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
- 2026-12-31
- 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 | 2026-10-12 | |
| excluded package | package | 59779-459 | 59779-459-34 | D | Discontinued by firm | 2026-10-12 | |
| excluded package | package | 59779-459 | 59779-459-38 | D | Discontinued by firm | 2026-10-12 | |
| excluded package | package | 59779-459 | 59779-459-50 | D | Discontinued by firm | 2026-10-12 |
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
- 2026-12-31
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 |
|---|---|---|---|---|---|---|
| CVS Childrens Cold and Allergy | BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | CVS PHARMACY, INC. | f4020c08-29f6-4609-834e-191ce6885130 | 2026-08-14 | Warnings | M012 |
| CVS Severe Cough, Flu Plus Sore Throat Honey | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | CVS PHARMACY | 95203001-7ca6-4513-83a3-9ef17855bc0f | 2026-08-14 | Warnings | M012 |
| Daytime Cold and Flu Relief | ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | CVS PHARMACY | 81d26e9c-b713-4fb3-b0a5-68526bad230e | 2026-08-14 | Warnings | M012 |
| nighttime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Amazon.com Services LLC | 212acd54-6ff0-446a-a3bb-3b40e1279711 | 2026-08-13 | Warnings | M012 |
| Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Walgreen Company | e9d0b6f9-e9f3-431c-9f34-4d63108282a1 | 2026-08-13 | Warnings | M012 |
| Best Health Caramel Apple Cough Drops | MENTHOL | Bestco | 58eee9b4-d696-995f-e063-6294a90a5db0 | 2026-08-13 | Warnings | M012 |
| Best Health Pumpkin Spice Cough Drops | MENTHOL | Bestco | 58ef6619-9087-5f41-e063-6294a90a7da6 | 2026-08-13 | Warnings | M012 |
| Best Health Bourbon Honey Cough Drops | MENTHOL | Bestco | 58efdf29-83ea-03b9-e063-6294a90ad306 | 2026-08-13 | Warnings | M012 |
| daytime nighttime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL | Amazon.com Services LLC | 9bb6bbd5-508e-4781-ad1c-69ccf0a5f13e | 2026-08-13 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Amazon.com Services LLC | 1e3c81b0-05de-4c4a-8579-f301f14626b3 | 2026-08-13 | Warnings | M012 |
| Tussin DM Daytime Nighttime | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | d59f6c64-8311-48ba-90d1-8000b04bfcda | 2026-08-13 | Warnings | M012 |
| TYLENOL COLD PLUS FLU MULTI-SYMPTOM GELS DAY PLUS NIGHT | ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Kenvue Brands LLC | 1c5578e6-7e67-c467-e063-6294a90a6e0b | 2026-08-12 | Warnings | M012 |
| Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Amazon.com Services LLC | f95220c5-e55c-4271-a267-d004ad2447bf | 2026-08-12 | Warnings | M012 |
| CVS PHARMACY Childrens Allergy Chews | DIPHENHYDRAMINE HCL | CVS PHARMACY, INC. | 569b8efa-8458-49f7-a665-6b7016a10505 | 2026-08-12 | Warnings | M012 |
| CVS PHARMACY DYE FREE Childrens Allergy Chews | DIPHENHYDRAMINE HCL | CVS PHARMACY, INC. | e6671e8b-653a-4f4e-b6f3-e31fcd14fbd7 | 2026-08-12 | Warnings | M012 |
| Cold and Flu Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | af35c833-316a-4d21-bd3a-9b71558cadbf | 2026-08-12 | Warnings | M012 |
| Tussin DM Max | DEXTROMETHORPHAN HBR, GUAIFENESIN | Wal-Mart Stores Inc | cc77f3a6-48ce-41b5-bf4e-5ed7d8c69e2c | 2026-08-11 | Warnings | M012 |
| Best Health Maple Spice Cough Drops | MENTHOL | Bestco | 58cfdacb-c713-220f-e063-6394a90acbfc | 2026-08-11 | Warnings | M012 |
| 7 Select Maximum Strength | DEXTROMETHORPHAN HBR, GUAIFENESIN | 7-ELEVEN | f9475972-0cbb-45c5-9e49-09569f1665a7 | 2026-08-11 | Warnings | M012 |
| Allergy Relief Childrens | DIPHENHYDRAMINE HCL | L.N.K. International, Inc. | 6ec5445b-a1f2-47ba-99f7-5a4a6d0c29e3 | 2026-08-10 | 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 |