FDA.reportPublic FDA data

Sorbugen

Product NDC
52083-660
11-digit product format
520830660
Labeler code
52083
Product ID
52083-660_796f9d98-f855-437f-9bca-bb322fa5b063
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan hydrobromide, glycerol guaiacolate
Dosage form
SYRUP
Route
ORAL
Labeler
Kramer Novis
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-10-08
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
15; 150 mg/7.5mL; mg/7.5mL
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
Sorbugen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE15 mg/7.5mL
GUAIFENESIN150 mg/7.5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, 495W7451VQ
Rxcui996520

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52083-660-162025-11-18C16284748780-12cef2736-ab86-d83d-e063-dadaa90ab31fSORBUGEN ® NR
52083-660-162025-01-30C16284748780-12cef2736-ab86-d83d-e063-dadaa90ab31fSORBUGEN ® NR

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52083-660-16Sorbugen480 mL in 1 BOTTLESYRUP4807

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52083-660-16ML - Milliliter52083-660b5276731-56be-48f8-b688-1537491875bf12014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHSORBUGEN (DEXTROMETHORPHAN HYDROBROMIDE, GLYCEROL GUAIACOLATE) SYRUP [KRAMER NOVIS]2
GUAIFENESINACTIVE INGREDIENT495W7451VQSORBUGEN (DEXTROMETHORPHAN HYDROBROMIDE, GLYCEROL GUAIACOLATE) SYRUP [KRAMER NOVIS]2
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSSORBUGEN (DEXTROMETHORPHAN HYDROBROMIDE, GLYCEROL GUAIACOLATE) SYRUP [KRAMER NOVIS]2
GUAIFENESINACTIVE MOIETY495W7451VQSORBUGEN (DEXTROMETHORPHAN HYDROBROMIDE, GLYCEROL GUAIACOLATE) SYRUP [KRAMER NOVIS]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSORBUGEN (DEXTROMETHORPHAN HYDROBROMIDE, GLYCEROL GUAIACOLATE) SYRUP [KRAMER NOVIS]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSORBUGEN (DEXTROMETHORPHAN HYDROBROMIDE, GLYCEROL GUAIACOLATE) SYRUP [KRAMER NOVIS]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TSORBUGEN (DEXTROMETHORPHAN HYDROBROMIDE, GLYCEROL GUAIACOLATE) SYRUP [KRAMER NOVIS]2
POTASSIUM CITRATEINACTIVE INGREDIENTEE90ONI6FFSORBUGEN (DEXTROMETHORPHAN HYDROBROMIDE, GLYCEROL GUAIACOLATE) SYRUP [KRAMER NOVIS]2
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4SORBUGEN (DEXTROMETHORPHAN HYDROBROMIDE, GLYCEROL GUAIACOLATE) SYRUP [KRAMER NOVIS]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHSORBUGEN (DEXTROMETHORPHAN HYDROBROMIDE, GLYCEROL GUAIACOLATE) SYRUP [KRAMER NOVIS]2
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4SORBUGEN (DEXTROMETHORPHAN HYDROBROMIDE, GLYCEROL GUAIACOLATE) SYRUP [KRAMER NOVIS]2
WATERINACTIVE INGREDIENT059QF0KO0RSORBUGEN (DEXTROMETHORPHAN HYDROBROMIDE, GLYCEROL GUAIACOLATE) SYRUP [KRAMER NOVIS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52083-660SORBUGEN (DEXTROMETHORPHAN HYDROBROMIDE, GLYCEROL GUAIACOLATE) SYRUP [KRAMER NOVIS]6Current NDC, Legacy NDC, 1 package rows20221029_a8f2a2d7-0360-45a8-9635-c852f4a7d7ba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996520dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral SolutionPSNa8f2a2d7-0360-45a8-9635-c852f4a7d7ba7
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCDa8f2a2d7-0360-45a8-9635-c852f4a7d7ba7
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSYa8f2a2d7-0360-45a8-9635-c852f4a7d7ba7
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSYa8f2a2d7-0360-45a8-9635-c852f4a7d7ba7
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSYa8f2a2d7-0360-45a8-9635-c852f4a7d7ba7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52083-660-1652083066016480 mL in 1 BOTTLE (52083-660-16) 480 ml2014-10-080000-00-00NoNoCurrent