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 | 2026-10-16 | ||
| excluded package | package | 69423-976 | 69423-976-01 | D | Discontinued by firm | 2026-10-16 | |
| excluded package | package | 69423-976 | 69423-976-08 | D | Discontinued by firm | 2026-10-16 |
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 |
|---|---|---|---|---|---|---|
| COLD AND FLU DAYTIME-NIGHTTIME | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | TARGET CORP | 9de9fab3-890a-158d-e053-2a95a90af423 | 2025-09-13 | Warnings | M012 |
| Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | Precision Dose, Inc. | 4d0f4f5b-3135-4457-bb8f-ad9d28ca5ea4 | 2025-09-12 | Warnings | M012 |
| Nasal Spray, Circle K | OXYMETAZOLINE HYDROCHLORIDE 0.05% SOLUTION | Lil' Drug Store Products, Inc. | 3ea06e88-a2c6-621b-e063-6294a90a1075 | 2025-09-12 | Warnings | M012 |
| Daytime Nighttime Cold Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Harris Teeter, LLC | a0090dc6-0fe5-4ab2-a2cf-6ed19892f363 | 2025-09-12 | Warnings | M012 |
| Multi Symptom Cold and Multi Symptom Nighttime Cold Childrens | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCI | CVS Pharmacy | ebf2dbb4-96fa-4bf6-9afd-8aa8b5369f2e | 2025-09-12 | Warnings | M012 |
| Daytime Nighttime Cold Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | FSA Store Inc. (Caring Mills) | 8d7bb31b-a47d-4252-a0a7-79d286179fb9 | 2025-09-12 | Warnings | M012 |
| Daytime Nighttime Cold Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Family Dollar (FAMILY WELLNESS) | 150e5c3a-7c86-4b66-af30-a376df697401 | 2025-09-12 | Warnings | M012 |
| SEVERE COUGH COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 67f8d405-a2ad-4ade-93b4-9b09a0d81d8e | 2025-09-11 | Warnings | M012 |
| equate MAXIMUM STRENGTH DAYTIME SEVERE Cold and Flu SOFTGELS | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | WALMART INC. | 3862aaa5-2281-e8f9-e063-6294a90a0f7e | 2025-09-09 | Warnings | M012 |
| McKesson Sugar Free Cough Suppressant Oral Anesthetic | MENTHOL LOZENGE | McKesson Medical-Surgical | e0dfa6ca-b311-25cb-e053-2a95a90a12cc | 2025-09-09 | Warnings | M012 |
| Medique at Home Decorel Forte | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Unifirst First Aid Corporation | e648f017-9e30-df6c-e053-2995a90adcd0 | 2025-09-09 | Warnings | M012 |
| Medi-First Honey Lemon Cough Drops | MENTHOL 8.6 MG | Unifirst First Aid Corporation | 826e1b87-e5a9-8637-e053-2991aa0aded1 | 2025-09-09 | Warnings | M012 |
| Unishield Cherry Cough | MENTHOL | Unishield | b8297bc1-44b2-3de0-e053-2995a90ad01b | 2025-09-09 | Warnings | M012 |
| McKesson Cough Supressant | MENTHOL | McKesson Medical-Surgical | db5e0490-2ed8-2d53-e053-2a95a90a98f5 | 2025-09-09 | Warnings | M012 |
| Duratuss AC | CODEINE PHOSPHATE, DEXBROMPHENIRAMINE MALEATE | Poly Pharmaceuticals, Inc. | 3e5ed178-d5d9-b8d4-e063-6394a90a91db | 2025-09-09 | Warnings | M012 |
| Rompe Pecho CF | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Efficient Laboratories Inc | 96c4dee1-6e66-4442-a7e3-56e874414c17 | 2025-09-09 | Warnings | M012 |
| Nighttime Cold and Flu Lil Drug Store Products | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | Lil' Drug Store Products, Inc | 57c458ed-7987-453b-ab24-bbfa6580f920 | 2025-09-09 | Warnings | M012 |
| equate MAXIMUM STRENGTH NIGHTTIME SEVERE Cold and Flu SOFTGELS | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | WALMART INC. | 38637189-d1ee-9405-e063-6394a90ae8b8 | 2025-09-09 | Warnings | M012 |
| Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Walgreens | fd52d8d8-7cd1-4e92-86da-354a1d5213c2 | 2025-09-08 | Warnings | M012 |
| Green Guard Advanced Sinus Relief | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE | Unifirst First Aid Corporation | e8e5fb21-a7fd-44d1-b9c4-83e949699ca6 | 2025-09-08 | 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 |