Vicks Sinex Severe
- Product NDC
- 84126-382
- 11-digit product format
- 841260382
- Labeler code
- 84126
- Product ID
- 84126-382_5d6c5cff-ea8c-53fd-e063-6394a90a9b18
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Guaifenesin
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- The Procter & Gamble Manufacturing Company
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-08-03
- Substance
- ACETAMINOPHEN; GUAIFENESIN
- Active strength
- 325; 200 mg/1; mg/1
- Pharmacologic classes
- Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
- 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
- Vicks Sinex Severe
- Brand name suffix
- PAIN, MUCUS and CHEST CONGESTION
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/1 |
| GUAIFENESIN | 200 mg/1 |
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 |
|---|---|---|---|---|---|---|
| Topcare Nasal Decongestant Maximum Strength Non Drowsy | PSEUDOEPHEDRINE HCL | Topco Associates LLC | 1a9e0336-c0c2-43f8-aeea-668d4a209714 | 2024-09-20 | Warnings | M012 |
| Leader Nasal Decongestant | PSEUDOEPHEDRINE HCL | Cardinal Health 110, LLC. dba Leader | 25609b66-047c-46e7-bc95-20eb8e6c9617 | 2024-09-20 | Warnings | M012 |
| equaline nasal | PHENYLEPHRINE HYDROCHLORIDE | United Natural Foods, Inc. dba UNFI | 67fdd277-7a7a-4404-8ca2-39802c46405f | 2024-09-20 | Warnings | M012 |
| equaline tussin | DEXTROMETHORPHAN HBR, GUAIFENESIN | United Natural Foods, Inc. dba UNFI | 8bc7fa7c-d565-48c9-9808-1042c3e9d428 | 2024-09-20 | Warnings | M012 |
| Leader Adult Tussin Mucus and Chest Congestion 541 | GUAIFENESIN | CARDINAL HEALTH 110, LLC. DBA LEADER | d7fae410-9c1c-4231-9fde-2c51ad3d7e95 | 2024-09-20 | Warnings | M012 |
| sinus | PSEUDOEPHEDRINE HYDROCHLORIDE | Kroger Company | 18812f2a-9b66-45a7-9631-123da6fd1c1f | 2024-09-20 | Warnings | M012 |
| Good Sense Nasal Four | PHENYLEPHRINE HYDROCHLORIDE | L. Perrigo Company | 930469c1-384c-4440-b3e6-9dcd674871c4 | 2024-09-19 | Warnings | M012 |
| Cold and Flu Relief Multi Symptom Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | WinCo Foods, LLC | 89272d2d-5533-4ae8-865b-cb204cec6d65 | 2024-09-17 | Warnings | M012 |
| Cold and Flu Relief Multi Symptom Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | WinCo Foods, LLC | 5791c1c7-f614-4940-a45a-6291742e1e22 | 2024-09-17 | Warnings | M012 |
| nasal decongestant | OXYMETAZOLINE HYDROCHLORIDE | Safeway | 2affd44d-2125-4a1f-919c-c082e7644ea8 | 2024-09-17 | Warnings | M012 |
| DAYTIME COLD AND FLU RELIEF SOFTGELS NON-DROWSY | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE | Advanced Rx LLC | fa1a4d86-87bb-0c50-e053-6394a90a56e2 | 2024-09-13 | Warnings | M012 |
| NIGHTTIME COLD AND FLU RELIEF SOFTGELS MULTI-SYMPTOM | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Advanced Rx LLC | fa1b60b1-49cb-1211-e053-6394a90a0a46 | 2024-09-13 | Warnings | M012 |
| nasal | PHENYLEPHRINE HYDROCHLORIDE | Walgreen Company | 8db7df1c-46b5-49bd-9002-50b12d58001a | 2024-09-13 | Warnings | M012 |
| meijer Daytime Cold and Flu SOFTGEL | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Meijer, Inc. | 1bdd7f8a-93ce-5309-e063-6294a90a91f0 | 2024-09-12 | Warnings | M012 |
| oxymetazoline hcl | OXYMETAZOLINE HYDROCHLORIDE | Padagis Israel Pharmaceuticals Ltd | a1103cd8-344b-4a65-8a60-3c7be86d01a6 | 2024-09-11 | Warnings | M012 |
| Good Sense Nasal | OXYMETAZOLINE HYDROCHLORIDE | L. Perrigo Company | 276d7d3c-c4a7-4754-8845-c38f85aac5f7 | 2024-09-08 | Warnings | M012 |
| foster and thrive nasal | OXYMETAZOLINE HYDROCHLORIDE | Strategic Sourcing Services LLC | 4ff5a4ae-9649-4a6d-a5f8-ca23efbbb479 | 2024-09-08 | Warnings | M012 |
| equate nasal original | OXYMETAZOLINE HYDROCHLORIDE | Wal-Mart Stores Inc | 7e40c9b8-e0b5-448a-a674-72388fbab189 | 2024-09-08 | Warnings | M012 |
| Anefrin Nasal Original | OXYMETAZOLINE HYDROCHLORIDE | Walgreen Company | 85b442dc-1703-4fef-948a-fad7cbe9f224 | 2024-09-07 | Warnings | M012 |
| equaline nasal | OXYMETAZOLINE HYDROCHLORIDE | United Natural Foods, Inc. dba UNFI | 07e0328e-1912-4f25-9e1e-9482d4665be0 | 2024-09-07 | Warnings | M012 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 84126-382-24 | 84126038224 | 2 BLISTER PACK in 1 CARTON (84126-382-24) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 2 blister pack | 2026-08-03 | No | No | Current |