cold and Flu Relief, 24-7 Life BY 7-Eleven | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL SOLUTION | Lil' Drug Store Products, Inc. | 2771d699-3f70-4318-e063-6394a90a89cc | 2025-12-09 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Shield Pharmaceuticals Corp | 3d243264-5cd8-47da-9f5e-cfcfc8d1fa4b | 2025-12-09 | Warnings | M012 |
| Circle K Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | Lil' Drug Store Products, Inc | 9a32bc6d-0499-48fa-a6ad-702c8a28bf5f | 2025-12-09 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Shield Pharmaceuticals Corp | 5015a380-a229-4eff-8e31-528065c6ed64 | 2025-12-09 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Harris Teeter | caf59320-5b48-4533-bda9-7b03a2fde0b5 | 2025-12-09 | Warnings | M012 |
| Sinus Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | STRATEGIC SOURCING SERVICES LLC | 30d41dc3-e2ef-4cad-b63c-d634bc749aa1 | 2025-12-09 | Warnings | M012 |
| Walgreens Childrens Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Walgreen Company | 327a7226-84b9-26d7-e063-6394a90a99b9 | 2025-12-09 | Warnings | M012 |
| Mucus Relief DM | DEXTROMETHORPHAN HBR AND GUAIFENESIN | Meijer Distribution Inc | 8ed5b802-a26e-45b4-a696-bc64dbac4733 | 2025-12-09 | Warnings | M012 |
| dg health cold plus flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Dolgencorp, LLC | ff4a2f0a-d638-4ed2-8e05-2a52afbc4909 | 2025-12-09 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCL | QUALITY CHOICE (Chain Drug Marketing Association) | 24894484-b834-4b2f-b365-c95b5e30d8bf | 2025-12-09 | Warnings | M012 |
| Nighttime Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Family Dollar (FAMILY WELLNESS) | 2c431220-c61b-4ad5-9ad2-58ccaee2d1c3 | 2025-12-09 | Warnings | M012 |
| Sinus PE Congestion Daytime Nighttime | DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Meijer Distribution, Inc. | 9da77306-5098-4c79-845c-97ead849c84a | 2025-12-08 | Warnings | M012 |
| Nighttime Cold and Flu Relief | ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE | QUALITY CHOICE (Chain Drug Marketing Association) | fdd0dadc-5313-4f6e-aef5-ca853efe5c4d | 2025-12-08 | Warnings | M012 |
| Mucolyte | GUAIFENESIN | Rising Pharma Holdings, Inc. | e4091aaf-44e3-4701-9986-aff248a2f1b8 | 2025-12-08 | Warnings | M012 |
| Mucolyte DM | GUAIFENESIN, DEXTROMETHORPHAN HBR | Rising Pharma Holdings, Inc. | c913d27d-bc00-4ace-9a5f-c55522e1cd1d | 2025-12-08 | Warnings | M012 |
| honey lemon cough drops | MENTHOL | American Sales | 47f504d5-3ec5-5227-e054-00144ff88e88 | 2025-12-07 | Warnings | M012 |
| Sugar Free Menthol Cough Drops | MENTHOL | American Sales | 4893ac0a-7769-5657-e054-00144ff8d46c | 2025-12-07 | Warnings | M012 |
| Cherry cough drop | MENTHOL | American Sales | 45e891ea-2f2a-31b7-e054-00144ff88e88 | 2025-12-07 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1110988 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | efb3bfc5-72e9-4221-8d03-e48f3d8e3821 | 20 |
| 1110988 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | efb3bfc5-72e9-4221-8d03-e48f3d8e3821 | 20 |
| 1110988 | APAP 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | efb3bfc5-72e9-4221-8d03-e48f3d8e3821 | 20 |
| 1110988 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | a986c666-3fb3-42cf-b0fb-d95002b89a23 | 6 |
| 1110988 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | a986c666-3fb3-42cf-b0fb-d95002b89a23 | 6 |
| 1110988 | APAP 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | a986c666-3fb3-42cf-b0fb-d95002b89a23 | 6 |
| 1110988 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | b618877b-9dbc-4ba2-be2c-bf1922c646cc | 4 |
| 1110988 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | b618877b-9dbc-4ba2-be2c-bf1922c646cc | 4 |
| 1110988 | APAP 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | b618877b-9dbc-4ba2-be2c-bf1922c646cc | 4 |
| 1110988 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | 8e87f8de-f83e-0f8d-e053-2a95a90a8d6a | 3 |
| 1110988 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | 8e87f8de-f83e-0f8d-e053-2a95a90a8d6a | 3 |
| 1110988 | APAP 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | 8e87f8de-f83e-0f8d-e053-2a95a90a8d6a | 3 |
| 1110988 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | 435e6387-1ee0-c20f-e063-6294a90adac5 | 1 |
| 1110988 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | f056015b-efb7-43d1-b39d-26d679ad8d2c | 1 |
| 1110988 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | be95332d-a2e0-42e8-bfb3-8850d74990ff | 1 |
| 1110988 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | 618ce449-5ad6-4e53-bbf6-152a907c493e | 1 |
| 1110988 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | be95332d-a2e0-42e8-bfb3-8850d74990ff | 1 |
| 1110988 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | 618ce449-5ad6-4e53-bbf6-152a907c493e | 1 |
| 1110988 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | 435e6387-1ee0-c20f-e063-6294a90adac5 | 1 |
| 1110988 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | f056015b-efb7-43d1-b39d-26d679ad8d2c | 1 |
| 1110988 | APAP 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | be95332d-a2e0-42e8-bfb3-8850d74990ff | 1 |
| 1110988 | APAP 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | 618ce449-5ad6-4e53-bbf6-152a907c493e | 1 |
| 1110988 | APAP 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | 435e6387-1ee0-c20f-e063-6294a90adac5 | 1 |
| 1110988 | APAP 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | f056015b-efb7-43d1-b39d-26d679ad8d2c | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50580-402-01 | 50580040201 | 2 TABLET, FILM COATED in 1 POUCH (50580-402-01) | 2017-07-07 | 0000-00-00 | No | No | Current | |
| 50580-402-02 | 50580040202 | 50 POUCH in 1 CARTON (50580-402-02) / 2 TABLET, FILM COATED in 1 POUCH | 50 pouch | 2017-07-07 | 0000-00-00 | No | No | Current |
| 50580-402-26 | 50580040226 | 2 BLISTER PACK in 1 CARTON (50580-402-26) / 12 TABLET, FILM COATED in 1 BLISTER PACK | 2 blister pack | 2012-07-11 | 0000-00-00 | No | No | Current |
| 50580-402-72 | 50580040272 | 3 CARTON in 1 PACKAGE (50580-402-72) / 2 BLISTER PACK in 1 CARTON / 12 TABLET, FILM COATED in 1 BLISTER PACK | 3 carton | 2012-07-11 | 0000-00-00 | No | No | Current |