Dologesic
- Product NDC
- 54859-001
- 11-digit product format
- 548590001
- Labeler code
- 54859
- Product ID
- 54859-001_47460679-895d-b4d5-e063-6394a90ab919
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dexbrompheniramine Maleate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Llorens Pharmaceutical International Division
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2016-04-01
- Substance
- ACETAMINOPHEN; DEXBROMPHENIRAMINE MALEATE
- Active strength
- 500; 1 mg/1; mg/1
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Dologesic
- Brand name suffix
- NF
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 500 mg/1 |
| DEXBROMPHENIRAMINE MALEATE | 1 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, BPA9UT29BS |
| Rxcui | 1798453 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 54859-001-01 | DologesicNF | 100 in 1 BOTTLE | TABLET | 100 | | 8 |
| 54859-001-50 | DologesicNF | 50 in 1 BOTTLE | TABLET | 50 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 54859-001 | DOLOGESIC NF (ACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATE) TABLET [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION] | 7 | Current NDC, Legacy NDC, 2 package rows | 20241225_974fc0d5-7a99-46fb-af38-b91240f728fa.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 |
|---|
| 54859-001-01 | 54859000101 | 100 TABLET in 1 BOTTLE (54859-001-01) | 100 tablet | 2016-04-01 | 0000-00-00 | No | No | Current |
| 54859-001-50 | 54859000150 | 50 TABLET in 1 BOTTLE (54859-001-50) | 50 tablet | 2016-04-01 | 0000-00-00 | No | No | Current |