NDC 0485-0204

Rynex DM

Brompheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride

Rynex DM is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Edwards Pharmaceuticals, Inc. The primary component is Brompheniramine Maleate; Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride.

• Product ID: 0485-0204_26c24b35-d227-4552-827c-a2ebf71658a3
• NDC: 0485-0204
• Product Type: Human Otc Drug
• Proprietary Name: Rynex DM
• Generic Name: Brompheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
• Dosage Form: Liquid
• Route of Administration: ORAL
• Marketing Start Date: 2011-03-14
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Edwards Pharmaceuticals, Inc
• Substance Name: BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 1 mg/5mL; mg/5mL; mg/5mL
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0485-0204-04

118 mL in 1 BOTTLE, PLASTIC (0485-0204-04)

• Marketing Start Date: 2011-03-14
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0485-0204-04 [00485020404]

Rynex DM LIQUID

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2011-03-14
• Inactivation Date: 2020-01-31
• Reactivation Date: 2020-04-08

NDC 0485-0204-16 [00485020416]

Rynex DM LIQUID

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2011-03-14
• Inactivation Date: 2020-01-31
• Reactivation Date: 2020-04-08

NDC 0485-0204-10 [00485020410]

Rynex DM LIQUID

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2011-06-27
• Marketing End Date: 2016-10-18

Drug Details

Active Ingredients

Ingredient	Strength
BROMPHENIRAMINE MALEATE	1 mg/5mL

OpenFDA Data

• SPL SET ID: 7be2c282-24ba-4f19-9b14-872d3f5746a7
• Manufacturer:
  • Edwards Pharmaceuticals, Inc
• UNII:
  • 04JA59TNSJ
  • 9D2RTI9KYH
  • IXA7C9ZN03
• RxNorm Concept Unique ID - RxCUI:
  • 1090463

NDC Crossover Matching brand name "Rynex DM" or generic name "Brompheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride"

NDC	Brand Name	Generic Name
53163-101	Altipres-B	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
45737-226	Bio T Pres-B	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
0485-0204	Rynex	Brompheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride