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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N012462-001	LOMOTIL	ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N012462-001	AA

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-08-18 06:07:40	2026-07	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N012462-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N012462-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012462-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N012462-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012462-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012462-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012462-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012462-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012462-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N012462-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N012462-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N012462-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N012462-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N012462-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N012462-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N012462-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N012462-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N012462-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N012462-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N012462-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N012462-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N012462-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N012462-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N012462-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N012462-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N012462-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N012462-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N012462-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N012462-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N012462-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N012462-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N012462-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N012462-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N012462-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N012462-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N012462-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N012462-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N012462-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N012462-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N012462-001	AA	1	`e64feba35796…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIPHENOXYLATE HYDROCHLORIDE	.025 mg/1
ATROPINE SULFATE	2.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
W24OD7YW48	Internal UNII lookup
03J5ZE7KA5	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1190572	Internal RxNorm lookup
1190641	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
f170584a-1072-4fd7-b1dc-6756703483b9	Available on FDA.report

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
0025-0061-31	Lomotil	100 in 1 BOTTLE	TABLET	100		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0025-0061-31	EA - Each	0025-0061	df49020e-8e56-4613-97af-d2b7869f69c3	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ATROPINE SULFATE	ACTIVE INGREDIENT	03J5ZE7KA5	LOMOTIL (DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE) TABLET [G.D. SEARLE LLC DIVISION OF PFIZER INC]	3
DIPHENOXYLATE HYDROCHLORIDE	ACTIVE INGREDIENT	W24OD7YW48	LOMOTIL (DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE) TABLET [G.D. SEARLE LLC DIVISION OF PFIZER INC]	3
ATROPINE	ACTIVE MOIETY	7C0697DR9I	LOMOTIL (DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE) TABLET [G.D. SEARLE LLC DIVISION OF PFIZER INC]	3
DIPHENOXYLATE	ACTIVE MOIETY	73312P173G	LOMOTIL (DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE) TABLET [G.D. SEARLE LLC DIVISION OF PFIZER INC]	3
ACACIA	INACTIVE INGREDIENT	5C5403N26O	LOMOTIL (DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE) TABLET [G.D. SEARLE LLC DIVISION OF PFIZER INC]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LOMOTIL (DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE) TABLET [G.D. SEARLE LLC DIVISION OF PFIZER INC]	3
SORBITOL	INACTIVE INGREDIENT	506T60A25R	LOMOTIL (DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE) TABLET [G.D. SEARLE LLC DIVISION OF PFIZER INC]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LOMOTIL (DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE) TABLET [G.D. SEARLE LLC DIVISION OF PFIZER INC]	3
SUCROSE	INACTIVE INGREDIENT	C151H8M554	LOMOTIL (DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE) TABLET [G.D. SEARLE LLC DIVISION OF PFIZER INC]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	LOMOTIL (DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE) TABLET [G.D. SEARLE LLC DIVISION OF PFIZER INC]	3
ATROPINE SULFATE	ACTIVE INGREDIENT	03J5ZE7KA5	LOMOTIL (DIPHENOXYLATE HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]	1
DIPHENOXYLATE HYDROCHLORIDE	ACTIVE INGREDIENT	W24OD7YW48	LOMOTIL (DIPHENOXYLATE HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]	1
ATROPINE	ACTIVE MOIETY	7C0697DR9I	LOMOTIL (DIPHENOXYLATE HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]	1
DIPHENOXYLATE	ACTIVE MOIETY	73312P173G	LOMOTIL (DIPHENOXYLATE HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]	1
ACACIA	INACTIVE INGREDIENT	5C5403N26O	LOMOTIL (DIPHENOXYLATE HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LOMOTIL (DIPHENOXYLATE HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	LOMOTIL (DIPHENOXYLATE HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LOMOTIL (DIPHENOXYLATE HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	LOMOTIL (DIPHENOXYLATE HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	LOMOTIL (DIPHENOXYLATE HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0025-0061	LOMOTIL (DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE) TABLET [PFIZER LABORATORIES DIV PFIZER INC]	12	Current NDC, Legacy NDC, 1 package rows	20250406_f170584a-1072-4fd7-b1dc-6756703483b9.zip

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lomotil	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	Pfizer Laboratories Div Pfizer Inc	f170584a-1072-4fd7-b1dc-6756703483b9	2026-02-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 012462 application number: NDA012462 ndc (product): 0025-0061
Diphenoxylate Hydrochloride and Atropine Sulfate	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	Mylan Pharmaceuticals Inc.	83bcc2fb-6fb0-4f0e-8e66-592d327684ec	2026-02-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 012462 application number: NDA012462
Diphenoxylate Hydrochloride and Atropine Sulfate	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	Aphena Pharma Solutions - Tennessee, LLC	59934cee-4e1f-4958-9e97-6de53b39daf3	2016-06-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 012462 application number: NDA012462

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
03J5ZE7KA5	ATROPINE SULFATE	5908-99-6	ATROPINE SULFATE
W24OD7YW48	DIPHENOXYLATE HYDROCHLORIDE	3810-80-8	DIPHENOXYLATE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1190572	diphenoxylate HCl 2.5 MG / atropine sulfate 0.025 MG Oral Tablet	PSN	f170584a-1072-4fd7-b1dc-6756703483b9	13
1190641	Lomotil 2.5 MG / 0.025 MG Oral Tablet	PSN	f170584a-1072-4fd7-b1dc-6756703483b9	13
1190641	atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral Tablet [Lomotil]	SBD	f170584a-1072-4fd7-b1dc-6756703483b9	13
1190572	atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral Tablet	SCD	f170584a-1072-4fd7-b1dc-6756703483b9	13
1190641	Lomotil (atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG) Oral Tablet	SY	f170584a-1072-4fd7-b1dc-6756703483b9	13
1190572	diphenoxylate HCl 2.5 MG / atropine sulfate 0.025 MG Oral Tablet	PSN	4f1bbc1d-9585-20b2-e054-00144ff88e88	3
1190572	atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral Tablet	SCD	4f1bbc1d-9585-20b2-e054-00144ff88e88	3
1190572	diphenoxylate HCl 2.5 MG / atropine sulfate 0.025 MG Oral Tablet	PSN	d2b171be-ac59-48ec-84da-03d3f2d34ca6	1
1190641	Lomotil 2.5 MG / 0.025 MG Oral Tablet	PSN	d2b171be-ac59-48ec-84da-03d3f2d34ca6	1
1190641	atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral Tablet [Lomotil]	SBD	d2b171be-ac59-48ec-84da-03d3f2d34ca6	1
1190572	atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral Tablet	SCD	d2b171be-ac59-48ec-84da-03d3f2d34ca6	1
1190641	Lomotil (atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG) Oral Tablet	SY	d2b171be-ac59-48ec-84da-03d3f2d34ca6	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0025-0061-31	00025006131	100 TABLET in 1 BOTTLE (0025-0061-31)	100 tablet	1960-09-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
LOMOTIL (diphenoxylate hydrochloride and atropine sulfate tablets), for oral use, C-V	Pfizer Laboratories Div Pfizer Inc \| Pfizer Manufacturing Deutschland GmbH	2026-02-23	HUMAN PRESCRIPTION DRUG LABEL	13
Lomotil - RedPharm Drug, Inc.	RedPharm Drug, Inc.	2022-01-20	HUMAN PRESCRIPTION DRUG LABEL	3
Lomotil - Physicians Total Care, Inc.	Physicians Total Care, Inc.	2009-09-30	HUMAN PRESCRIPTION DRUG LABEL	1