LOMOTIL- diphenoxylate hydrochloride and atropine sulfate tablets tablet

LOMOTIL by

Drug Labeling and Warnings

LOMOTIL by is a Prescription medication manufactured, distributed, or labeled by Neolpharma, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LOMOTIL 
diphenoxylate hydrochloride and atropine sulfate tablets tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 55466-783
Route of Administration	ORAL	DEA Schedule	CV

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENOXYLATE HYDROCHLORIDE (UNII: W24OD7YW48) (DIPHENOXYLATE - UNII:73312P173G)	DIPHENOXYLATE HYDROCHLORIDE	2.5 mg
ATROPINE SULFATE (UNII: 03J5ZE7KA5) (ATROPINE - UNII:7C0697DR9I)	ATROPINE SULFATE	0.025 mg

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SUCROSE (UNII: C151H8M554)
ACACIA (UNII: 5C5403N26O)

Product Characteristics
Color	white	Score	no score
Shape	ROUND (Biconvex)	Size	6mm
Flavor		Imprint Code	SEARLE;61
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55466-783-16	250 in 1 BOTTLE; Type 0: Not a Combination Product	07/24/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Export only		07/24/2025

Labeler - Neolpharma, Inc. (078709787)

Registrant - Neolpharma, Inc. (078709787)

Establishment
Name	Address	ID/FEI	Business Operations
Neolpharma, Inc.		078709787	manufacture(55466-783) , analysis(55466-783) , label(55466-783) , pack(55466-783)