maximum strength-cough and chest congestion dm

Generic: maximum strength-cough and chest congestion dm

Labeler: humanwell puracap pharmaceutical (wuhan) co., ltd.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name maximum strength-cough and chest congestion dm
Generic Name maximum strength-cough and chest congestion dm
Labeler humanwell puracap pharmaceutical (wuhan) co., ltd.
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 10 mg/1, guaifenesin 200 mg/1

Manufacturer
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.

Identifiers & Regulatory

Product NDC 53345-034
Product ID 53345-034_27c8006d-0566-29d6-e063-6394a90a7054
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2015-06-30

Pharmacologic Class

Established (EPC)
expectorant [epc]
Physiologic Effect
decreased respiratory secretion viscosity [pe] increased respiratory secretions [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 53345034
Hyphenated Format 53345-034

Supplemental Identifiers

RxCUI
1111663
UNII
9D2RTI9KYH 495W7451VQ
NUI
N0000193956 N0000008867 N0000009560

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name maximum strength-cough and chest congestion dm (source: ndc)
Generic Name maximum strength-cough and chest congestion dm (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
  • 200 mg/1
source: ndc
Packaging
  • 1 BAG in 1 BOX (53345-034-01) / 4000 CAPSULE, LIQUID FILLED in 1 BAG
source: ndc

Packages (1)

53345-034-01 1 BAG in 1 BOX (53345-034-01) / 4000 CAPSULE, LIQUID FILLED in 1 BAG

Ingredients (2)

dextromethorphan hydrobromide (10 mg/1) guaifenesin (200 mg/1)

Linked Drug Pages (1)

Maximum Strength-Cough and Chest Congestion DM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "27c8006d-0566-29d6-e063-6394a90a7054", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["1111663"], "spl_set_id": ["d1830989-fe82-4f08-8618-78979fcef568"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BAG in 1 BOX (53345-034-01)  / 4000 CAPSULE, LIQUID FILLED in 1 BAG", "package_ndc": "53345-034-01", "marketing_start_date": "20150630"}], "brand_name": "Maximum Strength-Cough and Chest Congestion DM", "product_id": "53345-034_27c8006d-0566-29d6-e063-6394a90a7054", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]", "Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]"], "product_ndc": "53345-034", "generic_name": "Maximum Strength-Cough and Chest Congestion DM", "labeler_name": "Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Maximum Strength-Cough and Chest Congestion DM", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/1"}, {"name": "GUAIFENESIN", "strength": "200 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20150630", "listing_expiration_date": "20261231"}