dr. sana cough and chest congestion dm

Generic: dextromethorphan hydrobromide, guaifenesin

Labeler: gadal laboratories, inc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name dr. sana cough and chest congestion dm
Generic Name dextromethorphan hydrobromide, guaifenesin
Labeler gadal laboratories, inc
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 20 mg/30mL, guaifenesin 200 mg/30mL

Manufacturer
GADAL Laboratories, Inc

Identifiers & Regulatory

Product NDC 53113-514
Product ID 53113-514_1c455366-014d-49d6-b502-caec4942f777
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2025-04-14

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 53113514
Hyphenated Format 53113-514

Supplemental Identifiers

RxCUI
2719927
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 dr. sana cough and chest congestion dm (source: ndc)
Generic Name dextromethorphan hydrobromide, guaifenesin (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/30mL
  • 200 mg/30mL
source: ndc
Packaging
  • 1 BOTTLE in 1 BOX (53113-514-06) / 180 mL in 1 BOTTLE
source: ndc

Packages (1)

53113-514-06 1 BOTTLE in 1 BOX (53113-514-06) / 180 mL in 1 BOTTLE

Ingredients (2)

dextromethorphan hydrobromide (20 mg/30mL) guaifenesin (200 mg/30mL)

Linked Drug Pages (1)

DR. SANA COUGH AND CHEST CONGESTION DM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1c455366-014d-49d6-b502-caec4942f777", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["2719927"], "spl_set_id": ["baca0580-4c30-4b94-89fa-a7cf06d4ff25"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["GADAL Laboratories, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 BOX (53113-514-06)  / 180 mL in 1 BOTTLE", "package_ndc": "53113-514-06", "marketing_start_date": "20250414"}], "brand_name": "DR. SANA COUGH AND CHEST CONGESTION DM", "product_id": "53113-514_1c455366-014d-49d6-b502-caec4942f777", "dosage_form": "LIQUID", "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": "53113-514", "generic_name": "Dextromethorphan Hydrobromide, Guaifenesin", "labeler_name": "GADAL Laboratories, Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "DR. SANA COUGH AND CHEST CONGESTION DM", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/30mL"}, {"name": "GUAIFENESIN", "strength": "200 mg/30mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250414", "listing_expiration_date": "20261231"}