Vicks NyQuil Severe Hot Remedy
- Product NDC
- 58933-541
- 11-digit product format
- 589330541
- Labeler code
- 58933
- Product ID
- 58933-541_e7043a0e-81e2-a290-e053-2a95a90a72eb
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride
- Dosage form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Labeler
- Procter & Gamble Manufactura S de RL de CV
- Application
- M012
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2022-07-20
- Marketing end
- 0000-00-00
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 650 mg/5g; mg/5g; mg/5g; mg/5g
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 58933-541 | D | Discontinued by firm | 2026-10-27 | ||
| excluded package | package | 58933-541 | 58933-541-01 | D | Discontinued by firm | 2026-10-27 | |
| excluded package | package | 58933-541 | 58933-541-08 | D | Discontinued by firm | 2026-10-27 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 58933-541-08 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 58933-541-01 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 58933-541-08 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 58933-541-01 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 58933-541-08 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 58933-541-01 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 58933-541-08 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 58933-541-01 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 58933-541-08 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 58933-541-01 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 58933-541-08 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 58933-541-01 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 58933-541-08 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 58933-541-01 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 58933-541-08 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 58933-541-01 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 58933-541-08 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 58933-541-01 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 58933-541-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 58933-541-01 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 58933-541-08 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 58933-541-01 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 58933-541-08 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 58933-541-01 | 557ba5c1ecfa… | 9c80585c8c6e… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
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 | OXYMETAZOLINE HYDROCHLORIDE | Topco Associates LLC | f1dd78e0-f700-4469-85d6-18cc299e8746 | 2024-08-28 | Warnings | M012 |
| equaline nasal | OXYMETAZOLINE HCL | United Natural Foods, Inc. dba UNFI | 69308693-a094-42a9-a041-e73647a25cc1 | 2024-08-27 | Warnings | M012 |
| signature care nasal decongestant | OXYMETAZOLINE HYDROCHLORIDE | Safeway | f9ac80d1-3753-412b-a407-18a6b50e5d1c | 2024-08-27 | Warnings | M012 |
| Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu PowerMax Gels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE | Bayer HealthCare LLC. | 20ac6010-84f4-eeff-e063-6294a90a50a7 | 2024-08-27 | Warnings | M012 |
| Exchange Select Nasal | OXYMETAZOLINE HCL | Army & Air Force Exchange Service | 40d2090d-c332-4dcb-9f43-5ee467e7b3d1 | 2024-08-27 | Warnings | M012 |
| Signature Care Nasal Decongestant | OXYMETAZOLINE HCL | Safeway | 23f0a5b3-59ae-4eb3-9b7d-e6a492060337 | 2024-08-27 | Warnings | M012 |
| DG Health Nasal | OXYMETAZOLINE HYDROCHLORIDE | Dolgencorp, LLC | debcda99-c605-4941-b873-9e4dbae27483 | 2024-08-27 | Warnings | M012 |
| Good Neighbor Pharmacy Nasal | OXYMETAZOLINE HCL | Amerisource Bergen | d374d697-2b57-4558-a20b-d3d89aea82d7 | 2024-08-27 | Warnings | M012 |
| nasal | OXYMETAZOLINE HCL | Meijer Distribution Inc | 3984cbc3-b60c-40a7-bc3a-7d1f600503ac | 2024-08-27 | Warnings | M012 |
| foster and thrive nasal | OXYMETAZOLINE HYDROCHLORIDE | Strategic Sourcing Services LLC | e6e51821-03ae-4ec3-82a9-b4a8feacd996 | 2024-08-27 | Warnings | M012 |
| Pyrilamine Maleate and Dextromethorphan Hydrobromide | PYRILAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDE | Westminster Pharmaceuticals, LLC | dd068449-9d24-41e6-8a6e-f69c9fe263f2 | 2024-08-26 | Warnings | M012 |
| basic care nasal | OXYMETAZOLINE HYDROCHLORIDE | Amazon.com Services LLC | a154e500-2b45-4242-a26c-9530849f99df | 2024-08-23 | Warnings | M012 |
| Daytime Nighttime Ultra Concentrated Cold and Flu | DAYTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, PHENYLEPHRINE HCL AND NIGHTTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATE | TARGET CORPORATION | 0c0cf76f-2dd3-45ef-e063-6394a90a9fef | 2024-08-22 | Warnings | M012 |
| Day Cold and Flu and Night Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCL | TARGET CORPORATION | 08ee56d1-b11d-3e36-e063-6294a90acd5f | 2024-08-22 | Warnings | M012 |
| Maximum Strength Daytime Cold and Flu and Nighttime Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE,TRIPROLIDINE HYDROCHLORIDE | TARGET CORPORATION | 0fc523ce-55a7-6384-e063-6394a90aad3f | 2024-08-22 | Warnings | M012 |
| Cold and Flu Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Walgreens | 8045aef9-22bc-4146-b494-dbb1ffef06df | 2024-08-19 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION, INC. | 5a2053d4-9c0d-4613-9cf5-0067173f3730 | 2024-08-16 | Warnings | M012 |
| QUALITY CHOICE Long Acting Cough Softgel | DEXTROMETHORPHAN HYDROBROMIDE | Chain Drug Marketing Association, Inc. | f1ea7dfc-c605-45a1-ad1d-6e636a8a7b1c | 2024-08-16 | Warnings | M012 |
| pseudoephedrine hydrochloride | PSEUDOEPHEDRINE HCL | Padagis Israel Pharmaceuticals Ltd | 458594e1-8d99-4de3-8923-2fd8ce2fc406 | 2024-08-16 | Warnings | M012 |
| Halls Sugar Free Mountain Menthol | MENTHOL | Mondelez Global LLC | 54e0d57e-1f48-45e2-86b3-0e50775996f4 | 2024-08-15 | Warnings | M012 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 58933-541-01 | 58933054101 | 5 g in 1 PACKET (58933-541-01) | 5 g | 2022-07-20 | 0000-00-00 | No | No | Current |
| 58933-541-08 | 58933054108 | 8 PACKET in 1 PACKAGE (58933-541-08) > 5 g in 1 PACKET | 8 packet | 2022-07-20 | 0000-00-00 | No | No | Current |