FDA.reportPublic FDA data

NDC 71764-101-01 - OPRECARE 3SET (07,12,21)

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
71764-101
Requested NDC
71764-101-01
Package NDCs from labels
71764-101-01, 71764-101-02
Manufacturer
O'PRECARE | Kolmar Korea Co., Ltd.
Effective date
2017-10-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
O'PRECARE TOOTHPASTE 3SET (07,12,21)O'PRECARE | Kolmar Korea Co., Ltd.2017-10-12HUMAN OTC DRUG LABEL
O'PRECARE 12O'PRECARE | Kolmar Korea Co., Ltd.2017-10-11HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71764-101-022020-01-31C16284748780-19d75b9d0-60a0-f424-e053-dadaa90a57ceO'PRECARE 12

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71764-101-01OPRECARE 3SET (07,12,21)60 g in 1 BOTTLE, PUMPGEL60 g1.71 g in 60g3
71764-101-01OPRECARE 1260 g in 1 BOTTLE, PUMPGEL603
71764-101-02OPRECARE 3SET (07,12,21)1 in 1 PACKAGEGEL1.71 g in 60g3
71764-101-02OPRECARE 121 in 1 PACKAGEGEL13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71764-101OPRECARE 12 (SILICON DIOXIDE) GEL [O'PRECARE]3Legacy NDC, 2 package rows20171013_4a0329cf-3244-49b7-93cc-6b389f975d59.zip
71764-101OPRECARE 3SET (07,12,21) (SODIUM MONOFLUOROPHOSPHATE, SILICON DIOXIDE) KIT [O'PRECARE]3Legacy NDC20171013_0d832fee-7409-46c7-bb57-475c09cfd6fc.zip

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 107 of 304 · 6,070 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Comfort for ColicCOMFORT FOR KIDSVitality Works, Inc.220209c1-18ab-1b78-e054-00144ff8d46c2025-12-17WarningsExact identifier
unii: FGL3685T2X
Comfort for TeethingCOMFORT FOR TEETHINGVitality Works, Inc.21b44c37-4fc8-14b4-e054-00144ff8d46c2025-12-17WarningsExact identifier
unii: 91D9GV0Z28
unii: FGL3685T2X
Mattifying Primer SPF 20TITANIUM DIOXIDE AND ZINC OXIDEColorescienceb27d7df0-3c84-4cc5-9ef3-07105311fed92025-12-17WarningsExact identifier
unii: 15FIX9V2JP
DigestivEaseARSENICUM ALB, CALC SULPH, CARBO AN, CARBO VEG, CINCHONA, HYDRASTIS, NOX VOM, ORNITHOGALUM, PYROGENIUM, SILICEAEight and Company L.L.C70840ff7-75c0-44a0-9eb8-b36f13518af22025-12-17WarningsExact identifier
unii: ETJ7Z6XBU4
Tiger Balm Ultra StrengthCAMPHOR (SYNTHETIC) AND MENTHOLHaw Par Healthcare Ltd.f0561804-e0f7-495d-9768-9b86a208c51e2025-12-17WarningsExact identifier
unii: L7T10EIP3A
Cetaphil Redness Relieving Daily Facial Moisturizer with sunscreen SPF 40TITANIUM DIOXIDE, ZINC OXIDEGalderma Laboratories, L.P.45d101be-2b88-4759-9ccc-556f5ec0553d2025-12-17WarningsExact identifier
unii: 15FIX9V2JP
Brightening Primer SPF 20TITANIUM DIOXIDE AND ZINC OXIDEColoresciencea42d6761-47cd-4c9b-9656-64e37e0656392025-12-17WarningsExact identifier
unii: 15FIX9V2JP
Kwan LoongMETHYL SALICYLATE AND MENTHOLHaw Par Healthcare Ltd.54bcb26e-786a-403e-9330-11ae9e3c013a2025-12-17WarningsExact identifier
unii: L7T10EIP3A
Bronzing Primer SPF 20TITANIUM DIOXIDE AND ZINC OXIDEColoresciencef749af07-0fcd-4376-be62-7c078b3e7eb62025-12-17WarningsExact identifier
unii: 15FIX9V2JP
NeuroCool PatchesNEUROCOOL PATCHESBlue Heron Pharmaceuticals LLC410c317c-abc3-f5da-e063-6394a90ab9162025-12-16WarningsExact identifier
unii: L7T10EIP3A
SUNSCREEN StickZINC OXIDE 15%, TITANIUM DIOXIDE 8%, HOMOSALATE 6%Foshan Sugar Max Cosmetics CO.,Ltd460e1038-30f0-a6e4-e063-6394a90ad5342025-12-16WarningsExact identifier
unii: 15FIX9V2JP
SUNSCREEN SPRAY150mlZINC OXIDE 15%, TITANIUM DIOXIDE 6%, HOMOSALATE 5%, OCTISALATE 4%Foshan Sugar Max Cosmetics CO.,Ltd460ead6c-dd44-e320-e063-6294a90a2b642025-12-16WarningsExact identifier
unii: 15FIX9V2JP
Sunscreen CreamZINC OXIDE 12%,TITANIUM DIOXIDE 8%, HOMOSALATE 12%, OCTISALATE4.5%,PHENYLBENZIMIDAZOLE SULFONIC ACID 3.5%Foshan Sugar Max Cosmetics CO.,Ltd460f0ca0-9440-9a6e-e063-6394a90a33b32025-12-16WarningsExact identifier
unii: 15FIX9V2JP
Non Tinted Facial Mineral ProtectantTITANIUM DIOXIDE, ZINC OXIDEEUROPEAN SKIN AND MASSAGE STUDIO3766496f-231c-f98c-e063-6294a90aae082025-12-16Exact identifier
unii: 15FIX9V2JP
Tinted Facial Mineral ProtectantTITANIUM DIOXIDE, ZINC OXIDEEUROPEAN SKIN AND MASSAGE STUDIO3766b0d8-20e6-a227-e063-6294a90af4da2025-12-16Exact identifier
unii: 15FIX9V2JP
Tinted Mineral Sunscreen Broad Spectrum SPF 40TITANIUM DIOXIDE, ZINC OXIDEWECARE FRISCO PLLC374f866d-eb52-61e3-e063-6394a90a77c72025-12-16Exact identifier
unii: 15FIX9V2JP
Tinted Lip ProtectionTITANIUM DIOXIDE, ZINC OXIDEWECARE FRISCO PLLC3750c23d-c3f8-fac3-e063-6394a90a135e2025-12-16Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEKATHY JONES AESTHETHICS LLC37dab729-5988-5eba-e063-6294a90ac6b72025-12-16Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDETory Sullivan, M.D., P.A.36241e60-f02a-50a7-e063-6394a90a63902025-12-16Exact identifier
unii: 15FIX9V2JP
UV Defense Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDECCLEAR SOLUTIONS ACNE & SKIN CARE CLINIC365e09a8-308b-b753-e063-6394a90ae9e52025-12-16Exact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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