Home NDC 62011-0390-01 NDC 62011-0390-01 - Anti-Diarrheal 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 62011-0390
Requested NDC 62011-0390-01
Package NDCs from labels 62011-0390-1, 62011-0390-01
Manufacturer Strategic Sourcing Services LLC | Bionpharma Inc. | Patheon Softgels Inc.
Effective date 2022-05-24
Current FDA listing Not matched in FDA.report NDC product tables DailyMed Labels# Label, Manufacturer, Effective date table Label Manufacturer Effective date Type Drug Facts Strategic Sourcing Services LLC | Bionpharma Inc. | Patheon Softgels Inc. 2022-05-24 HUMAN OTC DRUG LABEL
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 62011-0390-1 Anti-Diarrheal 2 in 1 CARTON CAPSULE, LIQUID FILLED 2 3 62011-0390-1 Anti-Diarrheal 12 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 12 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62011-0390 ANTI-DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [STRATEGIC SOURCING SERVICES LLC] 3 Current NDC, Legacy NDC, 2 package rows 20220525_1537febf-2816-438b-979a-8c8f16f06de5.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 33 of 34 · 675 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Anti-Diarrheal LOPERAMIDE HYDROCHLORIDE Strategic Sourcing Services LLC 1537febf-2816-438b-979a-8c8f16f06de5 2022-05-24 Warnings Exact identifier application number: NDA021855 ndc (package): 62011-0390-1 ndc (product): 62011-0390 ndc11 (package): 62011039001 rxcui: 978006 spl id: dfc6d50d-e754-c868-e053-2a95a90aafa8 spl set id: 1537febf-2816-438b-979a-8c8f16f06de5 unii: 77TI35393C Anti-Diarrheal LOPERAMIDE HYDROCHLORIDE HEB 3ea49be2-1744-4d14-bc43-09d35fd4b3c7 2022-05-19 Warnings Exact identifier application number: NDA021855 rxcui: 978006 unii: 77TI35393C Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Aphena Pharma Solutions - Tennessee, LLC 4d69532c-c71a-4880-9f74-4b37d912cabd 2022-05-11 Boxed warning, Warnings, Adverse reactions Exact identifier rxcui: 978006 unii: 77TI35393C Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Proficient Rx LP 82e65393-25b7-4114-9c71-5840ee8bad84 2022-05-02 Warnings Exact identifier unii: 77TI35393C Miracle FootCream Lavender UREA, GLYCERIN, ALOE, DISODIUM EDTA Aloe Vera Korea Co.,Ltd. db520c80-2a2a-5eb1-e053-2995a90a5bb4 2022-03-28 Warnings Exact identifier unii: PDC6A3C0OX Miracle FootCream Lemon UREA, GLYCERIN, ALOE, DISODIUM EDTA Aloe Vera Korea Co.,Ltd. db525c63-29fd-2033-e053-2995a90a56b9 2022-03-28 Warnings Exact identifier unii: PDC6A3C0OX Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Aurohealth LLC 93ebbb23-a9f0-4519-9793-c9056be39f23 2022-03-22 Warnings Exact identifier unii: 77TI35393C Anti-Diarrheal LOPERAMIDE HYDROCHLORIDE AMERISOURCE BERGEN 1a8f6a42-e74f-4725-b12e-b85c2d015191 2022-03-16 Warnings Exact identifier application number: NDA021855 rxcui: 978006 unii: 77TI35393C Sterile Water WATER American Regent, Inc. 78b35864-4bbc-4759-a5c1-7e4f25e22932 2022-01-31 Boxed warning Exact identifier unii: 059QF0KO0R Anti Diarrheal LOPERAMIDE HCL WinCo Foods 3ec4c6c7-c297-4ae4-b275-4c015e922bec 2022-01-06 Warnings Exact identifier unii: 77TI35393C Sterile Diluent for Treprostinil WATER Dr.Reddy's Laboratories Inc., 33050ee2-519b-1f0b-d4df-9e14dd329c57 2021-12-23 Warnings, Adverse reactions Exact identifier unii: 059QF0KO0R leader anti diarrheal LOPERAMIDE HCL Cardinal Health 110, LLC. dba Leader 6761d752-f529-41a7-9b33-73c79481d481 2021-10-07 Warnings Exact identifier unii: 77TI35393C Sterile Water STERILE WATER B. Braun Medical Inc. d99f9133-e4d0-4dee-b611-dbc3f918b547 2021-08-09 Warnings, Adverse reactions Exact identifier unii: 059QF0KO0R Sterile Water WATER B. Braun Medical Inc. 8924e52e-8622-4ed6-a061-1908183e0a18 2021-08-06 Warnings, Adverse reactions Exact identifier unii: 059QF0KO0R Eyewash EYEWASH Global Equipment Company c4f78121-4668-2e0c-e053-2995a90ab6c6 2021-06-17 Warnings Exact identifier unii: 059QF0KO0R Loperamide Hydrochloride, Simethicone LOPERAMIDE HYDROCHLORIDE, SIMETHICONE Guardian Drug Company 1b79204e-8a99-455b-84d6-f381fd7d1135 2021-06-01 Warnings Exact identifier unii: 77TI35393C basic care loperamide hydrochloride LOPERAMIDE HCL Amazon.com Services LLC 732edad8-9a3f-4ce0-a323-c8bffa4acb5f 2021-02-17 Warnings Exact identifier unii: 77TI35393C Sterile Water WATER Asclemed USA, Inc. 45c38269-883c-4198-a9d5-03810a4420ec 2021-01-14 Warnings, Adverse reactions Exact identifier unii: 059QF0KO0R Anti-Diarrheal MARC GLASSMAN Marc Glassman, Inc. ff8719b7-4283-4e2c-baf6-65f250f48938 2020-09-01 Warnings Exact identifier unii: 77TI35393C WELMATE Anti Diarrheal Loperamide HCl LOPERAMIDE HYDROCHLORIDE YYBA CORP ae2e006c-0347-6c35-e053-2a95a90ab7b1 2020-08-31 Warnings Exact identifier unii: 77TI35393C
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.