LOMOTIL

Manufacturer: Neolpharma, Inc.
Effective date: 2025-11-10
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 21:45:51

Label at a glance#

ProductLOMOTIL

Active ingredientDIPHENOXYLATE HYDROCHLORIDE, ATROPINE SULFATE

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Lomotil Canada

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1190572	diphenoxylate HCl 2.5 MG / atropine sulfate 0.025 MG Oral Tablet	PSN	2
1190641	Lomotil 2.5 MG / 0.025 MG Oral Tablet	PSN	2
1190641	atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral Tablet [Lomotil]	SBD	2
1190572	atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral Tablet	SCD	2
1190641	Lomotil (atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG) Oral Tablet	SY	2

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
ATROPINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813
DIPHENOXYLATE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c78bd43-efb4-4aeb-b7d8-eff1532f7822	Product name	4	20250801
41231c1e-8789-4da7-ac52-77fa90a85bf5	Product name	2	20250304
e77ab9a2-80cf-4832-bff0-469bbc7cbcd0	Product name	2	20250214
5f84b7a7-523a-f042-dffb-1dadcd9b2407	Product name	4	20240110
0cbc6fb2-78c0-4b88-98f0-a4cc76ff95ca	Product name	1	20230719
04cd5dc0-102f-46cb-8dbc-ca38dd2628d0	Product name	3	20230317
dfd25202-b8d2-4628-9213-f3e0f9eafce5	Product name	4	20210513
4199bf9b-4718-828a-6dd6-ac2fbbd61687	Product name	1	20140508
4edd8af5-cea7-ae42-8023-e91c5335db1d	Product name	1	20140508
d3908afb-7784-440f-c406-88294732d36a	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55466-783-16	LOMOTIL	250 in 1 BOTTLE	TABLET	250		2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

LOMOTIL
Diphenoxylate Hydrochloride and Atropine Sulfate Tablets
DIPHENOXYLATE HYDROCHLORIDE
DIPHENOXYLATE
SORBITOL
STARCH, CORN
TALC
LIGHT MINERAL OIL
MAGNESIUM STEARATE
SUCROSE
ATROPINE SULFATE
ATROPINE
ACACIA

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
55466-783	55466-783-16

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DIPHENOXYLATE HYDROCHLORIDE	W24OD7YW48	ACTIB
SORBITOL	506T60A25R	IACT
STARCH, CORN	O8232NY3SJ	IACT
TALC	7SEV7J4R1U	IACT
LIGHT MINERAL OIL	N6K5787QVP	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
SUCROSE	C151H8M554	IACT
ATROPINE SULFATE	03J5ZE7KA5	ACTIB
ACACIA	5C5403N26O	IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
43405f94-13c3-0096-e063-6394a90a0488			396ea336-9db3-6d4e-e063-6294a90aee63	2025-11-10		Exact identifier spl id: 43405f94-13c3-0096-e063-6394a90a0488 spl set id: 396ea336-9db3-6d4e-e063-6294a90aee63

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.