Vicks DayQuil Severe Hot Remedy
- Product NDC
- 69423-976
- 11-digit product format
- 694230976
- Labeler code
- 69423
- Product ID
- 69423-976_e703d760-1653-73eb-e053-2995a90ad173
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan hydrobromide, Guaifenesin and phenylephrine hydrochloride
- Dosage form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Labeler
- The Procter & Gamble Manufacturing Company
- Application
- M012
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2022-06-22
- 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 | 69423-976 | D | Discontinued by firm | 2026-10-12 | ||
| excluded package | package | 69423-976 | 69423-976-01 | D | Discontinued by firm | 2026-10-12 | |
| excluded package | package | 69423-976 | 69423-976-08 | D | Discontinued by firm | 2026-10-12 |
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 | 69423-976-01 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 69423-976-08 | 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 | 69423-976-01 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 69423-976-08 | 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 | 69423-976-01 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 69423-976-08 | 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 | 69423-976-01 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 69423-976-08 | 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 | 69423-976-01 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 69423-976-08 | 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 | 69423-976-01 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 69423-976-08 | 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 | 69423-976-01 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 69423-976-08 | 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 | 69423-976-01 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 69423-976-08 | 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 | 69423-976-01 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 69423-976-08 | 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 | 69423-976-01 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 69423-976-08 | 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 | 69423-976-01 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 69423-976-08 | 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 | 69423-976-01 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 69423-976-08 | 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 |
|---|---|---|---|---|---|---|
| Vicks Sinex Severe Original | OXYMETAZOLINE HYDROCHLORIDE | Procter & Gamble Manufacturing GmbH | cfd048c9-2f33-101d-e053-2995a90ad854 | 2026-04-22 | Warnings | M012 |
| Vicks Sinex SEVERE VapoCOOL ULTRA FINE MIST | OXYMETAZOLINE HYDROCHLORIDE | Procter & Gamble Manufacturing GmbH | d0768332-7c24-7c30-e053-2a95a90a26d4 | 2026-04-22 | Warnings | M012 |
| Histanaz | PSEUDOEPHEDRINE HCL, PYRILAMINE MALEATE | Capital Pharmaceutical, LLC | 3e87d0f3-f16c-5972-e063-6294a90acc8a | 2026-04-22 | Warnings | M012 |
| Good Sense Severe Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | L. Perrigo Company | d5faf89f-3641-4be1-8d43-35504f12fe8d | 2026-04-22 | Warnings | M012 |
| Multi-Symptom Cold childrens | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | WALMART INC. | 5ee5eb75-fc56-42a1-bf2c-b9c10ea8bfd4 | 2026-04-22 | Warnings | M012 |
| good sense nasal | OXYMETAZOLINE HYDROCHLORIDE | L. Perrigo Company | 95f23049-e523-4c59-904c-b8e9ae82602c | 2026-04-22 | Warnings | M012 |
| Mucinex Childrens FreeFrom Multi-Symptom Cold and Stuffy Nose | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | c07dad99-87b0-419b-9230-7c22a77ecf9e | 2026-04-21 | Warnings | M012 |
| Cough and Cold HBP | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Valu Merchandisers Company | 83db90da-9155-4f6a-8209-44c87d14b696 | 2026-04-21 | Warnings | M012 |
| Pain, Headache and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 613a2516-fc61-4bb4-bd44-ca6004548193 | 2026-04-21 | Warnings | M012 |
| Dr. Simi Allergy Relief | DIPHENHYDRAMINE HCL | Farmacias De Similares TX LLC | 4fe8bbe3-13c9-5458-e063-6294a90a9064 | 2026-04-20 | Warnings | M012 |
| Cold and Flu Day and Night, Severe | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | ARMY AND AIR FORCE EXCHANGE SERVICE | 58d722ef-db67-44ac-a295-dd10e1f5ca1d | 2026-04-20 | Warnings | M012 |
| Loratadine 10mg | LORATADINE | BETTER LIVING BRANDS, LLC | 46d615dd-45d5-2dfc-e063-6394a90a5d42 | 2026-04-18 | Warnings | M012 |
| Multi-Symptom Cold Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Valu Merchandisers Company | d0f896a6-5637-45ef-bf60-b343cbcdcf7e | 2026-04-17 | Warnings | M012 |
| MUCUS RELIEF | GUAIFENESIN | Bryant Ranch Prepack | 9ed5611f-4e1d-4f71-b430-a2a949bf7fe5 | 2026-04-17 | Warnings | M012 |
| Multi-Symptom Cold | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Valu Merchandisers Company | bf3158af-89ab-4b7c-9f39-0f316fbe9056 | 2026-04-17 | Warnings | M012 |
| MUCUS RELIEF | GUAIFENESIN | Bryant Ranch Prepack | 761825bc-f835-4947-bfa0-2940f1dff5fb | 2026-04-17 | Warnings | M012 |
| equate cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | WALMART INC. | e83d14cc-9b90-40ce-a00a-2702d8a8968f | 2026-04-17 | Warnings | M012 |
| Childrens Allergy Relief | DIPHENHYDRAMINE HCL | Walgreen Company | 0b34b5a3-98a2-4096-9d95-071bb5a63c86 | 2026-04-17 | Warnings | M012 |
| Mucus Relief | GUAIFENESIN | Walgreen Company | 1cd69ede-29c6-4216-95b7-b58fc96c084b | 2026-04-16 | Warnings | M012 |
| Sinus Severe | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | Valu Merchandisers Company | cdcb8e0d-7847-4f28-bb09-7dc7b5d35c13 | 2026-04-16 | Warnings | M012 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 69423-976-01 | 69423097601 | 5 g in 1 PACKET (69423-976-01) | 5 g | 2022-07-20 | 0000-00-00 | No | No | Current |
| 69423-976-08 | 69423097608 | 8 PACKET in 1 PACKAGE (69423-976-08) > 5 g in 1 PACKET | 8 packet | 2022-07-20 | 0000-00-00 | No | No | Current |