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 |
|---|---|---|---|---|---|---|
| Poly-Vent IR | GUAIFENESIN AND PSEUDOEPHEDRINE HCL | Poly Pharmaceuticals, Inc. | ce0d8c45-446a-4df4-a36b-5000ba69d30d | 2024-11-09 | Warnings | M012 |
| basic care tussin dm | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Amazon.com Services LLC | 306d5914-03ed-410a-9345-c54ba604e991 | 2024-11-09 | Warnings | M012 |
| care one nasal original | OXYMETAZOLINE HYDROCHLORIDE | American Sales Company | a0c35e06-c9e9-438e-8224-d4760b6e2aff | 2024-11-09 | Warnings | M012 |
| adult tussin dm | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Walgreen Company | 34174507-cf2e-4ed4-85ec-f915d4b910df | 2024-11-08 | Warnings | M012 |
| Childrens Benadryl Chewables | DIPHENHYDRAMINE HYDROCHLORIDE | Kenvue Brands LLC | b08f71d8-a06c-41ba-8ed1-fbc41dbc1919 | 2024-11-08 | Warnings | M012 |
| SUDAFED PE SINUS CONGESTION | DIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | a38fdfb8-db89-487f-9b68-aa9152b91f5f | 2024-11-08 | Warnings | M012 |
| SUDAFED Sinus Congestion | PSEUDOEPHEDRINE HYDROCHLORIDE | Kenvue Brands LLC | c05d7e27-6821-468f-b27d-9c0b02a07b0f | 2024-11-08 | Warnings | M012 |
| Benadryl | DIPHENHYDRAMINE HYDROCHLORIDE | Kenvue Brands LLC | 2884d2dc-2d4a-4ca6-ab73-688a80b428eb | 2024-11-08 | Warnings | M012 |
| Extra Strength TYLENOL Cold plus Flu Multi-Action Day/Night | ACETAMINOPHEN, PSEUDOEPHEDRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, AND CHLORPHENIRAMINE MALEATE | Kenvue Brands LLC | 712ba011-79aa-469b-9f0f-04a0b4b705bd | 2024-11-08 | Warnings | M012 |
| SUDAFED PE Pressure Plus Pain | ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | 8538c291-9ce9-4866-b268-f4cbdb52f5bd | 2024-11-08 | Warnings | M012 |
| Childrens Sudafed Nasal Decongestant | PSEUDOEPHEDRINE HYDROCHLORIDE | Kenvue Brands LLC | 52e9307b-ad38-4f65-bb2f-4fa262e82010 | 2024-11-08 | Warnings | M012 |
| Benadryl Allergy Plus Congestion | DIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | 685b51d3-cc25-47b2-ac8a-368924f43137 | 2024-11-08 | Warnings | M012 |
| Sudafed PE Sinus Pressure Plus Pain | ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | 60183922-bfd3-4377-884a-51b2f0a4c93a | 2024-11-08 | Warnings | M012 |
| Sudafed PE Sinus Congestion | PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | 2ca08917-1a75-4365-8520-c083e6a4225a | 2024-11-08 | Warnings | M012 |
| SUDAFED PE Head Congestion Plus Mucus | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | f0739186-41b9-4761-adf7-08101b30a18e | 2024-11-08 | Warnings | M012 |
| SUDAFED PE Head Congestion Plus Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | 1e528f78-0ced-4a06-935a-84056c921727 | 2024-11-08 | Warnings | M012 |
| TYLENOL Cold Plus Flu Severe and TYLENOL COLD MAX CoPack | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | 657a1e59-104c-4152-b2c9-00a8b82dc78e | 2024-11-08 | Warnings | M012 |
| Tylenol Cold plus Flu Severe and Tylenol Cold Max | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | 47c61858-72ce-409b-a3af-a63620cf7d13 | 2024-11-08 | Warnings | M012 |
| Childrens Benadryl Allergy Plus Congestion | DIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | b8b75904-3806-4258-89c1-d6ff486ed41c | 2024-11-08 | Warnings | M012 |
| Tylenol Cold Plus Flu Severe Day and Tylenol Cold Plus Flu Plus Cough Night 3-Pack | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | 464de5de-0e7a-41d6-875f-dd0e5fe7893c | 2024-11-08 | 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 |