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 120 of 304 · 6,070 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sheer Tinted Sunscreen SPF40TITANIUM DIOXIDE, ZINC OXIDESIMPLICITY SKIN, SPA & BOUTIQUE, LLC36ebdb85-ce8a-d7e0-e063-6394a90a22612025-12-11Exact identifier
unii: 15FIX9V2JP
Mineral Lip ProtectionTITANIUM DIOXIDE, ZINC OXIDECOLETTE TOMASI LLC3727b29f-fe51-0b15-e063-6394a90a780b2025-12-11Exact identifier
unii: 15FIX9V2JP
Prevention Acne Safe Facial Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDENY BEAUTY PALACE LLC373c291a-7839-8486-e063-6294a90a5af32025-12-11Exact identifier
unii: 15FIX9V2JP
Prevention 2 Acne Safe Facial Mineral Sunscreen Non TintedTITANIUM DIOXIDE, ZINC OXIDENY BEAUTY PALACE LLC373c0ab0-8828-542b-e063-6394a90a86332025-12-11Exact identifier
unii: 15FIX9V2JP
Prevention Acne Safe Facial Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDENY BEAUTY PALACE LLC373d4fad-141c-0904-e063-6394a90a97592025-12-11Exact identifier
unii: 15FIX9V2JP
Mattify Total Protection SunscreenTITANIUM DIOXIDE, ZINC OXIDECLEAN SLATE SKIN & BODY, INC.37617bd5-c275-aeee-e063-6394a90a214d2025-12-11Exact identifier
unii: 15FIX9V2JP
Mattify Total Protection SunscreenTITANIUM DIOXIDE, ZINC OXIDECLEAN SLATE SKIN & BODY, INC.37641f8b-0133-8bfc-e063-6294a90aac5c2025-12-11Exact identifier
unii: 15FIX9V2JP
Essential Mineral Sun ProtectionTITANIUM DIOXIDE, ZINC OXIDEFern Burg34a360b2-6798-c7e8-e063-6294a90a5cbb2025-12-11Exact identifier
unii: 15FIX9V2JP
Tinted Mineral Matte CE SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Maui Medical Group, Inc34b72d14-b69b-e9dd-e063-6394a90a748e2025-12-11Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESCIENCE CEUTICALS, LLC369b20e2-2cad-e047-e063-6294a90a1bba2025-12-11Exact identifier
unii: 15FIX9V2JP
Tinted Mineral Matte CE SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Maui Medical Group, Inc34b60880-5fe1-b78f-e063-6294a90a748d2025-12-11Exact identifier
unii: 15FIX9V2JP
Sheer Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Maui Medical Group, Inc34b51190-6a6d-c5e0-e063-6394a90ae8752025-12-11Exact identifier
unii: 15FIX9V2JP
Sheer Tinted Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEThe Maui Medical Group, Inc34b6e8d0-6235-dac2-e063-6394a90afefd2025-12-11Exact identifier
unii: 15FIX9V2JP
Tinted Sunscreen Face PrimerTITANIUM DIOXIDE, ZINC OXIDELIV BODY AND BEAUTY374f6b79-2ac4-61cf-e063-6394a90a699b2025-12-11Exact identifier
unii: 15FIX9V2JP
Daily Sun DefenseTITANIUM DIOXIDE, ZINC OXIDELIV BODY AND BEAUTY LLC3750c2fd-c5cc-fd00-e063-6394a90aeb892025-12-11Exact identifier
unii: 15FIX9V2JP
SPF 40 Broad SpectrumTITANIUM DIOXIDE, ZINC OXIDETeton Dermatology Holdings, Inc.35081ce0-2203-ab86-e063-6294a90aefd52025-12-11Exact identifier
unii: 15FIX9V2JP
Lip ProtectionTITANIUM DIOXIDE, ZINC OXIDETeton Dermatology Holdings, Inc.3509eea7-f966-2080-e063-6294a90aeeb52025-12-11Exact identifier
unii: 15FIX9V2JP
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEHALEM DERMATOLOGY PLLC35bce44e-d9f4-9279-e063-6394a90a64532025-12-11Exact identifier
unii: 15FIX9V2JP
Tinted Mineral Daily SunscreenTITANIUM DIOXIDE ,ZINC OXIDEJordan Macall Acne & Anti-Aging Skincare LLC350ad191-e51c-083d-e063-6394a90aa6462025-12-11Exact identifier
unii: 15FIX9V2JP
Tinted Mineral Daily SunscreenTITANIUM DIOXIDE ,ZINC OXIDEJordan Macall Acne & Anti-Aging Skincare LLC350b2246-6e00-38fc-e063-6294a90ae3822025-12-11Exact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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