Home NDC 17856-3194 Diphenoxylate Hydrochloride and Atropine Sulfate
Product NDC 17856-3194
11-digit product format 178563194
Labeler code 17856
Product ID 17856-3194_3362fdb8-3317-4bec-b42b-db6b54b2768a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Diphenoxylate Hydrochloride and Atropine Sulfate
Dosage form SOLUTION
Route ORAL
Labeler Atlantic Biologicals Corps
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 E
Listing certified through 2018-12-31
Current FDA listing Historical FDA.report record 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 · 44 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 17856-3194-5 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 17856-3194-5 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 17856-3194-5 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 17856-3194-5 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 17856-3194-5 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 17856-3194-5 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 17856-3194-5 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 17856-3194-5 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 17856-3194-5 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 17856-3194-5 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 17856-3194-5 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 17856-3194-5 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 17856-3194-5 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 17856-3194-5 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 17856-3194-5 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 17856-3194-5 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 17856-3194-5 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 17856-3194-5 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 17856-3194-5 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…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 17856-3194-5 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 17856-3194-5 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 17856-3194-5 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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 Product TE source text 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 17856-3194-5 Diphenoxylate Hydrochloride and Atropine Sulfate 5 mL in 1 CUP SOLUTION 5 2 17856-3194-5 Diphenoxylate Hydrochloride and Atropine Sulfate 72 in 1 BOX SOLUTION 72 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 17856-3194 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE SOLUTION [ATLANTIC BIOLOGICALS CORPS] 2 Legacy NDC, 2 package rows 20171221_b0c91667-ab6f-481d-a592-62da8a52abf7.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 17856-3194-5 17856319405 5 mL in 1 CUP 5 ml Historical