NDC 70154-112

DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE

Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride

DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Monarch Pcm, Llc.. The primary component is Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride.

• Product ID: 70154-112_9096f2cc-c9a0-61ba-e053-2995a90ad1d5
• NDC: 70154-112
• Product Type: Human Otc Drug
• Proprietary Name: DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
• Generic Name: Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride
• Dosage Form: Liquid
• Route of Administration: ORAL
• Marketing Start Date: 2019-08-19
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Monarch PCM, LLC.
• Substance Name: DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 18 mg/15mL; mg/15mL; mg/15mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 70154-112-08

240 mL in 1 BOTTLE (70154-112-08)

• Marketing Start Date: 2019-08-19
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70154-112-08 [70154011208]

DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE LIQUID

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2019-08-19
• Marketing End Date: 2019-08-26

Drug Details

Active Ingredients

Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	18 mg/15mL

OpenFDA Data

• SPL SET ID: 90960006-4946-0e18-e053-2a95a90a42ac
• Manufacturer:
  • Monarch PCM, LLC.
• UNII:
  • 04JA59TNSJ
  • 9D2RTI9KYH
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 1429362
• UPC Code:
  • 0370154112080

NDC Crossover Matching brand name "DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE" or generic name "Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride"

NDC	Brand Name	Generic Name
69367-184	DEXTROMETHORPHAN HYDROBROMIDE, Guaifenesin, and PHENYLEPHRINE HYDROCHLORIDE	DEXTROMETHORPHAN HYDROBROMIDE, Guaifenesin, and PHENYLEPHRINE HYDROCHLORIDE
70154-112	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
24286-1546	BACTIMICINA COUGH AND COLD	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
0031-8716	Childrens Robitussin Cough and Cold CF	dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride
28595-906	Duravent DM	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
41163-738	maximum strength mucus relief severe congestion and cough	dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride
41250-776	Maximum Strength Mucus Relief Severe Congestion and Cough	dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride
49035-774	Maximum Strength Mucus Relief Severe Congestion and Cough	dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride
49035-976	Maximum Strength Mucus Relief Severe Congestion and Cough	dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride
41250-446	Meijer Maximum Strength Severe Congestion and Cough	dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride
0031-8742	Robitussin Peak Cold Multi-Symptom Cold	dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride
50066-308	Tukol Children Cough and Congestion	Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride
50066-534	Tukol Cough And Cold Honey Flavor	Dextromethorphan Hydrobromide, Guaifenesin, and PHENYLEPHRINE HYDROCHLORIDE
50066-510	Tukol Cough and Congestion	Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride
50066-301	Tukol Honey Children Cough and Congestion	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
11673-738	Up and Up maximum Strength fast mucus relief	dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride