Leader Daytime Cold and Flu
- Product NDC
- 70000-0191
- 11-digit product format
- 700000191
- Labeler code
- 70000
- Product ID
- 70000-0191_216b2b43-c73d-4caf-91ce-75eb63e78301
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- acetaminophen, dextromethorphan Hbr, Phenylephrine HCl
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Cardinal Health 110, LLC. dba Leader
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2016-12-14
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 325; 10; 5 mg/15mL; mg/15mL; mg/15mL
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Leader Daytime Cold and Flu
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 325 mg/15mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/15mL |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/15mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, 9D2RTI9KYH, 04JA59TNSJ |
| Rxcui | 1113705 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70000-0191-1 | Leader Daytime Cold and Flu | 237 mL in 1 BOTTLE | SOLUTION | 237 | | 6 |
| 70000-0191-2 | Leader Daytime Cold and Flu | 355 mL in 1 BOTTLE | SOLUTION | 355 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70000-0191 | LEADER DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [CARDINAL HEALTH 110, LLC. DBA LEADER] | 6 | Current NDC, Legacy NDC, 2 package rows | 20240927_333c7042-95b8-4d98-9df1-4287017afa36.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70000-0191-1 | 70000019101 | 237 mL in 1 BOTTLE (70000-0191-1) | 237 ml | 2016-12-14 | 0000-00-00 | No | No | Current |
| 70000-0191-2 | 70000019102 | 355 mL in 1 BOTTLE (70000-0191-2) | 355 ml | 2017-01-11 | 0000-00-00 | No | No | Current |