Ultra Concentrated Daytime COLD AND FLU
- Product NDC
- 51013-667
- 11-digit product format
- 510130667
- Labeler code
- 51013
- Product ID
- 51013-667_300b2b2b-3aa6-fbf0-e063-6294a90a319b
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ultra Concentrated Daytime COLD AND FLU
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 325 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, 9D2RTI9KYH |
| Rxcui | 1867684 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51013-667-01 | Ultra Concentrated Daytime COLD AND FLU | 8 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 8 | | 1 |
| 51013-667-01 | Ultra Concentrated Daytime COLD AND FLU | 1 in 1 CARTON | CAPSULE, LIQUID FILLED | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51013-667 | ULTRA CONCENTRATED DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE) CAPSULE, LIQUID FILLED [PURACAP PHARMACEUTICAL LLC] | 1 | Current NDC, 2 package rows | 20250313_300b2357-933b-fe9a-e063-6294a90aa4b9.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 51013-667-01 | 51013066701 | 1 BLISTER PACK in 1 CARTON (51013-667-01) / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 1 blister pack | 2025-03-12 | No | No | Current |