Vicks Sinex Severe
- Product NDC
- 37000-951
- 11-digit product format
- 370000951
- Labeler code
- 37000
- Product ID
- 37000-951_5ce1124b-130f-d11f-e063-6394a90ab947
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Phenylephrine HCl, Guaifenesin
- 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
- PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; GUAIFENESIN
- Active strength
- 5; 325; 200 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
- Vicks Sinex Severe
- Brand name suffix
- All in One Sinus Mucus
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/1 |
| ACETAMINOPHEN | 325 mg/1 |
| GUAIFENESIN | 200 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 |
| 4fe95224-f543-4dbb-9445-8cca122b48c8 | Product name | 1 | 20150609 |
| e8718272-64cb-4436-969b-176c3067c8f4 | Product name | 1 | 20150609 |
| 106ff02a-57e1-4c4c-a307-fd582ff4e311 | Product name | 1 | 20150212 |
| 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 + Mucus LiquiCaps |
| 2021-02-11 | VICKS ® Sinex ™ Severe All in One Sinus + Mucus LiquiCaps |
| 2021-02-11 | VICKS ® Sinex ™ Severe All in One Sinus + Mucus LiquiCaps |
| 2021-01-29 | VICKS ® Sinex ™ Severe All in One Sinus + Mucus LiquiCaps |
| 2021-01-29 | VICKS ® Sinex ™ Severe All in One Sinus + Mucus LiquiCaps |
| 2021-01-29 | VICKS ® Sinex ™ Severe All in One Sinus + Mucus LiquiCaps |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 37000-951-24 | Vicks Sinex SevereAll in One Sinus Mucus | 2 in 1 CARTON | CAPSULE, LIQUID FILLED | 2 | 11 | |
| 37000-951-24 | Vicks Sinex SevereAll in One Sinus Mucus | 12 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 12 | 11 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 37000-951 | VICKS SINEX SEVERE ALL IN ONE SINUS MUCUS (ACETAMINOPHEN, PHENYLEPHRINE HCL, GUAIFENESIN) CAPSULE, LIQUID FILLED [THE PROCTER & GAMBLE MANUFACTURING COMPANY] | 9 | Current NDC, Legacy NDC, 2 package rows | 20241012_9a106291-edda-2135-e053-2995a90a44fd.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 |
|---|---|---|---|---|---|---|
| Daytime Nighttime Sinus Relief | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCL | Target Corporation | 23f50b88-52c3-2029-e063-6394a90ac73e | 2025-06-14 | Warnings | M012 |
| Cough Drops Dollar General Berries Flavor 25ct | PECTIN | Dollar General Corporation | c53c19a9-5984-4b08-ae46-a53dc8bb7d74 | 2025-06-13 | Warnings | M012 |
| Cough Drops Dollar General Strawberry Flavor 25ct | PECTIN | Dollar General Corporation | d82034ca-b7fd-48c8-ab4a-8e1e56418324 | 2025-06-13 | Warnings | M012 |
| Diphenhydramine HCL | DIPHENHYDRAMINE HCL | Belleview Biosciences | 1db57d86-39f0-f8ca-e063-6394a90a6397 | 2025-06-12 | Warnings | M012 |
| TARGET Cold and Cough and Nighttime Value Pack | BROMPHENIRAMINE MALEATE,DEXTROMETHORPHAN HBR,DIPHENHYDRAMINE HCL, | TARGET CORPORATION | ce536313-7265-405c-88b7-f45e62781da5 | 2025-06-11 | Warnings | M012 |
| Capron Max | DEXTROMETHORPHAN HBR AND PYRILAMINE MALEATE | Capital Pharmaceutical, LLC | 3756812b-f128-8946-e063-6294a90a59ba | 2025-06-11 | Warnings | M012 |
| SAFETUSSIN Non Drowsy Cough plus chest congestion | DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESIN | KRAMER LABORATORIES | 60311ca3-8544-417e-aa29-e9f65c6692ba | 2025-06-11 | Warnings | M012 |
| Cold Max Nighttime | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | RETAIL BUSINESS SERVICES , LLC. | e65d2815-6932-123c-e053-2a95a90a2cf9 | 2025-06-10 | Warnings | M012 |
| Cold Head Congestion Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | American Sales Company | 0cc66c6c-db26-4bb2-a97d-c4106210d70c | 2025-06-10 | Warnings | M012 |
| Nighttime Cough DM | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | L.N.K. International, Inc. | 75a9c736-bc7e-4b7f-84ea-9474a37508ec | 2025-06-10 | Warnings | M012 |
| DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | KJD Pharma Private Limited | 8877bb8d-479f-4968-8033-5c269d449a46 | 2025-06-10 | Warnings | M012 |
| Benadryl | DIPHENHYDRAMINE HYDROCHLORIDE | Morning Star OTC | f4ff84b3-bb0c-4900-8ba4-6d1b90394782 | 2025-06-09 | Warnings | M012 |
| Equate Kids Daytime Dex Cough Gels | DEXTROMETHORPHAN | Walmart | 37269cd6-1528-9879-e063-6394a90a2b54 | 2025-06-09 | Warnings | M012 |
| Nuvicare DayTime Cold and Flu Softgel | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | NUVICARE LLC | bdc35570-c8df-4797-a13e-7f2479ec42b7 | 2025-06-09 | Warnings | M012 |
| Nuvicare DayTime and NightTime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE | NUVICARE LLC | f5764925-c586-40e4-8252-24d92389af01 | 2025-06-09 | Warnings | M012 |
| Nuvicare NightTime Cold and Flu Softgel | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | NUVICARE LLC | 2a29f0ed-d86b-4787-84e0-f7a8c5e7581f | 2025-06-09 | Warnings | M012 |
| Nuvicare DayTime and NightTime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE | NUVICARE LLC | 7fa8e4ad-95cb-4905-90db-d53b3bc87c41 | 2025-06-09 | Warnings | M012 |
| Vaporizing Steam Liquid | MEDICATED COUGH SUPPRESSANT | NeilMed Pharmaceuticals Inc. | 36cf6218-adb8-9d8b-e063-6394a90a49a0 | 2025-06-05 | Warnings | M012 |
| Geri-Tussin DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Geri-Care Pharmaceuticals, Corp | 7e2fb43c-a7f1-4c1d-a700-7c6510999c03 | 2025-06-05 | Warnings | M012 |
| CHILDRENS ROBITUSSIN COUGH AND COLD LONG-ACTING | CHLORPHENIRAMINE MALEATE, DEXTROMETRORPHAN HBR | Haleon US Holdings LLC | becb4025-b63e-f2ea-9d11-d51fdf4e5c13 | 2025-06-04 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2049223 | acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Capsule | PSN | 9a106291-edda-2135-e053-2995a90a44fd | 11 |
| 2049223 | acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SCD | 9a106291-edda-2135-e053-2995a90a44fd | 11 |
| 2049223 | APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule | SY | 9a106291-edda-2135-e053-2995a90a44fd | 11 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 37000-951-24 | 37000095124 | 2 BLISTER PACK in 1 CARTON (37000-951-24) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 2 blister pack | 2018-07-10 | 0000-00-00 | No | No | Current |