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
- 2027-12-31
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 |
|---|---|---|---|---|---|---|
| Allergy Relief | DIPHENHYDRAMINE HCL | CVS Pharmacy | eafd9823-c0ad-454a-b725-562d88ebec92 | 2026-03-23 | Warnings | M012 |
| Daytime Severe Cold and Flu | ACETAMINOPHEN,DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Grocery Outlet, Inc. | 4db0470b-1bf0-9137-e063-6394a90a1d54 | 2026-03-23 | Warnings | M012 |
| Nighttime Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Grocery Outlet, Inc. | 4db066d4-ddbe-ddce-e063-6394a90ac5f8 | 2026-03-23 | Warnings | M012 |
| Throat Comfort Orange Mint Cinnamon Drops | MENTHOL | Ricola Ag | 27487e5c-044c-41eb-865f-2f34351afd52 | 2026-03-23 | Warnings | M012 |
| Daytime Nighttime Cold Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | f288eeca-9803-4962-a802-fe34f5983c7a | 2026-03-23 | Warnings | M012 |
| Throat Comfort Lemon Mint Ginger Drops | MENTHOL | Ricola Ag | d63b4d24-e926-418c-bb17-420aeaad5a62 | 2026-03-23 | Warnings | M012 |
| Mucus Relief Congestion Cough Maximum Strength Severe Congestion and Cough | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 6e7dfee1-3de9-46c8-9b58-83fcf8ee72e0 | 2026-03-23 | Warnings | M012 |
| Maximum Strength Mucus Relief | DEXTROMETHORPHAN HBR, GUAIFENESIN | Hyvee Inc | 44eafc83-8e7b-89b8-e063-6394a90ab0bc | 2026-03-23 | Warnings | M012 |
| Throat Comfort Lemon Mint Ginger Drops | MENTHOL | Ricola USA Inc. | 5d7889b1-3866-49b0-97e1-1e883a52d3cb | 2026-03-23 | Warnings | M012 |
| Throat Comfort Orange Mint Cinnamon Drops | MENTHOL | Ricola USA Inc. | 1487652c-dbc1-40f4-9d59-891ec74cc363 | 2026-03-23 | Warnings | M012 |
| Mucus Relief Cold Flu and Sore Throat Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 4e2a8b53-0074-42fd-8357-a39cc6afe608 | 2026-03-23 | Warnings | M012 |
| Mucus Relief Severe Cold Daytime Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | TARGET Corporation | 5ccaf3b0-096a-4644-9c6e-9f251c167b3c | 2026-03-23 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCL | Grocery Outlet, Inc. | 4d88180f-610c-d9ab-e063-6394a90a09f0 | 2026-03-21 | Warnings | M012 |
| Cold Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | HyVee Inc | cc371bc3-ba7a-430d-9ee4-22e9c50935f1 | 2026-03-20 | Warnings | M012 |
| Daytime Nighttime Multi Symptom Cold Childrens | DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL,ACETAMINOPHEN,DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Walgreens | da4c36f5-ec79-4489-bb18-8ddab79c34bd | 2026-03-20 | Warnings | M012 |
| Sanatos Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE | Pharmadel LLC | 3bddcd5a-7776-49ff-e063-6294a90a5dd1 | 2026-03-20 | Warnings | M012 |
| Vaporizing | CAMPHOR | Amazon.com Services LLC | 21cfe9cb-5ff5-4331-8358-4d1d9646d6ac | 2026-03-19 | Warnings, Adverse reactions | M012 |
| Equate Wild Cherry Throat Drop | PECTIN | Walmart | 4d66547a-b72a-a0ac-e063-6394a90adc71 | 2026-03-19 | Warnings | M012 |
| Nighttime Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Safeway, Inc. | 45d44cd2-5187-4a5c-983a-edb1e8eba0b2 | 2026-03-19 | Warnings | M012 |
| Sedalmex XL Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Belmora LLC | f2edfedf-e06e-4d1b-8c2d-732e08ec113c | 2026-03-19 | 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 |