FDA.reportPublic FDA data

NDC 68094-107-59 - 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
68094-107
Requested NDC
68094-107-59
Package NDCs from labels
68094-107-59, 68094-107-62
Manufacturer
Precision Dose Inc.
Effective date
2019-06-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
LOPERAMIDE HYDROCHLORIDE ORAL SUSPENSIONPrecision Dose Inc.2019-06-20HUMAN OTC DRUG LABEL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Loperamide HydrochlorideACTIVE INGREDIENT77TI35393CLOPERAMIDE HYDROCHLORIDE SUSPENSION [PRECISION DOSE INC.]1
LoperamideACTIVE MOIETY6X9OC3H4IILOPERAMIDE HYDROCHLORIDE SUSPENSION [PRECISION DOSE INC.]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLLOPERAMIDE HYDROCHLORIDE SUSPENSION [PRECISION DOSE INC.]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311LOPERAMIDE HYDROCHLORIDE SUSPENSION [PRECISION DOSE INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULOPERAMIDE HYDROCHLORIDE SUSPENSION [PRECISION DOSE INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLOPERAMIDE HYDROCHLORIDE SUSPENSION [PRECISION DOSE INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDLOPERAMIDE HYDROCHLORIDE SUSPENSION [PRECISION DOSE INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXLOPERAMIDE HYDROCHLORIDE SUSPENSION [PRECISION DOSE INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LOPERAMIDE HYDROCHLORIDE SUSPENSION [PRECISION DOSE INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EULOPERAMIDE HYDROCHLORIDE SUSPENSION [PRECISION DOSE INC.]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4LOPERAMIDE HYDROCHLORIDE SUSPENSION [PRECISION DOSE INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLOPERAMIDE HYDROCHLORIDE SUSPENSION [PRECISION DOSE INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RLOPERAMIDE HYDROCHLORIDE SUSPENSION [PRECISION DOSE INC.]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEELOPERAMIDE HYDROCHLORIDE SUSPENSION [PRECISION DOSE INC.]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 2 of 148 · 2,941 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
unii: 15FIX9V2JP
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: 6DC9Q167V3
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP
anti diarrhealLOPERAMIDE HCLCVS Pharmacy68467222-c8b4-4029-a180-59a57d0090d32026-08-19WarningsExact identifier
unii: 77TI35393C
Anti-DiarrhealLOPERAMIDE HCLDOLGENCORP, LLC78814c22-5be2-45ee-b0be-977844746fcc2026-08-18WarningsExact identifier
unii: 77TI35393C
Anti-DiarrhealLOPERAMIDE HCLRedpharm Drug594b9c93-488a-0df0-e063-6394a90a2e992026-08-18WarningsExact identifier
unii: 77TI35393C
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: 6DC9Q167V3
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: 6DC9Q167V3
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30HAMBLIN DERMATOLOGY5942e64c-416e-7525-e063-6394a90a28392026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Protect Tinted Mineral SunscreenBROAD SPECTRUM SPF30Opal Day Spa5943413a-48e1-0bdf-e063-6294a90a2fff2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30MedSpa By Beauty Bar LLC5943ba3d-688e-9e9c-e063-6294a90afa9a2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30CORBY, JR., TERRY L.594443fd-8e27-4ec6-e063-6294a90a3ff02026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: PDC6A3C0OX
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
BM BM164 DROPSARUM TRYPH, CAUSTICUM, BALSAMUM PERU, HELONIAS DIO, ACID PHOS, GLYCERINUM, EQUISETUMBM Private Limited5902770f-eb01-d099-e063-6394a90ad3eb2026-08-14WarningsExact identifier
unii: PDC6A3C0OX
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEStrides Pharma, Inc.4178b3cc-e1ca-4912-8b1f-eac0110a39402026-08-13WarningsExact identifier
unii: 77TI35393C
AdaptopathADENOSINUM CYCLOPHOSPHORICUM, ALPHA-LIPOICUM ACIDUM, ARGENTUM METALLICUM, AVENA SATIVA, CAPSICUM ANNUUM, CITRICUM ACIDUM, COENZYME A, CUPRUM METALLICUM, GINKGO BILOBA, GLANDULA SUPRARENALIS SUIS, GLYCYRRHIZA GLABRA, HYPOTHALAMUS (BOVINE), IODIUM, LEDUM PALUSTRE, MANGANUM ACETICUM, NADIDUM, NATRUM CARBONICUM, OLEUM MORRHUAE, PHOSPHORICUM ACIDUM, PICRICUM ACIDUM, RIBOFLAVINUM, SELENIUM METALLICUM SEPIA, SILICEA, THIAMINUM HYDROCHLORICUM, THYROIDINUM (BOVINE), VANADIUM METALLICUMEnergetix Corporation41234598-0cb5-41c2-bfbe-1c15ee9bf5022026-08-11WarningsExact identifier
unii: XF417D3PSL
Aller-Chord AALFALFA, ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, BRYONIA (ALBA), CITRICUM ACIDUM, COUMARINUM, EUPHRASIA OFFICINALIS, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, HYDRASTIS CANADENSIS, JUNIPERUS COMMUNIS, MUCOSA NASALIS SUIS, NATRUM SULPHURICUM, PHOSPHORUS, POTHOS FOETIDUS, PULSATILLA (VULGARIS), SOLIDAGO VIRGAUREA, SULPHUR, TANACETUM VULGARE, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSEEnergetix Corporation09e89c92-112d-4320-9df5-b9f938bb90952026-08-11WarningsExact identifier
unii: XF417D3PSL
Hepatic-ToneCARDUUS MARIANUS, CEANOTHUS AMERICANUS, CHELIDONIUM MAJUS, CHIONANTHUS VIRGINICA, CITRICUM ACIDUM, CYSTEINUM, HEPAR SUIS, LEPTANDRA VIRGINICA, MAGNESIA MURIATICA, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS, QUASSIA (AMARA), TARAXACUM OFFICINALEEnergetix Corporationd5f61f13-7e9f-4e46-8ad8-0336f36288df2026-08-11WarningsExact identifier
unii: XF417D3PSL

Reported adverse events (FAERS/openFDA)#

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