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 |
|---|---|---|---|---|---|---|
| Head Congestion plus Flu Severe PE | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | VALU MERCHANDISERS COMPANY | f6401b58-8cf8-4067-e053-2995a90a68fc | 2025-12-11 | Warnings | M012 |
| Sinus Relief Pressure, Pain and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | VALU MERCHANDISERS COMPANY | b1ba37b8-4558-0808-e053-2995a90a9f5e | 2025-12-11 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | VALU MERCHANDISERS COMPANY | b84f37bc-be37-4f2b-83ee-d7d134184490 | 2025-12-11 | Warnings | M012 |
| Mucus Relief Cold Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | VALU MERCHANDISERS COMPANY | b1b7c7fc-1068-f486-e053-2a95a90a8e8c | 2025-12-11 | Warnings | M012 |
| Mucus Relief Cold and Flu All in One | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | VALU MERCHANDISERS COMPANY | b1b9e0da-2c54-8b31-e053-2995a90a690b | 2025-12-11 | Warnings | M012 |
| Sinus Relief Daytime, Nighttime, Maximum Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCL | CVS PHARMACY | f6b3ca40-7638-477f-b800-4c28c40ff0a8 | 2025-12-11 | Warnings | M012 |
| Allergy Relief | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Walgreen Company | 0a6e3251-02e0-42c1-bdf3-51c77f88c17f | 2025-12-11 | Warnings | M012 |
| topcare nite time cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Topco Associates LLC | 516ab016-31f9-4829-8b94-2f968933093c | 2025-12-11 | Warnings | M012 |
| Sinus PE Congestion | DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Walgreen Company | 5b9151b7-3e40-4f37-b3e0-4c0fa0115b71 | 2025-12-10 | Warnings | M012 |
| Cough and Cold HBP | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Discount Drug Mart | 2344c048-0550-4c31-b54e-a198910c490e | 2025-12-10 | Warnings | M012 |
| CVS Maximum Strength Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN ,PHENYLEPHRINE HCL | CVS PHARMACY, INC | cf4eb4c4-68e0-4478-a81c-d3d1e66f5cc5 | 2025-12-10 | Warnings | M012 |
| Tylenol Cold plus Flu Severe, Lil Drug Store | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Lil Drug Store Products, Inc | f395c196-62d7-47ff-b38d-af37adf5980b | 2025-12-10 | Warnings | M012 |
| Tylenol Sinus Severe, Lil Drug Store | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Lil Drug Store Products, Inc | 88b68447-b016-4d5b-a5e3-c4ebccb14f8c | 2025-12-10 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Family Dollar Services Inc | d956f1b8-91f8-424b-bb6c-704c445b6f4c | 2025-12-10 | Warnings | M012 |
| good neighbor pharmacy day time cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Amerisource Bergen | e5c1bd96-d27d-49c1-b3b8-eee53a145ef5 | 2025-12-10 | Warnings | M012 |
| NiteTime SEVERE Cold and Flu Relief SOFTGELS | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Topco Associates LLC | 3ffe67bf-2c66-61e6-e063-6394a90a7f8f | 2025-12-10 | Warnings | M012 |
| DayTime SEVERE Cold and Flu Relief SOFTGELS | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Topco Associates LLC | 3ffe0f43-b92a-f947-e063-6394a90ab72c | 2025-12-10 | Warnings | M012 |
| MAXIMUM STRENGTH Sinus Relief Day and Night SOFTGELS - 24 ct | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Topco Associates LLC | a7285fe0-5a5b-42c4-be47-9a07a2ba75e8 | 2025-12-10 | Warnings | M012 |
| Cold and Flu Relief Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Rite Aid Corporation | f9b8dbe1-7ff9-4320-850c-6e86e98d4393 | 2025-12-09 | Warnings | M012 |
| Severe Nasal | OXYMETAZOLINE HYDROCHLORIDE 0.05% | ALAINA HEALTHCARE PRIVATE LIMITED | 27747a10-8d1d-41c2-80b9-45452f3b9abc | 2025-12-09 | 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 |