Daytime COLD AND FLU
- Product NDC
- 51013-666
- 11-digit product format
- 510130666
- Labeler code
- 51013
- Product ID
- 51013-666_300c7b40-7df4-a3f2-e063-6394a90af47c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- PuraCap Pharmaceutical LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-03-12
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
- Active strength
- 325; 10 mg/1; mg/1
- Pharmacologic classes
- 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
- 2026-12-31
- 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
- Daytime COLD AND FLU
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1867684 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 300c7c7b-ea0b-3650-e063-6294a90a65e8 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51013-666-01 | Daytime COLD AND FLU | 1 in 1 CARTON | CAPSULE, LIQUID FILLED | 1 | 1 | |
| 51013-666-01 | Daytime COLD AND FLU | 8 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 8 | 1 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|
| 1867684 | acetaminophen 325 MG / dextromethorphan HBr 10 MG Oral Capsule | PSN | 300c7c7b-ea0b-3650-e063-6294a90a65e8 | 1 |
| 1867684 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG Oral Capsule | SCD | 300c7c7b-ea0b-3650-e063-6294a90a65e8 | 1 |
| 1867684 | acetaminophen 325 MG / dextromethorphan HBr 10 MG Oral Capsule | SY | 300c7c7b-ea0b-3650-e063-6294a90a65e8 | 1 |
| 1867684 | APAP 325 MG / Dextromethorphan Hydrobromide 10 MG Oral Capsule | SY | 300c7c7b-ea0b-3650-e063-6294a90a65e8 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 51013-666-01 | 51013066601 | 1 BLISTER PACK in 1 CARTON (51013-666-01) / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 1 blister pack | 2025-03-12 | No | No | Current |