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 | 2026-10-15 | |
| excluded package | package | 59779-459 | 59779-459-34 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 59779-459 | 59779-459-38 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 59779-459 | 59779-459-50 | D | Discontinued by firm | 2026-10-15 |
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 |
|---|---|---|---|---|---|---|
| Dologesic DF | ACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATE | Llorens Pharmaceutical International Division | 55768b45-fd98-4779-85b6-6a50c628677e | 2025-12-31 | Warnings | M012 |
| Triponel | DEXTROMETHORPHAN HBR, PSEUFOEPHEDRINE HCL, TRIPROLIDINE HCL | Llorens Pharmaceutical International Division, Inc. | e9a8deb4-0595-4f0f-ac15-f936f15aca88 | 2025-12-31 | Warnings | M012 |
| Tusnel | DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL | Llorens Pharmaceutical International Division | 805dc611-355a-4af5-bf19-464c3290c5c6 | 2025-12-31 | Warnings | M012 |
| Tusnel Pediatric | DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL | Llorens Pharmaceutical International Division | 82f447f6-4f1b-4f56-9d7d-ea02adeea88c | 2025-12-31 | Warnings | M012 |
| Triponel | DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCL | LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION | cc774d33-96ce-4992-ad30-3cb03b0d119d | 2025-12-31 | Warnings | M012 |
| Tusnel SF | DEXTROMETHORPHAN HBR, GUAIFENESIN | Llorens Pharmaceutical International Division, Inc. | cb43b4df-5ccc-416e-abcd-98f079b3f2bb | 2025-12-31 | Warnings | M012 |
| Tusnel Cough Suppressant Expectorant | DEXTROMETHORPHAN HBR, GUAIFENESIN | Llorens Pharmaceutical International Division, Inc. | af71cdbc-33d6-4303-b494-d7321721d3be | 2025-12-31 | Warnings | M012 |
| Tusnel Pediatric DM | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Llorens Pharmaceutical International Division, Inc. | 63541753-de8d-42fe-a9b3-a5eac3fcdca4 | 2025-12-31 | Warnings | M012 |
| Tusnel Pediatric Drops | GUAIFENESIN, PHENYLEPHRINE HCL | LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION | dbf7c43a-7b29-4c70-9e6d-8a7ea924a9d7 | 2025-12-31 | Warnings | M012 |
| Tusnel DM Pediatric | DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL | Llorens Pharmaceutical International Division | d915eab8-013e-4ce3-b358-0d531e5ca1ba | 2025-12-31 | Warnings | M012 |
| Tusnel-DM Pediatric | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION | 64e36b02-b5be-4d20-8818-cb5b23596671 | 2025-12-31 | Warnings | M012 |
| Honey Lemon Cough Drops | MENTHOL | Bestco Inc. | 77f89a64-f4a4-f909-e053-2a91aa0ad44d | 2025-12-31 | Warnings | M012 |
| Honey Lemon Cough Drops | MENTHOL | Bestco Inc. | 77f65f59-7ea1-adce-e053-2991aa0a6f1f | 2025-12-31 | Warnings | M012 |
| Sugar Free Honey Lemon Cough Drops | MENTHOL | Bestco Inc. | 77f9e176-d87a-beed-e053-2991aa0aac20 | 2025-12-31 | Warnings | M012 |
| Sugar Free Cherry Cough Drops | MENTHOL | Bestco Inc. | 7858f380-bef7-3d30-e053-2a91aa0a7ea6 | 2025-12-31 | Warnings | M012 |
| Strawberry Cough Drops | MENTHOL | BestCo Inc. | 26a22cfd-395b-4ffb-e054-00144ff88e88 | 2025-12-31 | Warnings | M012 |
| Limpia Pecho | DEXTROMETHORPHAN HBR, GUAIFENESIN | Llorens Pharmaceutical International Division, Inc. | cbaea3e4-4c4b-4ff9-ae6f-95b6a2d3faf3 | 2025-12-31 | Warnings | M012 |
| Cherry Sore Throat Lozenges | BENZOCAINE | Bestco Inc. | 737efd41-2d59-6013-e053-2a91aa0a6c63 | 2025-12-31 | Warnings | M012 |
| Best Health Menthol Cough Drops | MENTHOL | Bestco LLC | dda66a3c-9006-ff1a-e053-2a95a90abfb3 | 2025-12-31 | Warnings | M012 |
| Rynex DM | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Edwards Pharmaceuticals, Inc | 7be2c282-24ba-4f19-9b14-872d3f5746a7 | 2025-12-31 | 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 |