Daytime Nighttime Cold Flu Relief
- Product NDC
- 68016-799
- 11-digit product format
- 680160799
- Labeler code
- 68016
- Product ID
- 68016-799_7b9b8f97-865c-4391-a6de-1ebdc6e5a875
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCL
- Dosage form
- KIT
- Labeler
- Chain Drug Consortium, LLC
- Application
- part341
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2022-09-15
- Marketing end
- 0000-00-00
- Active strength
- 0
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 68016-799 | D | Discontinued by firm | 2026-10-15 | ||
| excluded package | package | 68016-799 | 68016-799-48 | D | Discontinued by firm | 2026-10-15 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68016-799-48 | Daytime Nighttime Cold Flu Relief | 1 in 1 KIT | KIT | 1 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68016-799 | DAYTIME NIGHTTIME COLD FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CHAIN DRUG CONSORTIUM, LLC] | 3 | Legacy NDC, 1 package rows | 20240308_413b5e29-8b16-42e6-b069-b1fd0ba5b003.zip |
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 | 413b5e29-8b16-42e6-b069-b1fd0ba5b003 | 4 |
| 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 | 413b5e29-8b16-42e6-b069-b1fd0ba5b003 | 4 |
| 1086997 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule | PSN | 413b5e29-8b16-42e6-b069-b1fd0ba5b003 | 4 |
| 1094549 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule | PSN | 413b5e29-8b16-42e6-b069-b1fd0ba5b003 | 4 |
| 1086997 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SCD | 413b5e29-8b16-42e6-b069-b1fd0ba5b003 | 4 |
| 1094549 | acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SCD | 413b5e29-8b16-42e6-b069-b1fd0ba5b003 | 4 |
| 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 | 413b5e29-8b16-42e6-b069-b1fd0ba5b003 | 4 |
| 1086997 | APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SY | 413b5e29-8b16-42e6-b069-b1fd0ba5b003 | 4 |
| 1094549 | APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SY | 413b5e29-8b16-42e6-b069-b1fd0ba5b003 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68016-799-48 | 68016079948 | 1 KIT in 1 KIT (68016-799-48) * 16 BLISTER PACK in 1 CARTON > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 32 BLISTER PACK in 1 CARTON > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 1 kit | 2022-09-15 | 0000-00-00 | No | No | Current |