TYLENOL Cold Plus Flu
- Product NDC
- 50580-402
- 11-digit product format
- 505800402
- Labeler code
- 50580
- Product ID
- 50580-402_21aa0501-3ceb-19c5-e063-6294a90a12c6
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- TYLENOL Cold Plus Flu
- Brand name suffix
- Severe
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/1 |
| GUAIFENESIN | 200 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 362O9ITL9D, 9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ |
| Rxcui | 1110988 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50580-402-01 | 2024-02-06 | C162847 | 48780-1 | 1030e365-43f9-111a-e063-dadaa90a10e2 | TYLENOL ® Cold + Flu Severe |
| 50580-402-02 | 2024-02-06 | C162847 | 48780-1 | 1030e365-43f9-111a-e063-dadaa90a10e2 | TYLENOL ® Cold + Flu Severe |
| 50580-402-26 | 2024-02-06 | C162847 | 48780-1 | 1030e365-43f9-111a-e063-dadaa90a10e2 | TYLENOL ® Cold + Flu Severe |
| 50580-402-72 | 2024-02-06 | C162847 | 48780-1 | 1030e365-43f9-111a-e063-dadaa90a10e2 | TYLENOL ® Cold + Flu Severe |
| 50580-402-01 | 2024-01-30 | C162847 | 48780-1 | 1030e365-43f9-111a-e063-dadaa90a10e2 | TYLENOL ® Cold + Flu Severe |
| 50580-402-02 | 2024-01-30 | C162847 | 48780-1 | 1030e365-43f9-111a-e063-dadaa90a10e2 | TYLENOL ® Cold + Flu Severe |
| 50580-402-26 | 2024-01-30 | C162847 | 48780-1 | 1030e365-43f9-111a-e063-dadaa90a10e2 | TYLENOL ® Cold + Flu Severe |
| 50580-402-72 | 2024-01-30 | C162847 | 48780-1 | 1030e365-43f9-111a-e063-dadaa90a10e2 | 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 |
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 |