Nite-Time
- Product NDC
- 57243-501
- 11-digit product format
- 572430501
- Labeler code
- 57243
- Product ID
- 57243-501_99da41d1-ae1e-4a3a-b51a-11bed23be8bf
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- Salado Sales, Inc.
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2012-01-16
- 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
- 2026-12-31
- 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
- Nite-Time
- Brand name suffix
- COLD/FLU ORIGINAL
- 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 |
|---|---|
| fcd24753-b42b-4d05-8379-0ec0351ab217 | 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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 57243-501-25 | Nite-TimeCOLD/FLU ORIGINAL | 177 mL in 1 BOTTLE | LIQUID | 177 | 8 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 57243-501 | NITE-TIME COLD/FLU ORIGINAL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SALADO SALES, INC.] | 8 | Current NDC, Legacy NDC, 1 package rows | 20231230_fcd24753-b42b-4d05-8379-0ec0351ab217.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 |
|---|---|---|---|---|---|---|
| Aspirin | ASPIRIN | United Natural Foods, Inc. dba UNFI | 19c7f832-d7ec-4dcc-8aa4-f4cbf64c9ff6 | 2026-07-02 | Warnings | M013 |
| pain relief EXTRA STRENGTH | ACETAMINOPHEN | Meijer Distribution, Inc. | ae84eb7e-a70b-4311-b2dc-ad153047a516 | 2026-07-01 | Warnings | M013 |
| Aspirin 325 mg | ASPIRIN | Hi-Tech Nutraceuticals, LLC | b3426a9a-ea99-da30-e053-2995a90a1e4b | 2026-07-01 | Warnings | M013 |
| Headache Relief Extra Strength | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | Salado Sales, Inc. | ca21d576-be3c-495d-9dbd-ed514bf65da7 | 2026-07-01 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | Meijer Distribution Inc | 4e08a7cb-3894-84c3-e063-6394a90a0b42 | 2026-06-30 | Warnings | M013 |
| Headache Relief Extra Strength | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | Wal-Mart Stores Inc | 9b1201af-c802-4e19-b192-bbbf34367db4 | 2026-06-30 | Warnings | M013 |
| Pain Reliever | ACETAMINOPHEN | P & L Development, LLC | fc841cba-8f4f-407b-97de-0422977515bd | 2026-06-30 | Warnings | M013 |
| Headache Relief | ACETAMINOPHEN, ASPIRIN, CAFFEINE | United Natural Foods, Inc. dba UNFI | b6ff2b34-51ee-41bc-8b7d-7520ade0bf36 | 2026-06-30 | Warnings | M013 |
| Medline | ASPIRIN | Medline Industries, LP | 4b0c569a-ed7a-e104-e063-6394a90a6d54 | 2026-06-29 | Warnings | M013 |
| Pain Reliever PM | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | WALMART INC. | e50b3f60-b827-426c-8e78-8447c89130fe | 2026-06-29 | Warnings | M013 |
| Acetaminophen PM | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Chain Drug Marketing Association, Inc. | e58417f4-3575-4433-ac2e-b7bf9fe8ba10 | 2026-06-29 | Warnings | M013 |
| Dr Kids Pain and Fever | ACETAMINOPHEN | CalmCo LLC | 5534a784-a7b1-5599-e063-6294a90a7961 | 2026-06-27 | Warnings | M013 |
| TYLENOL Extra Strength | ACETAMINOPHEN | Select Consumer Group LLC | 529d3a51-a248-7c02-e063-6294a90a10ae | 2026-06-27 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | Sportpharm LLC | 830ffcaa-7ff8-4732-bc84-6a8c5e78722d | 2026-06-25 | Warnings | M013 |
| Aspirin | ASPIRIN | Strategic Sourcing Services LLC | ea2ef485-429e-4c63-ba7b-0a6b32892ad2 | 2026-06-25 | Warnings | M013 |
| Aspirin | ASPIRIN | Chain Drug Marketing Association, Inc. | 055d8420-c189-4a9e-acdc-21627935c8eb | 2026-06-25 | Warnings | M013 |
| Aspirin | ASPIRIN | Topco Associates, LLC | 5f32cf74-dbea-496c-ba23-2040ea354f40 | 2026-06-25 | Warnings | M013 |
| Aspirin | ASPIRIN | Salado Sales, Inc. | cf3139a5-e36e-48e3-bb6c-e102b0cec555 | 2026-06-25 | Warnings | M013 |
| Pain Relief Aspirin | ASPIRIN | Rite Aid Corporation | bd69d3d2-5d38-47c6-98a6-124f7a43b8b0 | 2026-06-25 | Warnings | M013 |
| Aspirin Regular Strength | ASPIRIN | Walgreen Company | 0b27c0fd-7ea8-4588-9169-5ad4e8df77ef | 2026-06-25 | Warnings | M013 |
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 | fcd24753-b42b-4d05-8379-0ec0351ab217 | 8 |
| 1043400 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SCD | fcd24753-b42b-4d05-8379-0ec0351ab217 | 8 |
| 1043400 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution | SY | fcd24753-b42b-4d05-8379-0ec0351ab217 | 8 |
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution | SY | fcd24753-b42b-4d05-8379-0ec0351ab217 | 8 |
| 1043400 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SY | fcd24753-b42b-4d05-8379-0ec0351ab217 | 8 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 57243-501-25 | 57243050125 | 177 mL in 1 BOTTLE (57243-501-25) | 177 ml | 2012-01-16 | 0000-00-00 | No | No | Current |