Original Night-Time
- Product NDC
- 53943-501
- 11-digit product format
- 539430501
- Labeler code
- 53943
- Product ID
- 53943-501_46538946-6c44-dce2-e063-6394a90ae990
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- Discount Drug Mart
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2014-10-21
- 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
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 | 53943-501-28 | 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 | 53943-501-28 | 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
- Original Night-Time
- Brand name suffix
- MULTI-SYMPTOM COLD/FLU RELIEF
- 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 |
|---|---|
| e243033b-6603-4c3e-a330-e7c7de51f69d | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 59361619-24d9-b610-eca6-5a7f25ed5e03 | Product name | 5 | 20240909 |
| f4368033-af8c-41bf-a84b-ff77392b8522 | Product name | 1 | 20161229 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 53943-501-28 | 2020-12-31 | C162847 | 48780-1 | 9d75b9d0-9043-f424-e053-dadaa90a57ce | e243033b-6603-4c3e-a330-e7c7de51f69d |
| 53943-501-28 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-9043-f424-e053-dadaa90a57ce | e243033b-6603-4c3e-a330-e7c7de51f69d |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53943-501-28 | Original Night-TimeMULTI-SYMPTOM COLD/FLU RELIEF | 354 mL in 1 BOTTLE | LIQUID | 354 | 6 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53943-501 | ORIGINAL NIGHT-TIME MULTI-SYMPTOM COLD/FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DISCOUNT DRUG MART] | 5 | Current NDC, Legacy NDC, 1 package rows | 20241222_e243033b-6603-4c3e-a330-e7c7de51f69d.zip |
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 |
|---|---|---|---|---|---|---|
| HyVee Daytime Severe Cold and Flu SOFTGEL | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | HyVee Inc | 496ec389-1aea-f202-e063-6394a90ae51c | 2026-08-20 | Warnings | M012 |
| CVS PHARMACY COLD and COUGH And NIGHTTIME VALUE PACK | BROMPHENIRAMINE MALEATE,DEXTROMETHORPHAN HBR,DIPHENHYDRAMINE HCL | CVS PHARMACY, INC. | 4d94968b-ada3-4344-8563-cba7fc491d74 | 2026-08-19 | Warnings | M012 |
| CVS Adult Mucus chest congestion | GUAIFENESIN | CVS PHARMACY | bec04049-03b2-4465-9cf5-0ad2ef8014ef | 2026-08-19 | Warnings | M012 |
| CVS Childrens Cough Relief | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | CVS PHARMACY, INC | fe12f3bd-3237-42d1-aec5-c831b9637175 | 2026-08-19 | Warnings | M012 |
| CVS Maximum Strength Severe Congestion and Cough | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | CVS PHARMACY, INC | bfb3d021-f65f-499c-bbb1-c1aceb7a7bf9 | 2026-08-19 | Warnings | M012 |
| CVS Long Acting Cough | DEXTROMETHORPHAN HBR | CVS PHARMACY, INC | 31a7c0e2-af1c-45dd-8a93-e0879cae6005 | 2026-08-19 | Warnings | M012 |
| Pain Relief PM | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Strategic Sourcing Services LLC | b3baf939-a9fd-47ac-9bc7-68435e32ea1e | 2026-08-19 | Warnings | M012 |
| Multi Symptom Flu Relief Max Strength Daytime Nighttime Combo Pack | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | CVS PHARMACY | 5151127a-4d09-413a-a08b-f76fb77e1188 | 2026-08-19 | Warnings | M012 |
| CVS DT and NT Combo Pack Cold and Flu | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE | CVS PHARMACY | 360c8c62-0945-4031-b291-d40c4270b940 | 2026-08-19 | Warnings | M012 |
| equate childrens cold cough | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | WALMART INC. | 24758ab0-ba08-4b4a-9861-449612bdb89c | 2026-08-19 | Warnings | M012 |
| CVS Adult Mucus plus Chest Congestion | GUAIFENESIN | CVS PHARMACY | 3cf425bd-9d90-4c19-a4f7-3cf7bd0b393a | 2026-08-19 | Warnings | M012 |
| CVS Childrens Cold plus Cough plus Runny Nose | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE | CVS | 7dc30e46-e289-40fc-b217-b123fee5daee | 2026-08-19 | Warnings | M012 |
| CVS ADULT COUGH PLUS CHEST CONGESTION DM | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | CVS PHARMACY | 4490a7e1-d5b9-459c-8751-c24486807981 | 2026-08-19 | Warnings | M012 |
| CVS DayTime and NightTime Value Pack Cold and Flu | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE | CVS PHARMACY | 4c813cd5-2c97-4fc3-926c-1a0396551a31 | 2026-08-19 | Warnings | M012 |
| CVS Adult Cough plus Chest Congestion DM Max with Honey | DEXTROMETHORPHAN HBR, GUAIFENESIN | CVS PHARMACY | 822d5bf6-8841-4b7f-bbf7-90c3d50b8024 | 2026-08-19 | Warnings | M012 |
| nighttime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Amazon.com Services LLC | 2517b241-c433-440f-999d-5a32d5bbaa26 | 2026-08-19 | Warnings | M012 |
| Daytime and Nighttime Cough and Chest Congestion Childrens | DEXTROMETHORPHAN HBR, GUAIFENESIN, CHLORPHENIRAMINE MALEATE | CVS Pharmacy | 347f1731-5b85-4220-ae2b-9497a3afa4ed | 2026-08-19 | Warnings | M012 |
| CVS Maximum Strength Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN ,PHENYLEPHRINE HCL | CVS PHARMACY | e1c246a4-7a8c-4761-ab26-13b5165029cc | 2026-08-19 | Warnings | M012 |
| CVS childrens Cough and Cold | CHLORPHENIRAMINE MALEATE, DEXTROMETRORPHAN HBR | CVS PHARMACY | 035c5e2a-04e3-490b-8f1a-233a5cb6eadb | 2026-08-19 | Warnings | M012 |
| rugby cough syrup | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Rugby Laboratories | 89752c69-25c8-45e3-9021-f81b35b52d36 | 2026-08-19 | 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 | e243033b-6603-4c3e-a330-e7c7de51f69d | 6 |
| 1043400 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SCD | e243033b-6603-4c3e-a330-e7c7de51f69d | 6 |
| 1043400 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution | SY | e243033b-6603-4c3e-a330-e7c7de51f69d | 6 |
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution | SY | e243033b-6603-4c3e-a330-e7c7de51f69d | 6 |
| 1043400 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SY | e243033b-6603-4c3e-a330-e7c7de51f69d | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53943-501-28 | 53943050128 | 354 mL in 1 BOTTLE (53943-501-28) | 354 ml | 2014-10-21 | 0000-00-00 | No | No | Current |