Duratuss AC
- Product NDC
- 50991-540
- 11-digit product format
- 509910540
- Labeler code
- 50991
- Product ID
- 50991-540_3e5ed178-d5d8-b8d4-e063-6394a90a91db
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Codeine Phosphate, Dexbrompheniramine Maleate
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- Poly Pharmaceuticals, Inc.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-09-08
- Substance
- CODEINE PHOSPHATE; DEXBROMPHENIRAMINE MALEATE
- Active strength
- 10; 1 mg/5mL; mg/5mL
- Pharmacologic classes
- Full Opioid Agonists [MoA], Opioid Agonist [EPC]
- DEA schedule
- CV
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Duratuss AC
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CODEINE PHOSPHATE | 10 mg/5mL |
| DEXBROMPHENIRAMINE MALEATE | 1 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | GSL05Y1MN6, BPA9UT29BS |
| Rxcui | 2727418 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50991-540-16 | Duratuss AC | 473 mL in 1 BOTTLE | LIQUID | 473 | | 1 |
| 50991-540-20 | Duratuss AC | 20 mL in 1 BOTTLE | LIQUID | 20 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 50991-540-16 | 50991054016 | 473 mL in 1 BOTTLE (50991-540-16) | 473 ml | 2025-09-08 | No | No | Current |
| 50991-540-20 | 50991054020 | 20 mL in 1 BOTTLE (50991-540-20) | 20 ml | 2025-09-08 | No | No | Current |