DayQuil and Nyquil Severe plus Vicks VapoCool
- Product NDC
- 37000-534
- 11-digit product format
- 370000534
- Labeler code
- 37000
- Product ID
- 37000-534_f171fa6b-ef91-6b5d-e053-2a95a90a9249
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Phenylephrine Hydrochloride, and Doxylamine Succinate
- Dosage form
- KIT
- Labeler
- The Procter & Gamble Manufacturing Company
- Application
- M012
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2018-08-01
- Marketing end
- 2024-07-07
- Active strength
- 0
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- 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 | 37000-534 | D | Discontinued by firm | 2026-10-16 | ||
| excluded product | product | 37000-534 | D | Discontinued by firm | 2026-10-16 | ||
| excluded package | package | 37000-534 | 37000-534-24 | D | Discontinued by firm | 2026-10-16 | |
| excluded package | package | 37000-534 | 37000-534-48 | D | Discontinued by firm | 2026-10-16 |
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 | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 37000-534-24 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 37000-534-48 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 37000-534-24 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 37000-534-48 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 37000-534-24 | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 37000-534-48 | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 37000-534-24 | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 37000-534-48 | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 37000-534-24 | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 37000-534-48 | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | D | Discontinued by firm | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | D | Discontinued by firm | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 37000-534-24 | D | Discontinued by firm | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 37000-534-48 | D | Discontinued by firm | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | D | Discontinued by firm | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | D | Discontinued by firm | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 37000-534-24 | D | Discontinued by firm | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 37000-534-48 | D | Discontinued by firm | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | D | Discontinued by firm | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | D | Discontinued by firm | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 37000-534-24 | D | Discontinued by firm | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 37000-534-48 | D | Discontinued by firm | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | D | Discontinued by firm | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | D | Discontinued by firm | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 37000-534-24 | D | Discontinued by firm | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 37000-534-48 | D | Discontinued by firm | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | D | Discontinued by firm | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | D | Discontinued by firm | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 37000-534-24 | D | Discontinued by firm | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 37000-534-48 | D | Discontinued by firm | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | D | Discontinued by firm | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | D | Discontinued by firm | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 37000-534-24 | D | Discontinued by firm | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 37000-534-48 | D | Discontinued by firm | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | D | Discontinued by firm | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | D | Discontinued by firm | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 37000-534-24 | D | Discontinued by firm | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 37000-534-48 | D | Discontinued by firm | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 37000-534-48 | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 37000-534-48 | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 37000-534-48 | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 37000-534-48 | 2023-03-09 | C162847 | 48780-1 | d6a99b39-860c-a426-e053-dadaa90af4c2 | DayQuil & Nyquil Severe + Vicks VapoCool Cold & Flu Caplets 48 ct Convenience Pack |
| 37000-534-48 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-860c-a426-e053-dadaa90af4c2 | DayQuil & Nyquil Severe + Vicks VapoCool Cold & Flu Caplets 48 ct Convenience Pack |
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 |
|---|---|---|---|---|---|---|
| Vicks Sinex Severe Original | OXYMETAZOLINE HYDROCHLORIDE | Procter & Gamble Manufacturing GmbH | cfd048c9-2f33-101d-e053-2995a90ad854 | 2026-04-22 | Warnings | M012 |
| Vicks Sinex SEVERE VapoCOOL ULTRA FINE MIST | OXYMETAZOLINE HYDROCHLORIDE | Procter & Gamble Manufacturing GmbH | d0768332-7c24-7c30-e053-2a95a90a26d4 | 2026-04-22 | Warnings | M012 |
| Histanaz | PSEUDOEPHEDRINE HCL, PYRILAMINE MALEATE | Capital Pharmaceutical, LLC | 3e87d0f3-f16c-5972-e063-6294a90acc8a | 2026-04-22 | Warnings | M012 |
| Good Sense Severe Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | L. Perrigo Company | d5faf89f-3641-4be1-8d43-35504f12fe8d | 2026-04-22 | Warnings | M012 |
| Multi-Symptom Cold childrens | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | WALMART INC. | 5ee5eb75-fc56-42a1-bf2c-b9c10ea8bfd4 | 2026-04-22 | Warnings | M012 |
| good sense nasal | OXYMETAZOLINE HYDROCHLORIDE | L. Perrigo Company | 95f23049-e523-4c59-904c-b8e9ae82602c | 2026-04-22 | Warnings | M012 |
| Mucinex Childrens FreeFrom Multi-Symptom Cold and Stuffy Nose | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | c07dad99-87b0-419b-9230-7c22a77ecf9e | 2026-04-21 | Warnings | M012 |
| Cough and Cold HBP | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Valu Merchandisers Company | 83db90da-9155-4f6a-8209-44c87d14b696 | 2026-04-21 | Warnings | M012 |
| Pain, Headache and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 613a2516-fc61-4bb4-bd44-ca6004548193 | 2026-04-21 | Warnings | M012 |
| Dr. Simi Allergy Relief | DIPHENHYDRAMINE HCL | Farmacias De Similares TX LLC | 4fe8bbe3-13c9-5458-e063-6294a90a9064 | 2026-04-20 | Warnings | M012 |
| Cold and Flu Day and Night, Severe | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | ARMY AND AIR FORCE EXCHANGE SERVICE | 58d722ef-db67-44ac-a295-dd10e1f5ca1d | 2026-04-20 | Warnings | M012 |
| Loratadine 10mg | LORATADINE | BETTER LIVING BRANDS, LLC | 46d615dd-45d5-2dfc-e063-6394a90a5d42 | 2026-04-18 | Warnings | M012 |
| Multi-Symptom Cold Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Valu Merchandisers Company | d0f896a6-5637-45ef-bf60-b343cbcdcf7e | 2026-04-17 | Warnings | M012 |
| MUCUS RELIEF | GUAIFENESIN | Bryant Ranch Prepack | 9ed5611f-4e1d-4f71-b430-a2a949bf7fe5 | 2026-04-17 | Warnings | M012 |
| Multi-Symptom Cold | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Valu Merchandisers Company | bf3158af-89ab-4b7c-9f39-0f316fbe9056 | 2026-04-17 | Warnings | M012 |
| MUCUS RELIEF | GUAIFENESIN | Bryant Ranch Prepack | 761825bc-f835-4947-bfa0-2940f1dff5fb | 2026-04-17 | Warnings | M012 |
| equate cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | WALMART INC. | e83d14cc-9b90-40ce-a00a-2702d8a8968f | 2026-04-17 | Warnings | M012 |
| Childrens Allergy Relief | DIPHENHYDRAMINE HCL | Walgreen Company | 0b34b5a3-98a2-4096-9d95-071bb5a63c86 | 2026-04-17 | Warnings | M012 |
| Mucus Relief | GUAIFENESIN | Walgreen Company | 1cd69ede-29c6-4216-95b7-b58fc96c084b | 2026-04-16 | Warnings | M012 |
| Sinus Severe | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | Valu Merchandisers Company | cdcb8e0d-7847-4f28-bb09-7dc7b5d35c13 | 2026-04-16 | Warnings | M012 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 37000-534-24 | 37000053424 | 1 KIT in 1 PACKAGE (37000-534-24) * 1 TABLET in 1 BLISTER PACK * 1 TABLET, COATED in 1 BLISTER PACK | 1 kit | 2018-08-01 | 0000-00-00 | No | No | Current |
| 37000-534-48 | 37000053448 | 1 KIT in 1 PACKAGE (37000-534-48) * 2 TABLET in 1 BLISTER PACK * 2 TABLET, COATED in 1 BLISTER PACK | 1 kit | 2018-08-01 | 0000-00-00 | No | No | Current |