NIGHTTIME COUGH DM
- Product NDC
- 51316-791
- 11-digit product format
- 513160791
- Labeler code
- 51316
- Product ID
- 51316-791_97e8504a-79e5-490f-8ae5-af970491af33
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Dextromethorphan Hydrobromide, Doxylamine Succinate
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-06-24
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
- Active strength
- 30; 12.5 mg/20mL; mg/20mL
- 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
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 COUGH DM
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 30 mg/20mL |
| DOXYLAMINE SUCCINATE | 12.5 mg/20mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9D2RTI9KYH | Internal UNII lookup |
| V9BI9B5YI2 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1115329 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 646f65f4-b9e4-4291-aadc-d2070848d35c | Available on FDA.report |
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 |
|---|---|---|---|---|---|---|
| DayQuil Cold and Flu w/VapoCOOL, 4ct (PE-free), BSX | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE TABLET, COATED | Lil' Drug Store Products, Inc. | 37c55543-e05e-2f7c-e063-6394a90a4534 | 2025-06-20 | Warnings | M012 |
| Exchange Select Cough Drops Honey Lemon Sugar-Free | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 38049d29-f47e-9478-e063-6294a90aa2a4 | 2025-06-20 | Warnings | M012 |
| Exchange Select Cough Drops Menthol Sugar Free | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 3804a271-9a11-848d-e063-6394a90af87d | 2025-06-20 | Warnings | M012 |
| Exchange Select Cough Drops Menthol Sugar Free | MENTHOL | Army & Air Force Exchange Service | 3805ef07-247d-0df7-e063-6394a90ac45b | 2025-06-20 | Warnings | M012 |
| Exchange Select Cough Drop Black Cherry Sugar Free | MENTHOL | Army & Air Force Exchange Service | 3805f8f5-562f-0ba8-e063-6394a90ac9d9 | 2025-06-20 | Warnings | M012 |
| Exchange Select Cough Drops Honey Lemon Sugar-Free | MENTHOL | Army & Air Force Exchange Service | 3805f90e-bd89-128d-e063-6394a90afa01 | 2025-06-20 | Warnings | M012 |
| TARGET Multi Symptom Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | TARGET CORPORATION | aebe3c15-53ef-46ea-af39-8c9b8114595f | 2025-06-20 | Warnings | M012 |
| TYLENOL Cold Plus Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Morning Star OTC | be95332d-a2e0-42e8-bfb3-8850d74990ff | 2025-06-19 | Warnings | M012 |
| Tylenol Sinus Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Morning Star OTC | 37e939c6-064b-3548-e063-6294a90a337d | 2025-06-19 | Warnings | M012 |
| Capron DM | DEXTROMETHORPHAN HBR AND PYRILAMINE MALEATE | Capital Pharmaceutical, LLC | cf778c5f-475e-4a86-a87c-2be1e665f5a5 | 2025-06-18 | Warnings | M012 |
| Cough Out | GUAIFENESIN | Efficient Laboratories Inc. | fe4c3921-8d30-4cd6-ba90-9211b362a38a | 2025-06-18 | Warnings | M012 |
| Guaifenesin STRAWBERRY-BANANA FLAVOR | GUAIFENESIN | Innovida Pharmaeutique Corporation | 1006906e-d6d7-4f49-92bf-3cb2d2cdbb16 | 2025-06-18 | Warnings | M012 |
| Mucinex Sinus Max Clear and Cool | ACETAMINOPHEN AND GUAIFENESIN | RB Health (US) LLC | 37de813a-54b7-672a-e063-6294a90a374e | 2025-06-18 | Warnings | M012 |
| childrens cold cough | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 4a1aeb41-a8fa-4116-8068-e11acd608e58 | 2025-06-18 | Warnings | M012 |
| NyQuil Cold and Flu w/VapoCOOL, 4ct, Travel BASIX | ACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HYDROBROMIDE TABLET, COATED | Lil' Drug Store Products, Inc. | 37c768f5-dabd-22d0-e063-6394a90af9e5 | 2025-06-17 | Warnings | M012 |
| DISCOUNT DRUG MART Childrens Allergy Chewable | DIPHENHYDRAMINE HCL | DISCOUNT DRUG MART | 51de95da-e8e8-48f0-9fa4-6191aa4a247b | 2025-06-16 | Warnings | M012 |
| Halls Cherry | MENTHOL | Mondelez Global LLC | 5f4af8e8-8550-45c7-a199-694efac9e7be | 2025-06-16 | Warnings | M012 |
| Halls Honey Lemon | MENTHOL | Mondelez Global LLC | 25eaae85-d516-40da-a472-70736ea2b75d | 2025-06-16 | Warnings | M012 |
| Halls Cherry | MENTHOL | Mondelez Global LLC | bad89968-22a7-4287-a57c-9e6206e574fe | 2025-06-16 | Warnings | M012 |
| Herbal Throat Drops | LEMON MINT HERBAL | Meijer, Inc. | 37dd58ad-95d1-568c-e063-6394a90a9433 | 2025-06-16 | Warnings | M012 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 51316-791-26 | 51316079126 | 1 BOTTLE in 1 CARTON (51316-791-26) / 118 mL in 1 BOTTLE (51316-791-00) | 1 bottle | 2026-06-24 | No | No | Current |