FDA.reportPublic FDA data

Diphenoxylate Hydrochloride and Atropine Sulfate

Product NDC
0054-3194
Requested package NDC
0054-3194-46
11-digit product format
000543194
Labeler code
0054
Product ID
0054-3194_92ce86bc-7f23-43ec-9374-a51bacef9461
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diphenoxylate Hydrochloride and Atropine Sulfate
Dosage form
SOLUTION
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA087708
Marketing category
ANDA
Marketing start
1982-05-03
Substance
ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE
Active strength
.025; 2.5 mg/5mL; mg/5mL
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
2026-12-31
Current FDA listing
Yes

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A087708-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE0.025MG/5ML;2.5MG/5MLSOLUTION / ORALRLD, RS1982-05-03

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A087708-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG/5ML;2.5MG/5MLSOLUTION / ORALRLD, RS1982-05-0384e616aacf4f…
2026-08-18 06:07:402026-07A087708-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG/5ML;2.5MG/5MLSOLUTION / ORALRLD, RS1982-05-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A087708-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG/5ML;2.5MG/5MLSOLUTION / ORALRLD, RS1982-05-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A087708-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG/5ML;2.5MG/5MLSOLUTION / ORALRLD, RS1982-05-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A087708-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG/5ML;2.5MG/5MLSOLUTION / ORALRLD, RS1982-05-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A087708-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG/5ML;2.5MG/5MLSOLUTION / ORALRS1982-05-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A087708-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG/5ML;2.5MG/5MLSOLUTION / ORALRS1982-05-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A087708-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG/5ML;2.5MG/5MLSOLUTION / ORALRS1982-05-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A087708-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG/5ML;2.5MG/5MLSOLUTION / ORALRS1982-05-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A087708-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG/5ML;2.5MG/5MLSOLUTION / ORALRS1982-05-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A087708-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG/5ML;2.5MG/5MLSOLUTION / ORALRS1982-05-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A087708-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG/5ML;2.5MG/5MLSOLUTION / ORALRS1982-05-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A087708-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG/5ML;2.5MG/5MLSOLUTION / ORALRS1982-05-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A087708-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG/5ML;2.5MG/5MLSOLUTION / ORALRS1982-05-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A087708-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG/5ML;2.5MG/5MLSOLUTION / ORALRS1982-05-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05A087708-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG/5ML;2.5MG/5MLSOLUTION / ORALRS1982-05-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A087708-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG/5ML;2.5MG/5MLSOLUTION / ORALRS1982-05-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A087708-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG/5ML;2.5MG/5MLSOLUTION / ORALRS1982-05-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A087708-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG/5ML;2.5MG/5MLSOLUTION / ORALRS1982-05-034b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A087708-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG/5ML;2.5MG/5MLSOLUTION / ORALRS1982-05-0374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A087708-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG/5ML;2.5MG/5MLSOLUTION / ORALRS1982-05-03bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A087708-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG/5ML;2.5MG/5MLSOLUTION / ORALRS1982-05-03782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A087708-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG/5ML;2.5MG/5MLSOLUTION / ORALRS1982-05-0387673890dc5c…
2021-03-12 10:30 UTC2021-03A087708-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG/5ML;2.5MG/5MLSOLUTION / ORALRS1982-05-035aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A087708-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG/5ML;2.5MG/5MLSOLUTION / ORALRS1982-05-038869cabd3fbd…
2020-11-12 02:37 UTC2020-11A087708-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG/5ML;2.5MG/5MLSOLUTION / ORALRS1982-05-03c0c555d07b60…
2019-12-14 00:12 UTC2019-12A087708-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG/5ML;2.5MG/5MLSOLUTION / ORALRS1982-05-033f01610625f2…
2019-09-15 20:21 UTC2019-09A087708-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG/5ML;2.5MG/5MLSOLUTION / ORALRS1982-05-03b00525d2431f…
2019-07-19 19:46 UTC2019-07A087708-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG/5ML;2.5MG/5MLSOLUTION / ORALRS1982-05-03ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A087708-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG/5ML;2.5MG/5MLSOLUTION / ORALRS1982-05-036a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A087708-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG/5ML;2.5MG/5MLSOLUTION / ORALRS1982-05-031c564ffb4f44…
2023-12-20 04:57 UTC2023-12A087708-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG/5ML;2.5MG/5MLSOLUTION / ORALRS1982-05-03ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A087708-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG/5ML;2.5MG/5MLSOLUTION / ORALRS1982-05-03a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A087708-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG/5ML;2.5MG/5MLSOLUTION / ORALRS1982-05-039b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A087708-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG/5ML;2.5MG/5MLSOLUTION / ORALRS1982-05-03a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A087708-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG/5ML;2.5MG/5MLSOLUTION / ORALRS1982-05-033f0d92c62455…
2023-05-13 08:27 UTC2023-05A087708-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG/5ML;2.5MG/5MLSOLUTION / ORALRS1982-05-03053a50430f4f…
2023-01-26 05:58 UTC2023-01A087708-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG/5ML;2.5MG/5MLSOLUTION / ORALRS1982-05-033bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A087708-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG/5ML;2.5MG/5MLSOLUTION / ORALRS1982-05-033a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A087708-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG/5ML;2.5MG/5MLSOLUTION / ORALRS1982-05-03f41ea6bd6efb…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Diphenoxylate Hydrochloride and Atropine Sulfate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENOXYLATE HYDROCHLORIDE2.5 mg/5mL
ATROPINE SULFATE.025 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
W24OD7YW48Internal UNII lookup
03J5ZE7KA5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1190568Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
88ed4ccf-9e35-4142-a5eb-d2b5edd36956Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c78bd43-efb4-4aeb-b7d8-eff1532f7822Product name420250801
41231c1e-8789-4da7-ac52-77fa90a85bf5Product name220250304
e77ab9a2-80cf-4832-bff0-469bbc7cbcd0Product name220250214
5f84b7a7-523a-f042-dffb-1dadcd9b2407Product name420240110
0cbc6fb2-78c0-4b88-98f0-a4cc76ff95caProduct name120230719
04cd5dc0-102f-46cb-8dbc-ca38dd2628d0Product name320230317
dfd25202-b8d2-4628-9213-f3e0f9eafce5Product name420210513
4199bf9b-4718-828a-6dd6-ac2fbbd61687Product name120140508
4edd8af5-cea7-ae42-8023-e91c5335db1dProduct name120140508
d3908afb-7784-440f-c406-88294732d36aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0054-3194-46Diphenoxylate Hydrochloride and Atropine Sulfate60 mL in 1 BOTTLESOLUTION608
0054-3194-46Diphenoxylate Hydrochloride and Atropine Sulfate1 in 1 CARTONSOLUTION18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-3194-46ML - Milliliter0054-31947a17f727-3f97-4c86-8c29-406cdc172fe612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATROPINE SULFATEACTIVE INGREDIENT03J5ZE7KA5DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE SOLUTION [ROXANE LABORATORIES, INC]3
DIPHENOXYLATE HYDROCHLORIDEACTIVE INGREDIENTW24OD7YW48DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE SOLUTION [ROXANE LABORATORIES, INC]3
ATROPINEACTIVE MOIETY7C0697DR9IDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE SOLUTION [ROXANE LABORATORIES, INC]3
DIPHENOXYLATEACTIVE MOIETY73312P173GDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE SOLUTION [ROXANE LABORATORIES, INC]3
ALCOHOLINACTIVE INGREDIENT3K9958V90MDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE SOLUTION [ROXANE LABORATORIES, INC]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE SOLUTION [ROXANE LABORATORIES, INC]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE SOLUTION [ROXANE LABORATORIES, INC]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE SOLUTION [ROXANE LABORATORIES, INC]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE SOLUTION [ROXANE LABORATORIES, INC]3
MALTOLINACTIVE INGREDIENT3A9RD92BS4DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE SOLUTION [ROXANE LABORATORIES, INC]3
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE SOLUTION [ROXANE LABORATORIES, INC]3
SORBITOLINACTIVE INGREDIENT506T60A25RDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE SOLUTION [ROXANE LABORATORIES, INC]3
WATERINACTIVE INGREDIENT059QF0KO0RDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE SOLUTION [ROXANE LABORATORIES, INC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0054-3194DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE SOLUTION [HIKMA PHARMACEUTICALS USA INC.]7Current NDC, Legacy NDC, 2 package rows20230502_88ed4ccf-9e35-4142-a5eb-d2b5edd36956.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEHikma Pharmaceuticals USA Inc.88ed4ccf-9e35-4142-a5eb-d2b5edd369562025-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087708
application number: ANDA087708
ndc (package): 0054-3194-46
ndc (product): 0054-3194
ndc11 (package): 00054319446

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1190568atropine sulfate 0.025 MG / diphenoxylate HCl 2.5 MG in 5 mL Oral SolutionPSN88ed4ccf-9e35-4142-a5eb-d2b5edd369568
1190568atropine sulfate 0.005 MG/ML / diphenoxylate hydrochloride 0.5 MG/ML Oral SolutionSCD88ed4ccf-9e35-4142-a5eb-d2b5edd369568
1190568atropine sulfate 0.025 MG / diphenoxylate HCl 2.5 MG per 5 ML Oral SolutionSY88ed4ccf-9e35-4142-a5eb-d2b5edd369568
1190568atropine sulfate 0.025 MG / diphenoxylate HCl 2.5 MG in 5 mL Oral SolutionPSNb0c91667-ab6f-481d-a592-62da8a52abf72
1190568atropine sulfate 0.025 MG / diphenoxylate HCl 2.5 MG in 5 mL Oral SolutionPSNcb933606-151e-4fa4-bebe-b11c1ec411002
1190568atropine sulfate 0.005 MG/ML / diphenoxylate hydrochloride 0.5 MG/ML Oral SolutionSCDb0c91667-ab6f-481d-a592-62da8a52abf72
1190568atropine sulfate 0.005 MG/ML / diphenoxylate hydrochloride 0.5 MG/ML Oral SolutionSCDcb933606-151e-4fa4-bebe-b11c1ec411002
1190568atropine sulfate 0.025 MG / diphenoxylate HCl 2.5 MG per 5 ML Oral SolutionSYb0c91667-ab6f-481d-a592-62da8a52abf72
1190568atropine sulfate 0.025 MG / diphenoxylate HCl 2.5 MG per 5 ML Oral SolutionSYcb933606-151e-4fa4-bebe-b11c1ec411002

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0054-3194-46000543194461 BOTTLE in 1 CARTON (0054-3194-46) / 60 mL in 1 BOTTLE1 bottle1982-05-030000-00-00NoNoCurrent