Natural Orange Flavor

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

Company

DUNS: 127602287

Effective Date

April 8, 2025

Labeling Type

HUMAN OTC DRUG LABEL

Active Ingredients

Plantago seed(3.4 g in 12 g)

Products1

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

NDC Product Code

68163-571

Application Number

M007

Marketing Category

OTC Monograph Drug (C200263)

Route of Administration

ORAL

Effective Date

April 8, 2025

Ingredients

RAW SUGARInactive

Code: 8M707QY5GHClass: IACT

GLYCERINInactive

Code: PDC6A3C0OXClass: IACT

Code: 0SHO53407GClass: ACTIBQuantity: 3.4 g in 12 g

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSLClass: IACT