FDA.reportPublic FDA data

NDC 71335-0311-01 - Diphenoxylate Hydrochloride and Atropine Sulfate

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
71335-0311
Requested NDC
71335-0311-01
Package NDCs from labels
71335-0311-1, 71335-0311-2, 71335-0311-3, 71335-0311-4, 71335-0311-5, 71335-0311-6, 71335-0311-7, 71335-0311-01
Manufacturer
Bryant Ranch Prepack
Effective date
2026-05-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Diphenoxylate Hydrochloride and Atropine Sulfate - Bryant Ranch PrepackBryant Ranch Prepack2026-05-21HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0311-1Diphenoxylate Hydrochloride and Atropine Sulfate20 in 1 BOTTLETABLET208
71335-0311-2Diphenoxylate Hydrochloride and Atropine Sulfate30 in 1 BOTTLETABLET308
71335-0311-3Diphenoxylate Hydrochloride and Atropine Sulfate15 in 1 BOTTLETABLET158
71335-0311-4Diphenoxylate Hydrochloride and Atropine Sulfate10 in 1 BOTTLETABLET108
71335-0311-5Diphenoxylate Hydrochloride and Atropine Sulfate40 in 1 BOTTLETABLET408
71335-0311-6Diphenoxylate Hydrochloride and Atropine Sulfate60 in 1 BOTTLETABLET608
71335-0311-7Diphenoxylate Hydrochloride and Atropine Sulfate90 in 1 BOTTLETABLET908

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0311DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [BRYANT RANCH PREPACK]7Current NDC, Legacy NDC, 7 package rows20200121_bd08ed90-dd26-4629-83c0-0f75af6ebb95.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0311-2EA - Each71335-031172bc112e-8029-4fd0-a9db-11463efecbe612022-11-07
71335-0311-4EA - Each71335-031190dba468-e143-4d76-b9f8-0870a57f9d2c12022-11-07

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 9 · 169 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Atropine SulfateATROPINE SULFATEREMEDYREPACK INC.8663ff94-8bea-4061-9fd5-3ab2e85e862e2026-09-04Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Atropine SulfateATROPINE SULFATEREMEDYREPACK INC.532aa441-92ec-42d6-862a-639f8cfe99512026-08-31Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Isopathic Phenolic RingsHOMEOPATHIC LIQUIDEnergetix Corporation98a7ca26-ccb7-43c7-bd65-892fcbacc8822026-08-11WarningsExact identifier
unii: C151H8M554
Lipo-ChordACETICUM AC, ACETYLSAL AC, ADRENOCORTICOTROPHIN, ALUMINA, ARSENICUM ALB, BORAGO, CEANOTHUS, CHELIDONIUM MAJ, CHIONANTHUS, CHLORAMPHENICOLUM, CHLORPROMAZINUM, CHOLESTERINUM, CORTISONE ACETICUM, DAMIANA, FOLLICULINUM, FUMARICUM AC, KALI IOD, LYCOPODIUM, NAT SULPHURICUM, NUX VOM, OLEUM MORRHUAE, PETROLEUM, PHENACETINUM, PHOSPHORICUM AC, PHOSPHORUS, PLUMB MET, SACCHARUM OFF, SILICEA, TARAXACUM, THYROIDINUM.Energetix Corporation5c83cbd5-46fb-48a0-a739-ff9c81e7129c2026-08-11WarningsExact identifier
unii: C151H8M554
AtropineATROPINE SULFATEGland Pharma Limiteda116af5c-ba4c-408c-9a02-4bc33772aa8d2026-08-03Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEA-S Medication Solutionsf94a0189-40d2-42e0-8d2b-c9dc433faad12026-07-29Warnings, Adverse reactionsExact identifier
application number: ANDA086727
rxcui: 1190572
unii: W24OD7YW48
unii: 03J5ZE7KA5
Atropine SulfateATROPINE SULFATEHenry Schein, Inc.0f5b0961-efe7-42c3-898e-2f7fc7fc90b12026-07-28Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
SET 4TE HOMOADEPS SUILLUS, BRYONIA (ALBA), CALCAREA PHOSPHORICA, CHOLINUM, DNA, DOPAMINE (HYDROCHLORIDE), FERRUM PHOSPHORICUM, FOLIC ACID, INSULINUM (HUMAN), LEPTIN, MAGNESIA MURIATICA, L-METHIONINE, METHYLCOBALAMIN, PROTEUS (VULGARIS), RHUS TOX, RIBOFLAVINUM, RUTA GRAVEOLENS, SACCHARUM OFFICINALE, THIOSINAMINUM, ZINCUM METALLICUMDeseret Biologicals, Inc.e7b8d75b-f2bc-4013-91e7-bf5bbec11a902026-06-25WarningsExact identifier
unii: C151H8M554
ATROPINE SULFATEATROPINE SULFATEHF Acquisition Co LLC, DBA HealthFirst768dc21a-b7d9-144c-e053-2991aa0af8892026-06-19Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEREMEDYREPACK INC.3d0e2877-7a74-433f-8a31-e3e54aa9dc9f2026-06-10Warnings, Adverse reactionsExact identifier
rxcui: 1190572
unii: W24OD7YW48
unii: 03J5ZE7KA5
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATERedpharm Drug5342df5c-12bb-565c-e063-6294a90a4ade2026-06-02Warnings, Adverse reactionsExact identifier
rxcui: 1190572
unii: W24OD7YW48
unii: 03J5ZE7KA5
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEBryant Ranch Prepackbd08ed90-dd26-4629-83c0-0f75af6ebb952026-05-21Warnings, Adverse reactionsExact identifier
application number: ANDA086727
ndc (package): 71335-0311-3
ndc (package): 71335-0311-4
ndc (package): 71335-0311-5
ndc (package): 71335-0311-1
ndc (package): 71335-0311-6
ndc (package): 71335-0311-2
ndc (package): 71335-0311-7
ndc (product): 71335-0311
ndc11 (package): 71335031101
rxcui: 1190572
spl id: 758bb992-fe97-4c59-aad1-7b3f7401fd47
spl set id: bd08ed90-dd26-4629-83c0-0f75af6ebb95
unii: W24OD7YW48
unii: 03J5ZE7KA5
PhenohytroPHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, AND SCOPOLAMINE HYDROBROMIDEATLANTIC BIOLOGICALS CORP.a5aaf1db-1938-4073-9da4-c47f959d013e2026-05-19Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Atropine SulfateATROPINE SULFATEHospira, Inc.ad8916e7-206e-409e-2582-30d072845dd42026-05-18Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Atropine sulfateATROPINE SULFATEEdenbridge Pharmaceuticals LLC.b39f5876-5d6f-4a8f-bd24-bd4be24ff5682026-05-07Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
ConnectionANACARDIUM ORIENTALE, AURUM MURIATICUM NATRONATUM, CAMPHORA, DNA, GERMANIUM METALLICUM, HELLEBORUS NIGER, HYDROGEN, LAC CANINUM, LAC MATERNA HUMANUM, LITHIUM CARBONICUM, LITHIUM CARBONICUM, MAGNESIA OXYDATA, NATRUM CARBONICUM, NEON, OXYTOCIN, PLACENTA TOTALIS SUIS, RHUS GLABRA, SACCHARUM OFFICINALE, STRAMONIUM, THUJA OCCIDENTALISDeseret Biologicals, Inc.4a8be3aa-9bd9-4bb1-af98-a940c13b2bd02026-04-10WarningsExact identifier
unii: C151H8M554
ConnectionANACARDIUM ORIENTALE, AURUM MURIATICUM NATRONATUM, CAMPHORA, DNA, GERMANIUM METALLICUM, HELLEBORUS NIGER, HYDROGEN, LAC CANINUM, LAC MATERNA HUMANUM, LITHIUM CARBONICUM, LITHIUM CARBONICUM, MAGNESIA OXYDATA, NATRUM CARBONICUM, NEON, OXYTOCIN, PLACENTA TOTALIS SUIS, RHUS GLABRA, SACCHARUM OFFICINALE, STRAMONIUM, THUJA OCCIDENTALISDeseret Biologicals, Inc.214eb19a-e7a2-421c-9f34-724ce430185c2026-04-10WarningsExact identifier
unii: C151H8M554
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEPreferred Pharmaceuticals Inc.46d5b27b-a710-4767-b308-4f673ddb354c2026-04-06Warnings, Adverse reactionsExact identifier
rxcui: 1190572
unii: W24OD7YW48
unii: 03J5ZE7KA5

Reported adverse events (FAERS/openFDA)#

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