FDA.reportPublic FDA data

Lomotil

Product NDC
0025-0061
11-digit product format
000250061
Labeler code
0025
Product ID
0025-0061_69fba82d-8e83-4efb-8c88-5175fda71617
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diphenoxylate hydrochloride and atropine sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Pfizer Laboratories Div Pfizer Inc
Application
NDA012462
Marketing category
NDA
Marketing start
1960-09-15
Substance
ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE
Active strength
.025; 2.5 mg/1; mg/1
Pharmacologic classes
Anticholinergic [EPC], Antidiarrheal [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
DEA schedule
CV
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lomotil
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATROPINE SULFATE.025 mg/1
DIPHENOXYLATE HYDROCHLORIDE2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii03J5ZE7KA5, W24OD7YW48
Rxcui1190572, 1190641

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c78bd43-efb4-4aeb-b7d8-eff1532f7822Product name420250801
41231c1e-8789-4da7-ac52-77fa90a85bf5Product name220250304
e77ab9a2-80cf-4832-bff0-469bbc7cbcd0Product name220250214
5f84b7a7-523a-f042-dffb-1dadcd9b2407Product name420240110
0cbc6fb2-78c0-4b88-98f0-a4cc76ff95caProduct name120230719
04cd5dc0-102f-46cb-8dbc-ca38dd2628d0Product name320230317
dfd25202-b8d2-4628-9213-f3e0f9eafce5Product name420210513
4199bf9b-4718-828a-6dd6-ac2fbbd61687Product name120140508
4edd8af5-cea7-ae42-8023-e91c5335db1dProduct name120140508
d3908afb-7784-440f-c406-88294732d36aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0025-0061-31Lomotil100 in 1 BOTTLETABLET10013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0025-0061-31EA - Each0025-0061df49020e-8e56-4613-97af-d2b7869f69c312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATROPINE SULFATEACTIVE INGREDIENT03J5ZE7KA5LOMOTIL (DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE) TABLET [G.D. SEARLE LLC DIVISION OF PFIZER INC]3
DIPHENOXYLATE HYDROCHLORIDEACTIVE INGREDIENTW24OD7YW48LOMOTIL (DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE) TABLET [G.D. SEARLE LLC DIVISION OF PFIZER INC]3
ATROPINEACTIVE MOIETY7C0697DR9ILOMOTIL (DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE) TABLET [G.D. SEARLE LLC DIVISION OF PFIZER INC]3
DIPHENOXYLATEACTIVE MOIETY73312P173GLOMOTIL (DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE) TABLET [G.D. SEARLE LLC DIVISION OF PFIZER INC]3
ACACIAINACTIVE INGREDIENT5C5403N26OLOMOTIL (DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE) TABLET [G.D. SEARLE LLC DIVISION OF PFIZER INC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LOMOTIL (DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE) TABLET [G.D. SEARLE LLC DIVISION OF PFIZER INC]3
SORBITOLINACTIVE INGREDIENT506T60A25RLOMOTIL (DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE) TABLET [G.D. SEARLE LLC DIVISION OF PFIZER INC]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLOMOTIL (DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE) TABLET [G.D. SEARLE LLC DIVISION OF PFIZER INC]3
SUCROSEINACTIVE INGREDIENTC151H8M554LOMOTIL (DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE) TABLET [G.D. SEARLE LLC DIVISION OF PFIZER INC]3
TALCINACTIVE INGREDIENT7SEV7J4R1ULOMOTIL (DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE) TABLET [G.D. SEARLE LLC DIVISION OF PFIZER INC]3
ATROPINE SULFATEACTIVE INGREDIENT03J5ZE7KA5LOMOTIL (DIPHENOXYLATE HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]1
DIPHENOXYLATE HYDROCHLORIDEACTIVE INGREDIENTW24OD7YW48LOMOTIL (DIPHENOXYLATE HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]1
ATROPINEACTIVE MOIETY7C0697DR9ILOMOTIL (DIPHENOXYLATE HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]1
DIPHENOXYLATEACTIVE MOIETY73312P173GLOMOTIL (DIPHENOXYLATE HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]1
ACACIAINACTIVE INGREDIENT5C5403N26OLOMOTIL (DIPHENOXYLATE HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LOMOTIL (DIPHENOXYLATE HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RLOMOTIL (DIPHENOXYLATE HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLOMOTIL (DIPHENOXYLATE HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]1
SUCROSEINACTIVE INGREDIENTC151H8M554LOMOTIL (DIPHENOXYLATE HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1ULOMOTIL (DIPHENOXYLATE HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0025-0061LOMOTIL (DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE) TABLET [PFIZER LABORATORIES DIV PFIZER INC]12Current NDC, Legacy NDC, 1 package rows20250406_f170584a-1072-4fd7-b1dc-6756703483b9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1190572diphenoxylate HCl 2.5 MG / atropine sulfate 0.025 MG Oral TabletPSNf170584a-1072-4fd7-b1dc-6756703483b913
1190641Lomotil 2.5 MG / 0.025 MG Oral TabletPSNf170584a-1072-4fd7-b1dc-6756703483b913
1190641atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral Tablet [Lomotil]SBDf170584a-1072-4fd7-b1dc-6756703483b913
1190572atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral TabletSCDf170584a-1072-4fd7-b1dc-6756703483b913
1190641Lomotil (atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG) Oral TabletSYf170584a-1072-4fd7-b1dc-6756703483b913
1190572diphenoxylate HCl 2.5 MG / atropine sulfate 0.025 MG Oral TabletPSN4f1bbc1d-9585-20b2-e054-00144ff88e883
1190572atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral TabletSCD4f1bbc1d-9585-20b2-e054-00144ff88e883
1190572diphenoxylate HCl 2.5 MG / atropine sulfate 0.025 MG Oral TabletPSNd2b171be-ac59-48ec-84da-03d3f2d34ca61
1190641Lomotil 2.5 MG / 0.025 MG Oral TabletPSNd2b171be-ac59-48ec-84da-03d3f2d34ca61
1190641atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral Tablet [Lomotil]SBDd2b171be-ac59-48ec-84da-03d3f2d34ca61
1190572atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral TabletSCDd2b171be-ac59-48ec-84da-03d3f2d34ca61
1190641Lomotil (atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG) Oral TabletSYd2b171be-ac59-48ec-84da-03d3f2d34ca61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0025-0061-3100025006131100 TABLET in 1 BOTTLE (0025-0061-31) 100 tablet1960-09-150000-00-00NoNoCurrent