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 |
|---|---|---|---|---|---|---|
| Mucus Relief DM | DEXTROMETHORPHAN HBR 20MG GUAIFENESIN 400MG | Pioneer Life Sciences, LLC | 3ce0f096-906e-47eb-8061-0ac1e9d8ea55 | 2025-12-26 | Warnings | M012 |
| MUCUS RELIEF | GUAIFENESIN 400 MG | Pioneer Life Sciences, LLC | 1194c338-e115-4105-93d8-9ab833c43193 | 2025-12-26 | Warnings | M012 |
| MUCUS RELIEF | GUAIFENESIN 400 MG | Pioneer Life Sciences, LLC | 9c9e558d-d991-4a2e-aa13-37c0b08071e6 | 2025-12-26 | Warnings | M012 |
| MUCUS RELIEF | GUAIFENESIN 400 MG | Pioneer Life Sciences, LLC | 1695e7ea-2f83-4d3a-980e-c91be6c1f2a5 | 2025-12-25 | Warnings | M012 |
| GUAIFENESIN | GUAIFENESIN | Pharbest Pharmaceuticals, Inc. | 0bf70fb4-d3c8-476d-b864-4eadc697a7d8 | 2025-12-24 | Warnings | M012 |
| PHARBINEX-DM | GUAIFENESIN 400MG AND DEXTROMETHORPHAN HBR 20MG | Pharbest Pharmaceuticals, Inc. | 8d71db43-da87-45ee-aa4a-7e870bc5016d | 2025-12-24 | Warnings | M012 |
| Daytime Nighttime Cold Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Safeway, Inc. | 764bcc58-bc5f-4ee6-82b7-cb0ed5baf3be | 2025-12-23 | Warnings | M012 |
| Tussin | GUAIFENESIN | Discount Drug Mart | 14de3d6d-4eb0-42cf-8941-cb42b3dd5c71 | 2025-12-23 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL 25 MG | Pioneer Life Sciences, LLC | c8dcba06-a461-4af5-a120-666a63f06ac4 | 2025-12-23 | Warnings | M012 |
| SAFETUSSIN MAX STRENGTH MS Cough, Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESIN | KRAMER LABORATORIES | 920bde5f-4079-45de-aa59-24b00e50cb56 | 2025-12-23 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE | Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd | 46996bbf-948c-0aba-e063-6394a90a09e3 | 2025-12-23 | Warnings | M012 |
| Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | Lil' Drug Store Products, Inc. | 1d2e2a5a-099b-41b3-82bd-5bf704377f78 | 2025-12-23 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Lil' Drug Store Products, Inc. | 5b493ed7-9044-4841-9935-236d0bdc71a9 | 2025-12-23 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Lil' Drug Store Products, Inc. | 77a7ff9a-a414-4053-8d8d-369907d4380d | 2025-12-23 | Warnings | M012 |
| Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | Lil' Drug Store Products, Inc. | 8f320235-f243-4211-b99c-18526e686548 | 2025-12-23 | Warnings | M012 |
| Circle K Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Lil' Drug Store Products, Inc. | b6a46498-d9a8-4da2-9283-57d135f305a5 | 2025-12-23 | Warnings | M012 |
| Circle K Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | Lil' Drug Store Products, Inc. | 7c5faec2-28c6-4c15-a268-d8b578140b74 | 2025-12-23 | Warnings | M012 |
| Sugar Free Honey Lemon Cough Drops | MENTHOL | Walmart | 67650b94-adbb-87fb-e053-2a91aa0a87e6 | 2025-12-23 | Warnings | M012 |
| Equate Benz-Dex Cough and Throat Lozenges | BENZOCAINE | Walmart | c0a6cb7f-a247-e610-e053-2a95a90a4199 | 2025-12-23 | Warnings | M012 |
| Equate Honey Lemon Cough Drops | MENTHOL | WalMart | 0028be18-5162-ff51-e063-6294a90ae517 | 2025-12-23 | 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 |