RYNEX PSE
- Product NDC
- 0485-0206
- 11-digit product format
- 004850206
- Labeler code
- 0485
- Product ID
- 0485-0206_4c48242c-1746-1a49-e063-6294a90ac81d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- BROMPHENIRAMINE MALEATE and PSEUDOEPHEDRINE HYDROCHLORIDE
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- EDWARDS PHARMACEUTICALS, INC.
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 2011-03-07
- Substance
- BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE
- Active strength
- 1; 15 mg/5mL; mg/5mL
- Pharmacologic classes
- Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- RYNEX PSE
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BROMPHENIRAMINE MALEATE | 1 mg/5mL |
| PSEUDOEPHEDRINE HYDROCHLORIDE | 15 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | IXA7C9ZN03, 6V9V2RYJ8N |
| Rxcui | 1098498 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0485-0206-16 | RYNEX PSE | 473 mL in 1 BOTTLE, PLASTIC | LIQUID | 473 | | 10 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| BROMPHENIRAMINE MALEATE | ACTIVE INGREDIENT | IXA7C9ZN03 | RYNEX PSE (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] | 2 | |
| PSEUDOEPHEDRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 6V9V2RYJ8N | RYNEX PSE (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] | 2 | |
| BROMPHENIRAMINE | ACTIVE MOIETY | H57G17P2FN | RYNEX PSE (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] | 2 | |
| PSEUDOEPHEDRINE | ACTIVE MOIETY | 7CUC9DDI9F | RYNEX PSE (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] | 2 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | RYNEX PSE (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] | 2 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | RYNEX PSE (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] | 2 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | RYNEX PSE (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] | 2 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | RYNEX PSE (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] | 2 | |
| POTASSIUM CITRATE | INACTIVE INGREDIENT | EE90ONI6FF | RYNEX PSE (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] | 2 | |
| POTASSIUM SORBATE | INACTIVE INGREDIENT | 1VPU26JZZ4 | RYNEX PSE (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] | 2 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | RYNEX PSE (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] | 2 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | RYNEX PSE (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] | 2 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | RYNEX PSE (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] | 2 | |
| SUCRALOSE | INACTIVE INGREDIENT | 96K6UQ3ZD4 | RYNEX PSE (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | RYNEX PSE (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0485-0206 | RYNEX PSE (BROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] | 8 | Current NDC, Legacy NDC, 1 package rows | 20241228_2f2d9b5a-f66b-4928-8d43-402ef9efcfdf.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 |
|---|
| 0485-0206-16 | 00485020616 | 473 mL in 1 BOTTLE, PLASTIC (0485-0206-16) | 473 ml | 2011-03-07 | 0000-00-00 | No | No | Current |