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
- 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 |
|---|---|
| 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 |
|---|---|---|---|---|---|---|
| ACETAMINOPHEN (RED) | ACETAMINOPHEN | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd | a352f588-4a70-42b2-8f9c-a73a0629517d | 2024-11-25 | Warnings | M013 |
| Pain Relief Extra Strength | ACETAMINOPHEN | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | 5c42dd28-820c-4cc5-9016-11ad5e580616 | 2024-11-25 | Warnings | M013 |
| equate pain reliever | ACETAMINOPHEN | WALMART INC. | 4518fe82-3ba8-4e9e-a036-776df7fb8d57 | 2024-11-21 | Warnings | M013 |
| Family Wellness Pain Reliever | ASPIRIN | FAMILY WELLNESS SERVICES, INC. | 075e19f4-1a58-aedd-e063-6294a90af708 | 2024-11-20 | Warnings | M013 |
| Mejoralito | ACETAMINOPHEN | OPMX Chula Vista | fd2ecde0-296e-060f-e053-6294a90afd98 | 2024-11-15 | Warnings | M013 |
| Temp X | ACETAMINOPHEN | OPMX Chula Vista | fd2edc32-0351-c991-e053-6294a90ab4ce | 2024-11-15 | Warnings | M013 |
| CVS Health Extra Strength Antacid and Pain Reliever | ASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATE | CVS Pharmacy | afe9e755-18ba-305f-e053-2995a90aa8d0 | 2024-11-14 | Warnings | M013 |
| Walgreens Effervescent Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | Walgreens | 667418fc-a3ab-cbc7-e053-2a91aa0a2023 | 2024-11-13 | Warnings | M013 |
| Up and Up Antacid and Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | Target Corporation | a72eef45-b985-638a-e053-2995a90aa20a | 2024-11-13 | Warnings | M013 |
| Signature Care Effervescent Antacid and Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | Safeway, Inc | 6e120024-475a-73af-e053-2a91aa0a42a6 | 2024-11-13 | Warnings, Adverse reactions | M013 |
| Kroger Effervescent Antacid and Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | Kroger Company | 6d858b0e-a3c8-2686-e053-2991aa0acc06 | 2024-11-13 | Warnings | M013 |
| TopCare Effervescent Antacid and Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | Topco Associates LLC | 639f9d57-f26a-708a-e053-2a91aa0a6962 | 2024-11-13 | Warnings, Adverse reactions | M013 |
| Effervescent Antacid and Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | H. E. Butt Grocery Company | 6418cde9-607b-4ca1-e053-2991aa0a9170 | 2024-11-13 | Warnings | M013 |
| Bromo Seltzer | ASPIRIN, SODIUM BICARBONATE, CITRIC ACID | Tower Laboratories Ltd | 8ff88ee1-e33e-4051-992f-24e2720c48ce | 2024-11-13 | Warnings | M013 |
| Care One Original Antacid and Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | Foodhold U.S.A. | 8f662c51-d2fa-6458-e053-2995a90ac6fd | 2024-11-13 | Warnings | M013 |
| Top Value Effervescent Pain Relief | APIRIN, CITRIC ACID, SODIUM BICARBONATE | Tower Laboratories Ltd | 43c7f435-735c-3fab-e054-00144ff88e88 | 2024-11-13 | Warnings, Adverse reactions | M013 |
| DG Health Effervescent Antacid and Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | DOLGENCORP, INC | 8f1343d5-2884-3a14-e053-2a95a90a2f90 | 2024-11-13 | Warnings | M013 |
| Good Sense Effervescent Antacid and Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | Good Sense | cd25b0c3-0134-beef-e053-2a95a90a092b | 2024-11-13 | Warnings | M013 |
| Drug Mart Effervescent Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | Discount Drug Mart, Inc | 8bc65603-1dbf-30ab-e053-2995a90a7c15 | 2024-11-13 | Warnings | M013 |
| Best Choice Effervescent Antacid Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | Valu Merchandisers Company | 8aab905b-5fe7-dddb-e053-2995a90a6c6f | 2024-11-13 | 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 |