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 |
|---|---|---|---|---|---|---|
| Aspirin Regular Strength | ASPIRIN | Rite Aid Corporation | 879e2258-f61b-47ad-a4b1-7d1e78823570 | 2026-03-05 | Warnings | M013 |
| Aspirin | ASPIRIN | ARMY AND AIR FORCE EXCHANGE SERVICE | 87c580d3-6009-4be9-aea7-13539fbe6e31 | 2026-03-05 | Warnings | M013 |
| Aspirin Low Dose Chewable Orange | ASPIRIN | MAJOR PHARMACEUTICALS | fb3a8e38-e991-49c9-93dc-1d29c0a97ba3 | 2026-03-05 | Warnings | M013 |
| Infants Pain and Fever | ACETAMINOPHEN | Kroger | 41e149df-4140-95cc-e063-6294a90a866b | 2026-03-03 | Warnings | M013 |
| Medique Pain Off | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Sportpharm LLC | 2b35acdc-ff88-46e6-a108-5240aac1d53f | 2026-03-03 | Warnings | M013 |
| Childrens Pain and Fever | ACETAMINOPHEN | Best Choice (Valu Merchandisers Company) | a8a0d9a5-1a36-4ed2-ae9c-7e1a3d674c07 | 2026-03-03 | Warnings | M013 |
| pain relief | ACETAMINOPHEN | HyVee Inc | 6820a515-4004-407b-969b-c4069dc0c3b5 | 2026-02-26 | Warnings | M013 |
| Acetaminophen, Diphenhydramine Hydrochloride | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE | LEADER/ Cardinal Health 110, Inc. | 7be4d67e-1af9-f059-e053-2991aa0a382e | 2026-02-26 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | NCS HealthCare of KY, LLC dba Vangard Labs | f32fc2e9-c0e3-4a25-8399-9cdba6ae8a16 | 2026-02-26 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | NCS HealthCare of KY, LLC dba Vangard Labs | 1f4ac0e6-e986-4c22-8248-0691d64e1a30 | 2026-02-26 | Warnings | M013 |
| Childrens Chewable Acetaminophen | ACETAMINOPHEN | Discount Drug Mart | f413a617-1166-4940-b6ec-fae32238a780 | 2026-02-26 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | NCS HealthCare of KY, LLC dba Vangard Labs | 19735691-33f3-4e19-85ad-e5f270251ec5 | 2026-02-26 | Warnings | M013 |
| Acetaminophen Liquid / Acetaminophen Diphenhydramine HCl Liquid | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Kroger | 44520aa1-b63f-4239-e063-6394a90a5e14 | 2026-02-25 | Warnings | M013 |
| Leader Extra Strength Effervescent Antacid and Pain Reliever | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | Cardinal Health | c5d7bf5f-3e59-52f2-e053-2a95a90a4a00 | 2026-02-25 | Warnings | M013 |
| Childrens Pain and Fever | ACETAMINOPHEN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 12fd643d-7c60-453f-a81f-407ed20e8725 | 2026-02-25 | Warnings | M013 |
| Childrens Pain and Fever | ACETAMINOPHEN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | d96a1531-772b-4a5c-89e4-66fff1fa3d78 | 2026-02-25 | Warnings | M013 |
| Gentle Care Kit | ZINC OXIDE | Kenvue Brands LLC | 4b8f7a5a-2fc4-ea00-e063-6294a90ab95b | 2026-02-24 | Warnings | M013 |
| Excedrin PM Triple Action Caplets and Excedrin Extra Strength Pain Reliever | ACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE, AND DIPHENHYDRAMINE CITRATE | Haleon US Holdings LLC | 444fa225-c204-45d1-b3b3-aa5650ee5d07 | 2026-02-23 | Warnings | M013 |
| Excedrin Extra Strength and Excedrin Tension Headache | ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE | Haleon US Holdings LLC | 2c8df1c7-7864-48df-939c-d9ae22e0f52c | 2026-02-23 | Warnings | M013 |
| Equate Childrens Pain and Fever | ACETAMINOPHEN | Wal-Mart Stores Inc | 40eedfe9-54e1-40a2-b4a2-55ff708b89cd | 2026-02-23 | 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 |