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 |
|---|---|---|---|---|---|---|
| LOW DOSE ASPIRIN | ASPIRIN | Bryant Ranch Prepack | 64c28b38-23bb-4c7e-9c19-1d1f0d597528 | 2024-01-18 | Warnings | M013 |
| Buscapina | ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE | OPMX LLC | e0dd4c04-6811-38a1-e053-2995a90aa3c9 | 2024-01-17 | Warnings | M013 |
| Regular Strength Acetaminophen | ACETAMINOPHEN | CARDINAL HEALTH | bdf8c511-ce25-0e30-e053-2a95a90a33f6 | 2024-01-10 | Warnings | M013 |
| Extra Strength Acetaminophen PM | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | KROGER COMPANY | 2560126e-a54a-4a47-9631-a1bca42f5277 | 2024-01-10 | Warnings | M013 |
| LOW DOSE ASPIRIN | ASPIRIN | A-S Medication Solutions | ee4451c9-4d0f-4373-8f64-fcc1f9dd5856 | 2024-01-05 | Warnings | M013 |
| Pharbetol | ACETAMINOPHEN | Proficient Rx LP | 51ba690e-d76b-41c6-a083-8bc803e1faa2 | 2024-01-01 | Warnings | M013 |
| MEDI-FIRST Non-Aspirin Extra Strength | ACETAMINOPHEN | Proficient Rx LP | 9071b047-5463-4f65-b775-bfb0ce066527 | 2024-01-01 | Warnings | M013 |
| LOW DOSE ASPIRIN | ASPIRIN | TIME CAP LABORATORIES, INC | 1acc8c1a-c746-4635-800c-de1ad758fce0 | 2023-12-30 | Warnings | M013 |
| MAX Cold, Flu, and Sore Throat | ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN , PHENYLEPHRINE HCL | H E B | 9b09b660-0758-48dc-84c9-26cdd2aacc03 | 2023-12-29 | Warnings | M013 |
| NIGHT-TIME MULTI-SYMPTOM COLD/FLU Original | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | DeMoulas Market Basket | eb24323f-82a1-4ba3-9359-fe81571c3fba | 2023-12-29 | Warnings | M013 |
| Nite-TimeCOLD/FLU CHERRY COLD/FLU CHERRY | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Salado Sales, Inc. | e6c3e545-b2ad-47f0-8318-c134a8e24f5b | 2023-12-29 | Warnings | M013 |
| Daytime Non-Drowsy COLD/FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Salado Sales, Inc. | e181b371-78c7-4163-865d-acc064be33ca | 2023-12-29 | Warnings | M013 |
| Childrens Pain and Fever Cherry flavor | ACETAMINOPHEN | Walgreen Company | 64c65244-f7a3-401b-b83a-bf66d45268e2 | 2023-12-29 | Warnings | M013 |
| Nite-Time COLD/FLU ORIGINAL | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Salado Sales, Inc. | fcd24753-b42b-4d05-8379-0ec0351ab217 | 2023-12-29 | Warnings | M013 57243-501 |
| NIGHT-TIME MULTI-SYMPTOM COLD/FLU Cherry | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | DeMoulas Market Basket | e772cdf5-d01d-4752-8cfb-7e7f4d7a8dd0 | 2023-12-29 | Warnings | M013 |
| Childrens Pain and Fever, Grape flavor | ACETAMINOPHEN | Walgreen Company | 0995d69f-61aa-40b0-b095-bb8595caf773 | 2023-12-29 | Warnings | M013 |
| DAY-TIME Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | DeMoulas Market Basket | ce900e42-d0c8-408d-a1c3-3a9bef1c97ee | 2023-12-29 | Warnings | M013 |
| Pain Relief PM | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | DOLGENCORP, INC. | 06553550-5685-f3c3-e063-6394a90aef07 | 2023-12-22 | Warnings | M013 |
| Tension Headache Pain Relieving Aid | ACETAMINOPHEN,CAFFEINE | WAL-MART STORES INC | 00fadd26-a6eb-dc5e-e063-6394a90a3cca | 2023-12-15 | Warnings | M013 |
| Dye-Free Aspirin 81 | ASPIRIN | WALGREENS | d71a9d3a-cd28-14a8-e053-2995a90a832b | 2023-12-15 | 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 |