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 | 2026-10-21 |
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 |
|---|---|---|---|---|---|---|
| McKesson Phenylephrine HCl | PHENYLEPHRINE HCL | McKesson Medical-Surgical | e09060f7-ca0b-5f7c-e053-2995a90ab344 | 2024-11-08 | Warnings | M012 |
| daytime severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | e0e216ef-300c-4f57-87e6-62a5327e09b4 | 2024-11-08 | Warnings | M012 |
| basic care daytime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Amazon.com Services LLC | 969c0718-ba6e-4edb-9f55-43bc9500450f | 2024-11-08 | Warnings | M012 |
| daytime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Walgreen Company | 62a70d9a-4e78-497c-8f75-012ab94e92f6 | 2024-11-08 | Warnings | M012 |
| adult tussin dm | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Publix Super Markets Inc | 25b2ad8a-5835-4496-815f-73a7fb40dcfd | 2024-11-08 | Warnings | M012 |
| severe cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Rite Aid Corporation | 296f20c0-8b5f-4a08-9329-f93c92e63867 | 2024-11-08 | Warnings | M012 |
| topcare tussin dm | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Topco Associates LLC | d3cae69e-41a5-4099-a3f4-ce25fd94df73 | 2024-11-08 | Warnings | M012 |
| foster and thrive daytime severe cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Strategic Sourcing Services LLC | 9d147d1e-8ea5-4e0f-8ae8-1da16f119496 | 2024-11-08 | Warnings | M012 |
| equate adult cough and chest congestion dm | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | WALMART INC. | e770bdb2-3662-4538-8199-fe4a4059c720 | 2024-11-08 | Warnings | M012 |
| DG Health Cold and Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Dolgencorp Inc | 23dcb627-c867-435f-9d1a-a9f49e58b58f | 2024-11-08 | Warnings | M012 |
| good neighbor pharmacy adult tussin DM | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Amerisource Bergen | ced71993-f535-4e28-bc1d-3fcb7d86e9b7 | 2024-11-08 | Warnings | M012 |
| adult tussin dm | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | CVS Pharmacy | 2f1dc8f8-79c5-4724-99aa-a55330ed9d5f | 2024-11-08 | Warnings | M012 |
| good sense day time cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | L. Perrigo Company | 4ac6b64a-8214-4b03-8aa5-0d3199cf0b72 | 2024-11-08 | Warnings | M012 |
| tussin | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | H E B | 1dd9afb6-9b58-4274-a557-900a0cb23524 | 2024-11-08 | Warnings | M012 |
| DG health sinus severe | OXYMETAZOLINE HYDROCHLORIDE | Dolgencorp, LLC | 7abaa912-be8b-463c-8818-104e79b33539 | 2024-11-07 | Warnings | M012 |
| Extra Strength TYLENOL Cold Plus Flu Multi-Action Day | ACETAMINOPHEN, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE | Kenvue Brands LLC | 7d3266dc-879a-4d28-b8ea-74d238c3020a | 2024-11-07 | Warnings | M012 |
| TYLENOL COLD PLUS FLU SEVERE DAY/NIGHT | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | 2ddb86a8-e34c-4a03-a60a-d3fedaf90608 | 2024-11-07 | Warnings | M012 |
| Tylenol Cold Plus Head Congestion Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | ce43e5c2-fe96-4462-882c-d7479318b33d | 2024-11-07 | Warnings | M012 |
| TYLENOL SINUS PLUS HEADACHE DAY | ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | e608d214-cc46-4a24-ac85-1040e36e7403 | 2024-11-07 | Warnings | M012 |
| Childrens TYLENOL COLD PLUS COUGH PLUS SORE THROAT | ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE | Kenvue Brands LLC | e83f7911-22b4-4ffc-8f49-68f6acd2ebf5 | 2024-11-07 | 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 |