Rynex
- Product NDC
- 0485-0204
- 11-digit product format
- 004850204
- Labeler code
- 0485
- Product ID
- 0485-0204_4746cbef-775f-90ce-e063-6394a90a0781
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Brompheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- Edwards Pharmaceuticals, Inc
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2011-03-14
- Substance
- BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 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
- Brand name suffix
- DM
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BROMPHENIRAMINE MALEATE | 1 mg/5mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 5 mg/5mL |
| PHENYLEPHRINE HYDROCHLORIDE | 2.5 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | IXA7C9ZN03, 9D2RTI9KYH, 04JA59TNSJ |
| Rxcui | 1090463 |
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 |
|---|
| 0485-0204-04 | RynexDM | 118 mL in 1 BOTTLE, PLASTIC | LIQUID | 118 | | 15 |
| 0485-0204-16 | RynexDM | 473 mL in 1 BOTTLE | LIQUID | 473 | | 15 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Brompheniramine Maleate | ACTIVE INGREDIENT | IXA7C9ZN03 | RYNEX DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] | 5 | |
| Dextromethorphan Hydrobromide | ACTIVE INGREDIENT | 9D2RTI9KYH | RYNEX DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] | 5 | |
| Phenylephrine Hydrochloride | ACTIVE INGREDIENT | 04JA59TNSJ | RYNEX DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] | 5 | |
| Brompheniramine | ACTIVE MOIETY | H57G17P2FN | RYNEX DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] | 5 | |
| Dextromethorphan | ACTIVE MOIETY | 7355X3ROTS | RYNEX DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] | 5 | |
| Phenylephrine | ACTIVE MOIETY | 1WS297W6MV | RYNEX DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] | 5 | |
| Citric Acid Monohydrate | INACTIVE INGREDIENT | 2968PHW8QP | RYNEX DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] | 5 | |
| Glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | RYNEX DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] | 5 | |
| Propylene Glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | RYNEX DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] | 5 | |
| Saccharin Sodium Dihydrate | INACTIVE INGREDIENT | SB8ZUX40TY | RYNEX DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] | 5 | |
| Sodium Citrate | INACTIVE INGREDIENT | 1Q73Q2JULR | RYNEX DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] | 5 | |
| Sorbitol | INACTIVE INGREDIENT | 506T60A25R | RYNEX DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] | 5 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | RYNEX DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC.] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0485-0204 | RYNEX DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [EDWARDS PHARMACEUTICALS, INC] | 13 | Current NDC, Legacy NDC, 2 package rows | 20241228_7be2c282-24ba-4f19-9b14-872d3f5746a7.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 |
|---|
| 0485-0204-04 | 00485020404 | 118 mL in 1 BOTTLE, PLASTIC (0485-0204-04) | 118 ml | 2011-03-14 | 0000-00-00 | No | No | Current |
| 0485-0204-16 | 00485020416 | 473 mL in 1 BOTTLE (0485-0204-16) | 473 ml | 2011-03-14 | 0000-00-00 | No | No | Current |