Tylenol Sinus Severe
- Product NDC
- 85237-1955
- Requested package NDC
- 85237-1955-4
- 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 |
|---|---|---|---|---|---|---|
| Giltuss Honey DM Cough | DEXTROMETHORPHAN HBR | Dextrum Laboratories, Inc | 3f79137f-f0b0-d22c-e063-6394a90a7245 | 2025-09-23 | Warnings | M012 |
| GoodSense Medicated Chest Rub | CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL | GOOD SENSE | 240bb6af-9d38-49fe-9011-3016246b0986 | 2025-09-23 | Warnings | M012 |
| Xpect Honey Lemon Cough Drops | HONEY LEMON COUGH DROPS | Cintas Corporation | 79e0b7c1-4acc-41d2-89cd-d075a8bac0c9 | 2025-09-23 | Warnings | M012 |
| Topcare NiteTime Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Topco Associates LLC | b2b3c450-e988-41d1-9e53-cc8e30d75cb4 | 2025-09-23 | Warnings | M012 |
| Xpect Cherry Cough Drops | CHERRY COUGH DROPS | Cintas Corporation | d1fd2f23-5435-405d-a7fd-644691f79e80 | 2025-09-23 | Warnings | M012 |
| Topcare DayTime NiteTime Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Topco Associates LLC | 560fb22b-391f-4d7b-a6fd-38d577d404b0 | 2025-09-23 | Warnings | M012 |
| Giltuss EX Expectorant | GUAIFENESIN | Dextrum Laboratories Inc. | 3f67ac3d-1503-3418-e063-6394a90a938f | 2025-09-22 | Warnings | M012 |
| Giltuss HBP Cough and Chest Congestion | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Dextrum Laboratories Inc. | 3f68e68a-cf32-9df8-e063-6394a90a3012 | 2025-09-22 | Warnings | M012 |
| SUPRESS A | DEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Kramer Novis | f0bec5f5-4d76-471e-9024-557eba848b93 | 2025-09-22 | Warnings | M012 |
| RIGHT REMEDIES NIGHTTIME SEVERE COLD AND FLU softgel | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Strive Pharmaceuticals Inc. | 9f050fb0-6100-4b14-b82f-1d5fcbf16540 | 2025-09-22 | Warnings | M012 |
| RIGHT REMEDIES DAYTIME SEVERE COLD AND FLU softgel | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Strive Pharmaceuticals Inc. | c6392ace-c7d1-4450-8b71-4dccc60b4f02 | 2025-09-22 | Warnings | M012 |
| Giltuss Cough and Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Dextrum Laboratories Inc. | 3f12ee8f-d1c6-d73a-e063-6394a90a9199 | 2025-09-18 | Warnings | M012 |
| CVS Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | CVS Pharmacy | 3d71d306-893a-e73a-e063-6394a90a0a3b | 2025-09-18 | Warnings | M012 |
| Giltuss D | GILTUSS D | Dextrum Laboratories Inc. | 3f17eefb-b625-b0f2-e063-6294a90afd4d | 2025-09-18 | Warnings | M012 |
| Cold and Flu Relief Daytime | ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Major Pharmaceuticals | 6c11c8c8-b2e1-4b9e-80cf-23247c03dd9b | 2025-09-17 | Warnings | M012 |
| Childrens Giltuss Honey DM Cough | DEXTROMETHORPHAN HBR | Dextrum Laboratories Inc | 3effaf4b-28c3-6131-e063-6294a90a17ff | 2025-09-17 | Warnings | M012 |
| AXIV DayTime - Liquid | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | VIVUNT PHARMA LLC | 1872e1ff-2e08-c404-e063-6294a90afa14 | 2025-09-17 | Warnings | M012 |
| AXIV Allergy | DIPHENHYDRAMINE HYDROCHLORIDE | VIVUNT PHARMA LLC | 1323a67c-b9c5-038c-e063-6394a90a5e6b | 2025-09-17 | Warnings | M012 |
| Giltuss Childrens Cough and Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Dextrum Laboratories Inc. | 3f025ef6-79e7-e833-e063-6294a90ab501 | 2025-09-17 | Warnings | M012 |
| AXIV Night Time - Liquid | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | VIVUNT PHARMA LLC | 186f8519-655d-bd21-e063-6294a90a16a8 | 2025-09-17 | Warnings | M012 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 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 |