NDC 54859-001
Dologesic NF
Acetaminophen, Dexbrompheniramine Maleate
Dologesic NF is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Llorens Pharmaceutical International Division. The primary component is Acetaminophen; Dexbrompheniramine Maleate.
| Product ID | 54859-001_0426888d-225e-421d-b528-4061999f1e4a |
| NDC | 54859-001 |
| Product Type | Human Otc Drug |
| Proprietary Name | Dologesic NF |
| Generic Name | Acetaminophen, Dexbrompheniramine Maleate |
| Dosage Form | Tablet |
| Route of Administration | ORAL |
| Marketing Start Date | 2016-04-01 |
| Marketing Category | OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL |
| Application Number | part343 |
| Labeler Name | Llorens Pharmaceutical International Division |
| Substance Name | ACETAMINOPHEN; DEXBROMPHENIRAMINE MALEATE |
| Active Ingredient Strength | 500 mg/1; mg/1 |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
Packaging
NDC 54859-001-01
100 TABLET in 1 BOTTLE (54859-001-01)
| Marketing Start Date | 2016-04-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 54859-001-50 [54859000150]
Dologesic NF TABLET
| Marketing Category | OTC monograph not final |
| Application Number | part343 |
| Product Type | HUMAN OTC DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2016-04-01 |
| Inactivation Date | 2020-01-31 |
NDC 54859-001-01 [54859000101]
Dologesic NF TABLET
| Marketing Category | OTC monograph not final |
| Application Number | part343 |
| Product Type | HUMAN OTC DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2016-04-01 |
| Inactivation Date | 2020-01-31 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 500 mg/1 |
OpenFDA Data
| SPL SET ID: | 974fc0d5-7a99-46fb-af38-b91240f728fa |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
NDC Crossover Matching brand name "Dologesic NF" or generic name "Acetaminophen, Dexbrompheniramine Maleate"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 63102-403 | ACTIDOGESIC DF | Acetaminophen, Dexbrompheniramine Maleate |
| 45737-610 | Biogesic | Acetaminophen, Dexbrompheniramine Maleate |
| 54859-001 | Dologesic | Acetaminophen, Dexbrompheniramine Maleate |
| 54859-010 | Dologesic | Acetaminophen, Dexbrompheniramine Maleate |
| 52083-681 | G-Dologen | acetaminophen, dexbrompheniramine maleate |
Trademark Results [Dologesic]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DOLOGESIC 87837413 5586001 Live/Registered |
LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION, INC. 2018-03-16 |
 DOLOGESIC 86301106 not registered Dead/Abandoned |
Llorens Pharmaceutical International Division 2014-06-05 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.