FDA.reportPublic FDA data

NDC 48433-090-01 - Spironolactone and Hydrochlorothiazide

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
48433-090
Requested NDC
48433-090-01
Package NDCs from labels
48433-090-01, 48433-090-20
Manufacturer
Safecor Health LLC
Effective date
2026-06-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Spironolactone and Hydrochlorothiazide - Safecor Health LLCSafecor Health LLC2026-06-29HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48433-090-01Spironolactone and Hydrochlorothiazide1 in 1 BLISTER PACKTABLET12
48433-090-20Spironolactone and Hydrochlorothiazide100 in 1 CARTONTABLET1002

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 32 of 176 · 3,513 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RICHTOFIT RAPID ACTIVE LEG AND FOOTMENTHOLRICHTOFIT LIMITED LIABILITY COMPANY4c357696-ca96-e6ad-e063-6294a90aaadb2026-03-16WarningsExact identifier
unii: L7T10EIP3A
Xpect Stopain ClinicalMENTHOLCintas Corporation348e6062-b31e-435e-a153-6aa868b50efa2026-03-13WarningsExact identifier
unii: L7T10EIP3A
DGH GREASELESS MUSCLE RUB ANALGESICMENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATEDOLLAR GENERAL225abfe0-ec72-4667-96b2-7657e989672b2026-03-13WarningsExact identifier
unii: L7T10EIP3A
NUMBINGMENTHOLFlexiGo Inc4ce416dd-2430-4648-e063-6294a90ab1992026-03-13WarningsExact identifier
unii: L7T10EIP3A
CVS Professional Pain ReliefMENTHOLCVS Pharmacy48836a5b-0baa-b7ee-e063-6294a90ac12b2026-03-13WarningsExact identifier
unii: L7T10EIP3A
LigatoneARNICA MONTANA, BRYONIA, CALCAREA PHOSPHORICA, CAUSTICUM, KALI CARBONICUM, MANGANESE GLUCONATE, MEZEREUM, RHUS TOX, RUTA GRAVEOLENS, SILICEABioActive Nutritional, Inc.3a3bdd55-daec-43b9-a380-54a747fb7d102026-03-13WarningsExact identifier
unii: ETJ7Z6XBU4
Spironolactone and HydrochlorothiazideSPIRONOLACTONE AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack905568ae-ce27-4978-90c7-b5c93279ecd12026-03-12Warnings, Adverse reactionsExact identifier
rxcui: 198224
unii: 0J48LPH2TH
unii: 27O7W4T232
NanoX Pain RelievingMENTHOL, METHYL SALICYLATEMG Science Technologies LLC4cc38927-8a8c-2df3-e063-6294a90aa0c12026-03-12WarningsExact identifier
unii: L7T10EIP3A
BEE VENOM SKIN FIRMING CreamBEE VENOMGuangzhou Mizi Biotechnology Co., LTD.4ccf576f-b6bb-42ac-e063-6294a90a36522026-03-12WarningsExact identifier
unii: AV092KU4JH
CVS Lidocaine Pain ReliefLIDOCAINE HYDROCHLORIDE, MENTHOLCVS Pharmacy48c045ae-56b5-62c2-e063-6394a90aaf442026-03-12WarningsExact identifier
unii: L7T10EIP3A
Medicated Pain Relief PatchCAMPHOR, MENTHOL, METHYL SALICYLATEKroger Company47cc4b05-a937-4624-bf41-85b8bd7c049e2026-03-12WarningsExact identifier
unii: L7T10EIP3A
RICHTOFIT RAPID ACTIVE ARTHRITISMENTHOL AND CAMPHORRICHTOFIT LIMITED LIABILITY COMPANY4b1cdab1-3e50-4ec3-e063-6394a90af75e2026-03-12WarningsExact identifier
unii: L7T10EIP3A
SpironolactoneSPIRONOLACTONEMylan Pharmaceuticals Inc.beaf74db-4159-3b59-ef99-575c3ac99aa12026-03-12Warnings, Adverse reactionsExact identifier
unii: 27O7W4T232
SpironolactoneSPIRONOLACTONERising Pharma Holdings, Inc.ac487ae2-e15f-4781-bae3-a03058cfcfe42026-03-11Warnings, Adverse reactionsExact identifier
unii: 27O7W4T232
5Kind DMSO 4 Lidocaine HCl Pain RelievingLIDOCAINE HYDROCHLORIDE, MENTHOL5KIND TRADING LTD67d8d045-7fa0-46c2-8072-645d8823903b2026-03-11WarningsExact identifier
unii: L7T10EIP3A
Spironolactone and HydrochlorothiazideSPIRONOLACTONE AND HYDROCHLOROTHIAZIDEMylan Pharmaceuticals Inc.0c8c973f-13a2-4883-8316-4006398e29312026-03-11Warnings, Adverse reactionsExact identifier
application number: ANDA086513
ndc (product): 0378-0403
rxcui: 198224
spl id: d37da837-e7ff-475b-b7fc-ae8d8ef5f020
spl set id: 0c8c973f-13a2-4883-8316-4006398e2931
unii: 0J48LPH2TH
unii: 27O7W4T232
Lower GI and Probiotic RestorationAETHUSA CYNAPIUM, ALLIUM SATIVUM, BAPTISIA TINCTORIA, CAPSICUM ANNUUM, CARBO VEGETABILIS, CHAMOMILLA, CINCHONA OFFICINALIS, COLLINSONIA CANADENSIS, COLOCYNTHIS, CONDURANGO, GAMBOGIA, GRATIOLA OFFICINALIS, LAC VACCINUM, LACTICUM ACIDUM, NATRUM CARBONICUM, NUX VOMICA, PODOPHYLLUM PELTATUM, SEPIA AND SILICEA.King Bio Inc.2e1f3ca1-9036-4f14-bd3c-d0eed9a9ff932026-03-10WarningsExact identifier
unii: ETJ7Z6XBU4
Benicar HCTOLMESARTAN MEDOXOMIL-HYDROCHLOROTHIAZIDECosette Pharmaceuticals, Inc.a90915ca-f9d3-4fff-8370-d5dc4cdfc5212026-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Natouch Antifungal Wipes PlusANTIFUNGAL ANTISEPTIC WIPES PLUSNatouch LLCa85cb307-b3ad-1584-e053-2995a90a9a702026-03-10WarningsExact identifier
unii: L7T10EIP3A
Constitutional EnhancerACONITUM NAPELLUS, ARSENICUM ALBUM, BARYTA CARBONICA, BRYONIA, CALCAREA CARBONICA, CANTHARIS, GELSEMIUM SEMPERVIRENS, GRAPHITES, HYDRASTIS CANADENSIS, KALI IODATUM, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, PHYTOLACCA DECANDRA, PULSATILLA, RHUS TOX, SEPIA, SILICEA AND SULPHUR.King Bio Inc.448becd7-58aa-40ae-9b4b-39f48a8f13dd2026-03-10WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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