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 |
|---|---|---|---|---|---|---|
| Tukol Max Action Cold and Flu Nighttime Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | Genomma Lab USA | cf0987a3-2c1d-4f40-8551-df9a8e08cd3d | 2026-08-03 | Warnings | M012 |
| Pressure, Pain and Mucus | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | Meijer Distribution, Inc. | 7d42e164-86e9-4baa-a389-3271cf99920e | 2026-08-03 | Warnings | M012 |
| DG Health Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Dolgencorp Inc | ed754d5c-74e1-4dee-a5c5-10ccec1b81db | 2026-08-03 | Warnings | M012 |
| RIGHT REMEDIES Mucus Relief DM | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Strive Pharmaceuticals Inc. | 51c4dcfb-8725-d547-e063-6394a90ac04c | 2026-07-31 | Warnings | M012 |
| Stona for Children | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | Sato Pharmaceutical Co., Ltd. | 18f3d694-9dff-407e-a264-916dbd201f9a | 2026-07-31 | Warnings | M012 |
| Stonarhini | CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE | Sato Pharmaceutical Co., Ltd. | cc353280-0b4c-418c-93fe-850125955009 | 2026-07-31 | Warnings | M012 |
| cold and flu HBP | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE | Meijer Distribution Inc | 5519e918-71cb-4430-ae57-e03cd5ac6002 | 2026-07-31 | Warnings | M012 |
| Good Neighbor Pharmacy allergy | DIPHENHYDRAMINE HYDROCHLORIDE | Amerisource Bergen | 9819522f-f3db-4cb8-9680-423114ace2f6 | 2026-07-31 | Warnings | M012 |
| Sinus Relief Daytime, Nighttime | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCL | Rite Aid Corporation | 352b89b5-6995-4873-a103-e8f89074fdc9 | 2026-07-30 | Warnings | M012 |
| Severe Congestion and Pain | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | Family Dollar Services Inc | ce590997-3cae-4f22-ac39-2b14d39494bc | 2026-07-30 | Warnings | M012 |
| allergy | DIPHENHYDRAMINE HYDROCHLORIDE | Meijer Distribution Inc | f1e83e43-011c-4470-bd55-fb2818a9fc84 | 2026-07-30 | Warnings | M012 |
| Robitussin Direct Cough | DEXTROMETHORPHAN HYDROBROMIDE | Haleon US Holdings LLC | 70c9556b-063a-4fb3-96f6-1d4ffa495ed4 | 2026-07-30 | Warnings | M012 |
| Major Nasal Decongestant | OXYMETAZOLINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | a302e341-1c00-4c3d-b71f-c4c0b307aa67 | 2026-07-29 | Warnings | M012 |
| Pain Reliever PM Extra Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Walgreens | 4c737cd6-fe56-4cef-887c-cd6cf83b254c | 2026-07-29 | Warnings | M012 |
| ROBITUSSIN LONG-ACTING COUGHGELS | DEXTROMETHORPHAN HYDROBROMIDE | Haleon US Holdings LLC | 472c5c1f-eb5a-444b-a17e-f0d71007fb15 | 2026-07-29 | Warnings | M012 |
| TOPCARE NITE TIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Topco Associates LLC | 905d1c5c-65c8-47a3-ad7a-61a4b4b98f0d | 2026-07-29 | Warnings | M012 |
| DAYTIME COLD AND FLU NITETIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Meijer Distribution Inc | 3a33c6ce-aada-4099-8c61-49c86c0fc1a8 | 2026-07-29 | Warnings | M012 |
| Tussin DM Max Nighttime | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Wal-Mart Stores Inc | 668c92ce-6c1f-4ab3-b0dd-822b0768cb5e | 2026-07-29 | Warnings | M012 |
| Benadryl | DIPHENHYDRAMINE HYDROCHLORIDE | Kenvue Brands LLC | 702f9786-7ce9-43e4-921d-e1db09612127 | 2026-07-28 | Warnings | M012 |
| LoHist-D | CHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCL | Larken Laboratories, Inc. | efaa354e-c25c-405b-9d30-001c2796978c | 2026-07-28 | 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 |