Senokot
Approved
Approval ID
d5bf67e5-82c6-edbf-e9ec-e027fdd47c84
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Apr 17, 2025
Manufacturers
FDA
Atlantis Consumer Healthcare, Inc.
DUNS: 118983925
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
standardized senna concentrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67618-120
Application NumberM007
Product Classification
M
Marketing Category
C200263
G
Generic Name
standardized senna concentrate
Product Specifications
Route of AdministrationORAL
Effective DateApril 17, 2025
FDA Product Classification
INGREDIENTS (11)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
LIGHT MINERAL OILInactive
Code: N6K5787QVP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
SENNOSIDESActive
Quantity: 17.2 mg in 1 1
Code: 3FYP5M0IJX
Classification: ACTIB
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 12/26/2023
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 11/6/2020
OTC - ACTIVE INGREDIENT SECTION
LOINC: 55106-9Updated: 11/6/2020
OTC - PURPOSE SECTION
LOINC: 55105-1Updated: 11/6/2020
OTC - WHEN USING SECTION
LOINC: 50567-7Updated: 11/6/2020
WARNINGS SECTION
LOINC: 34071-1Updated: 11/6/2020
OTC - DO NOT USE SECTION
LOINC: 50570-1Updated: 11/6/2020
OTC - ASK DOCTOR SECTION
LOINC: 50569-3Updated: 11/6/2020
OTC - STOP USE SECTION
LOINC: 50566-9Updated: 11/6/2020
OTC - PREGNANCY OR BREAST FEEDING SECTION
LOINC: 53414-9Updated: 11/6/2020
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
LOINC: 50565-1Updated: 11/6/2020
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 11/6/2020
DOSAGE FORMS & STRENGTHS SECTION
LOINC: 43678-2Updated: 11/6/2020
OTC - QUESTIONS SECTION
LOINC: 53413-1Updated: 11/6/2020
INACTIVE INGREDIENT SECTION
LOINC: 51727-6Updated: 11/6/2020