TYLENOL SINUS PLUS HEADACHE
- Product NDC
- 50580-598
- 11-digit product format
- 505800598
- Labeler code
- 50580
- Product ID
- 50580-598_21acf19d-d051-97ca-e063-6294a90a5e41
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen and Phenylephrine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Kenvue Brands LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2015-07-15
- Substance
- ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 325; 5 mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 50580-598 | 50580-598-01 | D | Discontinued by firm | 2026-10-27 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
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 SINUS PLUS HEADACHE
- Brand name suffix
- DAY
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1046378 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| e608d214-cc46-4a24-ac85-1040e36e7403 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50580-598-01 | TYLENOL SINUS PLUS HEADACHEDAY | 12 in 1 BLISTER PACK | TABLET, FILM COATED | 12 | 14 | |
| 50580-598-01 | TYLENOL SINUS PLUS HEADACHEDAY | 2 in 1 CARTON | TABLET, FILM COATED | 2 | 14 | |
| 50580-598-02 | TYLENOL SINUS PLUS HEADACHEDAY | 2 in 1 CARTON | TABLET, FILM COATED | 2 | 14 | |
| 50580-598-02 | TYLENOL SINUS PLUS HEADACHEDAY | 12 in 1 BLISTER PACK | TABLET, FILM COATED | 12 | 14 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50580-598-02 | EA - Each | 50580-598 | 7a916260-3b4f-4ee4-a69d-a2595f6b2cca | 1 | 2022-05-04 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50580-598 | TYLENOL SINUS PLUS HEADACHE DAY (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [KENVUE BRANDS LLC] | 14 | Current NDC, Legacy NDC, 4 package rows | 20241109_e608d214-cc46-4a24-ac85-1040e36e7403.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 |
|---|---|---|---|---|---|---|
| HealthWise Medicated Chest Rub | CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL | Veridian Healthcare | 25a19d3e-37b3-50d5-e063-6394a90a97d1 | 2024-10-29 | Warnings | M012 |
| Antigrip Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Pharmadel LLC | 25a23a03-6110-f595-e063-6394a90a70fe | 2024-10-29 | Warnings | M012 |
| Antigrip Cough and Cold | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Pharmadel LLC | 25a23e5e-302a-7b7f-e063-6294a90a0463 | 2024-10-29 | Warnings | M012 |
| Antigrip Extra Strength | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | Pharmadel LLC | 25a26adf-fd90-bf57-e063-6294a90a4073 | 2024-10-29 | Warnings | M012 |
| Menthol Cough Drops | MENTHOL | BOSTON NUTRACEUTICAL PRODUCTION, S.L | e82dac83-2910-44dc-e053-2995a90a38e1 | 2024-10-29 | Warnings | M012 |
| TheraCare Medicated Chest Rub | CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL | Veridian Healthcare | d6e789c7-a55a-dc9a-e053-2a95a90a2bdb | 2024-10-29 | Warnings | M012 |
| Careone daytime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | American Sales Company | 31187c98-6706-4962-91f6-022a390cda39 | 2024-10-28 | Warnings | M012 |
| basic care daytime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Amazon.com Services LLC | 0100f86e-257f-4197-9849-3c4429cdf0f2 | 2024-10-28 | Warnings | M012 |
| Premier Value Maximum Strength | DEXTROMETHORPHAN HBR, GUAIFENESIN | PHARMACY VALUE ALLIANCE LLC | 46bf124a-a44f-4066-b936-852d46da8f40 | 2024-10-28 | Warnings | M012 |
| Signature Care Non drowsy Daytime Severe Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Safeway | 25a26577-a9f8-49cb-9d75-d8c471e4aaf6 | 2024-10-28 | Warnings | M012 |
| daytime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Kroger Company | 2d5d7f1a-1d5d-4fc1-86f6-3b4aa073565e | 2024-10-28 | Warnings | M012 |
| Leader Daytime Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Cardinal Health 110, LLC. dba Leader | d38537c6-9553-4e93-a83e-11ed48c955ab | 2024-10-28 | Warnings | M012 |
| Severe Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | CVS Pharmacy | 2b3a1997-f382-4843-a44b-d80d1ad21a90 | 2024-10-28 | Warnings | M012 |
| Premier Value Tussin Cough Long Acting | DEXTROMETHORPHAN HBR | Chain Drug Consortium, LLC | 0e393287-5bb8-458b-98c4-55fa16674d06 | 2024-10-28 | Warnings | M012 |
| daytime cold flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Meijer, Inc. | 1740ccfc-6e68-46f4-a1ba-48fe092f0aa0 | 2024-10-28 | Warnings | M012 |
| night time cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Meijer, Inc. | d3bd0632-328c-4ad7-bb44-8383e1e51b8c | 2024-10-28 | Warnings | M012 |
| Premier Value | DEXTROMETHORPHAN HBR, GUAIFENESIN | PHARMACY VALUE ALLIANCE LLC | 1ae3c6ac-1646-4c67-a9d5-9c383924b81a | 2024-10-28 | Warnings | M012 |
| nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | CVS Pharmacy | 1c341cf5-ac33-4a6e-b023-a23d280d496c | 2024-10-25 | Warnings | M012 |
| Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Walgreen Company | b6d9f421-b236-4660-be7f-85a878f2fc61 | 2024-10-25 | Warnings | M012 |
| COLD AND FLU MULTI-SYMPTOM RELIEF/COLD AND FLU NIGHTTIME RELIEF | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | Chain Drug Consortium, LLC | f9c3c12b-4efa-4ec4-a156-c403aff81753 | 2024-10-24 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1046378 | acetaminophen 325 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | e608d214-cc46-4a24-ac85-1040e36e7403 | 14 |
| 1046378 | acetaminophen 325 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | e608d214-cc46-4a24-ac85-1040e36e7403 | 14 |
| 1046378 | APAP 325 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | e608d214-cc46-4a24-ac85-1040e36e7403 | 14 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50580-598-01 | 50580059801 | 2 BLISTER PACK in 1 CARTON (50580-598-01) > 12 TABLET, FILM COATED in 1 BLISTER PACK | 2 blister pack | 2015-07-15 | 0000-00-00 | No | No | Current |
| 50580-598-02 | 50580059802 | 2 BLISTER PACK in 1 CARTON (50580-598-02) / 12 TABLET, FILM COATED in 1 BLISTER PACK | 2 blister pack | 2019-05-08 | 0000-00-00 | No | No | Current |