Tylenol Sinus Severe
- Product NDC
- 85237-1955
- 11-digit product format
- 852371955
- Labeler code
- 85237
- Product ID
- 85237-1955_52c5c1df-46bc-f82a-e063-6294a90af6f0
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Select Consumer Group 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 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 495W7451VQ | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1243679 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 52c5fda0-c358-72e8-e063-6394a90a3f68 | Available on FDA.report |
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 |
|---|---|---|---|---|---|---|
| Foster and Thrive Cherry Cough Drops | MENTHOL | McKesson | 49eefa70-cef9-d7ec-e063-6294a90ac321 | 2026-02-03 | Warnings | M012 |
| Foster and Thrive Honey Lemon Cough Drops | MENTHOL | McKesson | 49f13ee3-6bb3-e500-e063-6394a90a152d | 2026-02-03 | Warnings | M012 |
| Daytime Cold and Flu Mini Softgels | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Shield Pharmaceuticals Corp | 63cb19d4-2306-4723-a95e-9d2d8b9eccd0 | 2026-02-03 | Warnings | M012 |
| Foster and Thrive SF Honey Lemon Cough Drops | MENTHOL | McKesson | 49f41c30-f806-44ba-e063-6394a90a5a67 | 2026-02-03 | Warnings | M012 |
| Nighttime Cold and Flu Mini Softgels | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Shield Pharmaceuticals Corp | b9af8ab4-a7cb-4adf-9f6f-398c6bb7f853 | 2026-02-03 | Warnings | M012 |
| allergy relief | DIPHENHYDRAMINE HCL | Meijer Distribution Inc | 7c2fc244-bfc5-4e3c-aa90-8bc3d067b64f | 2026-02-03 | Warnings | M012 |
| Cold and Allergy D | PSEUDOEPHEDRINE HCL, TRIPROLIDINE HCL | Walgreen Company | 832ac849-7f4a-489a-a704-9d4388a75a71 | 2026-02-03 | Warnings | M012 |
| severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | HyVee Inc | 987f908b-7af7-4705-bfb4-c48d771c380d | 2026-02-03 | Warnings | M012 |
| tussin dm nighttime max | DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | HyVee Inc | 1f3fb451-84c9-432e-ac67-2694dd66c815 | 2026-02-03 | Warnings | M012 |
| Robafen DM Cough | DEXTROMETHORPHAN HBR, GUAIFENESIN | Major Pharmaceuticals | 7c9660b7-cb00-449b-b65f-aa42d8ce1942 | 2026-02-03 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Walgreen Company | 6b0d261f-fc27-4b34-88b1-cd3d72766760 | 2026-02-02 | Warnings | M012 |
| Tussin DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Cardinal Health 110, LLC. DBA Leader | ebfcb699-3369-4697-9841-44015b1c9808 | 2026-02-02 | Warnings | M012 |
| Cherry Sore Throat Lozenges | BENZOCAINE, MENTHOL | Meijer Distribution Inc. | 2f6de590-7cad-25d7-e054-00144ff8d46c | 2026-02-02 | Warnings | M012 |
| Mixed Berry Sore Throat and Cough lozenge | DEXTROMETHORPHAN HYDROBROMIDE | Meijer Distribution, Inc. | 304ff4db-201a-60a4-e054-00144ff8d46c | 2026-02-02 | Warnings | M012 |
| Allergy Relief Plus Congestion | DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Walgreen Company | 38d91107-d95c-40f2-a27e-561f951e519d | 2026-02-02 | Warnings | M012 |
| Tussin Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | HyVee Inc | 85252999-3463-45fe-b4a9-7a97960b41b1 | 2026-02-02 | Warnings | M012 |
| Amazon Basics Cherry Cough Drops 30ct | MENTHOL | Amazon | 3e74e209-c9c9-3979-e063-6294a90afcfa | 2026-02-01 | Warnings | M012 |
| Amazon Basics Honey Lemon Cough Drops 30ct | MENTHOL | Amazon | 3e75838b-e1c9-2d42-e063-6294a90aab82 | 2026-02-01 | Warnings | M012 |
| cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | HyVee Inc | 5110526f-51fd-401e-ba52-520674d34f37 | 2026-02-01 | Warnings | M012 |
| Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Amazon.com Service LLC | 673996ab-6e57-4feb-8af3-d8b474741a8d | 2026-01-30 | Warnings, Adverse reactions | M012 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 85237-1955-1 | 85237195501 | 1 POUCH in 1 BLISTER PACK (85237-1955-1) / 2 TABLET, COATED in 1 POUCH (85237-1955-0) | 1 pouch | 2025-06-04 | No | No | Current |
| 85237-1955-2 | 85237195502 | 2 POUCH in 1 BLISTER PACK (85237-1955-2) / 2 TABLET, COATED in 1 POUCH (85237-1955-0) | 2 pouch | 2025-06-04 | No | No | Current |
| 85237-1955-3 | 85237195503 | 20 POUCH in 1 CARTON (85237-1955-3) / 2 TABLET, COATED in 1 POUCH (85237-1955-0) | 20 pouch | 2025-06-04 | No | No | Current |
| 85237-1955-4 | 85237195504 | 25 POUCH in 1 CARTON (85237-1955-4) / 2 TABLET, COATED in 1 POUCH (85237-1955-0) | 25 pouch | 2025-06-04 | No | No | Current |
| 85237-1955-6 | 85237195506 | 50 POUCH in 1 CARTON (85237-1955-6) / 2 TABLET, COATED in 1 POUCH (85237-1955-0) | 50 pouch | 2025-06-04 | No | No | Current |
| 85237-1955-7 | 85237195507 | 3 POUCH in 1 BLISTER PACK (85237-1955-7) / 2 TABLET, COATED in 1 POUCH (85237-1955-0) | 3 pouch | 2025-06-04 | No | No | Current |