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 | 2026-10-23 |
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 |
|---|---|---|---|---|---|---|
| Night Time Cold and Flu Relief Multi Symptom | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Rite Aid Corporation | 5f9c9c48-4e8f-4ace-a6fb-1c1bccaf02a0 | 2025-08-18 | Warnings | M012 |
| MAJOR NASAL DECONGESTANT | OXYMETAZOLINE HYDROCHLORIDE | A-S Medication Solutions | 4b78b9af-0975-43f8-8b44-daddef0478be | 2025-08-15 | Warnings | M012 |
| Dr Simi Mucus Relief Expectorant | GUAIFENESIN | Farmacias De Similares TX LLC | 3c6d0e75-a685-6020-e063-6294a90a5c1b | 2025-08-15 | Warnings | M012 |
| Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Rite Aid Corporation | 25bf4390-23f7-4bb6-b86e-c40eaf8d92da | 2025-08-15 | Warnings | M012 |
| Childrens Chewable Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | KROGER COMPANY | 2cac72be-4830-ad49-e063-6394a90a7832 | 2025-08-14 | Warnings | M012 |
| GOOD NEIGHBOR PHARMACY MUCUS RELIEF DM MAXIMUM STRENGTH | DEXTROMETHORPHAN HBR AND GUAIFENESIN | AMERISOURCE BERGEN | 2ea1e7bf-1bb9-4627-bbd4-4a78920a8b6e | 2025-08-12 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Walmart Inc. | 16fae164-28db-8ef1-e063-6294a90ab5da | 2025-08-12 | Warnings | M012 |
| Exchange Select Cough Drops Original Herb | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | fbece335-a7e5-4732-a086-561b23741579 | 2025-08-12 | Warnings | M012 |
| MGC Health Cough Drops Original Herb | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 779ddb89-b6e2-4bfb-bcb5-8c7ec916675a | 2025-08-12 | Warnings | M012 |
| Equaline Nasal | OXYMETAZOLINE HYDROCHLORIDE | United Natural Foods, Inc. dba UNFI | d7fa1720-eac4-4e82-9401-77215ce4f545 | 2025-08-12 | Warnings | M012 |
| Diabetic Tussin DM Maximum Strength | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | MEDTECH PRODUCTS INC | a10a3b33-7503-4334-8ed7-2bb881df4327 | 2025-08-08 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Cabinet Health, Inc | 26a55d74-f772-5d17-e063-6394a90a5583 | 2025-08-07 | Warnings | M012 |
| Daytime Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | H E B | b7434978-44a8-4c51-979d-0bc446461e43 | 2025-08-06 | Warnings | M012 |
| Tussin DM | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | CVS Pharmacy | fc1e224c-5c57-43fc-ae6e-36aa0a4ae439 | 2025-08-06 | Warnings | M012 |
| childrens cold cough dm | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | Publix Super Markets Inc | 6efe7097-2a99-4654-9d94-b47f2e64d19d | 2025-08-05 | Warnings | M012 |
| Quality Choice Throat Soothing Drops Creamy Strawberry | PECTIN | Chain Drug Marketing Association, Inc. | 3b7548ee-7cd3-62c3-e063-6294a90a0612 | 2025-08-03 | Warnings | M012 |
| Vaporizing chest rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | LJ Pharma | 065bb666-e482-4e96-ac75-c6577dcc5b48 | 2025-08-01 | Warnings | M012 |
| Nighttime Cough-Kids | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Genexa | 024bb864-4214-1d8b-e063-6394a90aa573 | 2025-08-01 | Warnings | M012 |
| Antigrip Cough and Cold | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Pharmadel LLC | 3b53e5fc-f258-c2b9-e063-6394a90ab500 | 2025-08-01 | Warnings | M012 |
| Diphenhydramine HCl | DIPHENHYDRAMINE HYDROCHLORIDE | Major Pharmaceuticals | 1b591e27-b00b-41c8-9fe9-c633aba09134 | 2025-08-01 | 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 |