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 |
|---|---|---|---|---|---|---|
| Best Health Maple Spice Cough Drops | MENTHOL | Bestco | 58cfdacb-c713-220f-e063-6394a90acbfc | 2026-08-11 | Warnings | M012 |
| 7 Select Maximum Strength | DEXTROMETHORPHAN HBR, GUAIFENESIN | 7-ELEVEN | f9475972-0cbb-45c5-9e49-09569f1665a7 | 2026-08-11 | Warnings | M012 |
| Allergy Relief Childrens | DIPHENHYDRAMINE HCL | L.N.K. International, Inc. | 6ec5445b-a1f2-47ba-99f7-5a4a6d0c29e3 | 2026-08-10 | Warnings | M012 |
| TRIPROLIDINE HYDROCHLORIDE | TRIPROLIDINE HYDROCHLORIDE | Westminster Pharmaceuticals, LLC | 4eeffb6d-fc5e-48bc-95f6-ec4d5cb6e0d2 | 2026-08-10 | Warnings | M012 |
| TRIPROLIDINE HYDROCHLORIDE | TRIPROLIDINE HYDROCHLORIDE | Westminster Pharmaceuticals, LLC | a9f01760-e335-4410-a9b8-8edce2841270 | 2026-08-10 | Warnings | M012 |
| Guaifed | GUAIFENESIN | Aldama Pharmaceuticals, Inc | 38f37272-2084-a33b-e063-6294a90ac150 | 2026-08-10 | Warnings | M012 |
| Chlorpheniramine Maleate | CHLORPHENIRAMINE MALEATE | PD-Rx Pharmaceuticals, Inc. | 7a3452a2-930f-48b1-8c59-dbceb10b9c78 | 2026-08-10 | Warnings | M012 |
| Guaifed DM | DEXTROMETHORPHAN, GUAIFENESIN | Aldama Pharmaceuticals, Inc | 396bf716-0f61-9563-e063-6394a90a171b | 2026-08-10 | Warnings | M012 |
| Daytime Cold and Flu mini Softgels | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Shield Pharmaceuticals Corp | eff114fe-fb15-48dd-b673-4d4d66406e69 | 2026-08-10 | Warnings | M012 |
| Sleep Aid | DIPHENHYDRAMINE HCL | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 651b03a3-b85e-4028-a9f2-472bec16c8f4 | 2026-08-10 | Warnings | M012 |
| NASAL | PHENYLEPHRINE HYDROCHLORIDE | Amazon.com Services LLC | 02a89765-2a75-470a-9fd6-8cce71dc19e9 | 2026-08-10 | Warnings | M012 |
| WINCO Maximum StrengthCold Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | WINCO FOODS, LLC | f34bfb71-2c81-44d0-a2a0-4d320c43c217 | 2026-08-07 | Warnings | M012 |
| DAYTIME NIGHTTIME ELDERBERRY COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Walgreen Company | 11cac20e-9bb6-4e2d-8efd-4451f055c7b4 | 2026-08-07 | Warnings | M012 |
| Winco Foods Childrens Multi Symptom Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | WINCO FOODS, LLC | 1d02b32a-e88d-4c70-b66d-7bdc22c25a43 | 2026-08-07 | Warnings | M012 |
| foster and thrive daytime cold and flu relief nighttime cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Strategic Sourcing Services LLC | c1ecc56b-8052-4b0a-900a-dc93a24771bd | 2026-08-07 | Warnings | M012 |
| Adult Long Lasting Cough Relief | DEXTROMETHORPHAN HBR | Shield Pharmaceuticals Corp | bbf7d296-fa3d-43e5-984c-e9d2881a074d | 2026-08-07 | Warnings | M012 |
| Severe Cold and Cough Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE | WinCo Foods, LLC | 790d534a-0f40-495b-a815-67851ac3d20d | 2026-08-07 | Warnings | M012 |
| Extra Moisturizing Nasal Pump Mist Anti Drip | OXYMETAZOLINE HYDROCHLORIDE | WinCo FOODS, LLC | 46ebd262-c6a4-43ea-a7f6-506561bb3de4 | 2026-08-07 | Warnings | M012 |
| Mucus Relief DM Maximum Strength | DEXTROMETHORPHAN HBR AND GUAIFENESIN | WINCO FOODS, LLC | e6afa830-6ce2-4abc-b5c9-3f5f156444df | 2026-08-07 | Warnings | M012 |
| Sinus PE Pressure plus Pain MAXIMUM STRENGTH | ACETAMINOPHEN, PHENYLEPHRINE HCL | CVS Pharmacy | a3b073b4-494c-4531-b08e-475c86ba321d | 2026-08-07 | Warnings | 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 |