Giltuss EX Expectorant

Product NDC
58552-338
11-digit product format
585520338
Labeler code
58552
Product ID
58552-338_51b2b733-3d4d-762d-e063-6294a90a41a5
Type
HUMAN OTC DRUG
Nonproprietary name
Giltuss EX Expectorant
Dosage form
TABLET
Route
ORAL
Labeler
Gil Pharmaceutical Corp
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-10-07
Substance
GUAIFENESIN
Active strength
600 mg/1
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Giltuss EX Expectorant
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii495W7451VQ
Rxcui636522

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58552-338-07Giltuss EX Expectorant7 in 1 BLISTER PACKTABLET72
58552-338-07Giltuss EX Expectorant1 in 1 CARTONTABLET12
58552-338-20Giltuss EX Expectorant20 in 1 BOTTLETABLET202
58552-338-20Giltuss EX Expectorant1 in 1 CARTONTABLET12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636522guaiFENesin 600 MG 12HR Extended Release Oral TabletPSN3b363fb9-c4d3-446f-927c-f705ffc715b52
63652212 HR guaifenesin 600 MG Extended Release Oral TabletSCD3b363fb9-c4d3-446f-927c-f705ffc715b52
636522guaifenesin 600 MG 12 HR Extended Release Oral TabletSY3b363fb9-c4d3-446f-927c-f705ffc715b52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58552-338-07585520338071 BLISTER PACK in 1 CARTON (58552-338-07) / 7 TABLET in 1 BLISTER PACK1 blister pack2025-10-07YesNoCurrent
58552-338-20585520338201 BOTTLE in 1 CARTON (58552-338-20) / 20 TABLET in 1 BOTTLE1 bottle2025-10-07NoNoCurrent