FDA.reportPublic FDA data

NDC 48433-063-01 - Loperamide Hydrochloride

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
48433-063
Requested NDC
48433-063-01
Package NDCs from labels
48433-063-01, 48433-063-20
Manufacturer
Cardinal Health 107, LLC
Effective date
2026-07-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Loperamide Hydrochloride - Cardinal Health 107, LLCCardinal Health 107, LLC2026-07-09HUMAN PRESCRIPTION DRUG LABEL
Loperamide Hydrochloride - Safecor Health LLCSafecor Health LLC2026-03-19HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48433-063-01Loperamide Hydrochloride1 in 1 BLISTER PACKCAPSULE13
48433-063-20Loperamide Hydrochloride100 in 1 CARTONCAPSULE1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
48433-063-20EA - Each48433-0634b519fea-c4ba-4eeb-8e59-d0c91851460f12026-05-22

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 133 of 146 · 2,917 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
bareMinerals Original Foundation Broad Spectrum SPF 15 Fairly Light 03TITANIUM DIOXIDEOrveon Global US LLCb2909888-5a98-4894-a895-230aa53f64d92023-10-04WarningsExact identifier
unii: 15FIX9V2JP
bareMinerals Original Foundation Broad Spectrum SPF 15 Tan 19TITANIUM DIOXIDE AND ZINC OXIDEOrveon Global US LLCa5888955-f381-4209-9589-bd2e79a84f592023-10-04WarningsExact identifier
unii: 15FIX9V2JP
bareMinerals Original Foundation Broad Spectrum SPF 15 Light 08TITANIUM DIOXIDE AND ZINC OXIDEOrveon Global US LLCad15bdee-67e6-4281-8144-e84b7c478a342023-10-04WarningsExact identifier
unii: 15FIX9V2JP
bareMinerals Original Foundation Broad Spectrum SPF 15 Medium Tan 18TITANIUM DIOXIDE AND ZINC OXIDEOrveon Global US LLCaa4d7945-6cc9-4f20-b588-a5588e57d30a2023-10-04WarningsExact identifier
unii: 15FIX9V2JP
bareMinerals Original Foundation Broad Spectrum SPF 15 Golden Tan 20TITANIUM DIOXIDE AND ZINC OXIDEOrveon Global US LLC2f8b6c57-dcae-408e-898d-d5630deeb0902023-10-04WarningsExact identifier
unii: 15FIX9V2JP
bareMinerals Original Foundation Broad Spectrum SPF 15 Golden Fair 04TITANIUM DIOXIDE AND ZINC OXIDEOrveon Global US LLCe486915b-8097-451a-a018-3279213239b32023-10-04WarningsExact identifier
unii: 15FIX9V2JP
bareMinerals Original Foundation Broad Spectrum SPF 15 Golden Deep 28TITANIUM DIOXIDE AND ZINC OXIDEOrveon Global US LLC5b51df09-40c3-4064-96d3-b7366fc838262023-10-04WarningsExact identifier
unii: 15FIX9V2JP
bareMinerals Original Foundation Broad Spectrum SPF 15 Fairly Medium 05TITANIUM DIOXIDE AND ZINC OXIDEOrveon Global US LLCf1714e23-030c-4bd9-b9e7-111c3813ed342023-10-04WarningsExact identifier
unii: 15FIX9V2JP
bareMinerals Original Foundation Broad Spectrum SPF 15 Medium Dark 23TITANIUM DIOXIDE AND ZINC OXIDEOrveon Global US LLC828fe263-f223-45c3-9710-fd8d59ad56b12023-10-04WarningsExact identifier
unii: 15FIX9V2JP
bareMinerals Multi-Tasking SPF 20 Concealer BisqueTITANIUM DIOXIDEOrveon Global US LLCd4c30bea-8c56-4ed8-8ec4-f1b1e0e456dd2023-10-04WarningsExact identifier
unii: 15FIX9V2JP
BareMinerals Mineral VeilTITANIUM DIOXIDE AND ZINC OXIDEOrveon Global US LLC64b163dd-8a86-483f-8dab-80fa8740b12f2023-10-04WarningsExact identifier
unii: 15FIX9V2JP
BHI MigraineACETIC ACID, ARANEUS DIADEMATUS, ASAFETIDA, BRYONIA ALBA WHOLE, TRIBASIC CALCIUM PHOSPHATE, ACTIVATED CHARCOAL, CINCHONA OFFICINALIS BARK, MARSDENIA CONDURANGO BARK, TUBOCURARINE CHLORIDE, KALMIA LATIFOLIA LEAF, LYCOPODIUM CLAVATUM SPORE, SODIUM SULFATE, PHOSPHORIC ACID, PULSATILLA VULGARIS, CLAVICEPS PURPUREA SCLEROTIUM, AND SILICON DIOXIDEMediNatura Inc11cad8ba-6914-420e-bab0-4ca37d33f2e62023-09-28WarningsExact identifier
unii: ETJ7Z6XBU4
ZeelALPHA LIPOIC ACID, ARNICA MONTANA WHOLE,SUS SCROFA CARTILAGE, COENZYME A,SOLANUM DULCAMARA TOP,SUS SCROFA EMBRYO,SUS SCROFA UMBILICAL CORD, NADIDE, SODIUM DIETHYL OXALACETATE,SUS SCROFA PLACENTA,TOXICODENDRON PUBESCENS LEAF, SANGUINARIA CANADENSIS ROOT, SILICON DIOXIDE,SULFUR,CORIANDERBiologische Heilmittel Heeld5d7a2e5-a6ce-4a41-9430-1378023aa7d02023-09-28WarningsExact identifier
unii: ETJ7Z6XBU4
DR ANDREW WEILS FOR ORIGINS MEGA-DEFENSE ADVANCED DAILY UV DEFENDER BROAD SPECTRUM SPF 45TITANIUM DIOXIDE AND ZINC OXIDEORIGINS NATURAL RESOURCES INC.11248cab-c3a5-4e16-8280-9f70bb863cf72023-09-11WarningsExact identifier
unii: 15FIX9V2JP
LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDEAurobindo Pharma Limited8d142533-4e87-4030-8fe9-4fc7473b04422023-09-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 978006
unii: 77TI35393C
Stomach DistressBISMUTHUM SUBNITRICUM, CALCAREA SULPHURICA, CARBO ANIMALIS, CARBO VEGETABILIS, CINCHONA OFFICINALIS, HYDRASTIS CANADENSIS, NUX VOMICA, ORNITHOGALUM UMBELLATUM, PYROGENIUM, SILICEA,Liddell Laboratories, Inc.4c764fbe-2fbf-4f06-9ad5-824373c6929a2023-09-11WarningsExact identifier
unii: ETJ7Z6XBU4
ANUBISMEDHA HYALURONICANUBIS COSMETICS SLeac771e2-4c1b-3808-e053-2995a90ac5fc2023-09-05WarningsExact identifier
unii: 6DC9Q167V3
AnubisMedSPF 50 BROAD SPECTRUM PROTECTION FLUID EMULSIONANUBIS COSMETICS SLe99d92c4-8768-9c0a-e053-2a95a90a609e2023-09-05WarningsExact identifier
unii: 6DC9Q167V3
unii: ETJ7Z6XBU4
unii: 15FIX9V2JP
AnubisMedAZELAIC ACID, SALICYLIC ACIDANUBIS COSMETICS SLebf3153d-30f5-54e4-e053-2995a90a74b12023-09-05WarningsExact identifier
unii: 6DC9Q167V3
AnubisMedGLYCOLIC ACID, CITRIC ACID, LACTIC ACID, KOJIC ACIDANUBIS COSMETICS SLeca95dde-cb57-2ab6-e053-2995a90af84f2023-09-05WarningsExact identifier
unii: 6DC9Q167V3

Reported adverse events (FAERS/openFDA)#

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