Childrens Ibuprofen
- Product NDC
- 68094-494
- 11-digit product format
- 680940494
- Labeler code
- 68094
- Product ID
- 68094-494_5413fd24-141e-4160-b982-0e87370069a3
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Precision Dose Inc.
- Application
- ANDA074937
- Marketing category
- ANDA
- Marketing start
- 2004-04-13
- Substance
- IBUPROFEN
- Active strength
- 100 mg/5mL
- 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
- Childrens Ibuprofen
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| IBUPROFEN | 100 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WK2XYI10QM |
| Rxcui | 197803 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68094-494-58 | Childrens Ibuprofen | 10 in 1 BAG | SUSPENSION | 10 | | 8 |
| 68094-494-58 | Childrens Ibuprofen | 5 in 1 CASE | SUSPENSION | 5 | | 8 |
| 68094-494-59 | Childrens Ibuprofen | 5 mL in 1 CUP, UNIT-DOSE | SUSPENSION | 5 | | 8 |
| 68094-494-61 | Childrens Ibuprofen | 10 in 1 CASE | SUSPENSION | 10 | | 8 |
| 68094-494-61 | Childrens Ibuprofen | 10 in 1 TRAY | SUSPENSION | 10 | | 8 |
| 68094-494-62 | Childrens Ibuprofen | 3 in 1 CASE | SUSPENSION | 3 | | 8 |
| 68094-494-62 | Childrens Ibuprofen | 10 in 1 TRAY | SUSPENSION | 10 | | 8 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68094-494 | CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [PRECISION DOSE INC.] | 7 | Current NDC, Legacy NDC, 7 package rows | 20250302_fbbc67a7-359f-4155-9367-3815c05ccf03.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 |
|---|
| 68094-494-58 | 68094049458 | 5 BAG in 1 CASE (68094-494-58) > 10 SYRINGE in 1 BAG > 5 mL in 1 SYRINGE | 5 bag | 2004-04-13 | 0000-00-00 | No | No | Current |
| 68094-494-59 | 68094049459 | 5 mL in 1 CUP, UNIT-DOSE | 5 ml | | | | | Historical |
| 68094-494-61 | 68094049461 | 10 TRAY in 1 CASE (68094-494-61) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68094-494-59) | 10 tray | 2004-04-13 | 0000-00-00 | No | No | Current |
| 68094-494-62 | 68094049462 | 3 TRAY in 1 CASE (68094-494-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68094-494-59) | 3 tray | 2004-04-13 | 0000-00-00 | No | No | Current |