nighttime
- Product NDC
- 59779-459
- 11-digit product format
- 597790459
- Labeler code
- 59779
- Product ID
- 59779-459_8de57c97-88c8-4808-94ff-27cb7dfd9f0c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- CVS Pharmacy
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2011-08-12
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
- Active strength
- 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL
- 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
- 2027-12-31
- Current FDA listing
- Yes
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 package | package | 59779-459 | 59779-459-30 | D | Discontinued by firm | 2026-10-20 | |
| excluded package | package | 59779-459 | 59779-459-34 | D | Discontinued by firm | 2026-10-20 | |
| excluded package | package | 59779-459 | 59779-459-38 | D | Discontinued by firm | 2026-10-20 | |
| excluded package | package | 59779-459 | 59779-459-50 | 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 | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | 59779-459-38 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 59779-459-30 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 59779-459-50 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 59779-459-34 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 59779-459-38 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 59779-459-30 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 59779-459-50 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 59779-459-34 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 59779-459-38 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 59779-459-30 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 59779-459-50 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 59779-459-38 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 59779-459-30 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 59779-459-50 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 59779-459-38 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 59779-459-30 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 59779-459-50 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 59779-459-38 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 59779-459-30 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 59779-459-50 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 59779-459-38 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 59779-459-30 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 59779-459-50 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 59779-459-38 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 59779-459-30 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 59779-459-50 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 59779-459-38 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 59779-459-30 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 59779-459-50 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 59779-459-38 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 59779-459-30 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 59779-459-50 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 59779-459-30 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 59779-459-38 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 59779-459-30 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 59779-459-38 | 557ba5c1ecfa… | 9c80585c8c6e… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- nighttime
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 650 mg/30mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 30 mg/30mL |
| DOXYLAMINE SUCCINATE | 12.5 mg/30mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
| V9BI9B5YI2 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1043400 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1c341cf5-ac33-4a6e-b023-a23d280d496c | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 59779-459-30 | nighttime | 177 mL in 1 BOTTLE | SOLUTION | 177 | 10 | |
| 59779-459-34 | nighttime | 237 mL in 1 BOTTLE | SOLUTION | 237 | 10 | |
| 59779-459-38 | nighttime | 295 mL in 1 BOTTLE | SOLUTION | 295 | 10 | |
| 59779-459-40 | nighttime | 355 mL in 1 BOTTLE | SOLUTION | 355 | 10 | |
| 59779-459-50 | nighttime | 355 mL in 1 BOTTLE | SOLUTION | 355 | 10 | |
| 59779-459-50 | nighttime | 2 in 1 PACKAGE | SOLUTION | 2 | 10 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 59779-459-34 | ML - Milliliter | 59779-459 | da64554e-5461-46f0-9f45-f214e9295964 | 1 | 2018-11-06 |
| 59779-459-40 | ML - Milliliter | 59779-459 | 86a3ea00-c6ce-48da-9553-b79c91e016bd | 1 | 2023-09-05 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Benadryl | DIPHENHYDRAMINE HYDROCHLORIDE | Morning Star OTC | f4ff84b3-bb0c-4900-8ba4-6d1b90394782 | 2025-06-09 | Warnings | M012 |
| Equate Kids Daytime Dex Cough Gels | DEXTROMETHORPHAN | Walmart | 37269cd6-1528-9879-e063-6394a90a2b54 | 2025-06-09 | Warnings | M012 |
| Nuvicare DayTime Cold and Flu Softgel | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | NUVICARE LLC | bdc35570-c8df-4797-a13e-7f2479ec42b7 | 2025-06-09 | Warnings | M012 |
| Nuvicare DayTime and NightTime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE | NUVICARE LLC | f5764925-c586-40e4-8252-24d92389af01 | 2025-06-09 | Warnings | M012 |
| Nuvicare NightTime Cold and Flu Softgel | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | NUVICARE LLC | 2a29f0ed-d86b-4787-84e0-f7a8c5e7581f | 2025-06-09 | Warnings | M012 |
| Nuvicare DayTime and NightTime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE | NUVICARE LLC | 7fa8e4ad-95cb-4905-90db-d53b3bc87c41 | 2025-06-09 | Warnings | M012 |
| Vaporizing Steam Liquid | MEDICATED COUGH SUPPRESSANT | NeilMed Pharmaceuticals Inc. | 36cf6218-adb8-9d8b-e063-6394a90a49a0 | 2025-06-05 | Warnings | M012 |
| Geri-Tussin DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Geri-Care Pharmaceuticals, Corp | 7e2fb43c-a7f1-4c1d-a700-7c6510999c03 | 2025-06-05 | Warnings | M012 |
| CHILDRENS ROBITUSSIN COUGH AND COLD LONG-ACTING | CHLORPHENIRAMINE MALEATE, DEXTROMETRORPHAN HBR | Haleon US Holdings LLC | becb4025-b63e-f2ea-9d11-d51fdf4e5c13 | 2025-06-04 | Warnings | M012 |
| Diphenhydramine HCL STRAWBERRY FLAVOR | DIPHENHYDRAMINE HCL | Innovida Pharmaeutique Corporation | 7eb709a5-c587-4f1d-bc2d-576d07a3a3bf | 2025-06-04 | Warnings | M012 |
| Children Allergy Relief Bubblegum flavor | DIPHENHYDRAMINE HCL | TARGET CORPORATION | 69d33f77-06e1-48fa-a516-892fdf11bb1c | 2025-06-03 | Warnings | M012 |
| oxymetazoline hydrochloride | OXYMETAZOLINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | fd058e2b-5445-e416-e053-6394a90a611b | 2025-06-03 | Warnings | M012 |
| Major Nasal Decongestant | OXYMETAZOLINE HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 36b1a7e0-c8b9-0890-e063-6394a90ab13a | 2025-06-03 | Warnings | M012 |
| COLD, FLU and SORE THROAT RELIEF | ACETAMINOPHEN 650 MG, DEXTROMETHORPHAN HBR 20 MG, GUAIFENESIN 400 MG, PHENYLEPHRINE HCL 10 MG | BETTER LIVING BRANDS, LLC | 202d60a8-83da-5afc-e063-6394a90ad779 | 2025-05-31 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | TARGET CORPORATION | f935341f-1e33-d78e-e053-6294a90a348e | 2025-05-30 | Warnings | M012 |
| Diphenhydramine HCl | DIPHENHYDRAMINE HCL | AARNA USA INC. | 365bb414-8425-a900-e063-6394a90aa887 | 2025-05-30 | Warnings | M012 |
| Childrens Allergy | DIPHENHYDRAMINE HYDROCHLORIDE | P & L Development, LLC | 8559be55-8b00-4353-8e26-b5dff2ada806 | 2025-05-30 | Warnings | M012 |
| Daytime Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Walmart Inc. | 35da8429-1f83-9e81-e063-6294a90a3515 | 2025-05-23 | Warnings | M012 |
| MAXIMUM STRENGTH COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | TARGET CORP | 9dfef3dc-dbc8-659a-e053-2995a90a8c3b | 2025-05-21 | Warnings | M012 |
| Adult Tussin | GUAIFENESIN | Camber Consumer Care | 896d2540-279a-4405-b176-acbff56303e5 | 2025-05-20 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution | PSN | 1c341cf5-ac33-4a6e-b023-a23d280d496c | 10 |
| 1043400 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SCD | 1c341cf5-ac33-4a6e-b023-a23d280d496c | 10 |
| 1043400 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution | SY | 1c341cf5-ac33-4a6e-b023-a23d280d496c | 10 |
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution | SY | 1c341cf5-ac33-4a6e-b023-a23d280d496c | 10 |
| 1043400 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SY | 1c341cf5-ac33-4a6e-b023-a23d280d496c | 10 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 59779-459-30 | 59779045930 | 177 mL in 1 BOTTLE (59779-459-30) | 177 ml | 2011-09-16 | 0000-00-00 | No | No | Current |
| 59779-459-34 | 59779045934 | 237 mL in 1 BOTTLE (59779-459-34) | 237 ml | 2012-07-05 | 0000-00-00 | No | No | Current |
| 59779-459-38 | 59779045938 | 295 mL in 1 BOTTLE (59779-459-38) | 295 ml | 2011-08-12 | 0000-00-00 | No | No | Current |
| 59779-459-40 | 59779045940 | 355 mL in 1 BOTTLE (59779-459-40) | 355 ml | 2011-08-19 | 0000-00-00 | No | No | Current |
| 59779-459-50 | 59779045950 | 2 BOTTLE in 1 PACKAGE (59779-459-50) > 355 mL in 1 BOTTLE (59779-459-40) | 2 bottle | 2011-08-19 | 0000-00-00 | No | No | Current |