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 8 of 126 · 2,520 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lancome Paris Teint Idole Ultra Wear Breathable Coverage Foundation Broad Spectrum SPF 25 SunscreenOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc7df9dbd2-7db9-4961-819d-e93d14a065c32026-05-15WarningsExact identifier
unii: 15FIX9V2JP
Lancome Paris Teint Idole Ultra Wear Breathable Coverage Foundation Broad Spectrum SPF 25 SunscreenOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE20efd5fa-3077-4fd4-82d0-ddca946e45282026-05-15WarningsExact identifier
unii: 15FIX9V2JP
MELAO Hydrating Lightweight SunscreenOCTOCRYLENE,HOMOSALATE,ETHYLHEXYL SALICYLATE,PHENYLBENZIMIDAZOLE SULFONIC ACID,BUTYL METHOXYDIBENZOYLMETHANE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd51c353cb-94c4-e110-e063-6394a90a497e2026-05-14WarningsExact identifier
unii: 15FIX9V2JP
Systane Pro PFPROPYLENE GLYCOLAlcon Laboratories, Inc.a12baf3d-f22b-4c9f-a4c8-4e0d09f6d6f12026-05-12WarningsExact identifier
unii: 6DC9Q167V3
Menstrual ReliefACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATECVS Pharmacy289ec101-c9a3-45f1-b2cd-8eaf8e5801302026-05-12WarningsExact identifier
application number: M027
PMS Relief Maximum StrengthACETAMINOPHEN, PAMABROM, PYRILAMINE MALEATECVS Pharmacy760ee367-0625-48d7-98a7-84c69389ad3e2026-05-12WarningsExact identifier
application number: M027
unii: UA8U0KJM72
Even Tone Mineral Sunscreen Broad Spectrum SPF 36 Medium - DarkTITANIUM DIOXIDE AND ZINC OXIDESENT, Inc.aedde765-931f-430e-9fc3-d87bde2b78cd2026-05-12WarningsExact identifier
unii: 15FIX9V2JP
Even Tone Mineral Sunscreen Broad Spectrum SPF 40 Light - MediumTITANIUM DIOXIDE AND ZINC OXIDESENT, Inc.417305d7-d32e-4bc9-8f77-0a42b6bdecf52026-05-12WarningsExact identifier
unii: 15FIX9V2JP
Market Basket Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEDemoulas Super Markets, Inc.e15439c7-0e3c-7752-e053-2995a90a1a402026-05-11WarningsExact identifier
unii: XF417D3PSL
Meijer Effervescent Antacid and Pain ReliefASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATEMeijer Distribution Inc7305972b-aa0f-4daa-e053-2991aa0adfd72026-05-11WarningsExact identifier
unii: XF417D3PSL
The Perfect Derma Mineral Perfection Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDEBella Medical Products LLC518f69fc-fd39-8195-e063-6294a90a3fdd2026-05-11WarningsExact identifier
unii: 15FIX9V2JP
Radical Rescue Morning UVA/UVB Defense Primer Broad Spectrum SPF 30 Universal Tint Mineral SunscreenRADICAL RESCUE SPF 30 MINERAL SUNSCREENProTransit, Inc.38e0139c-bb87-55ba-e063-6294a90a82ee2026-05-11WarningsExact identifier
unii: 15FIX9V2JP
EELHOE SunscreenTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.5196ccb0-4515-7e40-e063-6394a90a09bd2026-05-11WarningsExact identifier
unii: 15FIX9V2JP
Multi-Symptom PMS ReliefACETAMINOPHEN, PAMABROM, PYRILAMINE MALEATECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED81ef39e2-b91e-4d34-b594-4ba557cc319b2026-05-11WarningsExact identifier
application number: M027
unii: UA8U0KJM72
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 5.5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorbb65c8d7-318f-4d52-9d74-ca22ce3896382026-05-07WarningsExact identifier
unii: 15FIX9V2JP
MENSTRUAL RELIEFACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDa44a5cf4-e88a-4da9-907a-8d8497c7d79d2026-05-07WarningsExact identifier
application number: M027
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM, POTASSIUM SORBATE, RESORCINUM, SALICYLICUM ACIDUM,Energique, Inc.2831d28e-9cf1-4a72-9c6c-bb014d0595582026-05-06WarningsExact identifier
unii: 1VPU26JZZ4
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 4.5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior67b90f00-4c82-40cd-af96-f8dedf95f8af2026-05-06WarningsExact identifier
unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 4W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior7a2bd17d-0ea7-4326-9939-a747869c01d22026-05-06WarningsExact identifier
unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 4N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diora396c0eb-f91f-4732-9c20-6b25aa0634b72026-05-06WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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