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 |
|---|---|---|---|---|---|---|
| Pain Relief Extra Strength | ACETAMINOPHEN | Chain Drug Marketing Association | cfaf9495-e654-4dfc-ba23-d2358c3720c4 | 2024-06-13 | Warnings | M013 |
| Aspirin 81 mg Low Dose | ASPIRIN | CHAIN DRUG MARKETING ASSOCIATION, INC. | 18ff2df8-ee65-4219-ad93-cf5090bfac2d | 2024-06-13 | Warnings | M013 |
| Pain Relief Extra Strength | ACETAMINOPHEN | CHAIN DRUG MARKETING ASSOCIATION, INC. | 9fdbaf5e-f88b-4d18-97df-0b2e8dddf377 | 2024-06-13 | Warnings | M013 |
| Aspirin 81 mg Low dose | ASPIRIN | CHAIN DRUG MARKETING ASSOCIATION, INC. | bfb9af64-3195-44bf-bcf3-6b36b40d3cc7 | 2024-06-13 | Warnings | M013 |
| Pain Relief Extra Strength | ACETAMINOPHEN | CHAIN DRUG MARKETING ASSOCIATION, INC. | 1ac7ed71-5afe-d09c-e063-6294a90a3b88 | 2024-06-13 | Warnings | M013 |
| Pain Relief PM Extra Strength | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION, INC. | 3ce5bbf2-d449-464e-abeb-5c26866d1ab5 | 2024-06-13 | Warnings | M013 |
| Aspirin | ASPIRIN | AAA Pharmaceutical, Inc. | 609948d6-0f20-4d0c-adc0-6ae72a4f2b7a | 2024-06-13 | Warnings | M013 |
| Aspirin | ASPIRIN | AAA Pharmaceutical, Inc. | 3f73a359-59d7-47bb-872e-914b0db719af | 2024-06-13 | Warnings | M013 |
| topcare infants pain and fever | ACETAMINOPHEN | Topco Associates LLC | f1e940ef-3cf0-4a5c-8158-156d0e5a680d | 2024-06-13 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | Trifecta Pharmaceuticals USA LLC | 026bf664-d598-73de-e063-6394a90a9206 | 2024-06-12 | Warnings | M013 |
| Regular Strength Pain Relief | ACETAMINOPHEN | NuCare Pharmaceuticals,Inc. | 7c73fc75-af9b-177c-e053-2a91aa0ada56 | 2024-06-12 | Warnings | M013 |
| Low Dose Aspirin | ASPIRIN | Topco Associates | 4a6a1dbb-c813-42fd-9bb8-497aec339466 | 2024-06-11 | Warnings | M013 |
| Headache Relief Extra Strength | ACETAMINOPHEN, ASPIRIN, CAFFEINE | The Kroger Co. | fa234639-caf8-4c52-9ffe-f1c0c057ee5b | 2024-06-10 | Warnings | M013 |
| Headache Relief Extra Strength | ACETAMINOPHEN, ASPIRIN, CAFFEINE | The Kroger Co. | bc18590d-6481-4efe-8a3b-974f7543b754 | 2024-06-10 | Warnings | M013 |
| ASPIRIN | ASPIRIN | H-E-B | 085b35db-62e4-38db-e063-6394a90a9763 | 2024-06-07 | Warnings | M013 |
| pain and fever | ACETAMINOPHEN | Meijer Distribution Inc | cbfa2a25-f1e7-491e-9b67-ff2f4ba0b6cf | 2024-06-07 | Warnings | M013 |
| Headache Relief Extra Strength | ACETAMINOPHEN, ASPIRIN, CAFFEINE | The Kroger Co. | 5691ac45-5732-412e-abb8-2bfaac59160e | 2024-06-07 | Warnings | M013 |
| Cafiaspirina Rapid Headache Relief | ASPIRIN, CAFFEINE | Belmora LLC | d890acec-6528-4fb7-8d59-6c572a3f0786 | 2024-06-07 | Warnings | M013 |
| Headache Relief Extra Strength | ACETAMINOPHEN, ASPIRIN, CAFFEINE | TARGET Corporation | 611bc1ce-460a-44a3-8e2d-b28a399d9a44 | 2024-06-06 | Warnings | M013 |
| Childrens Pain and Fever | ACETAMINOPHEN | Meijer Distribution Inc | 033a6153-2651-4703-8a94-def461838113 | 2024-06-05 | 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 |