Dolex
- Product NDC
- 55758-026
- 11-digit product format
- 557580026
- Labeler code
- 55758
- Product ID
- 55758-026_12dcac76-11bc-2c3b-e063-6394a90a35c6
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ACETAMINOPHEN
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Pharmadel LLC
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-01-01
- Substance
- ACETAMINOPHEN
- Active strength
- 160 mg/5mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Dolex
- Brand name suffix
- Children Pain and Fever
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 160 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D |
| Rxcui | 307668 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55758-026-04 | DolexChildren Pain and Fever | 1 in 1 BOX | SUSPENSION | 1 | | 3 |
| 55758-026-04 | DolexChildren Pain and Fever | 118 mL in 1 BOTTLE | SUSPENSION | 118 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55758-026 | DOLEX CHILDREN PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [PHARMADEL LLC] | 3 | Current NDC, 2 package rows | 20240307_f9158463-aeb1-5de0-e053-6294a90a748b.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 |
|---|
| 55758-026-04 | 55758002604 | 1 BOTTLE in 1 BOX (55758-026-04) / 118 mL in 1 BOTTLE | 1 bottle | 2023-01-01 | No | No | Current |