FDA.reportPublic FDA data

NDC 68071-4063-01 - 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
68071-4063
Requested NDC
68071-4063-01
Package NDCs from labels
68071-4063-1, 68071-4063-5, 68071-4063-2, 68071-4063-3, 68071-4063-01
Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2024-07-18
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 USP, CV Rx onlyNuCare Pharmaceuticals,Inc.2024-07-18HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
68071-4063-12023-05-02Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only
68071-4063-22023-05-02Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only
68071-4063-32023-05-02Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only
68071-4063-52023-05-02Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only
68071-4063-12023-01-30Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only
68071-4063-22023-01-30Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only
68071-4063-32023-01-30Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only
68071-4063-52023-01-30Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only
68071-4063-12021-02-12Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only
68071-4063-22021-02-12Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only
68071-4063-32021-02-12Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only
68071-4063-52021-02-12Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only
68071-4063-12021-01-29Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only
68071-4063-22021-01-29Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only
68071-4063-32021-01-29Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only
68071-4063-52021-01-29Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USP, CV Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4063-1Diphenoxylate Hydrochloride and Atropine Sulfate10 in 1 BOTTLETABLET106
68071-4063-2Diphenoxylate Hydrochloride and Atropine Sulfate20 in 1 BOTTLETABLET206
68071-4063-3Diphenoxylate Hydrochloride and Atropine Sulfate30 in 1 BOTTLETABLET306
68071-4063-5Diphenoxylate Hydrochloride and Atropine Sulfate15 in 1 BOTTLETABLET156

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4063DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [NUCARE PHARMACEUTICALS,INC.]6Current NDC, Legacy NDC, 4 package rows20240720_575c38b4-7ec0-6d25-e053-2a91aa0a80fc.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 7 of 9 · 169 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
B05 GLUCO BALANCEADRENALINUM, ARGENTUM NITRICUM, BOS TAURUS PITUITARUM POSTERIUM, GLYCERINUM, GLYCYRRHIZA GLABRA, KALI CARBONICUM, LACTICUM ACIDUM, MAGNESIA SULPHURICA, NICCOLUM METALLICUM, PANCREATINUM, PHOSPHORICUM ACIDUM, SACCHARINUM, SACCHARUM LACTIS, SACCHARUM OFFICINALE, SARCOLACTICUM ACIDUM, SELENIUM METALLICUM, SYZYGIUM JAMBOLANUM, THYROIDINUM, ZINCUM METALLICUMApex Energetics Inc.bae9ff7e-eb69-c61d-e053-2995a90a26272024-01-08WarningsExact identifier
unii: C151H8M554
AtropineATROPINE SULFATEA-S Medication Solutions1b2d030e-c0ec-484b-a228-76011702cdd02024-01-02Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Atropine SulfateATROPINE SULFATEMedical Purchasing Solutions, LLC0aab13de-04bf-2a14-e063-6294a90aae112023-11-15Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Saccharum officinaleSUCROSEBoiron86d04552-b31a-0fcf-e053-2991aa0acecd2023-11-14Exact identifier
unii: C151H8M554
Saccharum officinaleSUCROSEBoiron86d05561-6f09-6f1f-e053-2a91aa0a4b982023-11-14Exact identifier
unii: C151H8M554
Atropine SulfateATROPINE SULFATEMedical Purchasing Solutions, LLC09d086f2-db9a-5e15-e063-6394a90abe182023-11-10Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
BHI Spasm PainATROPINE SULFATE, ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CITRULLUS COLOCYNTHIS FRUIT PULP, AND CUPRIC SULFATEMediNatura Inc3e117ea6-bbb2-4b77-b3ce-01572e6d71c12023-09-28WarningsExact identifier
unii: 03J5ZE7KA5
AllergiesAPIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUMNewton Laboratories, Inc.0631d5e5-9da4-bcb7-e063-6394a90a62de2023-09-25WarningsExact identifier
unii: C151H8M554
Hepaticol SarcodeCARDUUS MARIANUS, ZINGIBER OFFICINALE, BERBERIS VULGARIS, CHELIDONIUM MAJUS, MAGNESIA MURIATICA, LEPTANDRA VIRGINICA, NATRUM MURIATICUM, BRYONIA (ALBA), HEPAR (BOVINE), NATRUM SULPHURICUM, ATROPINUM SULPHURICUM, LYCOPODIUM CLAVATUMNutritional Specialties, Inc.f9d95b2f-53d9-4017-873f-5ad0b129f9f82023-08-14WarningsExact identifier
unii: 03J5ZE7KA5
Renal SarcodeRUBIA TINCTORUM, URTICA DIOICA, SARSAPARILLA (SMILAX REGELII), BERBERIS VULGARIS, COCCUS CACTI, BENZOICUM ACIDUM, KIDNEY (BOVINE), LITHIUM CARBONICUM, LYCOPODIUM CLAVATUM, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, COLOCYNTHIS, ATROPINUM SULPHURICUM, CALCAREA CARBONICA, HYDRANGEA ARBORESCENSNutritional Specialties, Inc.bb3e5fd7-11be-4f02-95b9-43a05c3b737f2023-08-11WarningsExact identifier
unii: 03J5ZE7KA5
Adrenal SarcodeCARDUUS MARIANUS, BERBERIS VULGARIS, CHELIDONIUM MAJUS, ECHINACEA PURPUREA, ZINGIBER OFFICINALE, BRYONIA (ALBA), GLANDULA SUPRARENALIS (BOVINE), SPLEEN (SUIS), ATROPINUM SULPHURICUM, MAGNESIA PHOSPHORICA, LYCOPODIUM CLAVATUMNutritional Specialties, Inc.31fc95f6-4089-4ec8-b787-518d7d5306f92023-08-04WarningsExact identifier
unii: 03J5ZE7KA5
AllergiesAPIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUMNewton Laboratories, Inc.017f3bcf-0e45-d390-e063-6394a90a588e2023-07-28WarningsExact identifier
unii: C151H8M554
AllergiesAPIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUMNewton Laboratories, Inc.017f0210-195d-11d7-e063-6294a90aa7502023-07-27WarningsExact identifier
unii: C151H8M554
Leaky Gut FormulaALFALFA, GLYCYRRHIZA GLABRA, ASTACUS FLUVIATILIS, BERBERIS AQUIFOLIUM, LAC DEFLORATUM, NATRUM CARBONICUM, SACCHARUM OFFICINALE, ALOE, FEL TAURI, PANCREAS SUIS, PANCREATINUM, FRAGARIA VESCA, ANTIMONIUM CRUDUM, CARBO VEGETABILIS, EUPHORBIUM OFFICINARUM, LYCOPODIUM CLAVATUM, MAGNESIA CARBONICA, ZINCUM METALLICUM, COLIBACILLINUM CUM NATRUM MURIATICUM, PROTEUS (VULGARIS)Deseret Biologicals, Inc.8679e9ab-8610-47f1-be0e-66897f99881d2023-07-14WarningsExact identifier
unii: C151H8M554
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATESpecGx LLC24915aa0-1600-44bb-99fc-46529a7941242023-06-27Warnings, Adverse reactionsExact identifier
rxcui: 1190572
unii: W24OD7YW48
unii: 03J5ZE7KA5
Grain and Seed AntigensAMARANTH, BAMBOO, BARLEY, BUCKWHEAT, CORN, FLAX SEED, LENTILS, MILLET, MILO, OAT, POPPY SEED, RICE, RYE, SESAME, SOYBEAN, SUGARCANE, SUNFLOWER SEED, WHEAT, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, SULPHURBioActive Nutritional, Inc.36ce44a5-e5ac-4eea-b76d-424dcd4e6b072023-06-20WarningsExact identifier
unii: C151H8M554
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEAphena Pharma Solutions - Tennessee, LLCc11574c7-8344-4987-85ef-f2404daa08852023-06-13Warnings, Adverse reactionsExact identifier
rxcui: 1190572
unii: W24OD7YW48
unii: 03J5ZE7KA5
Atropine SulfateATROPINE SULFATEMedical Purchasing Solutions, LLC6bb51b79-ae86-aebf-e053-2991aa0a8d332023-05-31Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Atropine SulfateATROPINE SULFATEMedical Purchasing Solutions, LLCc434062a-cd44-e684-e053-2995a90a91c32023-04-27Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
ATROPINE SULFATEATROPINE SULFATEMedical Purchasing Solutions, LLCfa1c953b-723b-1abe-e053-6394a90a967f2023-04-24Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5

Reported adverse events (FAERS/openFDA)#

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