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 | 2026-10-12 | ||
| excluded package | package | 69423-976 | 69423-976-01 | D | Discontinued by firm | 2026-10-12 | |
| excluded package | package | 69423-976 | 69423-976-08 | D | Discontinued by firm | 2026-10-12 |
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 |
|---|---|---|---|---|---|---|
| Allergy Relief | DIPHENHYDRAMINE HCL | WinCo Foods, LLC | 2cbf27b6-217c-46d8-89c9-e46f3668f002 | 2026-07-17 | Warnings | M012 |
| Best Choice | OXYMETAZOLINE HYDROCHLORIDE | BEST CHOICE (VALU MERCHANDISERS COMPANY) | d86d53cd-75ce-4c40-83cb-ada9b77a76f6 | 2026-07-17 | Warnings | M012 |
| LEADER Multi Symptom Flu Relief Daytime Max Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | CARDINAL HEALTH 110, LLC. DBA LEADER | 2212cf9e-6944-4922-b5b5-1373cf10b2e1 | 2026-07-16 | Warnings | M012 |
| Cold and Flu HBP | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE | CVS PHARMACY | 06756130-1608-4ae6-9772-95a4549853a1 | 2026-07-16 | Warnings | M012 |
| Medicated Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Old East Main Co. | 7855033e-6a12-4cd8-b0a2-c5d69018d117 | 2026-07-16 | Warnings, Adverse reactions | M012 |
| Oxymetazoline Hydrochloride 12-Hour | OXYMETAZOLINE HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | 34a79f8b-32b7-48db-a895-c942cc795292 | 2026-07-16 | Warnings | M012 |
| LoHist D | CHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCL | Larken Laboratories, Inc. | 93c9ad4f-3376-48c2-8276-0375663acd01 | 2026-07-16 | Warnings | M012 |
| Sanatos | MENTHOL | Pharmadel LLC | 522e1e7f-98ed-c475-e063-6294a90a622c | 2026-07-16 | Warnings | M012 |
| LEADER MS Flu Relief Nighttime | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND DEXTROMETHOPHAN HBR | CARDINAL HEALTH 110, LLC. DBA LEADER | 9db7d4e2-f7c1-41a7-8e1c-ef8d3512259d | 2026-07-16 | Warnings | M012 |
| NIGHTTIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Amazon.com Services LLC | 1bf4cd96-5800-434d-a0dc-e84c759ebb33 | 2026-07-16 | Warnings | M012 |
| Mucus Relief Cough Childrens | DEXTROMETHORPHAN HBR, GUAIFENSIN | Walgreens | 2ace231a-94c4-479d-bb26-454bd07b207b | 2026-07-16 | Warnings | M012 |
| LEADER No Drip | ALLERGY SINUS NASAL MIST | CARDINAL HEALTH 110, LLC. DBA LEADER | e7b2c1c1-6250-4af3-b131-22aced2b23d5 | 2026-07-16 | Warnings | M012 |
| Mucus Relief DM Cough | DEXTROMETHORPHAN HBR, GUAIFENESIN | Amerisource Bergen | 639a59b7-ccff-485e-a232-38b680827229 | 2026-07-16 | Warnings | M012 |
| Equate Nighttime Vapor Ice Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | WALMART INC. | 30470a01-4d42-44c6-a017-d68bb74cdef7 | 2026-07-15 | Warnings | M012 |
| Quality Choice Effervescent Cold Relief - Plus | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | Chain Drug Marketing Association | 1f93fe6d-ee21-e323-e063-6394a90a61bf | 2026-07-15 | Warnings | M012 |
| Pentrexcilina Daytime | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | OPMX LLC | b7b3c15a-bb28-5c25-e053-2a95a90ad3b1 | 2026-07-15 | Warnings | M012 |
| Quality Choice Effervescent Cold Relief - Orange | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | Chain Drug Marketing Association | 1f93c815-63c7-bfe0-e063-6394a90ab4a5 | 2026-07-15 | Warnings | M012 |
| Nighttime Severe Cold and Flu Maximum Strength mini softgels | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Shield Pharmaceuticals Corp | 5fa848ef-35ee-4e05-8ff2-781d034cf6ac | 2026-07-14 | Warnings | M012 |
| Cough and Cold HBP | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Cardinal Health 110, LLC. DBA Leader | 0fad61d8-4393-47ec-9ff6-7df5be761f5b | 2026-07-14 | Warnings | M012 |
| Sinus and Allergy Relief PE | CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL | Rite Aid Corporation | 211c4273-3b2c-4169-b9c6-7a87903e77cd | 2026-07-13 | 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 |