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 |
|---|---|---|---|---|---|---|
| Daytime Nighttime Cold Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | United Natural Foods, Inc. dba UNFI | 13910ea1-37dd-43bb-9fe8-e843f59201b7 | 2025-10-21 | Warnings | M012 |
| Quantum Health Bing Cherry Flavor | MENTHOL, UNSPECIFIED FORM | Quantum, Inc. | 94d40c95-fa2b-42cf-b9f5-a5027d86401d | 2025-10-20 | Warnings | M012 |
| Quantum Health Meyer Lemon and Honey Flavor | MENTHOL, UNSPECIFIED FORM | Quantum, Inc. | fe780067-5a20-4d55-a108-91237cd9e5f4 | 2025-10-20 | Warnings | M012 |
| OneSsip Diphenhydramine HCl 12.5 mg/ 5 mL Oral Solution (Cherry) | DIPHENHYDRAMINE HCL | MEDWISE LIFESCIENCES INC. | 4157e680-37ac-eb4c-e063-6394a90a2a99 | 2025-10-17 | Warnings | M012 |
| Norel AD | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HCL | U.S. PHARMACEUTICAL CORPORATION | 53d9ed3c-212d-4b12-ac35-8bd49382b49d | 2025-10-17 | Warnings | M012 |
| Severe Congestion, Cough, Cold and Flu Relief Maximum Strength, Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, TRIPROLIDINE HCL | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 92c570ff-139f-49ff-a7bd-8a540ecc07c7 | 2025-10-17 | Warnings | M012 |
| NoHist DM | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE | Larken Laboratories, Inc. | 6aafe912-28ff-442f-8e07-b3c5993ac943 | 2025-10-16 | Warnings | M012 |
| Signature Care Original | OXYMETAZOLINE HYDROCHLORIDE | SAFEWAY, INC. | f7ad687b-dcaf-928c-e053-6294a90a6abe | 2025-10-16 | Warnings | M012 |
| Daytime Nighttime Cold Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Care One (Retail Business Services, LLC.) | 90ccb29c-9967-46cb-a409-e440344e1a1a | 2025-10-15 | Warnings | M012 |
| Robitussin Childrens Honey Day Night DM Value Pack | DEXTROMETHORPHAN HBR, GUAIFENESIN, DOXYLAMINE SUCCINATE | Haleon US Holdings LLC | f9999875-3433-4052-a628-39539d373216 | 2025-10-15 | Warnings | M012 |
| Robitussin Day and Night Cough Relief Value Pack | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, CHLORPHENIRAMINE MALEATE | Haleon US Holdings LLC | 4029eccd-5443-4ae2-9232-2a1d922798f8 | 2025-10-15 | Warnings | M012 |
| EndaCof DM | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE | Larken Laboratories, Inc. | c68ea55a-8b9a-4a70-8b5c-1a2736651813 | 2025-10-15 | Warnings | M012 |
| DURATUSS DM | DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | Poly Pharmaceuticals, Inc. | 413a3951-d704-f14b-e063-6394a90a06dc | 2025-10-15 | Warnings | M012 |
| LoHist DM | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE | Larken Laboratories, Inc. | 29730dab-fa09-4351-9b36-0359ba4f7744 | 2025-10-15 | Warnings | M012 |
| M-END DMX | DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE | R. A. McNeil Company | ee1fae2e-3a21-4487-9989-c7620a4a7056 | 2025-10-15 | Warnings | M012 |
| Chlo Tuss | CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE | R.A. McNeil Company | 43610aaa-8b94-40d5-ae09-3d75bd2317c8 | 2025-10-15 | Warnings | M012 |
| Chlo Hist | CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE | R. A. McNeil Company | d046f4ba-5753-4ed5-a924-0b66fd116781 | 2025-10-15 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Care One (Retail Business Services, LLC.) | 6ca7372b-50c4-4b15-b133-fefa35525ade | 2025-10-15 | Warnings | M012 |
| Extra Strength Sinus Relief Nasal Decongestant | PHENYLEPHRINE HYDROCHLORIDE | CARDINAL HEALTH | 0d8a009c-30b5-4f12-90bd-f8aa1110243f | 2025-10-14 | Warnings | M012 |
| Tussin DM Cough plus Chest Congestion | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | Cardinal Health 110, Inc. DBA LEADER | 9d11f443-c93d-44e8-b5a3-2677b7b11212 | 2025-10-14 | 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 |