Vicks Sinex Severe
- Product NDC
- 37000-950
- 11-digit product format
- 370000950
- Labeler code
- 37000
- Product ID
- 37000-950_5ce10f5e-411a-a961-e063-6294a90ae770
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Phenylephrine HCl
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- The Procter & Gamble Manufacturing Company
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2018-07-10
- Substance
- ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 325; 5 mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], 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
- Vicks Sinex Severe
- Brand name suffix
- All in One Sinus
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/1 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e4e263da-1c53-440f-bb80-b7a575843b5a | Product name | 1 | 20260313 |
| d2168cac-a261-415a-9c78-3522859fa720 | Product name | 3 | 20251124 |
| 05a8cdd1-eeb8-409e-b938-0778225eca7d | Product name | 4 | 20250221 |
| e5b5c132-b15d-435b-9faa-2f74e5cadcf9 | Product name | 8 | 20250220 |
| f489e8f3-5c9e-4818-b539-a73587edcfc7 | Product name | 2 | 20240229 |
| 0f7ae452-206d-4fc4-868d-56fc47074084 | Product name | 1 | 20231011 |
| b5abe2e3-39a1-43eb-9bff-f3c1653fe3df | Product name | 2 | 20190930 |
| c5cd4727-ac49-4409-82b1-5bd8006c3ec7 | Product name | 1 | 20171122 |
| e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814 | Product name | 3 | 20150910 |
| 42f3c020-f1b3-89bc-7bdc-e1f10e680485 | Product name | 1 | 20140508 |
| e949165d-714d-e548-2b76-0cb5def16f30 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| Effective | Related label |
|---|---|
| 2021-02-11 | VICKS ® Sinex ™ Severe ALL IN ONE™ SINUS LiquiCaps |
| 2021-02-11 | VICKS ® Sinex ™ Severe ALL IN ONE™ SINUS LiquiCaps |
| 2021-01-29 | VICKS ® Sinex ™ Severe ALL IN ONE™ SINUS LiquiCaps |
| 2021-01-29 | VICKS ® Sinex ™ Severe ALL IN ONE™ SINUS LiquiCaps |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 37000-950-24 | Vicks Sinex SevereAll in One Sinus | 12 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 12 | 11 | |
| 37000-950-24 | Vicks Sinex SevereAll in One Sinus | 2 in 1 CARTON | CAPSULE, LIQUID FILLED | 2 | 11 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 37000-950 | VICKS SINEX SEVERE ALL IN ONE SINUS (ACETAMINOPHEN, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [THE PROCTER & GAMBLE MANUFACTURING COMPANY] | 9 | Current NDC, Legacy NDC, 2 package rows | 20241012_9a106398-6d9d-2146-e053-2995a90a3fdf.zip |
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 |
|---|---|---|---|---|---|---|
| TRIPROLIDINE HYDROCHLORIDE | TRIPROLIDINE HYDROCHLORIDE | Westminster Pharmaceuticals, LLC | 4eeffb6d-fc5e-48bc-95f6-ec4d5cb6e0d2 | 2026-08-10 | Warnings | M012 |
| TRIPROLIDINE HYDROCHLORIDE | TRIPROLIDINE HYDROCHLORIDE | Westminster Pharmaceuticals, LLC | a9f01760-e335-4410-a9b8-8edce2841270 | 2026-08-10 | Warnings | M012 |
| Guaifed | GUAIFENESIN | Aldama Pharmaceuticals, Inc | 38f37272-2084-a33b-e063-6294a90ac150 | 2026-08-10 | Warnings | M012 |
| Chlorpheniramine Maleate | CHLORPHENIRAMINE MALEATE | PD-Rx Pharmaceuticals, Inc. | 7a3452a2-930f-48b1-8c59-dbceb10b9c78 | 2026-08-10 | Warnings | M012 |
| Guaifed DM | DEXTROMETHORPHAN, GUAIFENESIN | Aldama Pharmaceuticals, Inc | 396bf716-0f61-9563-e063-6394a90a171b | 2026-08-10 | Warnings | M012 |
| Daytime Cold and Flu mini Softgels | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Shield Pharmaceuticals Corp | eff114fe-fb15-48dd-b673-4d4d66406e69 | 2026-08-10 | Warnings | M012 |
| Sleep Aid | DIPHENHYDRAMINE HCL | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 651b03a3-b85e-4028-a9f2-472bec16c8f4 | 2026-08-10 | Warnings | M012 |
| NASAL | PHENYLEPHRINE HYDROCHLORIDE | Amazon.com Services LLC | 02a89765-2a75-470a-9fd6-8cce71dc19e9 | 2026-08-10 | Warnings | M012 |
| WINCO Maximum StrengthCold Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | WINCO FOODS, LLC | f34bfb71-2c81-44d0-a2a0-4d320c43c217 | 2026-08-07 | Warnings | M012 |
| DAYTIME NIGHTTIME ELDERBERRY COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Walgreen Company | 11cac20e-9bb6-4e2d-8efd-4451f055c7b4 | 2026-08-07 | Warnings | M012 |
| Winco Foods Childrens Multi Symptom Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | WINCO FOODS, LLC | 1d02b32a-e88d-4c70-b66d-7bdc22c25a43 | 2026-08-07 | Warnings | M012 |
| foster and thrive daytime cold and flu relief nighttime cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Strategic Sourcing Services LLC | c1ecc56b-8052-4b0a-900a-dc93a24771bd | 2026-08-07 | Warnings | M012 |
| Adult Long Lasting Cough Relief | DEXTROMETHORPHAN HBR | Shield Pharmaceuticals Corp | bbf7d296-fa3d-43e5-984c-e9d2881a074d | 2026-08-07 | Warnings | M012 |
| Severe Cold and Cough Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE | WinCo Foods, LLC | 790d534a-0f40-495b-a815-67851ac3d20d | 2026-08-07 | Warnings | M012 |
| Extra Moisturizing Nasal Pump Mist Anti Drip | OXYMETAZOLINE HYDROCHLORIDE | WinCo FOODS, LLC | 46ebd262-c6a4-43ea-a7f6-506561bb3de4 | 2026-08-07 | Warnings | M012 |
| Mucus Relief DM Maximum Strength | DEXTROMETHORPHAN HBR AND GUAIFENESIN | WINCO FOODS, LLC | e6afa830-6ce2-4abc-b5c9-3f5f156444df | 2026-08-07 | Warnings | M012 |
| Sinus PE Pressure plus Pain MAXIMUM STRENGTH | ACETAMINOPHEN, PHENYLEPHRINE HCL | CVS Pharmacy | a3b073b4-494c-4531-b08e-475c86ba321d | 2026-08-07 | Warnings | M012 |
| Severe Cold and Cough Nighttime | ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE | WinCo Foods, LLC | dc56197c-c108-4b35-b791-dde5c3384ddd | 2026-08-07 | Warnings | M012 |
| Sinus Severe Non Drowsy, Daytime | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | Meijer Distribution, Inc. | 84c30ec9-a7b5-4d2f-95b2-d6fb895945de | 2026-08-07 | Warnings | M012 |
| Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | Cardinal Health 107, LLC | 887cabe5-46d0-4f4e-8f5a-2cfdbc157b58 | 2026-08-07 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1052670 | acetaminophen 325 MG / phenylephrine HCl 5 MG Oral Capsule | PSN | 9a106398-6d9d-2146-e053-2995a90a3fdf | 11 |
| 1052670 | acetaminophen 325 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SCD | 9a106398-6d9d-2146-e053-2995a90a3fdf | 11 |
| 1052670 | APAP 325 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SY | 9a106398-6d9d-2146-e053-2995a90a3fdf | 11 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 37000-950-24 | 37000095024 | 2 BLISTER PACK in 1 CARTON (37000-950-24) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 2 blister pack | 2018-07-10 | 0000-00-00 | No | No | Current |