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 166 of 302 · 6,027 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HealthWise Overnight Menthol PatchMENTHOLVeridian Healthcare6379f50d-2878-46ca-8acb-71c4554585e92025-08-28WarningsExact identifier
unii: L7T10EIP3A
CareOne Acid Reducer CompleteFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDEAmerican Sales Company19045840-2d25-43af-8c92-f36c8b903b282025-08-28WarningsExact identifier
unii: H0G9379FGK
Anti Itch Maximum ReliefPRAMOXINE HYDROCHLORIDE AND MENTHOLNatureplex LLC75de3d5e-ecbe-4d04-a39d-792200e6ee322025-08-28WarningsExact identifier
unii: L7T10EIP3A
Ki No SinCALCIUM CARBONATENPG Bio Pharmaceuticals Co.,Ltd.21fa2bad-5b8b-8aac-e063-6394a90a9f492025-08-27WarningsExact identifier
unii: H0G9379FGK
R CosCALCIUM CARBONATENPG Bio Pharmaceuticals Co.,Ltd.21fa767a-1344-5ed9-e063-6394a90a5fe62025-08-27WarningsExact identifier
unii: H0G9379FGK
Na Mi CalCALCIUM CARBONATENPG Bio Pharmaceuticals Co.,Ltd.20cfbcd1-eb13-933c-e063-6294a90a7e592025-08-27WarningsExact identifier
unii: H0G9379FGK
Ki No SinCALCIUM CARBONATENPG Bio Pharmaceuticals Co.,Ltd.20cf8f80-c638-4d94-e063-6294a90a54002025-08-27WarningsExact identifier
unii: H0G9379FGK
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 2ENSULIZOLE,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDEHangzhou Jingshen Trading Co., Ltd.3d55291c-9d4c-85c3-e063-6394a90af3302025-08-27WarningsExact identifier
unii: 15FIX9V2JP
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 3ENSULIZOLE ,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDEHangzhou Jingshen Trading Co., Ltd.3d565612-ade5-bfb3-e063-6294a90a0c652025-08-27WarningsExact identifier
unii: 15FIX9V2JP
ARCTIC HEATMENTHOL, METHYL SALICYLATERenu Laboratories, LLC402df5c1-b8cb-17a2-e054-00144ff8d46c2025-08-27WarningsExact identifier
unii: L7T10EIP3A
Sun Bum 30 Mineral Tinted Sunscreen FaceTITANIUM DIOXIDE, ZINC OXIDESun Bum, LLC3a290aad-7f40-cb10-e063-6394a90a2e692025-08-27WarningsExact identifier
unii: 15FIX9V2JP
ACID REDUCER COMPLETEFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDESafeway484ad323-82cf-4157-bacb-236af8210c872025-08-27WarningsExact identifier
unii: H0G9379FGK
MGC Health Calcium Carbonate Antacid Assorted FruitsCALCIUM CARBONATEXiamen Kang Zhongyuan Biotechnology Co., Ltd.3d4617bb-dfa8-ab8f-e063-6394a90a641b2025-08-26WarningsExact identifier
unii: H0G9379FGK
MGC Health Calcium Carbonate Antacid Assorted BerriesCALCIUM CARBONATEMedical Group Care LLC3d465ecd-12cc-ffbd-e063-6394a90aabac2025-08-26WarningsExact identifier
unii: H0G9379FGK
MGC Health Calcium Carbonate Antacid Assorted FruitsCALCIUM CARBONATEXiamen Kang Zhongyuan Biotechnology Co., Ltd.3d46afba-ff44-0088-e063-6294a90a919e2025-08-26WarningsExact identifier
unii: H0G9379FGK
Exchange Select Calcium Carbonate Antacid Smoothies Extra Strength Assorted BerriesCALCIUM CARBONATEXiamen Kang Zhongyuan Biotechnology Co., Ltd.3d470e3a-3c3f-d2b8-e063-6394a90a7edb2025-08-26WarningsExact identifier
unii: H0G9379FGK
MGC Health Calcium Carbonate Antacid Assorted BerriesCALCIUM CARBONATEXiamen Kang Zhongyuan Biotechnology Co., Ltd.f24634a6-bb7e-42e3-a775-723ac030eb1a2025-08-26WarningsExact identifier
unii: H0G9379FGK
MGC Health Calcium Carbonate Antacid Tropical FruitCALCIUM CARBONATEXiamen Kang Zhongyuan Biotechnology Co., Ltd.10d8c5b6-8541-4c82-aa6d-9ae8c624e45e2025-08-26WarningsExact identifier
unii: H0G9379FGK
Allergy and Sinus ReliefPELARGONIUM SIDOIDES ROOT, HYDRASTIS CANADENSIS WHOLE, POTASSIUM CHLORIDE, SANGUINARIA CANADENSIS ROOT, PULSATILLA VULGARIS, SILICON DIOXIDESchwabe North American, Inc.c90cc6f5-14ec-41a3-a20a-4e8018bb02fb2025-08-25WarningsExact identifier
unii: ETJ7Z6XBU4
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 6ENSULIZOLE ,HOMOSALATE ,OCTINOXATE,TITANIUM DIOXIDELongway Technology(Guangzhou) Co., Ltd.3d0359b6-088f-aa54-e063-6394a90a422f2025-08-23WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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