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 | 2026-10-20 | ||
| excluded product | product | 37000-534 | D | Discontinued by firm | 2026-10-20 | ||
| excluded package | package | 37000-534 | 37000-534-24 | D | Discontinued by firm | 2026-10-20 | |
| excluded package | package | 37000-534 | 37000-534-48 | D | Discontinued by firm | 2026-10-20 |
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 |
|---|---|---|---|---|---|---|
| ALKA SELTZER COLD Cold and Flu Severe Day Night Fast Dissolve | ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATE | Bayer HealthCare LLC. | 50762d7c-5efd-4f83-e063-6294a90abf7f | 2026-04-27 | Warnings | M012 |
| Cold and Flu Nighttime Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | L.N.K. International, Inc. | 6427b418-89d1-4eac-b25b-0adfefc204fc | 2026-04-27 | Warnings | M012 |
| Nighttime Sleep Aid | DIPHENHYDRAMINE HCL | Care One (American Sales Company) | bd5de3b3-7cb5-4403-b664-23ac70b9957f | 2026-04-27 | Warnings | M012 |
| Leader Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Cardinal Health 110, LLC. dba Leader | 333c7042-95b8-4d98-9df1-4287017afa36 | 2026-04-25 | Warnings | M012 |
| foster and thrive nasal | OXYMETAZOLINE HYDROCHLORIDE | Sportpharm LLC | f2d55d1b-c3d4-4c35-b761-681ed50273bd | 2026-04-24 | Warnings | M012 |
| Geri-Dryl allergy relief | DIPHENHYDRAMINE HCL | Sportpharm LLC | 2c4e0d5e-958d-4274-876a-52126c795c0f | 2026-04-24 | Warnings | M012 |
| ALKA SELTZER COLD Cold and Headache Maximum Strength Fast Dissolve | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | 50364a42-3333-51fe-e063-6394a90ab71e | 2026-04-24 | Warnings | M012 |
| ALKA SELTZER COLD Cold Flu Severe Fast Dissolve | CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Bayer HealthCare LLC. | 5036dc50-e95b-ea8d-e063-6394a90a6cfe | 2026-04-24 | Warnings | M012 |
| Cold and Flu Daytime Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | dcb33d5f-87fa-4043-9b6d-36adec96796c | 2026-04-24 | Warnings | M012 |
| Diphenhydramine HCl | DIPHENHYDRAMINE HCL | Cardinal Health 107, LLC | abc0e348-8532-4658-bd8c-d7dbe5a28c7d | 2026-04-23 | Warnings | M012 |
| nitetime severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Publix Super Markets Inc | c5535aaf-c029-48d8-97d1-105a49b5fd95 | 2026-04-23 | Warnings | M012 |
| ALKA SELTZER COLD Cold and Cough Maximum Strength Fast Dissolve | ASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE | Bayer Healthcare LLC. | 50228b3c-d54a-485d-e063-6394a90a4403 | 2026-04-23 | Warnings | M012 |
| ALKA SELTZER COLD Cold and Flu Severe Fast Chewables | CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Bayer HealthCare LLC. | 5025a333-6378-bf59-e063-6394a90af4f0 | 2026-04-23 | Warnings | M012 |
| POLY-HIST DM | DEXCHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HBR | POLY PHARMACEUTICALS, INC. | 5025c99f-b946-e2e0-e063-6394a90a13fb | 2026-04-23 | Warnings | M012 |
| ALKA SELTZER COLD Cold and Allergy Maximum Strength Fast Gels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 5026611c-93e7-8f90-e063-6394a90a7baa | 2026-04-23 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | DOLGENCORP, LLC | c9c1db0f-6ba4-433c-b0ce-e99e9351c0b0 | 2026-04-23 | Warnings | M012 |
| Severe Cold and Flu Plus Congestion | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL | COSTCO WHOLESALE CORPORATION | 5180abbc-c6c4-4b82-b6e7-4504e3bcff0f | 2026-04-23 | Warnings | M012 |
| Severe Cold and Flu Night time | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | HyVee Inc | 4f963491-e1f0-494d-acb6-5f4d2b267d4a | 2026-04-22 | Warnings | M012 |
| Vicks Sinex SEVERE MOISTURIZING ULTRA FINE MIST | OXYMETAZOLINE HYDROCHLORIDE | Procter & Gamble Manufacturing GmbH | f4b01827-7444-3bfc-e053-2a95a90aebed | 2026-04-22 | Warnings | M012 |
| Vicks Sinex SEVERE ORIGINAL ULTRA FINE MIST | OXYMETAZOLINE HYDROCHLORIDE | Procter & Gamble Manufacturing GmbH, | cfd43b8f-8064-6b88-e053-2a95a90a329e | 2026-04-22 | 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 |