Vicks NyQuil
- Product NDC
- 37000-557
- 11-digit product format
- 370000557
- Labeler code
- 37000
- Product ID
- 37000-557_eb543cb3-698d-3aa3-e053-2995a90ab9ac
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan Hydrobromide, and Doxylamine Succinate
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- The Procter & Gamble Manufacturing Company
- Application
- M012
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2011-06-09
- Marketing end
- 0000-00-00
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
- Active strength
- 325 mg/1; mg/1; mg/1
- Pharmacologic classes
- Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
- 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 | 37000-557 | D | Discontinued by firm | 2026-10-21 | ||
| excluded package | package | 37000-557 | 37000-557-02 | D | Discontinued by firm | 2026-10-21 | |
| excluded package | package | 37000-557 | 37000-557-08 | D | Discontinued by firm | 2026-10-21 | |
| excluded package | package | 37000-557 | 37000-557-16 | D | Discontinued by firm | 2026-10-21 | |
| excluded package | package | 37000-557 | 37000-557-24 | D | Discontinued by firm | 2026-10-21 | |
| excluded package | package | 37000-557 | 37000-557-48 | D | Discontinued by firm | 2026-10-21 | |
| excluded package | package | 37000-557 | 37000-557-72 | D | Discontinued by firm | 2026-10-21 |
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 | 37000-557-48 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 37000-557-02 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 37000-557-24 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 37000-557-08 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 37000-557-72 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 37000-557-16 | 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 | 37000-557-48 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 37000-557-02 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 37000-557-24 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 37000-557-08 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 37000-557-72 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 37000-557-16 | 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 | 37000-557-48 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 37000-557-02 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 37000-557-24 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 37000-557-08 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 37000-557-72 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 37000-557-16 | 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 | 37000-557-48 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 37000-557-02 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 37000-557-24 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 37000-557-08 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 37000-557-72 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 37000-557-16 | 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 | 37000-557-48 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 37000-557-02 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 37000-557-24 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 37000-557-08 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 37000-557-72 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 37000-557-16 | 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 | 37000-557-48 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 37000-557-02 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 37000-557-24 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 37000-557-08 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 37000-557-72 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 37000-557-16 | 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 | 37000-557-48 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 37000-557-02 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 37000-557-24 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 37000-557-08 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 37000-557-72 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 37000-557-16 | 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 | 37000-557-48 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 37000-557-02 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 37000-557-24 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 37000-557-08 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 37000-557-72 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 37000-557-16 | 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 | 37000-557-48 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 37000-557-02 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 37000-557-24 | 0efc9e666f02… | f202fb6c5f17… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bf324df6-7127-7deb-def5-2681c136cd03 | Product name | 3 | 20250325 |
| 59361619-24d9-b610-eca6-5a7f25ed5e03 | Product name | 5 | 20240909 |
| 43a1ed49-eae2-4840-8075-cb4b33478540 | Product name | 1 | 20230425 |
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| f4368033-af8c-41bf-a84b-ff77392b8522 | Product name | 1 | 20161229 |
| 76633df9-0d59-4b88-03ed-21dee1b966f8 | Product name | 1 | 20140508 |
DailyMed Socrata Ingredients#
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 |
|---|---|---|---|---|---|---|
| Berkley and Jensen Tussin DM Max | DEXTROMETHORPHAN HBR, GUAIFENESIN | BJWC | c15b97a8-968f-4d38-905e-863e9fd16ce6 | 2026-01-06 | Warnings | M012 |
| Complete Allergy Medicine | DIPHENHYDRAMINE HCL | Salado Sales, Inc. | c0f5c8ca-b187-40bf-9245-6a29f1c32c97 | 2026-01-06 | Warnings | M012 |
| Allergy Multi-Symptom | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | Cardinal Health 110, LLC. DBA Leader | c5776b1e-9f72-4a6a-9961-8ac8e05b3249 | 2026-01-06 | Warnings | M012 |
| Severe Congestion and Cough | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Family Dollar Services Inc | b9215a5e-3be8-44fd-9189-50dab760869c | 2026-01-06 | Warnings | M012 |
| Night Time Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Major Pharmaceuticals | f81efbf4-204b-45be-ae32-910d9e4ae4aa | 2026-01-06 | Warnings | M012 |
| SINUS AND NASAL DECONGESTANT | PSEUDOEPHEDRINE HYDROCHLORIDE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | d7646859-f996-46cd-a0b9-56b860f60901 | 2026-01-05 | Warnings | M012 |
| HyVee Cough Drops Honey Lemon | MENTHOL | HY-VEE, INC | 47a71cdf-856d-9ecd-e063-6294a90a70c6 | 2026-01-05 | Warnings | M012 |
| Guaifenesin | GUAIFENESIN | Oncor Pharmaceuticals | fd35036c-b722-48a3-85fd-60471beb6e74 | 2026-01-05 | Warnings | M012 |
| Diphenhydramine HCl | DIPHENHYDRAMINE HCL | NuCare Pharmaceuticals,Inc. | 3c323dc8-f734-b44c-e063-6394a90a6184 | 2026-01-05 | Warnings | M012 |
| Congestion and Cough Childrens | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | CVS PHARMACY | f43d97b1-aeb9-4ca5-8909-b28e7bf764f5 | 2026-01-05 | Warnings | M012 |
| Daytime Nighttime Cold Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | WinCo Foods, LLC | 6bd2b8fd-2023-413b-8988-a47d2058dc85 | 2026-01-05 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | WinCo Foods, LLC | 4c1046df-53a6-4219-83ac-bbf5cf4db9c8 | 2026-01-05 | Warnings | M012 |
| Night Time Cold and Flu Relief Multi Symptom | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | P & L Development, LLC | 80323208-9ba5-432b-a8a0-0c0b51e67145 | 2026-01-05 | Warnings | M012 |
| Sinus Pressure and Pain PE Maximum Strength | ACETAMINOPHEN AND PHENYLEPHRINE HCL | Rite Aid Corporation | 347868e4-0182-4e16-895c-ec269895c57c | 2026-01-02 | Warnings | M012 |
| HyVee Cough Drops Cherry | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | c5b11a9c-6d93-4772-93c2-1ef5c5647016 | 2026-01-02 | Warnings | M012 |
| HyVee Cough Drops Honey Lemon | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | fae96736-1453-42fe-8158-cde770b23165 | 2026-01-02 | Warnings | M012 |
| HyVee Cough Drops Menthol | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 8cac1229-8e8e-4d8c-9f18-c2cd0f6f50bd | 2026-01-02 | Warnings | M012 |
| Reliable-1 Tussin | GUAIFENESIN | RELIABLE 1 LABORATORIES LLC | 2a33ff82-49df-7aaa-e063-6294a90a1281 | 2026-01-02 | Warnings | M012 |
| Tussin DMMax | DEXTROMETHORPHAN HBR, GUAIFENESIN | RELIABLE 1 LABORATORIES LLC | c4bb2e12-e0f6-4cbf-ad24-cfad9326f7fa | 2026-01-02 | Warnings | M012 |
| Severe Sinus Pain and Congestion Daytime | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | CVS Pharmacy | 4af347ce-9745-4a5e-8ce9-e7c97a0a6cc7 | 2026-01-02 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1094549 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule | PSN | 620bc3dc-099b-40bd-be22-e4c3f9c8e09d | 1 |
| 1094549 | acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SCD | 620bc3dc-099b-40bd-be22-e4c3f9c8e09d | 1 |
| 1094549 | APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SY | 620bc3dc-099b-40bd-be22-e4c3f9c8e09d | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 37000-557-02 | 37000055702 | 2 CAPSULE, LIQUID FILLED in 1 POUCH (37000-557-02) | 2011-06-09 | 0000-00-00 | No | No | Current | |
| 37000-557-08 | 37000055708 | 4 BLISTER PACK in 1 CARTON (37000-557-08) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 4 blister pack | 2011-06-09 | 0000-00-00 | No | No | Current |
| 37000-557-16 | 37000055716 | 8 BLISTER PACK in 1 CARTON (37000-557-16) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 8 blister pack | 2011-06-09 | 0000-00-00 | No | No | Current |
| 37000-557-24 | 37000055724 | 12 BLISTER PACK in 1 CARTON (37000-557-24) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 12 blister pack | 2011-06-09 | 0000-00-00 | No | No | Current |
| 37000-557-48 | 37000055748 | 24 BLISTER PACK in 1 CARTON (37000-557-48) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 24 blister pack | 2011-06-09 | 0000-00-00 | No | No | Current |