Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
GCP Laboratories
965480861
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
GCP Laboratories
STRATEGIC SOURCING SERVICES LLC
GCP Laboratories
965480861
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
STOOL SOFTENER
Product Details
NDC Product Code
49348-167Application Number
M007Marketing Category
OTC Monograph Drug (C200263)Route of Administration
ORALEffective Date
March 3, 2025STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
DocusateActive
Code: F05Q2T2JA0Class: ACTIBQuantity: 100 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT