NDC 59762-1061-01 - 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
59762-1061
Requested NDC
59762-1061-01
Package NDCs from labels
59762-1061-1, 59762-1061-2, 59762-1061-01
Manufacturer
Mylan Pharmaceuticals Inc. | Pfizer Inc | Pfizer Manufacturing Deutschland GmbH
Effective date
2026-02-23
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 Tablets, for oral use C-VMylan Pharmaceuticals Inc. | Pfizer Inc | Pfizer Manufacturing Deutschland GmbH2026-02-23HUMAN PRESCRIPTION DRUG LABEL
Diphenoxylate Hydrochloride and Atropine Sulfate Tablets, for oral use C-VREMEDYREPACK INC.2024-02-27HUMAN PRESCRIPTION DRUG LABEL
Diphenoxylate Hydrochloride and Atropine Sulfate - RedPharm Drug, Inc.RedPharm Drug, Inc.2022-01-20HUMAN PRESCRIPTION DRUG LABEL
Diphenoxylate Hydrochloride and Atropine Sulfate - A-S Medication SolutionsA-S Medication Solutions2020-01-18HUMAN PRESCRIPTION DRUG LABEL
Diphenoxylate Hydrochloride and Atropine Sulfate - A-S Medication SolutionsA-S Medication Solutions2020-01-18HUMAN PRESCRIPTION DRUG LABEL
DIPHENOXYLATE HYDROCHLORIDE - Lake Erie Medical DBA Quality Care Products LLCLake Erie Medical DBA Quality Care Products LLC2017-12-13HUMAN PRESCRIPTION DRUG LABEL
Diphenoxylate Hydrochloride and Atropine Sulfate - Atlantic Biologicals CorpsAtlantic Biologicals Corps2017-06-16HUMAN PRESCRIPTION DRUG LABEL
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE - Direct RxDirect Rx2016-06-22HUMAN PRESCRIPTION DRUG LABEL
DIPHENOXYLATE HYDROCHLORIDE - Aphena Pharma Solutions - Tennessee, LLCAphena Pharma Solutions - Tennessee, LLC2016-06-10HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59762-1061-1Diphenoxylate Hydrochloride and Atropine Sulfate100 in 1 BOTTLETABLET10011
59762-1061-2Diphenoxylate Hydrochloride and Atropine Sulfate1000 in 1 BOTTLETABLET100011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59762-1061DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [MYLAN PHARMACEUTICALS INC.]10Current NDC, Legacy NDC, 2 package rows20250522_83bcc2fb-6fb0-4f0e-8e66-592d327684ec.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59762-1061-1EA - Each59762-1061623b343e-37e7-479a-94b5-cfb11604404112012-07-24
59762-1061-2EA - Each59762-1061dfb2e6a3-3875-45b5-b72a-7284a5b6716a12013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATROPINE SULFATEACTIVE INGREDIENT03J5ZE7KA5DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [GREENSTONE LLC]3
DIPHENOXYLATE HYDROCHLORIDEACTIVE INGREDIENTW24OD7YW48DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [GREENSTONE LLC]3
ATROPINEACTIVE MOIETY7C0697DR9IDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [GREENSTONE LLC]3
DIPHENOXYLATEACTIVE MOIETY73312P173GDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [GREENSTONE LLC]3
ACACIAINACTIVE INGREDIENT5C5403N26ODIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [GREENSTONE LLC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [GREENSTONE LLC]3
SORBITOLINACTIVE INGREDIENT506T60A25RDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [GREENSTONE LLC]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [GREENSTONE LLC]3
SUCROSEINACTIVE INGREDIENTC151H8M554DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [GREENSTONE LLC]3
TALCINACTIVE INGREDIENT7SEV7J4R1UDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [GREENSTONE LLC]3
ATROPINE SULFATEACTIVE INGREDIENT03J5ZE7KA5DIRECT RX (DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE) TABLET [DIRECT RX]1
DIPHENOXYLATE HYDROCHLORIDEACTIVE INGREDIENTW24OD7YW48DIRECT RX (DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE) TABLET [DIRECT RX]1
ATROPINEACTIVE MOIETY7C0697DR9IDIRECT RX (DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE) TABLET [DIRECT RX]1
DIPHENOXYLATEACTIVE MOIETY73312P173GDIRECT RX (DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE) TABLET [DIRECT RX]1
ACACIAINACTIVE INGREDIENT5C5403N26ODIRECT RX (DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE) TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIRECT RX (DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE) TABLET [DIRECT RX]1
SORBITOLINACTIVE INGREDIENT506T60A25RDIRECT RX (DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE) TABLET [DIRECT RX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDIRECT RX (DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE) TABLET [DIRECT RX]1
SUCROSEINACTIVE INGREDIENTC151H8M554DIRECT RX (DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE) TABLET [DIRECT RX]1
TALCINACTIVE INGREDIENT7SEV7J4R1UDIRECT RX (DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE) TABLET [DIRECT RX]1

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 10 · 197 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
rxcui: 1190572
unii: W24OD7YW48
unii: 03J5ZE7KA5
Atropine SulfateATROPINE SULFATEHenry Schein, Inc.0f5b0961-efe7-42c3-898e-2f7fc7fc90b12026-07-28Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BOVISTA, CARBO VEGETABILIS, CARBONEUM SULPHURATUM, COFFEA CRUDA, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SULPHUR, ACETYLSALICYLICUM ACIDUM, FORMALINUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, TEREBINTHINA, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM,Energique, Inc.2e361b50-9268-4053-b13c-93af645498482026-06-25WarningsExact identifier
unii: 506T60A25R
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
rxcui: 1190572
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
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM, POTASSIUM SORBATE, RESORCINUM, SALICYLICUM ACIDUM,Energique, Inc.2831d28e-9cf1-4a72-9c6c-bb014d0595582026-05-06WarningsExact identifier
unii: 506T60A25R
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
Atropine SulfateATROPINE SULFATEREMEDYREPACK INC.46ba6000-b842-449a-8dd4-7bb9dc7a74c52026-04-03Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
MotofenDIFENOXIN AND ATROPINE SULFATELegacy Pharma USA Inc.1fa11c67-5492-469c-9475-6bfa0e5e9ff82026-03-23Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5