FDA.reportPublic FDA data

NDC 65862-709-10 - Raloxifene 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
65862-709
Requested NDC
65862-709-10
Package NDCs from labels
65862-709-30, 65862-709-01, 65862-709-22, 65862-709-10, 65862-709-03, 65862-709-99
Manufacturer
A-S Medication Solutions
Effective date
2025-11-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Raloxifene Hydrochloride - A-S Medication SolutionsA-S Medication Solutions2025-11-06Human Prescription Drug Label
Raloxifene Hydrochloride - Bryant Ranch PrepackBryant Ranch Prepack2024-04-03HUMAN PRESCRIPTION DRUG LABEL
Raloxifene Hydrochloride - Aurobindo Pharma LimitedAurobindo Pharma Limited2024-02-17Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-709-01Raloxifene Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1007
65862-709-03Raloxifene Hydrochloride3 in 1 CARTONTABLET, FILM COATED37
65862-709-10Raloxifene Hydrochloride10 in 1 BLISTER PACKTABLET, FILM COATED107
65862-709-22Raloxifene Hydrochloride2000 in 1 BOTTLETABLET, FILM COATED20007
65862-709-30Raloxifene Hydrochloride30 in 1 BOTTLETABLET, FILM COATED307
65862-709-99Raloxifene Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED10007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-709RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]7Current NDC, Legacy NDC, 6 package rows20240220_e8b6cbe0-c1f4-4678-b852-f629a7f6a1b5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-709-01EA - Each65862-7091fbb9680-3188-4851-90d6-5d0eeccf881f12021-05-05
65862-709-30EA - Each65862-709d5df931c-abb5-4c2a-8f3b-4340042bd16912021-11-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RALOXIFENE HYDROCHLORIDEACTIVE INGREDIENT4F86W47BR6RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]1
RALOXIFENEACTIVE MOIETYYX9162EO3IRALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPRALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKRALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]1
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQRALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HRALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XRALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]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 4 of 111 · 2,207 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ESPOIR BE VELVET COVER CUSHIONHOMOSALATE, TITANIUM DIOXIDEESPOIR Corporation54ce2420-4ac0-eb51-e063-6294a90a2de92026-06-21WarningsExact identifier
unii: 15FIX9V2JP
BABIES KIDSSUN PROTECTIONMINERAL SUNSCREENPANERGYTEK USA INC3a554118-b71d-a844-e063-6294a90a699f2026-06-20WarningsExact identifier
unii: 15FIX9V2JP
Rohto Cool ReliefNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companydc8f1ff3-87ae-47ca-815f-5a0e34f8cf302026-06-19WarningsExact identifier
unii: 6OZP39ZG8H
Creamy Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc548b7c90-ef97-38ab-e063-6394a90ac6092026-06-18WarningsExact identifier
unii: 15FIX9V2JP
GlowBiotics Tinted Sunscreen SPF 30ZINC OXIDERum Brands, LLC544dba29-4785-4ab6-e063-6394a90a17b32026-06-16WarningsExact identifier
unii: 15FIX9V2JP
Societe Prime and DefendZINC OXIDE SUNSCREENSociete Clinical Skincare5439bd31-5ee1-9bca-e063-6394a90a748c2026-06-16WarningsExact identifier
unii: 15FIX9V2JP
Societe CoverShield Tinted SPFZINC OXIDESociete Clinical Skincare545efbc4-82d4-f126-e063-6294a90a97102026-06-16WarningsExact identifier
unii: 15FIX9V2JP
Shield by HEALTHY SKIN LAB MD SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEHEALTHY SKIN LAB LIMITED6838b754-9915-48ff-af35-5338dbd06ac42026-06-15WarningsExact identifier
unii: 15FIX9V2JP
ACD ACITRIC ACID MONOHYDRATE, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATETerumo BCT, Ltd.395aec48-198a-4aed-8e38-7accfb3232f92026-06-15Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
SFL SUNSCREEN - SOL DEFENSE SPF 30TITANIUM DIOXIDE, ZINC OXIDELifeline Medical, Inc5438c185-31c9-c51e-e063-6394a90ae9ef2026-06-14WarningsExact identifier
unii: 15FIX9V2JP
Sunbetter Daily Mineral Protection Broad Spectrum SPF 75 SunscreenTITANIUM DIOXIDE AND ZINC OXIDESKINBETTER SCIENCE LLC54106748-9810-d3ff-e063-6394a90a5b7a2026-06-12WarningsExact identifier
unii: 15FIX9V2JP
Sunbetter Daily Mineral Protection Broad Spectrum SPF 70 Sheer SunscreenTITANIUM DIOXIDE AND ZINC OXIDESKINBETTER SCIENCE LLC5410e0ed-aed5-3279-e063-6294a90a0c3e2026-06-12WarningsExact identifier
unii: 15FIX9V2JP
Visine Red Eye Total Comfort Multi-SymptomTETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, AND ZINC SULFATE, UNSPECIFIED FORMKenvue Brands LLC5747edef-7a87-41d7-9594-6c78508b9ba22026-06-11WarningsExact identifier
unii: B697894SGQ
GUNA-CELLACETYLCARNITINE, L-AMPC-ALPHA-LIPOIC AC-A-TOCOPHEROL-ASCORBIC ACID-CALC CARB-CITRIC AC-COBALAMIN-COLCHICUM-CONIUM-CUPRIC SULF-HERRING SPERM DNA-FERROUS FUMARATE-FOLIC ACID-FUMARIC ACID-KALI ASPARTATE-MANG PHOS-MANG GLUCONATE-MANG PHOS II-PYRUVALDEHYDE-NAT OXALACETICUM-SODIUM PYRUVATE-NIACIN-PANTOTHENIC ACID-PH-PODOPHYLLUM PELTATUM-PYRIDOXINE HYDROCHLORIDE-RIBOFLAVIN-SACCHAROMYCES CEREVISIAE RNA-SELENOMETHIONINE-SUCCINIC ACID-SULFUR-THIAMINE HYDROCHLORIDE-ZINCGuna spa90db80ed-c037-4e8f-a7f6-304a65f9fe222026-06-11WarningsExact identifier
unii: 2968PHW8QP
it cosmetics Your Skin But Better CC Plus Natural Matte Color Correcting Pore Refining Full Coverage Skin Balancing Serum Broad Spectrum SPF 40 SunscreenENSULIZOLE, OCTISALATE AND TITANIUM DIOXIDEIT COSMETICS, LLCf2990320-b61d-40b8-ba79-18d6b37e7f522026-06-11WarningsExact identifier
unii: 15FIX9V2JP
GUNA-FLAMACONITUM NAPELLUS - APIS MELLIFERA - ATROPA BELLADONNA - BASIC CUPRIC CARBONATE - BRYONIA ALBA ROOT - CALCIUM SULFIDE - CITRIC ACID MONOHYDRATE - FERRIC PHOSPHATE - INTERLEUKIN-10 - MELATONIN - METENKEFALIN - PHYTOLACCA AMERICANA ROOT - RANCID BEEF - SODIUM PYRUVATE - SUS SCROFA CONJUNCTIVA - SUS SCROFA PINEAL GLAND - SUS SCROFA PITUITARY GLAND - TRANSFORMING GROWTH FACTOR BETA-1 - ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT -Guna spa7bda7eb0-8fd5-42d9-b336-39920bfc964d2026-06-10WarningsExact identifier
unii: 2968PHW8QP
RE-NUTRIV AGE REVERSAL VITAL RADIANCE SERUM FOUNDATION SPF 20OCTINOXATE AND TITANIUM DIOXIDEESTEE LAUDER INC53d76b02-442e-7a5d-e063-6394a90ae1b32026-06-09WarningsExact identifier
unii: 15FIX9V2JP
FUTURIST HYDRATING COLLAGEN-PEPTIDE MAKEUP BROAD SPECTRUM SPF 20OCTINOXATE AND TITANIUM DIOXIDEESTEE LAUDER INC53d9d689-4a86-5b9c-e063-6394a90aef182026-06-09WarningsExact identifier
unii: 15FIX9V2JP
Eryfotona Ageless Tinted Lightweight Emulsion SunscreenTITANIUM DIOXIDEISDIN Corp.293a1116-e8a2-495f-83db-20dd82ed13c22026-06-08WarningsExact identifier
unii: 15FIX9V2JP
Eryfotona Actinica TintedTITANIUM DIOXIDEISDIN Corp.97357703-0e93-4216-bd1b-a9b2027819592026-06-05WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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