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 |
|---|---|---|---|---|---|---|
| Good Neighbor Dye Free Adult Tussin DM Cough and Chest Congestion | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | AMERISOURCE BERGEN | 404a3521-8340-4476-a068-0e69cd0e514f | 2026-07-13 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 8a8bd1e3-f3ce-484b-a98c-2cf3f03f1ab5 | 2026-07-13 | Warnings | M012 |
| Good Neighbor Long Acting Cough Adult Tussin | DEXTROMETHORPHAN HBR | AMERISOURCE BERGEN | df3c76bd-bd5b-42d7-a5f1-560fd3cba646 | 2026-07-13 | Warnings | M012 |
| Good Neighbor Adult Tussin Mucus and chest congestion | GUAIFENESIN | AMERISOURCE BERGEN | 97e9cd18-dd55-4a26-80e3-4c17b9e1a1e8 | 2026-07-13 | Warnings | M012 |
| GOOD NEIGHBOR PHARMACY No Drip Nasal Mist | OXYMETAZOLINE HYDROCHLORIDE | AMERISOURCE BERGEN | a217ca8a-1c00-4816-bc26-cc0f71c80c90 | 2026-07-13 | Warnings | M012 |
| Severe Congestion and Cough | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Walgreen Company | 1ddc04fb-069c-44fe-814b-ba4f503c4be0 | 2026-07-10 | Warnings | M012 |
| COUGH DROPS- menthol granule | MENTHOL GRANULE | Anhui Jiuhe Health Industry Co., Ltd | 5351b943-5830-e4e7-e063-6394a90a5b66 | 2026-07-10 | Warnings | M012 |
| ValuMeds Nasal Decongestant PE Phenylephrine | PHENYLEPHRINE HYDROCHLORIDE | Cabinet Health P.B.C. | 3f284420-87c1-4c17-99e5-bc569bf9d45f | 2026-07-10 | Warnings | M012 |
| Severe Congestion and Cough Multi-Symptom Maximum Strength | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | CVS Pharmacy | 707eb066-cdfc-444b-833a-9d6d133d48e4 | 2026-07-10 | Warnings | M012 |
| Sinus Congestion | PHENYLEPHRINE HCL | L.N.K. International, Inc. | 81f0276a-99a2-4a57-a0d8-224735aa8c79 | 2026-07-10 | Warnings | M012 |
| SINUS AND HEADACHE | ACETAMINOPHEN, PHENYLEPHRINE HCL | Rite Aid Corporation | efaf3be1-ab39-45f7-a45c-7fea8705c8d0 | 2026-07-10 | Warnings | M012 |
| Equate Daytime Nighttime Vapor Ice Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | WALMART INC. | f847d9f2-aa47-4bbe-8f06-19356c637398 | 2026-07-10 | Warnings | M012 |
| Sinus and Allergy Relief PE | CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | Topco Associates, LLC | 2a80fba9-5e30-4ec0-bd8e-8957c0654b6c | 2026-07-10 | Warnings | M012 |
| ALKA SELTZER COLD Cold and Headache Maximum Strength Fast Dissolve Orange | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | 50230cad-3d04-8882-e063-6294a90acf3c | 2026-07-09 | Warnings | M012 |
| Sinus Congestion and Pain Maximum Strength | ACETAMINOPHEN, PHENYLEPHRINE HCL | Rugby Laboratories | fc42e97d-1224-4d29-a55d-1a1885e0bf8f | 2026-07-09 | Warnings | M012 |
| Head Congestion and Mucus | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | Cardinal Health 110, LLC. DBA Leader | 7418d92d-a540-40d6-91d0-b7eb1f87f8ff | 2026-07-08 | Warnings | M012 |
| DG HEALTH COUGH AND CHEST CONGESTION | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Dolgencorp Inc | 5d9d57aa-e43a-4dbe-9d35-36a7b82d4e6d | 2026-07-08 | Warnings | M012 |
| Childrens Allergy Relief | DIPHENHYDRAMINE HCL | Topco Associates, LLC | bfcabe02-7961-4407-a748-8cd087731398 | 2026-07-08 | Warnings | M012 |
| Aller-chlor | CHLORPHENIRAMINE MALEATE | Rugby Laboratories | 04ca3806-72be-47d4-9fea-5b0dee087683 | 2026-07-08 | Warnings | M012 |
| nighttime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 24c22c9f-0c2f-46dc-850e-ed05f00d3e95 | 2026-07-08 | 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 |