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 | 2026-10-15 | ||
| excluded package | package | 69423-976 | 69423-976-01 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 69423-976 | 69423-976-08 | D | Discontinued by firm | 2026-10-15 |
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 |
|---|---|---|---|---|---|---|
| Zicam Extreme Congestion Relief | OXYMETAZOLINE HYDROCHLORIDE | Church & Dwight Co., Inc. | ccada339-656c-a461-e053-2a95a90a3479 | 2025-12-31 | Warnings | M012 |
| ED A-HIST DM | DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE | EDWARDS PHARMACEUTICALS, INC. | e0e2b117-62bc-4132-9f7c-fe2a912052b1 | 2025-12-31 | Warnings | M012 |
| Bio-Z-Cough | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Advanced Generic Corporation | 05e70eab-1467-4b09-991e-ef03f222e021 | 2025-12-31 | Warnings | M012 |
| Altipres-B | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Alternative Pharmacal Corporation | fd00c41d-0580-4177-afaa-60bb12ca5a09 | 2025-12-31 | Warnings | M012 |
| Ninjacof-D | CHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE | Centurion Labs, LLC | 5188aa20-41f1-4998-81e1-f4de055874bc | 2025-12-31 | Warnings | M012 |
| Llorens Care Tussin DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Llorens Pharmaceutical International Division, Inc. | 4743e562-1217-50ab-e063-6394a90af88d | 2025-12-31 | Warnings | M012 |
| Llorens Care Tussin | GUAIFENESIN | Llorens Pharmaceutical International Division, Inc. | 474459c1-bfd7-dec7-e063-6394a90ac18d | 2025-12-31 | Warnings | M012 |
| Geri Care Tussin CF Max | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN | GERI-CARE PHARMACEUTICAL CORP | 4744669c-7f33-e35f-e063-6394a90a79b7 | 2025-12-31 | Warnings | M012 |
| Geri-Tussin | GUAIFENESIN | Geri-Care Pharmaceuticals, Corp | 65545ca3-4e93-4b59-9e17-4742e086e8e7 | 2025-12-31 | Warnings | M012 |
| GeriCare Tussin DM Max | DEXTROMETHORPHAN HBR, GUAIFENESIN | GERI-CARE PHARMACEUTICALS, CORP | 47451cd8-7aab-90e2-e063-6394a90ad1b7 | 2025-12-31 | Warnings | M012 |
| Curewell Tussin | GUAIFENESIN | RMT HEALTH LLC | 47455587-5074-e70d-e063-6294a90a78bb | 2025-12-31 | Warnings | M012 |
| Menthol Cough Drops | MENTHOL | Bestco Inc. | 77e25027-3c96-21fa-e053-2991aa0a1f31 | 2025-12-31 | Warnings | M012 |
| Puregen Labs Allergy Relief | DIPHENHYDRAMINE HCL | Advanced Rx LLC | 4745d4f9-bbdf-a4a6-e063-6294a90a15b2 | 2025-12-31 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION | 2a46ea9b-29e9-5197-e063-6394a90abc73 | 2025-12-31 | Warnings | M012 |
| Cherry Cough Drops | MENTHOL | Bestco Inc. | 77e50410-306d-b2fb-e053-2a91aa0af3c5 | 2025-12-31 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION | e086a6d2-f664-454e-9524-f656bfbf45df | 2025-12-31 | Warnings | M012 |
| Cherry Cough Drops | MENTHOL | Bestco Inc. | 77f45efb-8ee0-1186-e053-2991aa0a9884 | 2025-12-31 | Warnings | M012 |
| Conex Pediatric | DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCL | Llorens Pharmaceutical International Division | 2a46af43-ef36-e14e-e063-6394a90a8285 | 2025-12-31 | Warnings | M012 |
| Conex | DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCL | Llorens Pharmaceutical International Division | 2a343656-ac6d-8b20-e063-6294a90ab319 | 2025-12-31 | Warnings | M012 |
| Dologesic NF | ACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATE | Llorens Pharmaceutical International Division | 974fc0d5-7a99-46fb-af38-b91240f728fa | 2025-12-31 | 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 |