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 116 of 304 · 6,070 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ring Relief PM Nighttime FormulaARNICA MONTANA, CALCIUM SULFIDE, HYPERICUM PERFORATUM, LYCOPODIUM CLAVATUM SPORE, THIOSINAMINUM, MERCURIUS SOLUBILIS, SALICYLIC ACID, SILICON DIOXIDE, ALLYLTHIOUREATRP Company92ef0dd1-84f9-086c-e053-2a95a90ac6472025-12-15WarningsExact identifier
unii: ETJ7Z6XBU4
Swimmers Ear Complete ReliefCALCIUM SULFIDE, LOESELIA MEXICANA TOP, MERCURIUS SOLUBILIS, POTASSIUM CHLORIDE, SILICON DIOXIDE, TRIBASIC CALCIUM PHOSPHATE, VALERIANTRP Companya3425da3-ace9-05c2-e053-2995a90ab09f2025-12-15WarningsExact identifier
unii: 91D9GV0Z28
unii: ETJ7Z6XBU4
Salonpas pain relieving JETMENTHOL, METHYL SALICYLATEHisamitsu Pharmaceutical Co., Inc.dd1ea3bf-891a-402e-8f43-14302bc9c3e52025-12-15WarningsExact identifier
unii: L7T10EIP3A
COOLA BARE REPUBLIC MINERAL SPORT SPF50TITANIUM DIOXIDE, ZINC OXIDECOOLA, LLCbbf15e58-c160-d599-e053-2a95a90a06962025-12-14WarningsExact identifier
unii: 15FIX9V2JP
CVS Orange Cream Antacid ChewsCALCIUM CARBONATECVS Pharmacy45f6b593-a09c-ce0b-e063-6394a90ae3072025-12-14WarningsExact identifier
unii: H0G9379FGK
Menthol Cough DropMENTHOLHEB39178eb7-ada9-30bf-e054-00144ff88e882025-12-13WarningsExact identifier
unii: L7T10EIP3A
SF Menthol Cough DropMENTHOLHEB3a443179-b7a6-3242-e054-00144ff8d46c2025-12-13WarningsExact identifier
unii: L7T10EIP3A
Cherry cough dropMENTHOLHEB39bd0ca1-348f-0ce1-e054-00144ff88e882025-12-13WarningsExact identifier
unii: L7T10EIP3A
Strawberry Cough DropsMENTHOLHEB766236e2-3302-2232-e053-2991aa0af5032025-12-13WarningsExact identifier
unii: L7T10EIP3A
Honey Lemon Cough DropMENTHOLHEB3a30a427-6ab4-24ae-e054-00144ff88e882025-12-13WarningsExact identifier
unii: L7T10EIP3A
Cherry Antacid Soft ChewCALCIUM CARBONATEHEB3b4e6ac5-4d9b-3e84-e054-00144ff88e882025-12-13WarningsExact identifier
unii: H0G9379FGK
HEB Menthol Cough DropsMENTHOLHEBc197855d-15b4-38fc-e053-2a95a90a2dc72025-12-13WarningsExact identifier
unii: L7T10EIP3A
HEB SF Honey Lemon Cough DropsMENTHOLHEBd09ed4bb-7595-5e54-e053-2a95a90aa1092025-12-13WarningsExact identifier
unii: L7T10EIP3A
HEB Cherry Cough DropsMENTHOLHEBc198e3c7-5ba7-ece6-e053-2995a90adb382025-12-13WarningsExact identifier
unii: L7T10EIP3A
HEB Honey Lemon Cough DropsMENTHOLHEBc19a79bc-9872-2e87-e053-2a95a90a94272025-12-13WarningsExact identifier
unii: L7T10EIP3A
HEB Wild Berry Antacid ChewsCALCIUM CARBONATEHEBd826abde-5090-1ace-e053-2995a90a8b4d2025-12-13WarningsExact identifier
unii: H0G9379FGK
HEB Wild Berry Antacid Chews 60ctCALCIUM CARBONATEHEBd827a6d6-3e01-6d73-e053-2995a90a791b2025-12-13WarningsExact identifier
unii: H0G9379FGK
Vapor RubCOUGH SUPPRESSANTNeilmed Pharmaceuticals Inc.39190f9f-8a5a-e4d8-e063-6294a90a57dd2025-12-12WarningsExact identifier
unii: L7T10EIP3A
unii: 2R04ONI662
Joint and Muscle ReliefMENTHOLSmart Cookie Solutions Inc.45c24d56-4dc9-2884-e063-6294a90a52cc2025-12-12WarningsExact identifier
unii: L7T10EIP3A
Orajel 4X Medicated For Toothache and GumBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.999851ac-925c-7d1f-e053-2a95a90a240b2025-12-12WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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