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 |
|---|---|---|---|---|---|---|
| Cough and Runny Nose Childrens Plus | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | TOP CARE (Topco Associates LLC) | 6f04bd51-093c-4624-aef3-0145ac387386 | 2026-06-01 | Warnings | M012 |
| Nasal | PHENYLEPHRINE HYDROCHLORIDE | CVS Pharmacy | 694a3116-1b75-42cd-bbcf-d19831c2d796 | 2026-06-01 | Warnings | M012 |
| night time | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | H E B | cf31538c-9eee-4c81-80cb-66eecabf0aff | 2026-06-01 | Warnings | M012 |
| Mucinex Childrens Mighty Chews Cough | DEXTROMETHORPHAN HYDROBROMIDE | Reckitt Benckiser LLC | 155e07b3-0a08-3be8-e063-6394a90a7635 | 2026-05-31 | Warnings | M012 |
| Mucinex Childrens Mighty Chews Cough Nighttime | DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE | Reckitt Benckiser LLC | 156033ae-b16a-007b-e063-6294a90a7445 | 2026-05-31 | Warnings | M012 |
| Cold and Flu Day | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Walgreen Company | ebf8c82d-a653-4c02-893b-61704901acbb | 2026-05-29 | Warnings | M012 |
| Allergy Relief Childrens | DIPHENHYDRAMINE HCL | Amerisource Bergen | 934c7b91-3cba-47f0-8efa-77216f3f15c4 | 2026-05-29 | Warnings | M012 |
| Allergy Medicine | DIPHENHYDRAMINE HCL | COSTCO WHOLESALE CORPORATION | d9f03e11-d11f-43ee-8ed0-9e07d1058f66 | 2026-05-29 | Warnings | M012 |
| Cold Childrens, Multi Symptom | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | CVS PHARMACY | eaa07dd4-cb7e-45ca-abe4-7a3f7a9d928d | 2026-05-29 | Warnings | M012 |
| NebuClear MD | RACEPINEPHRINE HYDROCHLORIDE | Blue Echo Care LLC | 3598ac5b-29f9-f002-e063-6294a90a62cb | 2026-05-28 | Warnings | M012 |
| NebuClear MD | RACEPINEPHRINE HYDROCHLORIDE | Blue Echo Care LLC | 51badd2f-4a43-3dbe-e063-6294a90a4bd1 | 2026-05-28 | Warnings | M012 |
| Kids Cough and Chest Congestion | DEXTROMETHORPHAN HBR, GUAIFENESIN | Genexa Inc. | a7ab2140-de09-158f-e053-2a95a90a25a0 | 2026-05-28 | Warnings | M012 |
| Kids Multi Symptom Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | Genexa Inc. | 2d918ec8-3098-1d09-e063-6294a90a9e8f | 2026-05-28 | Warnings | M012 |
| Daytime and Nighttime Kids Multi-Symptom Cold and Flu combo pack | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL | Genexa Inc. | 213fe898-dace-9a0f-e063-6394a90afd64 | 2026-05-28 | Warnings | M012 |
| MGC Health Cough Drops Honey Lemon Flavor | MENTHOL | Medical Group Care LLC | 556628ab-e233-92fe-e063-6394a90a0090 | 2026-05-28 | Warnings | M012 |
| Sinus Decongestion PE | PHENYLEPHRINE HCL | Kroger Company | 68eff734-177e-4999-9126-6b92bb204107 | 2026-05-28 | Warnings | M012 |
| Cough and Cold HBP | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | ARMY AND AIR FORCE EXCHANGE SERVICE | ff39084f-ab2f-48ed-ac62-837f7fff2b65 | 2026-05-28 | Warnings | M012 |
| Tylenol Sinus Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Select Consumer Group LLC | 52c5fda0-c358-72e8-e063-6394a90a3f68 | 2026-05-27 | Warnings | M012 85237-1955 |
| Mucinex Childrens Mighty Chews Cough Daytime and Nighttime Combo Pack | DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE | Reckitt Benckiser LLC | 16637d54-8049-d3ce-e063-6394a90aafc9 | 2026-05-27 | Warnings | M012 |
| Childrens Delsym Cough Plus Cold Night Time | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 00689aa5-ed39-4c9a-92b8-105d2c0e2e15 | 2026-05-27 | 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 |