NDC 50383-618-05 - 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
50383-618
Requested NDC
50383-618-05
Package NDCs from labels
50383-618-04, 50383-618-05, 50383-618-06, 50383-618-10, 50383-618-11
Manufacturer
Akorn | Akorn Operating Company LLC
Effective date
2022-03-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Loperamide Hydrochloride - Akorn | Akorn Operating Company LLCAkorn | Akorn Operating Company LLC2022-03-14HUMAN OTC DRUG LABEL
Drug FactsPreferred Pharmaceuticals, Inc.2021-07-12HUMAN OTC DRUG LABEL
Loperamide Hydrochloride - Atlantic Biologicals CorpsAtlantic Biologicals Corps2019-10-16HUMAN OTC DRUG LABEL
Loperamide Hydrochloride - Carilion Materials ManagementCarilion Materials Management2017-12-28HUMAN OTC DRUG LABEL
Loperamide Hydrochloride - A-S Medication SolutionsA-S Medication Solutions2017-10-05HUMAN OTC DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50383-618-04ML - Milliliter50383-6188b63b39a-50bc-4955-a19f-2bf658aab63812012-07-24
50383-618-05ML - Milliliter50383-618cebec501-71fb-4138-b911-b4abaea5d47912013-10-17
50383-618-06ML - Milliliter50383-6184aff43b9-f08c-42f0-891d-7d579728476b12013-08-02
50383-618-10ML - Milliliter50383-61887fa7eba-05a0-4c90-b62a-deeca64cc69a12013-10-17
50383-618-11ML - Milliliter50383-618fdcbc23c-0d0d-4c51-9133-220296523bcb12013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LOPERAMIDE HYDROCHLORIDEACTIVE INGREDIENT77TI35393CLOPERAMIDE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]4
LOPERAMIDEACTIVE MOIETY6X9OC3H4IILOPERAMIDE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]4
ALCOHOLINACTIVE INGREDIENT3K9958V90MLOPERAMIDE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]4
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLLOPERAMIDE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]4
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMLOPERAMIDE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]4
CHERRYINACTIVE INGREDIENTBUC5I9595WLOPERAMIDE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXLOPERAMIDE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]4
MINTINACTIVE INGREDIENTFV98Z8GITPLOPERAMIDE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LOPERAMIDE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]4
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EULOPERAMIDE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]4
SORBITOLINACTIVE INGREDIENT506T60A25RLOPERAMIDE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]4
SUCROSEINACTIVE INGREDIENTC151H8M554LOPERAMIDE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]4
WATERINACTIVE INGREDIENT059QF0KO0RLOPERAMIDE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]4
LOPERAMIDE HYDROCHLORIDEACTIVE INGREDIENT77TI35393CLOPERAMIDE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]3
LOPERAMIDEACTIVE MOIETY6X9OC3H4IILOPERAMIDE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]3
ALCOHOLINACTIVE INGREDIENT3K9958V90MLOPERAMIDE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLLOPERAMIDE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]3
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMLOPERAMIDE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]3
CHERRYINACTIVE INGREDIENTBUC5I9595WLOPERAMIDE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXLOPERAMIDE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]3
MINTINACTIVE INGREDIENTFV98Z8GITPLOPERAMIDE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LOPERAMIDE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EULOPERAMIDE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]3
SORBITOLINACTIVE INGREDIENT506T60A25RLOPERAMIDE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]3
SUCROSEINACTIVE INGREDIENTC151H8M554LOPERAMIDE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RLOPERAMIDE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]3
LOPERAMIDE HYDROCHLORIDEACTIVE INGREDIENT77TI35393CLOPERAMIDE HYDROCHLORIDE SOLUTION [PREFERRED PHARMACEUTICALS, INC.]2
LOPERAMIDEACTIVE MOIETY6X9OC3H4IILOPERAMIDE HYDROCHLORIDE SOLUTION [PREFERRED PHARMACEUTICALS, INC.]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MLOPERAMIDE HYDROCHLORIDE SOLUTION [PREFERRED PHARMACEUTICALS, INC.]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLLOPERAMIDE HYDROCHLORIDE SOLUTION [PREFERRED PHARMACEUTICALS, INC.]2
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMLOPERAMIDE HYDROCHLORIDE SOLUTION [PREFERRED PHARMACEUTICALS, INC.]2
CHERRYINACTIVE INGREDIENTBUC5I9595WLOPERAMIDE HYDROCHLORIDE SOLUTION [PREFERRED PHARMACEUTICALS, INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXLOPERAMIDE HYDROCHLORIDE SOLUTION [PREFERRED PHARMACEUTICALS, INC.]2
MINTINACTIVE INGREDIENTFV98Z8GITPLOPERAMIDE HYDROCHLORIDE SOLUTION [PREFERRED PHARMACEUTICALS, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LOPERAMIDE HYDROCHLORIDE SOLUTION [PREFERRED PHARMACEUTICALS, INC.]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EULOPERAMIDE HYDROCHLORIDE SOLUTION [PREFERRED PHARMACEUTICALS, INC.]2
SORBITOLINACTIVE INGREDIENT506T60A25RLOPERAMIDE HYDROCHLORIDE SOLUTION [PREFERRED PHARMACEUTICALS, INC.]2
SUCROSEINACTIVE INGREDIENTC151H8M554LOPERAMIDE HYDROCHLORIDE SOLUTION [PREFERRED PHARMACEUTICALS, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RLOPERAMIDE HYDROCHLORIDE SOLUTION [PREFERRED PHARMACEUTICALS, INC.]2

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 192 · 3,828 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Advanced Alcohol Gel SanitizerALCOHOLBetco Corporation, Ltda23b997c-b010-5985-e053-2995a90aadf32026-09-09WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hydrating Hand Sanitizer Cotton CandyALCOHOLChurch & Dwight Co., Inc.5b107dd2-a76c-9c80-e063-6394a90aaedb2026-09-09WarningsExact identifier
unii: 3K9958V90M
Pink Touchland Power Mist Hydrating Hand Sanitizer Wild WatermelonALCOHOLChurch & Dwight Co., Inc.5b108f13-6474-fdbd-e063-6294a90a1a2b2026-09-09WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hydrating Hand Sanitizer Mango PassionALCOHOLChurch & Dwight Co., Inc.5b1099ae-f1e8-b79d-e063-6394a90add6f2026-09-09WarningsExact identifier
unii: 3K9958V90M
Touchland Gentle Mist Hand Sanitizer Lily of The ValleyALCOHOLChurch & Dwight Co., Inc.5b10a3a7-1cca-2a34-e063-6294a90a3f6c2026-09-09WarningsExact identifier
unii: 3K9958V90M
Touchland Glow Mist Hand Sanitizer RosewaterALCOHOLChurch & Dwight Co., Inc.5a850866-bc5d-e595-e063-6394a90a335f2026-09-09WarningsExact identifier
unii: 3K9958V90M
Leader Eye Drops Redness ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDECardinal Healthaee4bbe2-4f11-4c54-be8b-df48b3ba4f3a2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDEYYBA CORP5a728c6d-26ec-3316-e063-6394a90ade082026-09-09WarningsExact identifier
unii: 77TI35393C
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMRite Aid Corporation407c78ca-6fee-4ed6-b61b-711ec049c86e2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
Clear Eyes NighttimeGLYCERINPrestige Brands Holdings, Inc.af75e2f7-81dd-43e0-a390-b52bbfbebf622026-09-08WarningsExact identifier
unii: PDC6A3C0OX
hand sanitizer - cherry sundaeALCOHOLGanzhou Olivee Cosmetic Co., Ltd.270d2ce0-6310-4a84-be8a-72db6062bae72026-09-07WarningsExact identifier
unii: 3K9958V90M
hand sanitizer - vanilla frostingALCOHOLGanzhou Olivee Cosmetic Co., Ltd.f6cabda2-6e1c-4238-9a2e-df10e263517d2026-09-07WarningsExact identifier
unii: 3K9958V90M
hydrating mist hand sanitizer with silicone keychain holder - beaver nuggetsALCOHOLGanzhou Olivee Cosmetic Co., Ltd.ba3612b3-9696-417a-ba66-eb9dc5ea27c62026-09-07WarningsExact identifier
unii: 3K9958V90M
hydrating mist hand sanitizer with silicone keychain holder - signature scentALCOHOLGanzhou Olivee Cosmetic Co., Ltd.5b0ac694-66e0-437f-86cd-09f259344b892026-09-07WarningsExact identifier
unii: 3K9958V90M
Sweethearts - Crush On You - Peach SkinALCOHOLScent Theory Products LLC5ac32582-d888-edf4-e063-6394a90a40ab2026-09-05WarningsExact identifier
unii: 3K9958V90M
Sweethearts - Be Mine - Sugared BerriesALCOHOLScent Theory Products LLC5ac32ffb-926a-f249-e063-6394a90a8d872026-09-05WarningsExact identifier
unii: 3K9958V90M
Sweethearts - UR Sweet - Sweet Cherry Hand SanitizerALCOHOLScent Theory Products LLC5ac33b21-9192-8baa-e063-6294a90a6e752026-09-05WarningsExact identifier
unii: 3K9958V90M
Sweethearts - Ooo La La - Banana Cream Hand SanitizerALCOHOLScent Theory Products LLC5ac34dda-fbdf-0ca7-e063-6394a90ab7642026-09-05WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Salted Caramel Scented Hydrating Hand sanitizerALCOHOLChurch & Dwight Co., Inc.5aaa5f5b-7a8b-e887-e063-6294a90a9be52026-09-04WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Peppermint Mocha Scented Hydrating Hand sanitizerALCOHOLChurch & Dwight Co., Inc.5aaa72fe-7667-fb21-e063-6294a90a5e112026-09-04WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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