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 |
|---|---|---|---|---|---|---|
| Equate Menthol Chewable Gels | MENTHOL | Walmart | 1ba4b2be-7242-0a23-e063-6294a90af29c | 2025-12-23 | Warnings | M012 |
| Walgreens Severe Menthol Throat Drops | MENTHOL | Walgreens | 21dd3c68-cbc6-4799-e063-6394a90a6972 | 2025-12-23 | Warnings | M012 |
| cherry throat relief lozenges | BENZOCAINE | Zee Medical | 499d0748-538f-678c-e054-00144ff8d46c | 2025-12-23 | Warnings | M012 |
| Guaiasorb DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | NuCare Pharmaceuticals, Inc. | 46a480c7-7092-b809-e063-6294a90a60cd | 2025-12-23 | Warnings | M012 |
| menthol cough drops | MENTHOL | Winco Foods | 360a6304-206d-5475-e054-00144ff8d46c | 2025-12-23 | Warnings | M012 |
| menthol cough drops | MENTHOL | Winco Foods | 36342d8c-34ab-6178-e054-00144ff8d46c | 2025-12-23 | Warnings | M012 |
| cherry cough drops | MENTHOL | Winco Foods | 37244333-1307-5121-e054-00144ff8d46c | 2025-12-23 | Warnings | M012 |
| honey lemon cough drops | MENTHOL | Winco foods | 37718c73-880e-4a5c-e054-00144ff8d46c | 2025-12-23 | Warnings | M012 |
| honey lemon cough drops | MENTHOL | Winco Foods | 40676ddc-577f-5cc9-e054-00144ff88e88 | 2025-12-23 | Warnings | M012 |
| Sugar Free Menthol Cough Drops | MENTHOL | Winco Foods | 3788e8b6-ab9e-1513-e054-00144ff88e88 | 2025-12-23 | Warnings | M012 |
| SAFETUSSIN Non Drowsy Cough plus chest congestion | DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESIN | KRAMER LABORATORIES | eeca6370-29ea-4540-8139-e8461d58a286 | 2025-12-23 | Warnings | M012 |
| Tussin DM | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Discount Drug Mart | dd31f86b-f59e-459a-8e5f-176828706a4a | 2025-12-23 | Warnings | M012 |
| Tussin CF | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Discount Drug Mart | f8e7a08e-7422-4a1b-bfec-93e0b50d10cd | 2025-12-23 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL 25 MG | Pioneer Life Sciences, LLC | ab45ae97-7951-4058-e053-2995a90a7b2e | 2025-12-23 | Warnings | M012 |
| Childrens Chest Congestion Relief Grape | GUAIFENESIN | Discount Drug Mart | 3e5d245f-515c-4106-a855-fb97681b646a | 2025-12-23 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL 25 MG | Pioneer Life Sciences, LLC | ab45ed16-86bb-3faf-e053-2995a90acfbc | 2025-12-23 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL 25 MG | Pioneer Life Sciences, LLC | a7999da7-148a-4c6d-a2ea-0f4cc1d5b283 | 2025-12-23 | Warnings | M012 |
| Safetussin High Blood Pressure and diabetes Cough, Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESIN | KRAMER LABORATORIES | 279e309c-040d-4001-808d-b7d986a9a1d8 | 2025-12-23 | Warnings | M012 |
| Sinus PE Head Congestion and Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 76fd1f8e-2670-421c-a9e6-c8adefb7962e | 2025-12-23 | Warnings | M012 |
| Leader Cough Drops Vanilla Honey | MENTHOL | Cardinal Health 110, LLC. DBA Leader | 1f6f1218-be7d-4b80-ad0d-eb4d1a54a1e2 | 2025-12-22 | 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 |