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FDA Approval

Fleet

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
C.B. Fleet Company, Inc.
DUNS: 003119054
Effective Date
May 5, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Glycerin(2 g in 1 1)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Fleet

Product Details

NDC Product Code
0132-0075
Application Number
M007
Marketing Category
OTC Monograph Drug (C200263)
Route of Administration
RECTAL
Effective Date
May 5, 2025
WATERInactive
Code: 059QF0KO0RClass: IACT
GlycerinActive
Code: PDC6A3C0OXClass: ACTIBQuantity: 2 g in 1 1
ALOEInactive
Code: V5VD430YW9Class: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
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