Tylenol Sinus Severe
- Product NDC
- 50580-507
- 11-digit product format
- 505800507
- Labeler code
- 50580
- Product ID
- 50580-507_5e691fd8-3462-c044-e063-6294a90ad886
- 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 |
|---|---|---|---|---|---|---|
| Safetussin PM Nighttime Cough relief | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Kramer Laboratories | 33dd2245-9abd-4b32-ac76-0f45a54c0f33 | 2025-12-29 | Warnings | M012 |
| Winco Foods Medicated Chest Rub | CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL | WinCo Foods, LLC | f54eb60d-c602-1272-e053-2995a90aa95a | 2025-12-28 | Warnings | M012 |
| Gencare-Nasal Decongestant PE | PHENYLEPHRINE HYDROCHLORIDE | Pioneer Life Sciences, LLC | ad4d74a8-a762-4378-9016-f7c83421073e | 2025-12-26 | Warnings | M012 |
| Sorbutuss NR | SORBUTUSS | Dextrum Laboratories Inc. | 304f1d5a-218c-51ae-e054-00144ff88e88 | 2025-12-26 | Warnings | M012 |
| caring mill Cough drops CHERRY | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 274a28aa-00e9-8b9d-e063-6394a90ace2a | 2025-12-26 | Warnings | M012 |
| Creamy Strawberry Flavor Cough Drop | CREAMY STRAWBERRY FLAVOR COUGH DROP WITH MENTHOL AND PECTIN | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 2749b83a-ea4f-d8ca-e063-6394a90a69b7 | 2025-12-26 | Warnings | M012 |
| DISCOUNT DRUG MART | COUGH DROPS CHERRY | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 29f4a026-c4d2-2645-e063-6294a90aac58 | 2025-12-26 | Warnings | M012 |
| DISCOUNT DRUG MART | COUGH DROPS MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 274a13b5-6fcb-70ed-e063-6394a90a7fb3 | 2025-12-26 | Warnings | M012 |
| Honey Lemon Flavor Cough Drop | HONEY LEMON FLAVOR COUGH DROP | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 274a4802-7c02-ccce-e063-6394a90ad71d | 2025-12-26 | Warnings | M012 |
| DISCOUNT DRUG MART | COUGH DROPS HONEY LEMON | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 2749f353-9286-15b9-e063-6394a90a7693 | 2025-12-26 | Warnings | M012 |
| Leader Cough Drops Vanilla Honey | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 26a93c2c-a663-e3d1-e063-6394a90ad859 | 2025-12-26 | Warnings | M012 |
| Nite-Time COLD/FLU Medicine | ACETAMINOPHEN | AptaPharma Inc. | 344440bc-d810-4296-93ec-e6ae6673856b | 2025-12-26 | Warnings | M012 |
| Nite-Time COLD/FLU Medicine Cherry | ACETAMINOPHEN | AptaPharma Inc. | 87c2b823-ed88-44f3-8f6a-df30430b40f3 | 2025-12-26 | Warnings | M012 |
| TUSSIN CF | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | AptaPharma Inc. | c005c6cf-7891-463e-b65d-1129ad4bf6ec | 2025-12-26 | Warnings | M012 |
| Childrens Allergy | DIPHENHYDRAMINE HYDROCHLORIDE | AptaPharma Inc. | b2cef61f-ab54-4a20-a7f7-6d3da4754e8b | 2025-12-26 | Warnings | M012 |
| CHILDRENS MUCUS RELIEF COUGH - CHERRY FLAVOR | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | AptaPharma Inc. | 9ae6fe74-80cd-482a-b3b9-3acafd6708ec | 2025-12-26 | Warnings | M012 |
| Tussin Expectorant | GUAIFENESIN | AptaPharma, Inc. | ca8fa216-09c1-42b2-a95b-fa3d0f13363c | 2025-12-26 | Warnings | M012 |
| Gencare DayTime Cold and Flu Softgel | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Pioneer Life Sciences, LLC | a9875dc9-6a27-413c-a2c7-68a86483ffc1 | 2025-12-26 | Warnings | M012 |
| MUCUS RELIEF | GUAIFENESIN 400 MG | Pioneer Life Sciences, LLC | 3b7e0ee7-4dda-4bbe-842c-6cbbc208acd5 | 2025-12-26 | Warnings | M012 |
| MUCUS RELIEF | GUAIFENESIN 400 MG | Pioneer Life Sciences, LLC | 0d604fc6-7bb9-4f7c-99cd-fdae4df4bb6f | 2025-12-26 | 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 |
| 50580-507-72 | 50580050772 | 3 CARTON in 1 CARTON (50580-507-72) / 1 BLISTER PACK in 1 CARTON / 24 TABLET, COATED in 1 BLISTER PACK | 3 carton | 2026-03-16 | No | No | Current |