Night-Time
- Product NDC
- 53943-508
- 11-digit product format
- 539430508
- Labeler code
- 53943
- Product ID
- 53943-508_efbf6971-12d1-4471-9443-cca8d13be3ec
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- Discount Drug Mart
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2014-10-27
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
- Active strength
- 30; 12.5 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
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 | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded product | product | e2bbac7714bc… | 27bdfed8d636… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 53943-508-28 | e2bbac7714bc… | 27bdfed8d636… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded product | product | 9bebd1f3094a… | 5416666fcb17… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 53943-508-28 | 9bebd1f3094a… | 5416666fcb17… |
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
- Night-Time
- Brand name suffix
- COUGH RELIEF
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 30 mg/30mL |
| DOXYLAMINE SUCCINATE | 12.5 mg/30mL |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bf324df6-7127-7deb-def5-2681c136cd03 | Product name | 3 | 20250325 |
| 59361619-24d9-b610-eca6-5a7f25ed5e03 | Product name | 5 | 20240909 |
| 43a1ed49-eae2-4840-8075-cb4b33478540 | Product name | 1 | 20230425 |
| e2db08c6-133f-4f4f-afb4-e90a2418d6f6 | Product name | 1 | 20230320 |
| ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906 | Product name | 7 | 20210625 |
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| 11ed6f83-cdd2-4637-8379-b1a1d3ae3cde | Product name | 1 | 20181101 |
| 86c45a79-b9f0-4476-a27c-6e10db098497 | Product name | 1 | 20180125 |
| f4368033-af8c-41bf-a84b-ff77392b8522 | Product name | 1 | 20161229 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 76633df9-0d59-4b88-03ed-21dee1b966f8 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| Effective | Related label |
|---|---|
| 2020-12-31 | 3baea6f7-9524-46e8-ba82-8892f0842278 |
| 2020-12-31 | 3baea6f7-9524-46e8-ba82-8892f0842278 |
| 2020-01-31 | 3baea6f7-9524-46e8-ba82-8892f0842278 |
| 2020-01-31 | 3baea6f7-9524-46e8-ba82-8892f0842278 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53943-508-28 | Night-TimeCOUGH RELIEF | 354 mL in 1 BOTTLE | LIQUID | 354 | 6 |
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 |
|---|---|---|---|---|---|---|
| Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu | DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE | Bayer HealthCare LLC. | b13d5132-cb91-3cf6-e053-2a95a90aa47c | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Maximum Strength Sinus Congestion and Pain PowerFast Fizz | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | bd97e91f-1ae1-379c-e053-2995a90acfdd | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Maximum Strength Cough, Mucus and Congestion Powermax | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | a6a2dd4a-a3c8-2dfa-e053-2995a90ada86 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Cold Sparkling Original PowerFast Fizz | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | bd49121c-7cba-c51f-e053-2995a90a921e | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Maximum Strength Cough, Mucus and Congestion Day and Night | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare, LLC. | a6b8dc25-0fb9-1823-e053-2a95a90adf93 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Severe Cold PowerFast Fizz Day and Night | ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | c2232241-6e57-1427-e053-2995a90a488a | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Maximum Strength Cold and Cough Power Max Gels | ACETAMINOPHEN, CHLORPHENIRAMINE MALAEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 51dec468-fbb2-3489-e054-00144ff88e88 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Severe Cold PowerFast Fizz Day and Night | ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | d7711cd6-5058-548d-e053-2a95a90ac54d | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz | CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE | Bayer HealthCare LLC. | a2f0285b-8550-fd26-e053-2995a90ab615 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Cold Day and Night PowerMax gels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATE | Bayer HealthCare LLC. | f6c73f61-f4fc-377f-e053-6294a90a3797 | 2025-12-04 | Warnings | M012 |
| Alka Seltzer Plus Maximum Strength Cough Chest Congestion PowerFast Fizz | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Bayer Healthcare LLC. | a32e2a5e-9aa0-4e7c-e053-2995a90a3190 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Cold Day and Night PowerMax gels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATE | Bayer HealthCare LLC. | e2877488-3539-cba2-e053-2995a90a6005 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Cough and Sore Throat FizzyChews | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Bayer HealthCare LLC. | 14951faa-9476-6f29-e063-6394a90a14c7 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Severe Cough Mucus and Congestion Liquid Gels | ALKA-SELTZER PLUS SEVERE COUGH MUCUS AND CONGESTION | Bayer HealthCare LLC. | 0c120569-622d-3a23-e054-00144ff88e88 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Cold and Flu FizzyChews | CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Bayer HealthCare LLC. | 149330be-24bd-b4a4-e063-6394a90a9007 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Severe Cough Mucus and Congestion Day and Night | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE, GUAIFENESIN | Bayer HealthCare LLC. | 5278a128-41ec-4494-e054-00144ff8d46c | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Cold Orange Zest | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | 53188c41-3f13-311b-e054-00144ff88e88 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Cold Day and Night | ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATE | Bayer HealthCare LLC. | 75894849-a0ba-57be-e053-2a91aa0a049a | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Cold Sparkling Original | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | 531ab703-179a-70ad-e054-00144ff88e88 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Cold Night | ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | 7588ea67-68a9-4dc0-e053-2991aa0aa471 | 2025-12-04 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1234386 | dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution | PSN | 3baea6f7-9524-46e8-ba82-8892f0842278 | 6 |
| 1234386 | dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SCD | 3baea6f7-9524-46e8-ba82-8892f0842278 | 6 |
| 1234386 | dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution | SY | 3baea6f7-9524-46e8-ba82-8892f0842278 | 6 |
| 1234386 | dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution | SY | 3baea6f7-9524-46e8-ba82-8892f0842278 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53943-508-28 | 53943050828 | 354 mL in 1 BOTTLE (53943-508-28) | 354 ml | 2014-10-27 | 0000-00-00 | No | No | Current |