NDC 50580-402-25 - TYLENOL Cold Plus Flu Severe
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 50580-402
- Requested NDC
- 50580-402-25
- Package NDCs from labels
- 50580-402-26, 50580-402-72, 50580-402-01, 50580-402-02, 50580-402-25
- Manufacturer
- Kenvue Brands LLC
- Effective date
- 2026-09-24
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| TYLENOL Cold Plus Flu Severe - Kenvue Brands LLC | Kenvue Brands LLC | 2026-09-24 | HUMAN OTC DRUG LABEL |
| TYLENOL Cold Plus Flu Severe - Select Consumer Group | Select Consumer Group | 2026-07-03 | HUMAN OTC DRUG LABEL |
| Tylenol Cold Plus Flu Severe - Savings Distributors LLC | Savings Distributors LLC | 2026-05-01 | HUMAN OTC DRUG LABEL |
| Tylenol Cold + Flu Severe | JC World Bell Wholesale Co., Inc. | 2026-01-06 | HUMAN OTC DRUG LABEL |
| TYLENOL COLD AND FLU - R J General Corporation | Johnson & Johnson | R J General Corporation | Johnson & Johnson | 2025-11-17 | HUMAN OTC DRUG LABEL |
| TYLENOL ® Cold + Flu Severe | Navajo Manufacturing Company Inc. | 2025-11-11 | HUMAN OTC DRUG LABEL |
| TYLENOL Cold Plus Flu Severe - Morning Star OTC | Morning Star OTC | 2025-06-19 | HUMAN OTC DRUG LABEL |
| CARNAUBA WAX - JC World Bell Wholesale Co., Inc. | Kenvue Brands LLC | JC World Bell Wholesale Co., Inc. | Kenvue Brands LLC | 2024-12-31 | HUMAN OTC DRUG LABEL |
| Tylenol Cold Plus Flu Severe - Select Corporation | Select Corporation | 2022-03-30 | HUMAN OTC DRUG LABEL |
| National Council for Prescription Drug Programs indexing - billing unit | National Council for Prescription Drug Programs | 2012-07-24 | Indexing - Billing Unit |
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 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 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#
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 |
|---|---|---|---|---|---|---|
| Daytime Sinus Severe | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | Kroger Company | 1022767d-a456-4fbc-95cf-91337c74c330 | 2026-10-01 | Warnings | M012 04JA59TNSJ 362O9ITL9D 495W7451VQ |
| COLTALIN-DM | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | FORTUNE PHARMACAL COMPANY LIMITED | 33e1bec0-323b-40b7-809a-cb65a71ad0ce | 2026-09-17 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
| 12 hr relief cough dm | DEXTROMETHORPHAN POLISTIREX | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 03c44e2f-d6e3-4c78-9c9a-92d1708a62fe | 2026-09-16 | Warnings | 9D2RTI9KYH |
| Cough and Cold HBP | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Geiss, Destin & Dunn Inc. | 1ea07a01-8779-48c2-a287-b7be866cce7b | 2026-09-10 | Warnings | M012 9D2RTI9KYH |
| Childrens Cold and Allergy Relief | BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | Strategic Sourcing Services LLC | d64fe757-9948-4727-b5dd-1f8e4e4763e2 | 2026-09-10 | Warnings | M012 04JA59TNSJ |
| Cold and Flu HBP | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE | Kroger Company | fd41e4a4-330f-4409-8ba3-0b3bb6f45bca | 2026-09-10 | Warnings | M012 362O9ITL9D |
| Nighttime Sleep Aid Berry Flavor | DIPHENHYDRAMINE HYDROCHLORIDE | Raritan Pharmaceuticals Inc | 303d7651-9c8f-4a14-9f2c-7181fa0f003e | 2026-09-09 | Warnings | M012 |
| childrens fever reducer and pain reliever | ACETAMINOPHEN | Rite Aid Corporation | 7f445de3-30cf-4bd8-892d-05979cd399e7 | 2026-09-09 | Warnings | 362O9ITL9D |
| dual action | ACETAMINOPHEN, IBUPROFEN | Rite Aid Corporation | 54b08d24-d5e9-4111-9d97-329896e8309d | 2026-09-09 | Warnings | 362O9ITL9D |
| DRx Choice Fruit Punch | GUAIFENESIN | Raritan Pharmaceuticals Inc | a19d7e1c-c04e-41c6-8af6-ecde96299216 | 2026-09-09 | Warnings | M012 495W7451VQ |
| Mucus Relief Cold Flu and Sore Throat Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Raritan Pharmaceuticals Inc | 2cb3e17f-3858-4773-a53f-0860ae6ff1b9 | 2026-09-09 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D 495W7451VQ |
| Foster and Thrive Mucus Relief | GUAIFENESIN | Strategic Sourcing Services LLC | f4ab5611-8abb-4c1f-8f85-917e2e1328e3 | 2026-09-09 | Warnings | 495W7451VQ |
| Stay Ageless Tinted Mineral Sunscreen | BROAD SPECTRUM SPF30 | W Aesthetics | 5b0f2c8f-d6fa-5e25-e063-6394a90a084d | 2026-09-09 | Warnings | 15FIX9V2JP |
| MUCINEX FAST-MAX Liquid Gels Day Night Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | Reckitt Benckiser LLC | 3856c1e4-814f-85c4-e063-6394a90ab8a8 | 2026-09-09 | Warnings | M012 |
| DRx Choice Long Acting Cough | DEXTROMETHORPHAN HBR | RARITAN PHARMACEUTICALS | 875b40bd-7955-4048-abbf-7f43d9ea3ac5 | 2026-09-09 | Warnings | M012 9D2RTI9KYH |
| Mucus Relief | GUAIFENESIN | Strategic Sourcing Services LLC | cd7955b2-8eee-43d3-973f-6de2f3929512 | 2026-09-09 | Warnings | 495W7451VQ |
| severe cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Rite Aid Corporation | 4b8ae971-ab57-4937-a878-72d905d7b849 | 2026-09-09 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
| Cold and Flu Relief | ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | CARDINAL HEALTH 110, LLC. DBA LEADER 70000 | 82ba9a73-60ef-49fd-960f-5ca2bb79555e | 2026-09-09 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
| Mucus Relief DM | DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN | The Kroger Co. | 49829083-5c0a-4620-bfb3-7103642368db | 2026-09-09 | Warnings | M012 9D2RTI9KYH 495W7451VQ |
| DRx Choice Childrens Stuffy Nose and Chest Congestion | GUAIFENESIN AND PHENYLEPHRINE HCL | RARITAN PHARMACEUTICALS | 7a3bb739-ff50-4d29-b270-d6b084906493 | 2026-09-09 | Warnings | M012 04JA59TNSJ 495W7451VQ |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.