Lomotil

Product NDC: 67296-1210
Requested package NDC: 67296-1210-1
11-digit product format: 672961210
Labeler code: 67296
Product ID: 67296-1210_d6101780-6a99-5493-e053-2995a90a3908
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lomotil
Dosage form: TABLET
Route: ORAL
Labeler: RedPharm Drug, Inc.
Application: NDA012462
Marketing category: NDA
Marketing start: 1960-09-15
Marketing end: 0000-00-00
Substance: ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE
Active strength: 0 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: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	67296-1210	67296-1210-1	I	Inactivated by FDA		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 16 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2019-12-08 06:16 UTC · source 2019-12-05	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67296-1210-1	2024-01-30	C162847	48780-1	1030e365-3123-111a-e063-dadaa90a10e2	4f1bbc1d-9585-20b2-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67296-1210-1	Lomotil	15 in 1 BOTTLE	TABLET	15		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67296-1210	LOMOTIL TABLET [REDPHARM DRUG, INC.]	3	Legacy NDC, 1 package rows	20220121_4f1bbc1d-9585-20b2-e054-00144ff88e88.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
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	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67296-1210-1	67296121001	15 TABLET in 1 BOTTLE (67296-1210-1)	15 tablet	1960-09-15	0000-00-00	No	No	Current