Diphenoxylate Hydrochloride and Atropine Sulfate

Product NDC: 53002-3400
11-digit product format: 530023400
Labeler code: 53002
Product ID: 53002-3400_144b4367-53e8-46b5-be57-3d85ef76d9e7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diphenoxylate Hydrochloride and Atropine Sulfate
Dosage form: TABLET
Route: ORAL
Labeler: RPK Pharmaceuticals, Inc.
Application: ANDA086727
Marketing category: ANDA
Marketing start: 2017-07-07
Marketing end: 0000-00-00
Substance: DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE
Active strength: 3 mg/1; mg/1
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: 2021-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	53002-3400		I	Inactivated by FDA	2026-08-03
excluded package	package	53002-3400	53002-3400-1	I	Inactivated by FDA	2026-08-03
excluded package	package	53002-3400	53002-3400-2	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 · 33 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53002-3400-1	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53002-3400-2	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53002-3400-1	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53002-3400-2	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53002-3400-1	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53002-3400-2	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53002-3400-1	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53002-3400-2	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53002-3400-1	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53002-3400-2	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53002-3400-1	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53002-3400-2	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53002-3400-1	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53002-3400-2	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53002-3400-1	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53002-3400-2	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53002-3400-1	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53002-3400-2	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53002-3400-2	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53002-3400-1	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53002-3400-1	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53002-3400-2	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

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
A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE	0.025MG;2.5MG	TABLET / ORAL	AA	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
A086727-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL		Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL		Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL		Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL		Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL		Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL		Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL		Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL		Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL		Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL		Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL		Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL		Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A086727-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A086727-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086727-001	AA	1	`31067a03dcf5…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086727-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A086727-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A086727-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A086727-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A086727-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A086727-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086727-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A086727-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A086727-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A086727-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A086727-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A086727-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A086727-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A086727-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A086727-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A086727-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A086727-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A086727-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A086727-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A086727-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A086727-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A086727-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A086727-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A086727-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A086727-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A086727-001	AA	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A086727-001	AA	1	`a50c72e98297…`

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, Related label table
NDC	Effective	Related label
53002-3400-1	2025-01-30	Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only
53002-3400-2	2025-01-30	Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only
53002-3400-1	2023-06-07	Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only
53002-3400-2	2023-06-07	Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only
53002-3400-1	2023-01-30	Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only
53002-3400-2	2023-01-30	Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only
53002-3400-1	2020-12-15	Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only
53002-3400-2	2020-12-15	Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only
53002-3400-1	2020-01-31	Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only
53002-3400-2	2020-01-31	Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53002-3400-1	Diphenoxylate Hydrochloride and Atropine Sulfate	10 in 1 BOTTLE	TABLET	10		6
53002-3400-2	Diphenoxylate Hydrochloride and Atropine Sulfate	20 in 1 BOTTLE	TABLET	20		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53002-3400	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [RPK PHARMACEUTICALS, INC.]	6	Legacy NDC, 2 package rows	20230609_2a6786a1-bf8c-4f19-98c5-8119df787a21.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 · 7 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	A-S Medication Solutions	f94a0189-40d2-42e0-8d2b-c9dc433faad1	2026-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086727 application number: ANDA086727
Diphenoxylate Hydrochloride and Atropine Sulfate	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	Bryant Ranch Prepack	bd08ed90-dd26-4629-83c0-0f75af6ebb95	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086727 application number: ANDA086727
Diphenoxylate Hydrochloride and Atropine Sulfate	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	Bryant Ranch Prepack	64be1529-f290-422c-a076-32c0e1ced1a1	2026-03-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086727 application number: ANDA086727
Diphenoxylate Hydrochloride and Atropine Sulfate	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	ANI Pharmaceuticals, Inc.	73dc5f91-d562-44c5-a556-66c96ed1dd82	2025-12-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086727 application number: ANDA086727
Diphenoxylate Hydrochloride and Atropine Sulfate	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	NuCare Pharmaceuticals,Inc.	575c38b4-7ec0-6d25-e053-2a91aa0a80fc	2024-07-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086727 application number: ANDA086727
Diphenoxylate Hydrochloride and Atropine Sulfate	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	Proficient Rx LP	c832ef16-a06e-4e47-9df3-ab33bdfa6e56	2020-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086727 application number: ANDA086727
Diphenoxylate Hydrochloride and Atropine Sulfate	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	Aphena Pharma Solutions - Tennessee, LLC	435e5e75-5a4c-4806-8d9e-d4be3fef9229	2017-08-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086727 application number: ANDA086727

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
1190572	diphenoxylate HCl 2.5 MG / atropine sulfate 0.025 MG Oral Tablet	PSN	2a6786a1-bf8c-4f19-98c5-8119df787a21	6
1190572	atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral Tablet	SCD	2a6786a1-bf8c-4f19-98c5-8119df787a21	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53002-3400-1	53002340001	10 TABLET in 1 BOTTLE (53002-3400-1)	10 tablet	2017-10-01	0000-00-00	No	No	Current
53002-3400-2	53002340002	20 TABLET in 1 BOTTLE (53002-3400-2)	20 tablet	2017-10-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	6