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 |
|---|---|---|---|---|---|---|
| Maximum Strength Multi-Symptom Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | KROGER COMPANY | 30d4c4b9-0f5f-0279-e063-6394a90af1b5 | 2026-06-19 | Warnings | M012 |
| GoodMeds Nasal Decongestant | PHENYLEPHRINE HYDROCHLORIDE | Cabinet Health P.B.C. | 6a8a961c-d2d2-428d-8af7-8527aae25c8a | 2026-06-19 | Warnings | M012 |
| DESENFRIOL D | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE | OPMX LLC | 5489442a-3e34-3b47-e063-6294a90a0d2f | 2026-06-19 | Warnings | M012 |
| equaline nighttime cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | United Natural Foods, Inc. dba UNFI | 490766e7-1781-4b2b-a8f4-d4efb9fff560 | 2026-06-19 | Warnings | M012 |
| Equate Nasal | PHENYLEPHRINE HYDROCHLORIDE | WALMART INC. | 30f6d588-ad80-4348-a45f-77337e067bca | 2026-06-19 | Warnings | M012 |
| GUAIFENESIN | GUAIFENESIN | Cardinal Health 107, LLC | 888b6a2e-6631-4585-a7fe-eb122eb51b23 | 2026-06-18 | Warnings | M012 |
| Extra Strength TYLENOL Cold plus Flu Multi Symptom Day | ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE | Kenvue Brands LLC | 5487b2e1-b0e5-0236-e063-6394a90a3a8b | 2026-06-18 | Warnings | M012 |
| Vaporizing Colds Rub | MENTHOL | Delon Laboratories (1990) Ltd | 3ed8bc0c-c229-450b-a491-06b578c1b8ee | 2026-06-18 | Warnings | M012 |
| Allergy Childrens | DIPHENHYDRAMINE HCL | DOLGENCORP, LLC | 218c447e-9ddd-428a-9b33-0acec35e0d1b | 2026-06-17 | Warnings | M012 |
| Childrens Allergy Relief | DIPHENHYDRAMINE HCL | WALMART INC. | a9d5f9f4-ddec-4ad6-ad06-4a612008bb68 | 2026-06-17 | Warnings | M012 |
| Childrens Allergy Relief | DIPHENHYDRAMINE HCL | Walgreen Company | e49d2a0f-6588-439b-8a46-c073e0bc4f9a | 2026-06-17 | Warnings | M012 |
| COLD AND FLU RELIEF | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Safeway | ac0380ad-c9fa-4bda-ab84-c2e6aa672bdf | 2026-06-17 | Warnings | M012 |
| daytime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Amazon.com Services LLC | 1a21cbb2-1ba5-414f-a31f-42b7a7bddae5 | 2026-06-16 | Warnings | M012 |
| Tussin DM Regular | DEXTROMETHORPHAN HBR AND GUAIFENESIN | AARNA USA, Inc. | 5460c809-71c8-3ad6-e063-6294a90a4e4f | 2026-06-16 | Warnings | M012 |
| Equate Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | WALMART INC. | 4b111580-cd20-43ec-9ff4-4b9f74f7d2e8 | 2026-06-16 | Warnings | M012 |
| Sinus Congestion | PHENYLEPHRINE HCL | Chain Drug Marketing Association, Inc. | 43a77f89-e66a-4db6-8067-f614c0e207df | 2026-06-16 | Warnings | M012 |
| severe sinus congestion relief Maximum Strength | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | Rite Aid Corporation | 51175d3e-e1c3-4e4d-ad32-61600e87568c | 2026-06-16 | Warnings | M012 |
| foster and thrive daytime cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Strategic Sourcing Services LLC | 067ce5de-dbb4-4b65-8ec0-f4aacbe5e0a6 | 2026-06-16 | Warnings | M012 |
| Equate Severe Cold Cough and Flu | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE | WALMART INC. | a35531d7-1a96-45cb-922f-61db085cde1f | 2026-06-16 | Warnings | M012 |
| Cold and Flu Daytime, Nighttime, Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL | Walgreen Company | 5fe9f313-d6e7-41f5-abfc-e4c72b708961 | 2026-06-15 | 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 |