Dolex Children
- Product NDC
- 55758-304
- 11-digit product format
- 557580304
- Labeler code
- 55758
- Product ID
- 55758-304_ac3c264f-da36-a474-e053-2a95a90abdad
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- Pharmadel LLC
- Application
- ANDA210602
- Marketing category
- ANDA
- Marketing start
- 2020-08-07
- Substance
- IBUPROFEN
- Active strength
- 100 mg/100mL
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Dolex Children
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| IBUPROFEN | 100 mg/100mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WK2XYI10QM |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55758-304-04 | Dolex Children | 1 in 1 CARTON | LIQUID | 1 | | 1 |
| 55758-304-04 | Dolex Children | 118 mL in 1 BOTTLE | LIQUID | 118 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55758-304 | DOLEX CHILDREN (IBUPROFEN) LIQUID [PHARMADEL LLC] | 1 | Current NDC, Legacy NDC, 2 package rows | 20200904_ac3c264f-da37-a474-e053-2a95a90abdad.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 55758-304-04 | 55758030404 | 1 BOTTLE in 1 CARTON (55758-304-04) / 118 mL in 1 BOTTLE | 1 bottle | 2020-08-07 | 0000-00-00 | No | No | Current |