FDA.reportPublic FDA data

Childrens Giltuss EX Expectorant

Product NDC
58552-146
11-digit product format
585520146
Labeler code
58552
Product ID
58552-146_40b92b1e-3784-2ed2-e063-6394a90a8737
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
SOLUTION
Route
ORAL
Labeler
Gil Pharmaceutical Corp
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-06-22
Substance
GUAIFENESIN
Active strength
200 mg/5mL
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Childrens Giltuss EX Expectorant
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN200 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii495W7451VQ
Rxcui310625

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
58552-146-042022-01-30C16284748780-1d6a99b39-8fdc-a426-e053-dadaa90af4c2Childrens Giltuss EX Expectorant
58552-146-042022-01-30C16284748780-1d6a99b39-8fdc-a426-e053-dadaa90af4c2Childrens Giltuss EX Expectorant
58552-146-042022-01-28C16284748780-1d6a99b39-8fdc-a426-e053-dadaa90af4c2Childrens Giltuss EX Expectorant
58552-146-042022-01-28C16284748780-1d6a99b39-8fdc-a426-e053-dadaa90af4c2Childrens Giltuss EX Expectorant

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58552-146-04Childrens Giltuss EX Expectorant118 mL in 1 BOTTLESOLUTION1186
58552-146-04Childrens Giltuss EX Expectorant1 in 1 CARTONSOLUTION16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58552-146-04ML - Milliliter58552-1464f524ff2-0b2b-45e6-b3c6-3d9abe601dc612022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58552-146CHILDRENS GILTUSS EX EXPECTORANT (GUAIFENESIN) SOLUTION [GIL PHARMACEUTICAL CORP]5Current NDC, Legacy NDC, 2 package rows20241027_a8c59e6d-c11c-2664-e053-2a95a90a8333.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310625guaiFENesin 200 MG in 5 mL Oral SolutionPSNa8c59e6d-c11c-2664-e053-2a95a90a83336
310625guaifenesin 40 MG/ML Oral SolutionSCDa8c59e6d-c11c-2664-e053-2a95a90a83336
310625guaifenesin 200 MG per 5 ML Oral SolutionSYa8c59e6d-c11c-2664-e053-2a95a90a83336
310625guaifenesin 400 MG per 10 ML Oral SolutionSYa8c59e6d-c11c-2664-e053-2a95a90a83336

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58552-146-04585520146041 BOTTLE in 1 CARTON (58552-146-04) / 118 mL in 1 BOTTLE1 bottle2020-06-220000-00-00NoNoCurrent