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 |
|---|---|---|---|---|---|---|
| Mucus Relief Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | HEB | b1ba8ade-3441-f243-e053-2995a90a1230 | 2024-10-21 | Warnings | M012 |
| Mucus Relief Cold, Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | HEB | b1ba22ac-c38d-a42e-e053-2995a90a6900 | 2024-10-21 | Warnings | M012 |
| Diphenhydramine HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | 25034563-6422-daf6-e063-6394a90af980 | 2024-10-21 | Warnings | M012 |
| Childrens Allergy Relief Dye Free | DIPHENHYDRAMINE HCL | CARDINAL HEALTH 110, LLC. DBA LEADER | 198add5f-20b7-75b0-e063-6394a90a6bd4 | 2024-10-21 | Warnings | M012 |
| Tukol Honey Children Cough and Congestion | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Genomma Lab USA | dae33df8-2294-4242-a25b-2d89d1f63b23 | 2024-10-18 | Warnings | M012 |
| sinus pressure and pain pe | ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE | GOODSENSE | a7931e4c-8a5e-66e2-e053-2995a90af2a4 | 2024-10-18 | Warnings | M012 |
| Sinus Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | GoodSense | 570ea130-6a99-446e-9f97-14fc95809006 | 2024-10-18 | Warnings | M012 |
| Sinus and Headache | ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE | GOODSENSE | a14999e3-a9d9-0a1f-e053-2995a90af7b3 | 2024-10-18 | Warnings | M012 |
| Allergy Multi Symptom | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE | GOODSENSE | a793000b-3ef9-5662-e053-2a95a90ad0da | 2024-10-18 | Warnings | M012 |
| Cold Multi-Symptom Daytime and Nighttime | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | GoodSense | 37455f86-ab21-472b-9e80-40324699f3ca | 2024-10-18 | Warnings | M012 |
| Head Congestion Mucus PE | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | GOODSENSE | e3396a27-8643-71fa-e053-2a95a90a713d | 2024-10-18 | Warnings | M012 |
| Head Congestion Flu Severe PE | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | GOODSENSE | e3397f69-3267-ca0b-e053-2995a90a7db5 | 2024-10-18 | Warnings | M012 |
| Cold and Head Congestion Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | GoodSense | 747512a2-3b6d-496b-ab80-819060314163 | 2024-10-18 | Warnings | M012 |
| Allergy Multi Symptom | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE | AMERISOURCE BERGEN | 9daf7f40-d9c5-4367-be41-894208358fc1 | 2024-10-18 | Warnings | M012 |
| Cold Max | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | AmeriSource Bergen | 608e6808-29e4-40bc-8496-24c092681a1b | 2024-10-18 | Warnings | M012 |
| Cold Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | AmeriSource Bergen | 665db127-ee04-46c4-bff0-e0fe9950c3e2 | 2024-10-18 | Warnings | M012 |
| Cold Max Day and Night | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | AmeriSource Bergen | 87a1cc06-9994-4fa9-8c64-e2ffdd33a2f8 | 2024-10-18 | Warnings | M012 |
| Cold Head Congestion Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | AmeriSource Bergen | 604d7e53-4bfd-4cdd-aed2-b304ae82ce44 | 2024-10-18 | Warnings | M012 |
| Allergy | DIPHENHYDRAMINE HYDROCHLORIDE | DISCOUNT DRUG MART | 4d93a703-c905-4fb3-b772-11c207065d4d | 2024-10-17 | Warnings | M012 |
| Sinus Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | DISCOUNT DRUG MART | 62c35320-87b5-46e2-9f6f-cb0882bdb52e | 2024-10-17 | 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 |