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NDC 50844-0043-36 Nighttime Cough DM 30; 12.5 mg/20mL; mg/20mL Details

Nighttime Cough DM 30; 12.5 mg/20mL; mg/20mL

Nighttime Cough DM is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by L.N.K. International, Inc.. The primary component is DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE.

MedlinePlus Drug Summary

Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.

Related Packages: 50844-0043-36
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dextromethorphan

Doxylamine is used in the short-term treatment of insomnia (difficulty falling asleep or staying asleep). Doxylamine is also used in combination with decongestants and other medications to relieve sneezing, runny nose, and nasal congestion caused by the common cold. Doxylamine should not be used to cause sleepiness in children. Doxylamine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.

Related Packages: 50844-0043-36
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Doxylamine

Product Information

NDC	50844-0043
Product ID	50844-043_fb52d1d3-1827-4c78-8ec4-c127afb7c93d
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Nighttime Cough DM
Proprietary Name Suffix	n/a
Non-Proprietary Name	Dextromethorphan HBr, Doxylamine Succinate
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	ORAL
Active Ingredient Strength	30; 12.5
Active Ingredient Units	mg/20mL; mg/20mL
Substance Name	DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Labeler Name	L.N.K. International, Inc.
Pharmaceutical Class	Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH DRUG
Application Number	M012
Listing Certified Through	2024-12-31

Package

NDC 50844-0043-36 (50844004336)

Pricing Information	N/A
NDC Package Code	50844-043-36
Billing NDC	50844004336
Package	1 BOTTLE, PLASTIC in 1 CARTON (50844-043-36) / 118 mL in 1 BOTTLE, PLASTIC
Marketing Start Date	2021-07-16
NDC Exclude Flag	N