Nighttime Cold and Flu Relief
- Product NDC
- 69168-418
- 11-digit product format
- 691680418
- Labeler code
- 69168
- Product ID
- 69168-418_1cf8bb4f-4be1-4670-9329-b0eae96944bb
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Allegiant Health
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2020-11-11
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
- Active strength
- 325; 15; 6.25 mg/1; mg/1; mg/1
- 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
- Nighttime Cold and Flu Relief
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 15 mg/1 |
| DOXYLAMINE SUCCINATE | 6.25 mg/1 |
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 |
|---|---|
| 1094549 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| b97126d7-847d-483e-b3d1-e2b61ab1743f | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69168-418-86 | Daytime Nighttime Cold and Flu Relief Combo Pack | 12 in 1 BLISTER PACK | CAPSULE | 12 | 325 mg | 6 |
| 69168-418-86 | Daytime Nighttime Cold and Flu Relief Combo Pack | 1 in 1 CARTON | CAPSULE | 6.25 mg | 6 | |
| 69168-418-29 | Nighttime Cold and Flu Relief | 8 in 1 BLISTER PACK | CAPSULE | 8 | 5 | |
| 69168-418-51 | Nighttime Cold and Flu Relief | 20 in 1 BLISTER PACK | CAPSULE | 20 | 5 | |
| 69168-418-86 | Daytime and Nighttime Cold and Flu Kit | 1 in 1 CARTON | CAPSULE | 15 mg | 5 | |
| 69168-418-86 | Daytime and Nighttime Cold and Flu Kit | 12 in 1 BLISTER PACK | CAPSULE | 12 | 6.25 mg | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 69168-418 | DAYTIME NIGHTTIME COLD AND FLU RELIEF COMBO PACK (DAYTIME NIGHTTIME COLD AND FLU) KIT [ALLEGIANT HEALTH] | 5 | Current NDC, Legacy NDC | 20231020_fa7ed5db-4da7-46b4-a08d-1d79cb7a5674.zip |
| 69168-418 | NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN) CAPSULE [ALLEGIANT HEALTH] | 3 | Current NDC, Legacy NDC, 2 package rows | 20231116_b97126d7-847d-483e-b3d1-e2b61ab1743f.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.
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2634564 | {1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule) } Pack | GPCK | fa7ed5db-4da7-46b4-a08d-1d79cb7a5674 | 6 |
| 2634564 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) Pack | PSN | fa7ed5db-4da7-46b4-a08d-1d79cb7a5674 | 6 |
| 1086997 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule | PSN | fa7ed5db-4da7-46b4-a08d-1d79cb7a5674 | 6 |
| 1094549 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule | PSN | fa7ed5db-4da7-46b4-a08d-1d79cb7a5674 | 6 |
| 1086997 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SCD | fa7ed5db-4da7-46b4-a08d-1d79cb7a5674 | 6 |
| 1094549 | acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SCD | fa7ed5db-4da7-46b4-a08d-1d79cb7a5674 | 6 |
| 2634564 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) Pack | SY | fa7ed5db-4da7-46b4-a08d-1d79cb7a5674 | 6 |
| 1086997 | APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SY | fa7ed5db-4da7-46b4-a08d-1d79cb7a5674 | 6 |
| 1094549 | APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SY | fa7ed5db-4da7-46b4-a08d-1d79cb7a5674 | 6 |
| 2676954 | {1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG Oral Capsule) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule) } Pack | GPCK | 0533db78-7809-46ea-9998-deb5f6f1d0d9 | 5 |
| 2676954 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) Pack | PSN | 0533db78-7809-46ea-9998-deb5f6f1d0d9 | 5 |
| 1867684 | acetaminophen 325 MG / dextromethorphan HBr 10 MG Oral Capsule | PSN | 0533db78-7809-46ea-9998-deb5f6f1d0d9 | 5 |
| 1094549 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule | PSN | b97126d7-847d-483e-b3d1-e2b61ab1743f | 5 |
| 1094549 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule | PSN | 0533db78-7809-46ea-9998-deb5f6f1d0d9 | 5 |
| 1867684 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG Oral Capsule | SCD | 0533db78-7809-46ea-9998-deb5f6f1d0d9 | 5 |
| 1094549 | acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SCD | b97126d7-847d-483e-b3d1-e2b61ab1743f | 5 |
| 1094549 | acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SCD | 0533db78-7809-46ea-9998-deb5f6f1d0d9 | 5 |
| 2676954 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) Pack | SY | 0533db78-7809-46ea-9998-deb5f6f1d0d9 | 5 |
| 1867684 | acetaminophen 325 MG / dextromethorphan HBr 10 MG Oral Capsule | SY | 0533db78-7809-46ea-9998-deb5f6f1d0d9 | 5 |
| 1867684 | APAP 325 MG / Dextromethorphan Hydrobromide 10 MG Oral Capsule | SY | 0533db78-7809-46ea-9998-deb5f6f1d0d9 | 5 |
| 1094549 | APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SY | b97126d7-847d-483e-b3d1-e2b61ab1743f | 5 |
| 1094549 | APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SY | 0533db78-7809-46ea-9998-deb5f6f1d0d9 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 69168-418-29 | 69168041829 | 8 CAPSULE in 1 BLISTER PACK (69168-418-29) | 8 capsule | 2020-11-11 | 0000-00-00 | No | No | Current |
| 69168-418-51 | 69168041851 | 20 CAPSULE in 1 BLISTER PACK (69168-418-51) | 20 capsule | 2020-11-11 | 0000-00-00 | No | No | Current |
| 69168-418-86 | 69168041886 | 12 in 1 BLISTER PACK | Historical |