FDA.reportPublic FDA data

Sorbutuss

Product NDC
68436-120
11-digit product format
684360120
Labeler code
68436
Product ID
68436-120_46dba920-03e1-9996-e063-6394a90ad9f8
Type
HUMAN OTC DRUG
Nonproprietary name
Sorbutuss
Dosage form
LIQUID
Route
ORAL
Labeler
Dextrum Laboratories Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2007-01-01
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
10; 100 mg/5mL; mg/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
Sorbutuss
Brand name suffix
NR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE10 mg/5mL
GUAIFENESIN100 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, 495W7451VQ
Rxcui996520

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68436-120-162021-02-12C16284748780-19d75b9d0-6c3a-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Sorbutuss. See full prescribing information for Initial U.S. Approval OTC Monograph
68436-120-162020-01-31C16284748780-19d75b9d0-6c3a-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Sorbutuss. See full prescribing information for Initial U.S. Approval OTC Monograph

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68436-120-16SorbutussNR474 mL in 1 BOTTLE, PLASTICLIQUID4748

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68436-120-16ML - Milliliter68436-120ba80cd4d-7896-40cd-8164-62967b1a219d12016-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68436-120SORBUTUSS NR (SORBUTUSS) LIQUID [DEXTRUM LABORATORIES INC.]7Current NDC, Legacy NDC, 1 package rows20241211_304f1d5a-218c-51ae-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996520dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral SolutionPSN304f1d5a-218c-51ae-e054-00144ff88e888
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD304f1d5a-218c-51ae-e054-00144ff88e888
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY304f1d5a-218c-51ae-e054-00144ff88e888
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSY304f1d5a-218c-51ae-e054-00144ff88e888
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSY304f1d5a-218c-51ae-e054-00144ff88e888

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68436-120-1668436012016474 mL in 1 BOTTLE, PLASTIC (68436-120-16) 474 ml2007-01-010000-00-00NoNoCurrent