Vicks DayQuil Severe Hot Remedy
- Product NDC
- 69423-976
- Requested package NDC
- 69423-976-01
- 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 package | package | 69423-976 | 69423-976-01 | D | Discontinued by firm | 2026-10-20 |
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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 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 |
|---|---|---|---|---|---|---|
| Alka-Seltzer Plus Multi-Symptom Cold and Flu Day and Night Liquid Gels | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Bayer HealthCare LLC. | 34b2e77f-5d04-15a7-e054-00144ff8d46c | 2025-01-17 | Warnings | M012 |
| Alka-Seltzer Plus Severe Cold PowerFast Fizz Orange Zest | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | a23a6db6-4585-2882-e053-2a95a90ab01a | 2025-01-17 | Warnings | M012 |
| Alka-Seltzer Plus Severe Cold Night PowerFast Fizz | ASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | fc754dff-cecd-fc6b-e053-6394a90ab371 | 2025-01-17 | Warnings | M012 |
| Kroger DayTime Cold and Flu SOFTGEL | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | The Kroger Co. | 2499210b-c162-76b9-e063-6294a90adbc3 | 2025-01-17 | Warnings | M012 |
| Childrens Multi Symptom Cold Very Berry | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | CVS | 2a849ae9-338f-4642-e063-6394a90a1ca4 | 2025-01-17 | Warnings | M012 |
| Kroger NightTime Cold and Flu SOFTGEL | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | The Kroger Co. | 24a73de3-e9eb-4cd4-e063-6394a90aa263 | 2025-01-17 | Warnings | M012 |
| Diphenhydramine HCl Oral Solution | DIPHENHYDRAMINE HCL ORAL | Everpharm LLC | d7aaf874-69ac-49cf-93be-6d4a38b9a557 | 2025-01-16 | Warnings | M012 |
| Cough Relief | DEXTROMETHORPHAN HBR | Best Choice (Valu Merchandisers Company) | 204a7fc4-142d-45fd-8a77-0612857132be | 2025-01-16 | Warnings | M012 |
| daytime cold and flu nighttime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE | Meijer, Inc. | df31056b-d0eb-4094-98d9-3d444210d50d | 2025-01-16 | Warnings | M012 |
| Childrens Ibuprofen Oral Suspension | IBUPROFEN | Reliable 1 Laboratories LLC | 28dd9baa-43bd-b60a-e063-6394a90a8cf7 | 2025-01-15 | Warnings | M012 |
| Guaifenesin | GUAIFENESIN | Reliable 1 Laboratories LLC | ae469d4f-91c4-cff0-e053-2995a90a0497 | 2025-01-15 | Warnings | M012 |
| Diphenhydramine HCL 25 mg | DIPHENHYDRAMINE HCL | Reliable 1 Laboratories LLC | 32f58cb3-941f-263b-e054-00144ff8d46c | 2025-01-15 | Warnings | M012 |
| Diphenhydramine HCl 25 mg | DIPHENHYDRAMINE HCL | Reliable 1 Laboratories LLC | 32fa40ad-fed5-586f-e054-00144ff88e88 | 2025-01-15 | Warnings | M012 |
| CVS Health Chest Congestion and Cough HBP SOFTGEL | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | CVS Pharmacy, Inc | 2741ba44-1cc7-1812-e063-6394a90a8faa | 2025-01-14 | Warnings | M012 |
| DAY COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | TARGET CORPORATION | 2b941963-8a8c-4148-e063-6294a90a1dfb | 2025-01-13 | Warnings | M012 |
| Diphenhydramine HCL | DIPHENHYDRAMINE HCL | SDA Laboratories, Inc. | 437e6a13-a4ff-4f98-8973-042f224ee85e | 2025-01-13 | Warnings | M012 |
| Diphenhydramine HCL | DIPHENHYDRAMINE HCL | SDA Laboratories, Inc. | 6a520986-1004-4ee6-9a47-1dfd90bb1b2c | 2025-01-13 | Warnings | M012 |
| good sense daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | L. Perrigo Company | 5ddf3283-94e4-465d-842a-471ee946c330 | 2025-01-10 | Warnings | M012 |
| Vicks VapoSteam | CAMPHOR (SYNTHETIC) | Kaz USA, Inc | c28da455-07ad-4053-8b9e-fc559f9a3f72 | 2025-01-10 | Warnings | M012 |
| Guaifenesin 200mg | GUAIFENESIN | Aphena Pharma Solutions - Tennessee, LLC | 45ac210a-8c54-4469-8e10-e6fe52b89cb5 | 2025-01-09 | 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 |