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 | L.N.K. International, Inc. | db264d2f-bf81-4da2-8595-2bfa1e4ba2f1 | 2026-05-18 | Warnings | M012 |
| equate nighttime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Wal-Mart Stores Inc | b8fc9b0e-8ab7-46e6-9fd9-18f8d4a14b5c | 2026-05-15 | Warnings | M012 |
| good neighbor pharmacy cold and cough | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Amerisource Bergen | da91e6b6-32ff-44fd-afce-33ea9549554b | 2026-05-15 | Warnings | M012 |
| Antihistamine | DIPHENHYDRAMINE HCL | Gendose Pharmaceuticals, LLC | 847cdee8-410f-4ff3-9245-976ed6f4c776 | 2026-05-15 | Warnings | M012 |
| Antihistamine | DIPHENHYDRAMINE HCL | Gendose Pharmaceuticals, LLC | d3b2f300-d919-44cd-ab71-b74b5bdfd977 | 2026-05-15 | Warnings | M012 |
| ONESSIP DAY TIME KIDS COLD AND COUGH PLUS FEVER | ACETAMINOPHEN 325 MG AND DEXTROMETHORPHAN HBR 10 MG ORAL LIQUID DAY TIME KIDS | MEDWISE LIFESCIENCES INC. | 51d52ce4-98c4-2b9b-e063-6294a90ade44 | 2026-05-15 | Warnings | M012 |
| Curewell Tussin DM | DEXTROMETHORPHAN, GUAIFENESIN | RMT HEALTH LLC | 4fe9ad93-cdc4-b4df-e063-6294a90a90ae | 2026-05-15 | Warnings | M012 |
| CounterAct Cough Drops Orchard Cherry | MENTHOL | Melaleuca, Inc. | 6049842c-d763-4a91-a225-976ed74e1693 | 2026-05-15 | Warnings | M012 |
| CounterAct Cough Drops Honey Lemon | MENTHOL | Melaleuca, Inc. | 84ac3489-9d64-401f-ab78-715af4de5440 | 2026-05-15 | Warnings | M012 |
| ALKA SELTZER COLD Cold Flu and Congestion Maximum Strength Day Night Fast Gels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE | Bayer HealthCare LLC. | 51e03b5b-b05a-07c1-e063-6394a90ab201 | 2026-05-15 | Warnings | M012 |
| Sinus Congestion and Pain Relief Non-Drowsy/Daytime | ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL | Rite Aid Corporation | 38d73a1e-ac78-4f67-9291-bb48ab80306e | 2026-05-15 | Warnings | M012 |
| Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | WALMART INC. | 071615ba-f50a-4d2a-a358-43140bccce72 | 2026-05-14 | Warnings | M012 |
| Severe Cold and Flu Nighttime Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | HyVee Inc | d4bcfabb-a054-4f53-8dc9-d361a03558b8 | 2026-05-14 | Warnings | M012 |
| Cough and Chest Congestion DM Adult | DEXTROMETHORPHAN HBR, GUAIFENESIN | CVS Pharmacy | 4444c05a-eba6-4633-b86f-34f455699fa9 | 2026-05-14 | Warnings | M012 |
| Topcare Day Time Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Topco Associates LLC | a88e5b8e-e6dd-4a1c-9628-5861d3205bdb | 2026-05-14 | Warnings | M012 |
| equate daytime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Wal-Mart Stores Inc | 69b24c67-cf4b-46d7-a44b-d1917cc876b1 | 2026-05-14 | Warnings | M012 |
| GILTUSS DIABETIC EX | GILTUSS DIABETIC EX | Gil Pharmaceutical Corp | ab7915e7-323a-4fe1-887a-a3bd3f0aac98 | 2026-05-13 | Warnings | M012 |
| Giltuss EX Maximum Strength Expectorant | GILTUSS EX MAXIMUM STRENGTH EXPECTORANT | Gil Pharmaceutical Corp | 950db1ca-6936-47f8-a112-e3594d4c922c | 2026-05-13 | Warnings | M012 |
| Giltuss EX Expectorant | GILTUSS EX EXPECTORANT | Gil Pharmaceutical Corp | 3b363fb9-c4d3-446f-927c-f705ffc715b5 | 2026-05-13 | Warnings | M012 |
| Giltuss HBP EX Expectorant | GILTUSS HBP EX EXPECTORANT | Gil Pharmaceutical Corp | 31bd6356-27cf-4188-8fd5-9cd9392021ca | 2026-05-13 | 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 |