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 | 2026-10-23 | ||
| excluded product | product | 37000-534 | D | Discontinued by firm | 2026-10-23 | ||
| excluded package | package | 37000-534 | 37000-534-24 | D | Discontinued by firm | 2026-10-23 | |
| excluded package | package | 37000-534 | 37000-534-48 | D | Discontinued by firm | 2026-10-23 |
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 |
|---|---|---|---|---|---|---|
| Daytime Nighttime Cold Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Care One (Retail Business Services, LLC.) | 90ccb29c-9967-46cb-a409-e440344e1a1a | 2025-10-15 | Warnings | M012 |
| Robitussin Childrens Honey Day Night DM Value Pack | DEXTROMETHORPHAN HBR, GUAIFENESIN, DOXYLAMINE SUCCINATE | Haleon US Holdings LLC | f9999875-3433-4052-a628-39539d373216 | 2025-10-15 | Warnings | M012 |
| Robitussin Day and Night Cough Relief Value Pack | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, CHLORPHENIRAMINE MALEATE | Haleon US Holdings LLC | 4029eccd-5443-4ae2-9232-2a1d922798f8 | 2025-10-15 | Warnings | M012 |
| EndaCof DM | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE | Larken Laboratories, Inc. | c68ea55a-8b9a-4a70-8b5c-1a2736651813 | 2025-10-15 | Warnings | M012 |
| DURATUSS DM | DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | Poly Pharmaceuticals, Inc. | 413a3951-d704-f14b-e063-6394a90a06dc | 2025-10-15 | Warnings | M012 |
| LoHist DM | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE | Larken Laboratories, Inc. | 29730dab-fa09-4351-9b36-0359ba4f7744 | 2025-10-15 | Warnings | M012 |
| M-END DMX | DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE | R. A. McNeil Company | ee1fae2e-3a21-4487-9989-c7620a4a7056 | 2025-10-15 | Warnings | M012 |
| Chlo Tuss | CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE | R.A. McNeil Company | 43610aaa-8b94-40d5-ae09-3d75bd2317c8 | 2025-10-15 | Warnings | M012 |
| Chlo Hist | CHLOPHEDIANOL HYDROCHLORIDE, DEXBROMPHENIRAMINE MALEATE | R. A. McNeil Company | d046f4ba-5753-4ed5-a924-0b66fd116781 | 2025-10-15 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Care One (Retail Business Services, LLC.) | 6ca7372b-50c4-4b15-b133-fefa35525ade | 2025-10-15 | Warnings | M012 |
| Extra Strength Sinus Relief Nasal Decongestant | PHENYLEPHRINE HYDROCHLORIDE | CARDINAL HEALTH | 0d8a009c-30b5-4f12-90bd-f8aa1110243f | 2025-10-14 | Warnings | M012 |
| Tussin DM Cough plus Chest Congestion | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | Cardinal Health 110, Inc. DBA LEADER | 9d11f443-c93d-44e8-b5a3-2677b7b11212 | 2025-10-14 | Warnings | M012 |
| Rompe Pecho SF | GUAIFENESIN | Efficient Laboratories, Inc. | 31ff48fc-9603-413c-ab7c-2598b3e08f9c | 2025-10-14 | Warnings | M012 |
| Rompe Pecho DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Efficient Laboratories Inc | d108c712-bc36-41d7-9ccd-720496b5599e | 2025-10-14 | Warnings | M012 |
| Rompe Pechito DM for Kids | DEXTROMETHORPHAN HBR, GUAIFENESIN | Efficient Laboratories Inc | 004d12e1-6e3d-84c8-e063-6394a90aa653 | 2025-10-14 | Warnings | M012 |
| VANACOF CP Allergy / Cough | CHLOPHEDIANOL HCL, PYRILAMINE MALEATE | GM Pharmaceuticals, INC | 0bdea30a-39da-6611-e063-6394a90aa4cf | 2025-10-14 | Warnings | M012 |
| VANACOF | CHLOPHEDIANOL HYDROCHLORIDE, DEXCHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HYDROCHLORIDE | GM Pharmaceuticals, INC | cf3886ab-62b3-497a-a587-18cbfbaf3634 | 2025-10-14 | Warnings | M012 |
| Sugar Free Cherry Fishermans Friend Menthol Cough Suppressant | MENTHOL | Lofthouse of Fleetwood, Ltd. | 42d4bafb-b630-487e-b63d-13ad37a59454 | 2025-10-14 | Warnings | M012 |
| SUPRESS A | DEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Dextrum Laboratories, Inc | 410c19f7-213d-cd99-e063-6294a90af5a3 | 2025-10-13 | Warnings | M012 |
| TexaClear Pain and Chest Congestion Relief | CHOLINE SALICYLATE,GUAIFENESIN | GM Pharmaceuticals, INC | 672bc78a-2c71-4135-b64a-2b8c40ac688c | 2025-10-13 | 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 |