DR. SANA COUGH AND CHEST CONGESTION DM

Product NDC
53113-514
11-digit product format
531130514
Labeler code
53113
Product ID
53113-514_1c455366-014d-49d6-b502-caec4942f777
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan Hydrobromide, Guaifenesin
Dosage form
LIQUID
Route
ORAL
Labeler
GADAL Laboratories, Inc
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-04-14
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
20; 200 mg/30mL; mg/30mL
Pharmacologic classes
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]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DR. SANA COUGH AND CHEST CONGESTION DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINGADAL Laboratories, Incbaca0580-4c30-4b94-89fa-a7cf06d4ff252025-07-22WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings Do not use • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have • a cough that is accompanied by excessive phlegm (mucus) • a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema. Stop use and ask the doctor if • cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition. If pregnant or breast-feeding, ask health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Additional Listing Data#

Finished product
Yes
Brand name base
DR. SANA COUGH AND CHEST CONGESTION DM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE20 mg/30mL
GUAIFENESIN200 mg/30mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, 495W7451VQ
Rxcui2719927

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53113-514-06DR. SANA COUGH AND CHEST CONGESTION DM180 mL in 1 BOTTLELIQUID1802
53113-514-06DR. SANA COUGH AND CHEST CONGESTION DM1 in 1 BOXLIQUID12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2719927dextromethorphan hydrobromide 20 MG / guaiFENesin 200 MG in 30 mL Oral SuspensionPSNbaca0580-4c30-4b94-89fa-a7cf06d4ff252
2719927dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 6.667 MG/ML Oral SuspensionSCDbaca0580-4c30-4b94-89fa-a7cf06d4ff252
2719927dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 30 mL Oral SuspensionSYbaca0580-4c30-4b94-89fa-a7cf06d4ff252

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53113-514-06531130514061 BOTTLE in 1 BOX (53113-514-06) / 180 mL in 1 BOTTLE1 bottle2025-04-14NoNoCurrent