Vicks DayQuil Severe
- Product NDC
- 69423-967
- 11-digit product format
- 694230967
- Labeler code
- 69423
- Product ID
- 69423-967_eed9f977-14c3-70bb-e053-2a95a90a1ecf
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- Procter & Gamble Manufacturing Company
- Application
- M012
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2021-07-07
- Marketing end
- 0000-00-00
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 325 mg/15mL; mg/15mL; mg/15mL; mg/15mL
- 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 | 69423-967 | D | Discontinued by firm | 2026-10-20 | ||
| excluded package | package | 69423-967 | 69423-967-12 | 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 | 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 | 69423-967-12 | 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 | 69423-967-12 | 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 | 69423-967-12 | 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 | 69423-967-12 | 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 | 69423-967-12 | 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 | 69423-967-12 | 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 | 69423-967-12 | 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 | 69423-967-12 | 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 | 69423-967-12 | 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 | 69423-967-12 | ad56d346431e… | cc804d4bbf1e… |
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 |
|---|---|---|---|---|---|---|
| G-Supress DX | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | KRAMER NOVIS | 5dd44337-f3aa-4e73-a206-4a29850a2f7c | 2025-11-12 | Warnings | M012 |
| Allergy Relief Complete | DIPHENHYDRAMINE HCL | WinCo Foods, LLC | 15b3de6c-7ccc-408b-8789-d0e2f21a8835 | 2025-11-12 | Warnings | M012 |
| PRESGEN PEDIATRIC | GUAIFENESIN, PHENYLEPHRINE HCL,DEXTROMETHORPHAN HYDROBROMIDE | KRAMER NOVIS | 12fb91e5-6059-4b3a-a2de-762aa51a25b7 | 2025-11-12 | Warnings | M012 |
| Sorbugen | DEXTROMETHORPHAN HYDROBROMIDE, GLYCEROL GUAIACOLATE | Kramer Novis | a8f2a2d7-0360-45a8-9635-c852f4a7d7ba | 2025-11-12 | Warnings | M012 |
| DESGEN DM | DEXTROMETHORPHAN HBR ,GUAIFENESIN ,PHENYLEPHRINE HCL | Kramer Novis | 6ab47174-e1fd-47ce-8788-06b7cdad5218 | 2025-11-12 | Warnings | M012 |
| Presgen | GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE | Kramer Novis | edad7a86-0d27-4a98-85b2-4b6725904f28 | 2025-11-12 | Warnings | M012 |
| TUSSI PRES PEDIATRIC | GUAIFENESIN, PHENYLEPHRINE HCL,DEXTROMETHORPHAN HYDROBROMIDE | KRAMER NOVIS | b01a45df-3cea-4729-80c1-7f35b7f707f0 | 2025-11-12 | Warnings | M012 |
| TUSICOF | DEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINE | Kramer Novis | e966b75c-4bb4-4216-8247-baada8f5d759 | 2025-11-12 | Warnings | M012 |
| Fast Acting Mucus Relief Maximum Strength Severe Cough and Congestion | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 52327ed0-ea49-4d1c-b928-20ab381be9f2 | 2025-11-11 | Warnings | M012 |
| TOPCO Childrens Cough Relief | DEXTROMETHORPHAN HBR AND GUAIFENESIN | Topco Associates, LLC | ee0f5627-5104-4990-88ee-2fb46965bc1e | 2025-11-11 | Warnings | M012 |
| TOPCARE Childrens Cold and Cough and Runny Nose | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE | Topco Associates, LLC | 8931d4ca-c599-49be-87e1-8c0598f38b77 | 2025-11-11 | Warnings | M012 |
| TOPCARE Multi Symptom Flu Relief Combo Pack | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Topco Associates, LLC | 01c517e5-d693-4926-9eb5-4b894a2f6917 | 2025-11-11 | Warnings | M012 |
| Tylenol Sinus Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Navajo Manufacturing Company Inc. | 435b4a2a-d6bf-ec25-e063-6294a90a3f06 | 2025-11-11 | Warnings | M012 |
| TYLENOL Cold Plus Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Navajo Manufacturing Company Inc. | 435e6387-1ee0-c20f-e063-6294a90adac5 | 2025-11-11 | Warnings | M012 |
| Buscapina | ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE | OPMX LLC | 10b09674-d6bd-41cd-b92c-b5b6a0fd2f5b | 2025-11-10 | Warnings | M012 |
| TOPCARE Childrens Allergy Chews | DIPHENHYDRAMINE HCL | Topco Associates, LLC | b5e15dd1-6e99-411c-9183-8a4265eae404 | 2025-11-08 | Warnings | M012 |
| Severe Sinus Congestion and Pain | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE | Shield Pharmaceuticals Corp | 103de130-ef12-4c58-bbcf-234b3f3b2cbf | 2025-11-08 | Warnings | M012 |
| Cough Drops Dollar General Strawberry 30ct | MENTHOL | Dollar General Corporation | 2b3fbab9-92b5-42a7-b27b-ff46350ce055 | 2025-11-07 | Warnings | M012 |
| Robitussin Day and Night Maximum Strength Cough DM | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE | Haleon US Holdings LLC | b43d8fbd-1977-4465-aa64-79e7b7f54e09 | 2025-11-07 | Warnings | M012 |
| Allergy plus Sinus Headache | ACETAMINOPHEN 325 MG, DIPHENHYDRAMINE HCL 12.5 MG, PHENYLEPHRINE HCL 5 MG | Shield Pharmaceuticals Corp | 093649a4-f968-49bd-83af-bb7e0f448ecf | 2025-11-07 | Warnings | M012 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 69423-967-08 | 69423096708 | 236 mL in 1 BOTTLE, PLASTIC (69423-967-08) | 236 ml | 2021-07-07 | 0000-00-00 | No | No | Current |
| 69423-967-12 | 69423096712 | 354 mL in 1 BOTTLE, PLASTIC (69423-967-12) | 354 ml | 2021-07-07 | 0000-00-00 | No | No | Current |