Diphenoxylate Hydrochloride and Atropine Sulfate

Product NDC: 70166-630
Requested package NDC: 70166-630-01
11-digit product format: 701660630
Labeler code: 70166
Product ID: 70166-630_923a6862-5383-889a-e053-2a95a90a3700
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diphenoxylate Hydrochloride and Atropine Sulfate
Dosage form: SOLUTION
Route: ORAL
Labeler: Lohxa
Application: ANDA087708
Marketing category: ANDA
Marketing start: 1982-05-03
Marketing end: 0000-00-00
Substance: DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE
Active strength: 3 mg/5mL; mg/5mL
Pharmacologic classes: Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]
DEA schedule: CV
NDC exclude flag: No
Listing certified through: 2020-12-31
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	70166-630	70166-630-01	I	Inactivated by FDA		2026-08-03

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL		RLD, RS	1982-05-03

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RLD, RS	1982-05-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RLD, RS	1982-05-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RLD, RS	1982-05-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`cb3db0bc1861…`

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
70166-630-01	2023-01-30	C162847	48780-1	f386c649-ec4d-0266-e053-dadaa90a7c1a	Diphenoxylate Hydrochloride and Atropine Sulfate Oral Solution USP CV

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70166-630-01	Diphenoxylate Hydrochloride and Atropine Sulfate	12 in 1 BOX	SOLUTION	12		2
70166-630-01	Diphenoxylate Hydrochloride and Atropine Sulfate	1 in 1 BAG	SOLUTION	1		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70166-630-01	ML - Milliliter	70166-630	af6404bd-f246-423b-b310-510fff2a6248	1	2024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70166-630	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE SOLUTION [LOHXA]	2	Legacy NDC, 2 package rows	20190911_cb933606-151e-4fa4-bebe-b11c1ec41100.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diphenoxylate Hydrochloride and Atropine Sulfate	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	Hikma Pharmaceuticals USA Inc.	88ed4ccf-9e35-4142-a5eb-d2b5edd36956	2025-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087708 application number: ANDA087708

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1190568	atropine sulfate 0.025 MG / diphenoxylate HCl 2.5 MG in 5 mL Oral Solution	PSN	cb933606-151e-4fa4-bebe-b11c1ec41100	2
1190568	atropine sulfate 0.005 MG/ML / diphenoxylate hydrochloride 0.5 MG/ML Oral Solution	SCD	cb933606-151e-4fa4-bebe-b11c1ec41100	2
1190568	atropine sulfate 0.025 MG / diphenoxylate HCl 2.5 MG per 5 ML Oral Solution	SY	cb933606-151e-4fa4-bebe-b11c1ec41100	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70166-630-01	70166063001	12 BAG in 1 BOX (70166-630-01) > 1 SYRINGE in 1 BAG > 5 mL in 1 SYRINGE	12 bag	2018-02-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diphenoxylate Hydrochloride and Atropine Sulfate Oral Solution USP CV	Lohxa	2019-09-10	HUMAN PRESCRIPTION DRUG LABEL	2