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 17 of 309 · 6,176 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leg Cramps PMOYSTER SHELL CALCIUM CARBONATE, CRUDE, CAUSTICUM, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, COPPER, LYCOPODIUM CLAVATUM SPORE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, SILICON DIOXIDE, AND SULFURHyland's Inc.b0574a7e-88fa-417e-b6d5-60ced59eba472026-07-15WarningsExact identifier
unii: ETJ7Z6XBU4
VARICOSE VEINS MAXIMUM STRENGTHMENTHOLOWELL NATURAL & LLC5692914f-1b14-e3e3-e063-6394a90a94bf2026-07-14WarningsExact identifier
unii: L7T10EIP3A
Freshen UpSODIUM FLUORIDE, POTASSIUM NITRATEMKJ BRANDS LLC476f453b-9215-0a11-e063-6294a90a5cd42026-07-14WarningsExact identifier
unii: C810JCZ56Q
Mederma for KidsALLANTOINL. Perrigo Companyed4ff435-9819-46d3-9375-914712943f772026-07-14WarningsExact identifier
unii: 344S277G0Z
Major Regular Strength Assorted FlavorsANTACID TABLETSMajor Pharmaceuticals2ba0eeb2-7048-4259-83d5-9f4ec1c92d322026-07-13WarningsExact identifier
unii: H0G9379FGK
SanatosMENTHOLPharmadel LLC5683b099-f029-2d08-e063-6394a90ad4822026-07-13WarningsExact identifier
unii: L7T10EIP3A
Propolis Cooling Relief Cherry Cough DropsMENTHOL, UNSPECIFIED FORMBeekeeper's Naturals USA Inc7087566d-f24a-4508-aa25-7f42d055c43e2026-07-13WarningsExact identifier
unii: L7T10EIP3A
Colgate Optic White Advanced Icy FreshSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companyf95496e3-11ec-4cd6-b3ee-cf6c657b790b2026-07-13WarningsExact identifier
unii: C810JCZ56Q
Good Neighbor Extra Strength Assorted FruitsCALCIUM CARBONATEAMERISOURCE BERGENabf564a1-0823-433d-a023-8be4e085daf42026-07-13WarningsExact identifier
unii: H0G9379FGK
Topcare Pain Relief PatchPAIN RELIEF PATCH MEDICATED 5% MENTHOL761624f00d0b8-d2f4-843b-e063-6294a90a332b2026-07-12WarningsExact identifier
unii: L7T10EIP3A
COUGH DROPS- menthol granuleMENTHOL GRANULEAnhui Jiuhe Health Industry Co., Ltd5351b943-5830-e4e7-e063-6394a90a5b662026-07-10WarningsExact identifier
unii: L7T10EIP3A
Biofreeze ProfessionalMENTHOLReckitt Benckiser LLC485c8208-c93b-5b84-e063-6394a90ab77a2026-07-10WarningsExact identifier
unii: L7T10EIP3A
Jacksons Cell Salts SILICA 12X 12SILICEAZettl Health Inc.5647dafc-1fff-6a25-e063-6294a90a8b4f2026-07-10Exact identifier
unii: ETJ7Z6XBU4
Fit Mist Pain ReliefMENTHOLAroma Sensations Incf5a98544-8bd7-42dc-a594-5559e3920e292026-07-09WarningsExact identifier
unii: L7T10EIP3A
Nuturna SciaticaMENTHOLMicelle Laboratories, Incorporatedff200864-bedf-4138-bdec-2b23701406dd2026-07-09WarningsExact identifier
unii: L7T10EIP3A
Nervionix Pro Magnesium IceLIDOCAINE HYDROCHLORIDE, MENTHOL,MAGNESIUM CHLORIDEMicelle Laboratories, Incorporatedc11e0963-90fb-48c6-938a-3dcbbad17aca2026-07-09WarningsExact identifier
unii: L7T10EIP3A
Bombee Honey Daily Glow Shield SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDEABT ASIA Inc.56112dff-b091-7a56-e063-6294a90a77d32026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Crest 3D White Deep Stain Remover Ultra WhiteSODIUM MONOFLUOROPHOSPHATEThe Procter & Gamble Manufacturing Company2f24a9eb-7a89-30e1-e063-6394a90a032b2026-07-08Exact identifier
unii: C810JCZ56Q
CAREALL Musle and JointMENTHOLNew World Imports, Inc561cc103-ae88-8f30-e063-6294a90a05c42026-07-08WarningsExact identifier
unii: L7T10EIP3A
HealthWise Medicated Cold HotMENTHOLVeridian Healthcare, LLC561e1409-d1d8-e35d-e063-6394a90a4d8f2026-07-08WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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