SanaTos Boost

Product NDC
55758-323
11-digit product format
557580323
Labeler code
55758
Product ID
55758-323_27369b75-842b-86f3-e063-6394a90a44ad
Type
HUMAN OTC DRUG
Nonproprietary name
DEXTROMETHORPHAN HBR
Dosage form
LIQUID
Route
ORAL
Labeler
Pharmadel LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-09-03
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
20; 400 mg/100mL; mg/100mL
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
SanaTos Boost
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE20 mg/100mL
GUAIFENESIN400 mg/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, 495W7451VQ

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
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55758-323-06SanaTos Boost177 mL in 1 BOTTLE, PLASTICLIQUID1773

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55758-323SANATOS BOOST (DEXTROMETHORPHAN HBR) LIQUID [PHARMADEL LLC]3Current NDC, Legacy NDC, 1 package rows20241122_ae6a424f-f3f0-3f6c-e053-2995a90a972d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55758-323-0655758032306177 mL in 1 BOTTLE, PLASTIC (55758-323-06) 177 ml2020-09-030000-00-00NoNoCurrent