Tylenol Sinus Severe
- Product NDC
- 50580-507
- 11-digit product format
- 505800507
- Labeler code
- 50580
- Product ID
- 50580-507_5c488f61-69f1-896a-e063-6394a90abf1a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Kenvue Brands LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2015-05-15
- Substance
- ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 325; 200; 5 mg/1; mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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 Sinus Severe
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/1 |
| GUAIFENESIN | 200 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/1 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50580-507-01 | Tylenol Sinus Severe | 12 in 1 BLISTER PACK | TABLET, COATED | 12 | 16 | |
| 50580-507-01 | Tylenol Sinus Severe | 2 in 1 CARTON | TABLET, COATED | 2 | 16 | |
| 50580-507-02 | Tylenol Sinus Severe | 2 in 1 CARTON | TABLET, COATED | 2 | 16 | |
| 50580-507-02 | Tylenol Sinus Severe | 3 in 1 PACKAGE | TABLET, COATED | 3 | 16 | |
| 50580-507-03 | Tylenol Sinus Severe | 2 in 1 POUCH | TABLET, COATED | 2 | 16 | |
| 50580-507-04 | Tylenol Sinus Severe | 50 in 1 CARTON | TABLET, COATED | 50 | 16 | |
| 50580-507-04 | Tylenol Sinus Severe | 2 in 1 POUCH | TABLET, COATED | 2 | 16 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50580-507-01 | EA - Each | 50580-507 | ee10d929-4cd2-4906-8663-c84fe7e61be4 | 1 | 2016-01-13 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50580-507 | TYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [KENVUE BRANDS LLC] | 16 | Current NDC, Legacy NDC, 7 package rows | 20241103_7a60184f-91a9-4b85-b243-871deca63450.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 |
|---|---|---|---|---|---|---|
| Panadol Cold and Flu Night | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Haleon US Holdings LLC | 3417993d-8e3c-23d6-e063-6394a90a7d50 | 2026-04-29 | Warnings | M012 |
| Halls Sugar Free Mountain Menthol | MENTHOL | Mondelez Global LLC | 509f233e-ff01-8927-e063-6394a90a9929 | 2026-04-29 | Warnings | M012 |
| Broncomiel Adults | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Pharmadel LLC | 509c61d3-ae16-be5c-e063-6294a90a68da | 2026-04-29 | Warnings | M012 |
| Mucus Relief DM Max Maximum Strength | DEXTROMETHORPHAN HBR, GUAIFENESIN | TOP CARE (Topco Associates LLC) | aa1eb90c-e565-455f-8978-6f2f9e00a814 | 2026-04-29 | Warnings | M012 |
| Tussin Cough and Chest Congestion DM adult | DEXTROMETHORPHAN HBR, GUAIFENESIN | Harris Teeter, LLC | e1280355-da81-489f-9bd2-ffea9a68010c | 2026-04-29 | Warnings | M012 |
| Mucus Relief Childrens | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | TOPCO ASSOCIATES LLC | 7b095ec5-9951-4491-9b68-7ac0a7f10053 | 2026-04-29 | Warnings | M012 |
| Mucus Relief Severe Congestion and Cough Maximum Strength | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | TOP CARE (Topco Associates LLC) | 98dd0ba6-0109-46b2-92df-11a030984240 | 2026-04-28 | Warnings | M012 |
| Pain, Headache and Congestion | ACETAMINOPHEN, GUAIFENESIN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 41a77cbb-6a4d-46a4-ab27-c7affa2cc682 | 2026-04-28 | Warnings | M012 |
| ALKA SELTZER COLD Cold Flu and Congestion Severe Fast Dissolve | CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE | Bayer HealthCare LLC. | dd7da15a-4e0b-405f-e053-2995a90a06d2 | 2026-04-28 | Warnings | M012 |
| CAREONE CHILDRENS COLD COUGH | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | Retail Business Services, LLC | 382f7d51-ceb8-4bdf-9bd5-440b50c65cd3 | 2026-04-28 | Warnings | M012 |
| Cold and Flu Daytime Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | L.N.K. International, Inc. | 1a520b4f-6a4b-4e37-94c5-9387f2e4c34a | 2026-04-27 | Warnings | M012 |
| Childrens Multi-Symptom Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Kroger | 49a7cd2a-8c0e-2196-e063-6294a90a134a | 2026-04-27 | Warnings | M012 |
| Guaifenesin,Dextromethorphan Hbr | GUAIFENESIN,DEXTROMETHORPHAN HBR | Softgel Healthcare Pvt Ltd | 3e5d978f-cc70-60a5-e063-6394a90a67d3 | 2026-04-27 | Warnings | M012 |
| Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine Hydrochloride | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDE | Softgel Healthcare Pvt Ltd | 36ced59c-12dc-441f-e063-6294a90a3239 | 2026-04-27 | Warnings | M012 |
| Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg | ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL | Softgel Healthcare Private Limited | 30ab39f3-27cc-5728-e063-6394a90a9cbe | 2026-04-27 | Warnings | M012 |
| Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate | ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE | Softgel Healthcare Private Limited | 353f71f7-81e0-08c2-e063-6294a90acb49 | 2026-04-27 | Warnings | M012 |
| Acetaminophen, Dextromethorphan HBr ,Guaifenesin | ACETAMINOPHEN, DEXTROMETHORPHAN HBR ,GUAIFENESIN | Softgel Healthcare Pvt Ltd | 353ef34f-760d-ae92-e063-6294a90a5b4a | 2026-04-27 | Warnings | M012 |
| DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE | SOFTGEL HEALTHCARE PRIVATE LIMITED | 0203d919-dc1f-cca0-e063-6394a90aa1aa | 2026-04-27 | Warnings | M012 |
| ALKA SELTZER COLD Cold Flu and Congestion Severe Fast Dissolve | CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE | Bayer HealthCare LLC. | 507214ad-1e06-fe21-e063-6294a90a59cd | 2026-04-27 | Warnings | M012 |
| ALKA SELTZER COLD Cold Congestion Severe Day Night Fast Dissolve | ASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | 50738a43-7299-270c-e063-6294a90af2cc | 2026-04-27 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1243679 | acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | 7a60184f-91a9-4b85-b243-871deca63450 | 16 |
| 1243679 | acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | 7a60184f-91a9-4b85-b243-871deca63450 | 16 |
| 1243679 | APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | 7a60184f-91a9-4b85-b243-871deca63450 | 16 |
| 1243679 | APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral Tablet | SY | 7a60184f-91a9-4b85-b243-871deca63450 | 16 |
| 1243679 | acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | 4bff8a41-ec6f-4bc5-a3df-2ea4695d9e24 | 6 |
| 1243679 | acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | 4bff8a41-ec6f-4bc5-a3df-2ea4695d9e24 | 6 |
| 1243679 | APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | 4bff8a41-ec6f-4bc5-a3df-2ea4695d9e24 | 6 |
| 1243679 | APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral Tablet | SY | 4bff8a41-ec6f-4bc5-a3df-2ea4695d9e24 | 6 |
| 1243679 | acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | 8eecb3f0-eb5e-e847-e053-2995a90a86bd | 3 |
| 1243679 | acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | 8eecb3f0-eb5e-e847-e053-2995a90a86bd | 3 |
| 1243679 | APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | 8eecb3f0-eb5e-e847-e053-2995a90a86bd | 3 |
| 1243679 | APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral Tablet | SY | 8eecb3f0-eb5e-e847-e053-2995a90a86bd | 3 |
| 1243679 | acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | 435b4a2a-d6bf-ec25-e063-6294a90a3f06 | 1 |
| 1243679 | acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | 37e939c6-064b-3548-e063-6294a90a337d | 1 |
| 1243679 | acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | 1560b3a0-fe81-4e33-b581-20b43511dba3 | 1 |
| 1243679 | acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | 435b4a2a-d6bf-ec25-e063-6294a90a3f06 | 1 |
| 1243679 | acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | 37e939c6-064b-3548-e063-6294a90a337d | 1 |
| 1243679 | acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | 1560b3a0-fe81-4e33-b581-20b43511dba3 | 1 |
| 1243679 | APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | 435b4a2a-d6bf-ec25-e063-6294a90a3f06 | 1 |
| 1243679 | APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | 37e939c6-064b-3548-e063-6294a90a337d | 1 |
| 1243679 | APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | 1560b3a0-fe81-4e33-b581-20b43511dba3 | 1 |
| 1243679 | APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral Tablet | SY | 435b4a2a-d6bf-ec25-e063-6294a90a3f06 | 1 |
| 1243679 | APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral Tablet | SY | 37e939c6-064b-3548-e063-6294a90a337d | 1 |
| 1243679 | APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral Tablet | SY | 1560b3a0-fe81-4e33-b581-20b43511dba3 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50580-507-01 | 50580050701 | 2 BLISTER PACK in 1 CARTON (50580-507-01) / 12 TABLET, COATED in 1 BLISTER PACK | 2 blister pack | 2015-05-15 | 0000-00-00 | No | No | Current |
| 50580-507-02 | 50580050702 | 3 CARTON in 1 PACKAGE (50580-507-02) / 2 BLISTER PACK in 1 CARTON / 12 TABLET, COATED in 1 BLISTER PACK | 3 carton | 2020-07-06 | No | No | Current | |
| 50580-507-03 | 50580050703 | 2 TABLET, COATED in 1 POUCH (50580-507-03) | 2017-07-17 | 0000-00-00 | No | No | Current | |
| 50580-507-04 | 50580050704 | 50 POUCH in 1 CARTON (50580-507-04) / 2 TABLET, COATED in 1 POUCH | 50 pouch | 2017-07-17 | 0000-00-00 | No | No | Current |