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 |
|---|---|---|---|---|---|---|
| Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | LEADER/ Cardinal Health 110, Inc. | e33cbd1d-1848-145a-e053-2995a90aeb50 | 2026-02-20 | Warnings | M012 |
| Head Congestion and Flu Severe Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Rite Aid Corporation | 416080a9-e817-485b-a4ae-6c9d0152c165 | 2026-02-20 | Warnings | M012 |
| Walmart Dye Free Chidrens Allergy Chews | DIPHENHYDRAMINE HCL | WALMART STORES INC | 18436026-b0e4-4481-a647-d735a27d0b00 | 2026-02-19 | Warnings | M012 |
| Vaporizing | CAMPHOR | Meijer, Inc. | 7afc98d7-f64f-42d5-9022-28ad6b01db8a | 2026-02-19 | Warnings, Adverse reactions | M012 |
| CHILDRENS COLD AND COUGH | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | Kroger Company | 8196b482-070e-4d7d-8943-129141f926ee | 2026-02-19 | Warnings | M012 |
| Walmart Dye Free Chidrens Allergy Chews Bubblegum | DIPHENHYDRAMINE HCL | WALMART STORES INC | 9f83d2f0-9718-4f2b-bc7f-e29ba2917412 | 2026-02-19 | Warnings | M012 |
| tussin dm max | DEXTROMETHORPHAN HBR, GUAIFENESIN | Kroger Company | be9aaf66-6c59-4042-88e2-acd920dcf992 | 2026-02-19 | Warnings | M012 |
| Allergy Relief Dye-Free | DIPHENHYDRAMINE HCL | CVS Pharmacy | 08459cf4-feb3-4283-88e1-d61e030c57f9 | 2026-02-19 | Warnings | M012 |
| allergy relief | CHLORPHENIRAMINE MALEATE | Rite Aid Corporation | b0d70488-ea1d-4c1d-bd07-53dfb0e4d03c | 2026-02-18 | Warnings | M012 |
| Walgreens Wild Cherry Pectin Throat Drops | PECTIN | Walgreens | 424fda2d-c1e5-0ed9-e063-6394a90a06ea | 2026-02-18 | Warnings | M012 |
| cough suppressant and topical analgesic | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Target Corporation | df21d9d6-36a9-49cf-a29c-c4a573899bd5 | 2026-02-18 | Warnings, Adverse reactions | M012 |
| Allergy Relief | CHLORPHENIRAMINE MALEATE | Amerisource Bergen | eeda80ff-212d-428e-a0c6-782f271357b4 | 2026-02-18 | Warnings | M012 |
| good sense night time | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | L. Perrigo Company | e47dffdf-5778-4804-8ce2-54c5a72bba3a | 2026-02-18 | Warnings | M012 |
| Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | United Natural Foods, Inc. dba UNFI | b139e7d6-bf4d-45b9-b7cf-d34e5352095c | 2026-02-17 | Warnings, Adverse reactions | M012 |
| Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Strategic Sourcing Services LLC | bd54bf7a-2304-4c3f-9cd2-bafea217466e | 2026-02-17 | Warnings, Adverse reactions | M012 |
| Creomulsion For Children | DEXTROMETHORPHAN HYDROBROMIDE | Socius Care, LLC | 39d0e96c-1cc3-4961-e054-00144ff88e88 | 2026-02-17 | Warnings | M012 |
| Creomulsion Cough Medicine Adult Formula | DEXTROMETHORPHAN HYDROBROMIDE | Socius Care, LLC | 39d07486-99b7-5c06-e054-00144ff8d46c | 2026-02-17 | Warnings | M012 |
| Cold and Flu Severe, Day, Night | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR. GUAIFENESIN, PHENYLEPHRINE HCL | L.N.K. International, Inc. | 6e6bae79-1231-4b74-81c1-f0c914ed4af3 | 2026-02-17 | Warnings | M012 |
| COUGH AND CHEST CONGESTION | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | dfe69c12-b5fe-46d1-a3bf-ef3729c2e786 | 2026-02-17 | Warnings | M012 |
| NIGHTTIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 3fb49f64-2d77-44db-8186-5904837eedbe | 2026-02-17 | 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 |