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 51 of 309 · 6,176 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Foamgle Foam Super MintALLANTOINKMPHARMACEUTICAL CO.,LTD4c006ee3-bf69-e65c-e063-6294a90a4b962026-03-01WarningsExact identifier
unii: 344S277G0Z
Refresh Optive Mega-3 PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.326cb5d6-c784-404f-9a13-6d69262dda6e2026-03-01WarningsExact identifier
unii: K679OBS311
Antiseptic MouthrinseEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLChain Drug Marketing Association27ff8499-63e0-49ad-a4dd-dde6da584f932026-02-27Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Antiseptic Mouth RinseEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLChain Drug Marketing Association1c4b22aa-4f2b-8f30-e063-6394a90a6ed52026-02-27Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Antiseptic MouthrinseEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLChain Drug Marketing Associationbd8a4b8b-cd59-4d0d-8ceb-40bba777e61b2026-02-27Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Mouth RinseEUCALYPTOL, MENTHOL, METHYLSALICYLATE, THYMOLThe Kroger Co.d97cdb55-c6bc-4138-ad1d-c7124d7f5cec2026-02-27Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLThe Kroger Co.116146db-719f-4c48-8a8a-1120ea62b0d52026-02-27Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
unii: 2R04ONI662
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLThe Kroger Co.e4844ad3-6073-4c2c-9029-5c4f4ea024e82026-02-27Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Tartar control plusEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLThe Kroger Co.0407d06e-a8d4-4522-8213-3a7a0c5e336e2026-02-27Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
MEDISTIK PROFESSIONAL DUAL ACTIONMENTHOL, METHYL SALICYLATE, EUCALUPTUSNatureteq Inc.99c7f08a-ab14-4371-9147-189f75cb66332026-02-27WarningsExact identifier
unii: L7T10EIP3A
Mouth RinseEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLThe Kroger Co.f6ccdce2-ae3c-44f7-803d-5a135a7a7e8e2026-02-27Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Antiseptic MouthrinseEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWalmart Inc.a8daefba-b985-4ef9-b900-e5647324662e2026-02-27Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
AntisepticEUCALYPTOL, MENTHOL, METYL SALICYLATE, THYMOLWalmart Inc.404dfa0f-8ac1-463a-9e10-fc87f70697952026-02-27Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWalmart Inc.d2515c9c-79b4-4874-be6e-fe8312477fc82026-02-27Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Aloe Vera GelLIDOCAINE HCL, MENTHOLWalmart Inc.309dcf5b-7166-976a-e063-6394a90af9522026-02-27Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Tartar control plusEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWalmart Inc.4da4ecf6-038e-4a64-83f7-c29d70e831742026-02-27Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
ASYSTEM Radical Relief Gel Roll-OnMENTHOL, METHYL SALICYLATECosco International, Inc.7239733e-5510-4a63-96c3-dd88b4a431a32026-02-27WarningsExact identifier
unii: L7T10EIP3A
Icy Hot Pro Pain Massaging BalmCAMPHOR AND MENTHOLChattem, Inc.09e2b0cb-5186-4f9c-b256-edaced4ca0142026-02-27WarningsExact identifier
unii: L7T10EIP3A
911 Adrenal Burnout and FatigueACETICUM AC, ADRENALINUM, ADRENOCORTICOTROPHIN (30X), AESCULUS HIPPOCASTANUM, FLOS, ALFALFA, ALPHA-LIPOIC AC, AMBRA, ARG NIT, AVENA SATIVA, BRYONIA, CARBONEUM OXYGENISATUM, CARPINUS BETULUS, FLOS, DNA, FUMARICUM ACIDUM, GELSEMIUM SEMPERVIRENS, HEPAR SULPHURIS CALCAREUM, HYPOTHALAMUS, KALI PHOSPHORICUM, LACTICUM ACIDUM, LECITHIN, NATRUM MURIATICUM, OXALICUM ACIDUM, PHOSPHORICUM ACIDUM, PITUITARUM POSTERIUM, SARCOLACTICUM ACIDUM, SELENIUM METALLICUM, SEPIA, SILICEA, SUCCINICUM ACIDUM AND THYROIDINUM.King Bio Inc.21c6b6c1-e846-4f25-a1dc-02e79d1be7562026-02-26WarningsExact identifier
unii: ETJ7Z6XBU4
Rapid Repair Healing CreamALLANTOIN, DIMETHICONEJune Jacobs Labs LLC186c13be-5e41-b9c9-e063-6294a90ad5742026-02-26WarningsExact identifier
unii: 344S277G0Z

Reported adverse events (FAERS/openFDA)#

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