Diphenoxylate Hydrochloride and Atropine Sulfate

Product NDC: 12634-531
11-digit product format: 126340531
Labeler code: 12634
Product ID: 12634-531_2a2ec5f4-ddaa-383d-e054-00144ff8d46c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: diphenoxylate hydrochloride and atropine sulfate
Dosage form: TABLET
Route: ORAL
Labeler: Apotheca Inc.
Application: ANDA085762
Marketing category: ANDA
Marketing start: 1977-11-17
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: 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 · 14 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	12634-531		I	Inactivated by FDA	2026-10-05
excluded package	package	12634-531	12634-531-00	I	Inactivated by FDA	2026-10-05
excluded package	package	12634-531	12634-531-50	I	Inactivated by FDA	2026-10-05
excluded package	package	12634-531	12634-531-54	I	Inactivated by FDA	2026-10-05
excluded package	package	12634-531	12634-531-55	I	Inactivated by FDA	2026-10-05
excluded package	package	12634-531	12634-531-59	I	Inactivated by FDA	2026-10-05
excluded package	package	12634-531	12634-531-60	I	Inactivated by FDA	2026-10-05
excluded package	package	12634-531	12634-531-61	I	Inactivated by FDA	2026-10-05
excluded package	package	12634-531	12634-531-79	I	Inactivated by FDA	2026-10-05
excluded package	package	12634-531	12634-531-80	I	Inactivated by FDA	2026-10-05
excluded package	package	12634-531	12634-531-82	I	Inactivated by FDA	2026-10-05
excluded package	package	12634-531	12634-531-91	I	Inactivated by FDA	2026-10-05
excluded package	package	12634-531	12634-531-95	I	Inactivated by FDA	2026-10-05
excluded package	package	12634-531	12634-531-97	I	Inactivated by FDA	2026-10-05

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 5 · 266 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-531-91	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-531-55	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-531-59	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-531-00	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-531-54	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-531-61	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-531-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-531-82	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-531-79	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-531-80	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-531-97	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-531-95	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	12634-531-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-531-91	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-531-55	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-531-59	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-531-00	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-531-54	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-531-61	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-531-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-531-82	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-531-79	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-531-80	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-531-97	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-531-95	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12634-531-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-531-91	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-531-55	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-531-59	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-531-00	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-531-54	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-531-61	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-531-50	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-531-82	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-531-79	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-531-80	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-531-97	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-531-95	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12634-531-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-531-91	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-531-55	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-531-59	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-531-00	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-531-54	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-531-61	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-531-50	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-531-82	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-531-79	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-531-80	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-531-97	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-531-95	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12634-531-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	12634-531-91	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	12634-531-55	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	12634-531-59	`cfe11265f3b6…`	`090c488252e2…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A085762-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE	0.025MG;2.5MG	TABLET / ORAL		Approved before 1982

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 · 43 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
2026-09-14 22:38:34	2026-08	A085762-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL		Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A085762-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL		Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A085762-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL		Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085762-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL		Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A085762-001	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	A085762-001	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	A085762-001	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	A085762-001	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	A085762-001	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	A085762-001	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	A085762-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL		Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A085762-001	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	A085762-001	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	A085762-001	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	A085762-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL		Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A085762-001	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	A085762-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A085762-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A085762-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A085762-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A085762-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A085762-001	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	A085762-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A085762-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A085762-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A085762-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A085762-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A085762-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A085762-001	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	A085762-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A085762-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A085762-001	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	A085762-001	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	A085762-001	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	A085762-001	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	A085762-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A085762-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A085762-001	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	A085762-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A085762-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A085762-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A085762-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A085762-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A085762-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A085762-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A085762-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A085762-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A085762-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A085762-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A085762-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A085762-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A085762-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A085762-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A085762-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A085762-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A085762-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A085762-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A085762-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A085762-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A085762-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A085762-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A085762-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A085762-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A085762-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A085762-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A085762-001	AA	1	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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, Related label table
NDC	Related label
12634-531-00	620bf3e4-46ef-4eaf-95b8-f3ffc1a937ad
12634-531-50	620bf3e4-46ef-4eaf-95b8-f3ffc1a937ad
12634-531-54	620bf3e4-46ef-4eaf-95b8-f3ffc1a937ad
12634-531-55	620bf3e4-46ef-4eaf-95b8-f3ffc1a937ad
12634-531-59	620bf3e4-46ef-4eaf-95b8-f3ffc1a937ad
12634-531-60	620bf3e4-46ef-4eaf-95b8-f3ffc1a937ad
12634-531-61	620bf3e4-46ef-4eaf-95b8-f3ffc1a937ad
12634-531-79	620bf3e4-46ef-4eaf-95b8-f3ffc1a937ad
12634-531-80	620bf3e4-46ef-4eaf-95b8-f3ffc1a937ad
12634-531-82	620bf3e4-46ef-4eaf-95b8-f3ffc1a937ad
12634-531-91	620bf3e4-46ef-4eaf-95b8-f3ffc1a937ad
12634-531-95	620bf3e4-46ef-4eaf-95b8-f3ffc1a937ad
12634-531-97	620bf3e4-46ef-4eaf-95b8-f3ffc1a937ad

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
12634-531-00	Diphenoxylate Hydrochloride and Atropine Sulfate	10 in 1 BOTTLE	TABLET	10	14
12634-531-50	Diphenoxylate Hydrochloride and Atropine Sulfate	50 in 1 BOTTLE	TABLET	50	14
12634-531-54	Diphenoxylate Hydrochloride and Atropine Sulfate	14 in 1 BLISTER PACK	TABLET	14	14
12634-531-55	Diphenoxylate Hydrochloride and Atropine Sulfate	15 in 1 BLISTER PACK	TABLET	15	14
12634-531-59	Diphenoxylate Hydrochloride and Atropine Sulfate	30 in 1 BLISTER PACK	TABLET	30	14
12634-531-60	Diphenoxylate Hydrochloride and Atropine Sulfate	60 in 1 BOTTLE	TABLET	60	14
12634-531-61	Diphenoxylate Hydrochloride and Atropine Sulfate	10 in 1 BLISTER PACK	TABLET	10	14
12634-531-79	Diphenoxylate Hydrochloride and Atropine Sulfate	25 in 1 BOTTLE	TABLET	25	14
12634-531-80	Diphenoxylate Hydrochloride and Atropine Sulfate	20 in 1 BOTTLE	TABLET	20	14
12634-531-82	Diphenoxylate Hydrochloride and Atropine Sulfate	12 in 1 BOTTLE	TABLET	12	14
12634-531-91	Diphenoxylate Hydrochloride and Atropine Sulfate	1 in 1 BLISTER PACK	TABLET	1	14
12634-531-95	Diphenoxylate Hydrochloride and Atropine Sulfate	5 in 1 BOTTLE	TABLET	5	14
12634-531-97	Diphenoxylate Hydrochloride and Atropine Sulfate	7 in 1 BOTTLE	TABLET	7	14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ATROPINE SULFATE	ACTIVE INGREDIENT	03J5ZE7KA5	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [APOTHECA, INC]	1
DIPHENOXYLATE HYDROCHLORIDE	ACTIVE INGREDIENT	W24OD7YW48	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [APOTHECA, INC]	1
ATROPINE	ACTIVE MOIETY	7C0697DR9I	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [APOTHECA, INC]	1
DIPHENOXYLATE	ACTIVE MOIETY	73312P173G	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [APOTHECA, INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
12634-531	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [APOTHECA INC.]	14	Legacy NDC, 13 package rows	20160412_620bf3e4-46ef-4eaf-95b8-f3ffc1a937ad.zip

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	620bf3e4-46ef-4eaf-95b8-f3ffc1a937ad	14
1190572	atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral Tablet	SCD	620bf3e4-46ef-4eaf-95b8-f3ffc1a937ad	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
12634-531-00	12634053100	10 in 1 BOTTLE	Historical
12634-531-50	12634053150	50 in 1 BOTTLE	Historical
12634-531-54	12634053154	14 in 1 BLISTER PACK	Historical
12634-531-55	12634053155	15 in 1 BLISTER PACK	Historical
12634-531-59	12634053159	30 in 1 BLISTER PACK	Historical
12634-531-60	12634053160	60 in 1 BOTTLE	Historical
12634-531-61	12634053161	10 in 1 BLISTER PACK	Historical
12634-531-79	12634053179	25 in 1 BOTTLE	Historical
12634-531-80	12634053180	20 in 1 BOTTLE	Historical
12634-531-82	12634053182	12 in 1 BOTTLE	Historical
12634-531-91	12634053191	1 in 1 BLISTER PACK	Historical
12634-531-95	12634053195	5 in 1 BOTTLE	Historical
12634-531-97	12634053197	7 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diphenoxylate Hydrochloride and Atropine Sulfate - Apotheca Inc.	Apotheca Inc.	2016-01-25	HUMAN PRESCRIPTION DRUG LABEL	14