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 |
|---|---|---|---|---|---|---|
| Guaifenesin | GUAIFENESIN | Bryant Ranch Prepack | 1e9887f6-209f-4f1f-9afa-a5ca649721cb | 2026-03-18 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Famora Inc. | 5a7bf4cd-1d44-424d-9ef4-d484e626e326 | 2026-03-18 | Warnings | M012 |
| Harris Teeter Menthol Cough Drops | MENTHOL | Harris Teeter | 4d502c1f-7307-ac50-e063-6294a90a6ff4 | 2026-03-18 | Warnings | M012 |
| Harris Teeter Cherry Cough Drops | MENTHOL | Harris Teeter | 4d50cc62-c84f-0761-e063-6394a90af54a | 2026-03-18 | Warnings | M012 |
| Harris Teeter Honey Lemon Cough Drops | MENTHOL | Harris Teeter | 4d516fce-d219-eee9-e063-6294a90ac59a | 2026-03-18 | Warnings | M012 |
| Harris Teeter SF Honey Lemon Cough Drops | MENTHOL | Harris Teeter | 4d524b45-260e-7411-e063-6294a90af639 | 2026-03-18 | Warnings | M012 |
| Guaifenesin and Dextromethorphan Hydrobromide | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | Bryant Ranch Prepack | 9a77465c-6d3a-4399-9734-ad22e4b435db | 2026-03-18 | Warnings | M012 |
| good sense childrens cold cough | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | Preferred Pharmaceuticals Inc. | a56d2fe4-5bea-4668-8e66-5a6f4279d461 | 2026-03-18 | Warnings | M012 |
| Mucus Relief DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Cardinal Health 110, LLC. DBA Leader | 4136e5f4-cc00-46d6-aa7f-ef56d087d7ec | 2026-03-18 | Warnings | M012 |
| M-Dryl | DIPHENHYDRAMINE HYDROCHLORIDE | Bryant Ranch Prepack | f9a0fb35-46d6-434f-8f9a-425a4bf50e84 | 2026-03-18 | Warnings | M012 |
| Headache Relief Extra Strength | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | Grocery Outlet | 7398a372-7679-423b-a3ca-8da905a979dd | 2026-03-17 | Warnings | M012 |
| Allergy Relief | ALLERGY RELIEF | Grocery Outlet | 0661ddeb-6289-471e-af89-7f4b7452c355 | 2026-03-16 | Warnings | M012 |
| Daytime Cold and Cough Nighttime Cold and Congestion | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | CVS | 2cf361eb-6055-2364-e063-6294a90a69a1 | 2026-03-16 | Warnings | M012 |
| Severe Cold and Flu Relief Daytime/Nighttime | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | CVS PHARMACY | b024ab38-e5da-4f5a-888f-e2a281578290 | 2026-03-16 | Warnings | M012 |
| good neighbor pharmacy night time cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Amerisource Bergen | 41f87d59-3245-46dc-88a8-b947675a90fc | 2026-03-16 | Warnings | M012 |
| Childrens Cold and Cough | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN, PHENYLEPHRINE HCL | CVS | 2bc3eae8-ffe6-bc96-e063-6394a90a2283 | 2026-03-16 | Warnings | M012 |
| Daytime Nighttime Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | CVS HEALTH CORP | 23e2d2dc-12d4-294d-e063-6394a90a9523 | 2026-03-16 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | CVS Pharmacy | 48438525-e49f-9303-e063-6394a90a44f2 | 2026-03-16 | Warnings | M012 |
| Daytime | ACETAMINOPHEN, GUAIFENESIN | CVS HEALTH CORP | 4985c332-6602-fd2d-e063-6394a90accd2 | 2026-03-16 | Warnings | M012 |
| Daytime Cold and Flu and Nighttime Softgels | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | CVS Pharmacy | 4981bbcd-7178-335f-e063-6394a90ae961 | 2026-03-16 | 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 |