FDA.reportPublic FDA data

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

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