FDA.reportPublic FDA data

Giltuss Honey Cough and Chest Congestion

Product NDC
58552-140
11-digit product format
585520140
Labeler code
58552
Product ID
58552-140_40b8aa4b-9a4a-7312-e063-6394a90a7952
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin
Dosage form
SOLUTION
Route
ORAL
Labeler
Gil Pharmaceutical Corp
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-06-22
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
20; 200 mg/10mL; mg/10mL
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
Giltuss Honey Cough and Chest Congestion
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE20 mg/10mL
GUAIFENESIN200 mg/10mL

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
58552-140-042022-01-30C16284748780-1d6a99b39-dcea-a426-e053-dadaa90af4c2Giltuss Honey Cough & Chest Congestion
58552-140-042022-01-30C16284748780-1d6a99b39-dcea-a426-e053-dadaa90af4c2Giltuss Honey Cough & Chest Congestion
58552-140-042022-01-28C16284748780-1d6a99b39-dcea-a426-e053-dadaa90af4c2Giltuss Honey Cough & Chest Congestion
58552-140-042022-01-28C16284748780-1d6a99b39-dcea-a426-e053-dadaa90af4c2Giltuss Honey Cough & Chest Congestion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58552-140-04Giltuss Honey Cough and Chest Congestion1 in 1 CARTONSOLUTION16
58552-140-04Giltuss Honey Cough and Chest Congestion118 mL in 1 BOTTLESOLUTION1186

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58552-140-04ML - Milliliter58552-140457e8127-e5cd-40ec-b243-3b9ce63c901c12021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58552-140GILTUSS HONEY COUGH AND CHEST CONGESTION (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [GIL PHARMACEUTICAL CORP]5Current NDC, Legacy NDC, 2 package rows20241027_a8b2c847-25e9-8714-e053-2995a90a73ce.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996520dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral SolutionPSNa8b2c847-25e9-8714-e053-2995a90a73ce6
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCDa8b2c847-25e9-8714-e053-2995a90a73ce6
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSYa8b2c847-25e9-8714-e053-2995a90a73ce6
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSYa8b2c847-25e9-8714-e053-2995a90a73ce6
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSYa8b2c847-25e9-8714-e053-2995a90a73ce6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58552-140-04585520140041 BOTTLE in 1 CARTON (58552-140-04) / 118 mL in 1 BOTTLE1 bottle2020-06-220000-00-00NoNoCurrent