FDA.reportPublic FDA data

NDC 52389-325-01 - Diurex

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
52389-325
Requested NDC
52389-325-01
Package NDCs from labels
52389-325-01, 52389-325-42, 52389-325-21
Manufacturer
Alva-Amco Pharmacal Companies, Inc.
Effective date
2024-05-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Diurex CapsulesAlva-Amco Pharmacal Companies, Inc.2024-05-15HUMAN OTC DRUG LABEL

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52389-325DIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]8Legacy NDC20240517_ab10451e-ff87-4974-bec4-7ba19c5bbe65.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PamabromACTIVE INGREDIENTUA8U0KJM72DIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
PamabromACTIVE MOIETYUA8U0KJM72DIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
Butyl alcoholINACTIVE INGREDIENT8PJ61P6TS3DIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
Citric acidINACTIVE INGREDIENT2968PHW8QPDIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDDIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOADIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8DIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
GelatinINACTIVE INGREDIENT2G86QN327LDIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
Magnesium oxideINACTIVE INGREDIENT3A3U0GI71GDIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
Polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HDIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
Potassium sorbateINACTIVE INGREDIENT1VPU26JZZ4DIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
PovidoneINACTIVE INGREDIENTFZ989GH94EDIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
Propylene glycolINACTIVE INGREDIENT6DC9Q167V3DIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
RiboflavinINACTIVE INGREDIENTTLM2976OFRDIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
ShellacINACTIVE INGREDIENT46N107B71ODIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
Sodium hydroxideINACTIVE INGREDIENT55X04QC32IDIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
SucroseINACTIVE INGREDIENTC151H8M554DIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
TalcINACTIVE INGREDIENT7SEV7J4R1UDIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
Titanium dioxideINACTIVE INGREDIENT15FIX9V2JPDIUREX (PAMABROM) CAPSULE [ALVA-AMCO PHARMACAL COMPANIES, INC.]3

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 126 · 2,520 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: FZ989GH94E
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPSPOVIDONE, POLYVINYL ALCOHOL SOLUTIONHarrow Eye, LLC049e9cc9-0663-53bc-e063-6294a90a2c4f2026-09-04WarningsExact identifier
unii: FZ989GH94E
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
unii: 15FIX9V2JP
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
unii: FZ989GH94E
Rohto Max StrengthNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companye4b49550-1ca3-4bd7-854d-409b53fa5e262026-08-20WarningsExact identifier
unii: 6OZP39ZG8H
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: 6DC9Q167V3
unii: FZ989GH94E
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: 6DC9Q167V3
unii: FZ989GH94E
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
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: TLM2976OFR
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

Reported adverse events (FAERS/openFDA)#

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