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 | 2026-10-16 |
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 |
|---|---|---|---|---|---|---|
| NIGHTTIME SEVERE COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | d1115a55-35cd-4f20-8872-f42983a5ebcd | 2026-07-28 | Warnings | M012 |
| TUSSIN | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Safeway | a5e2bda4-2da6-4c20-855d-2888dadf0c3a | 2026-07-28 | Warnings | M012 |
| DM Maximum | DEXTROMETHORPHAN HBR, GUAIFENESIN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | f6029b04-e681-40fc-be4f-14091b76dd4e | 2026-07-27 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | CVS PHARMACY | e958eef1-8aae-4365-ac64-95a9e8e7e0f2 | 2026-07-27 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | DOLGENCORP INC | 38400854-27fa-e291-e063-6294a90a5c4e | 2026-07-27 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Better Living Brands, LLC | 65802aa7-64e7-4435-ad6b-65895fba17ce | 2026-07-27 | Warnings | M012 |
| Cold and Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCL | Walgreen Company | 0a48f650-ad2a-4105-9ff4-2bc4d94b46d3 | 2026-07-27 | Warnings | M012 |
| Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Walgreen Company | 84202ebe-97b6-4be2-bb09-7f2729303f96 | 2026-07-27 | Warnings | M012 |
| Daytime Severe Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Rite Aid Corporation | 8d41defe-8120-4cbb-b42e-c805cc5a794b | 2026-07-24 | Warnings | M012 |
| Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE | Prodose, Inc. | 3afc88c7-388a-dbd9-e063-6294a90a4faf | 2026-07-24 | Warnings | M012 |
| Giltuss Allergy Plus | CHLOPHEDIANOL HCL, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | Gil Pharmaceutical Corp | 85a0dc7f-ffb5-7d52-e053-2991aa0a602a | 2026-07-23 | Warnings | M012 |
| Giltuss Cough and Cold | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Gil Pharmaceutical Corp | 8590fcc9-c0dd-f43b-e053-2991aa0a692e | 2026-07-23 | Warnings | M012 |
| Giltuss Sinus and Chest Congestion | GUAIFENESIN, PHENYLEPHRINE HCL | Gil Pharmaceutical Corp | 8591003c-c2f2-df65-e053-2a91aa0a42fb | 2026-07-23 | Warnings | M012 |
| COLDTAC Plus | ACETAMINOPHEN, PHENYLEPHRIN HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE | OPMX LLC | 3496866c-682f-420b-bfdb-64ecebbf70a2 | 2026-07-23 | Warnings | M012 |
| nighttime cough dm | DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Meijer, Inc. | 5a45b4c2-6a15-40b4-9ac6-d1554244ec42 | 2026-07-23 | Warnings | M012 |
| DAY TIME NITE TIME INTENSE FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Meijer, Inc. | 6372cbdd-a3a3-499d-91ce-53bcdb83e739 | 2026-07-23 | Warnings | M012 |
| Daytime Nighttime Cold Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | CVS Pharmacy | df6e522c-3e30-4aa0-8ab9-3b579c80bcad | 2026-07-22 | Warnings | M012 |
| Cold and Flu Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 0ab2ba6a-1fac-4a34-ab76-0b50b425d0ba | 2026-07-22 | Warnings | M012 |
| TYLENOL COLD PLUS FLU MULTI-SYMPTOM GELS NIGHT | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE | Kenvue Brands LLC | 1c5386c1-e45d-9dcb-e063-6294a90aff07 | 2026-07-22 | Warnings | M012 |
| Allergy plus Sinus Headache | ACETAMINOPHEN 325 MG, DIPHENHYDRAMINE HCL 12.5 MG, PHENYLEPHRINE HCL 5 MG | Shield Pharmaceuticals Corp | 772d0184-8c41-40f1-bbef-7e68692eec66 | 2026-07-22 | 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 |