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
- 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
- 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 |
|---|---|---|---|---|---|---|
| Bayer Rapid Relief | ASPIRIN/CAFFEINE ORAL POWDER | Bayer HealthCare LLC. | f1fecbb0-5b55-fe8f-e053-2995a90a0977 | 2025-12-05 | Warnings | M013 |
| Headache Relief, Extra Strength 24/7 Life by 7-Eleven | ACETAMINOPHEN, ASPIRIN, CAFFEINE TABLET, FILM COATED | Lil' Drug Store Products, Inc. | 45381b1c-2acd-1524-e063-6394a90a83d9 | 2025-12-05 | Warnings | M013 |
| Acetaminophen Easy Tabs Extra Strength | ACETAMINOPHEN | United Natural Foods, Inc. dba UNFI | 729132cd-f209-447a-8949-a90b5a5c01da | 2025-12-05 | Warnings | M013 |
| Menstrual Pain Relief Complete | ACETAMINOPHEN, PYRILAMINE MALEATE, CAFFEINE | Shield Pharmaceuticals Corp | 05fda811-d65f-41b2-89e4-297cdddb3d99 | 2025-12-05 | Warnings | M013 |
| aspirin | ASPIRIN | Health Pharma USA, LLC | 3165b0a3-556b-6abe-e063-6394a90a7682 | 2025-12-04 | Warnings | M013 |
| Bayer Genuine Aspirin | ASPIRIN | Bayer HealthCare LLC. | 44a08904-68b9-4d06-a28d-21aae3d6140c | 2025-12-04 | Warnings | M013 |
| Extra Strength Acetaminophen | ACETAMINOPHEN | Geri-Care Pharmaceutical Corp | 7a29dde6-a177-6206-e053-2991aa0a01f2 | 2025-12-04 | Warnings | M013 |
| Extra Strength Pain Relief | ACETAMINOPHEN | Geri-Care Pharmaceutical Corp | 7570aaa2-3238-4cd3-b788-915caa970dba | 2025-12-04 | Warnings | M013 |
| Bayer Headache | ASPIRIN AND CAFFEINE | Bayer HealthCare LLC. | c0a92873-0914-6a86-e053-2995a90ac41c | 2025-12-04 | Warnings | M013 |
| Alka-Seltzer Original Flavor | ALKA-SELTZER ORIGINAL FLAVOR | Bayer HealthCare LLC. | 07478020-5ba0-3b67-e054-00144ff88e88 | 2025-12-04 | Warnings | M013 |
| Alka-Seltzer Plus Severe Sinus Cold and Cough Liquid Gels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 0dba1329-5b0d-5688-e054-00144ff8d46c | 2025-12-04 | Warnings | M013 |
| Alka-Seltzer Plus Cold Medicine Sparkling Original | ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | 78537dcf-b157-4b67-a8b2-5cb144815166 | 2025-12-04 | Warnings | M013 |
| BAYER Aspirin Extra Strength Caplets | BAYER ASPIRIN EXTRA STRENGTH | Bayer HealthCare LLC. | 0ae64cdb-4ea0-23af-e054-00144ff88e88 | 2025-12-04 | Warnings | M013 |
| Bayer Chewable - Aspirin Regimen Low Dose Aspirin Cherry Flavored | ASPIRIN | Bayer HealthCare LLC. | 070d5713-e018-2913-e054-00144ff8d46c | 2025-12-04 | Warnings | M013 |
| Bayer Low Dose | ASPIRIN | Bayer HealthCare LLC. | 075b103e-0bb4-4b7a-ac0e-5645bcbd0a07 | 2025-12-04 | Warnings | M013 |
| Alka-Seltzer Original | ANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATE | Bayer HealthCare LLC. | 5be36a7f-7d1f-468d-9c29-92c8cd3ef1bc | 2025-12-04 | Warnings | M013 |
| Bayer Aspirin Regimen enteric coated | ASPIRIN | Bayer HealthCare LLC. | 0c6ae05f-7634-34d1-e054-00144ff88e88 | 2025-12-04 | Warnings | M013 |
| aspirin pain relief | ASPIRIN | Rite Aid Corporation | ae9d9977-7576-4894-8a32-454828abec9a | 2025-12-04 | Warnings | M013 |
| ASPIRIN | ASPIRIN | RMT HEALTH LLC | 2bacffd1-4870-73af-e063-6294a90a19c8 | 2025-12-02 | Warnings | M013 |
| Pain Reliever Extra Strength | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | Rite Aid Corporation | d9caee45-be43-45ec-927f-e7fec5c14f07 | 2025-12-02 | 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 |