FDA.reportPublic FDA data

NDC 10237-750-12 - Orajel for Cold Sores

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
10237-750
Requested NDC
10237-750-12
Package NDCs from labels
10237-750-21, 10237-750-12
Manufacturer
Church & Dwight Co., Inc.
Effective date
2017-12-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
DRUG FACTSChurch & Dwight Co., Inc.2017-12-06HUMAN OTC DRUG LABEL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZOCAINEACTIVE INGREDIENTU3RSY48JW5ORAJEL FOR COLD SORES (BENZOCAINE) CREAM [CHURCH & DWIGHT CO., INC.]1
PETROLATUMACTIVE INGREDIENT4T6H12BN9UORAJEL FOR COLD SORES (BENZOCAINE) CREAM [CHURCH & DWIGHT CO., INC.]1
BENZOCAINEACTIVE MOIETYU3RSY48JW5ORAJEL FOR COLD SORES (BENZOCAINE) CREAM [CHURCH & DWIGHT CO., INC.]1
PETROLATUMACTIVE MOIETY4T6H12BN9UORAJEL FOR COLD SORES (BENZOCAINE) CREAM [CHURCH & DWIGHT CO., INC.]1
.ALPHA.-TOCOPHEROL ACETATE, D-INACTIVE INGREDIENTA7E6112E4NORAJEL FOR COLD SORES (BENZOCAINE) CREAM [CHURCH & DWIGHT CO., INC.]1
ALPHA-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1ORAJEL FOR COLD SORES (BENZOCAINE) CREAM [CHURCH & DWIGHT CO., INC.]1
CHOLECALCIFEROLINACTIVE INGREDIENT1C6V77QF41ORAJEL FOR COLD SORES (BENZOCAINE) CREAM [CHURCH & DWIGHT CO., INC.]1
CORN OILINACTIVE INGREDIENT8470G57WFMORAJEL FOR COLD SORES (BENZOCAINE) CREAM [CHURCH & DWIGHT CO., INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TORAJEL FOR COLD SORES (BENZOCAINE) CREAM [CHURCH & DWIGHT CO., INC.]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPORAJEL FOR COLD SORES (BENZOCAINE) CREAM [CHURCH & DWIGHT CO., INC.]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AORAJEL FOR COLD SORES (BENZOCAINE) CREAM [CHURCH & DWIGHT CO., INC.]1
PRUNELLA VULGARISINACTIVE INGREDIENTID3IB81B1CORAJEL FOR COLD SORES (BENZOCAINE) CREAM [CHURCH & DWIGHT CO., INC.]1
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVCORAJEL FOR COLD SORES (BENZOCAINE) CREAM [CHURCH & DWIGHT CO., INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RORAJEL FOR COLD SORES (BENZOCAINE) CREAM [CHURCH & DWIGHT CO., INC.]1

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 35 of 70 · 1,386 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COCOA BUTTER PETROLEUM jellyPETROLATUMSavvy Care & Cosmetics Pvt. Ltd.397d13f1-3b86-3c76-e063-6394a90a0f242025-07-09WarningsExact identifier
unii: 4T6H12BN9U
Desitin Multi-Purpose HealingPETROLATUMKenvue Brands LLC30f06dbb-de8c-43ee-b1ed-99ffd59dd3ab2025-07-07WarningsExact identifier
unii: 4T6H12BN9U
Hemorrhoid CreamHEMORRHOID CREAMHenan Shouerkang Health Industry Co., Ltd426c0602-63a5-104b-e063-6294a90ae9642025-07-07WarningsExact identifier
unii: H4N855PNZ1
Creamy PetroleumPETROLATUMSavvy Care & Cosmetics Pvt Ltd3916daee-f8d2-e3f0-e063-6294a90a38832025-07-04WarningsExact identifier
unii: 4T6H12BN9U
Hemorrhoidal CreamGLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUMTrifecta Pharmaceuticals Usa Llc38cf4e43-280b-eb96-e063-6294a90a59492025-07-02WarningsExact identifier
unii: 4T6H12BN9U
DenTek Instant Pain Relief Maximum StrengthBENZOCAINEDenTek Oral Care, Inc.ae92b76e-815a-4b4c-8128-bd045098caa52025-06-30WarningsExact identifier
unii: U3RSY48JW5
Walgreens Healing Balm Skin ProtectantPETROLATUMWalgreensbc585145-3588-446e-926f-e6baf43ca4ba2025-06-24WarningsExact identifier
unii: 4T6H12BN9U
Meret Sting Relief PadBENZOCAINE, ISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd.385def83-38fe-df7f-e063-6394a90abbf02025-06-24WarningsExact identifier
unii: U3RSY48JW5
Plaque identifyingPLAQUE IDENTIFYINGShenzhen Yagao Technology Co., Ltd.37eeb656-22f1-7372-e063-6394a90ad0412025-06-19WarningsExact identifier
unii: 059QF0KO0R
ProCure HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLTwin Med LLC37a4cc43-0d53-f1bf-e063-6394a90a2dc92025-06-15WarningsExact identifier
unii: 4T6H12BN9U
unii: T5L8T28FGP
Iolite-SBENZOCAINEDharma Research, Inc.b3b68914-2adc-4f07-9521-0b18756be5222025-06-14WarningsExact identifier
unii: U3RSY48JW5
Hemorrhoidal Pain ReliefHEMORRHOIDAL PAIN RELIEF OINTMENTNeilmed Pharmaceuticals Inc.374d89b6-9305-9adf-e063-6394a90adb322025-06-11WarningsExact identifier
unii: 4T6H12BN9U
unii: T5L8T28FGP
Dermoplast Post PartumBENZOCAINEAdvantice Health, LLC374dced3-6527-b458-e063-6394a90a911e2025-06-11WarningsExact identifier
unii: U3RSY48JW5
MaterviaASCORBIC ACID, CHOLECALCIFEROL, THIAMINE, PYRIDOXAL-5-PHOSPHATE, FOLIC ACID, METHYLCOBALAMIN, CALCIUM CITRATE, IRON, IODINEV2 Pharma LLCa918e273-4742-4417-8ae5-88d3870011f02025-06-11WarningsExact identifier
unii: 1C6V77QF41
HemorrhoidalOintmentMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCITrifecta Pharmaceuticals USA LLC4eb3c9ac-268a-5246-e054-00144ff88e882025-06-09WarningsExact identifier
unii: 4T6H12BN9U
unii: T5L8T28FGP
Everlight Survival Sting Relief PadBENZOCAINEYiwu Ori-Power Medtech Co.,Ltd.364c9882-339e-fe22-e063-6294a90a37f42025-06-04WarningsExact identifier
unii: U3RSY48JW5
LIGHTS Sting Relief Prep PadBENZOCAINELights Medical Manufacture Co., Ltd.4f4d7758-be62-4304-8871-087a90497fa52025-06-04WarningsExact identifier
unii: U3RSY48JW5
Onral Oral Pain Reliever MouthwashBENZOCAINESyka Pharma Inc.5dd8d933-6f32-4eaf-8eca-9365d7de55a22025-06-03WarningsExact identifier
unii: U3RSY48JW5
Orajel Rescue Relief PenORAL PAIN RELIEVERChurch & Dwight Co., Inc.2d68eec5-ae8a-9cdf-e063-6294a90a97992025-06-01WarningsExact identifier
unii: U3RSY48JW5
Sterile WaterWATERHenry Schein, Inc.88403fcf-a276-42c0-88b6-bd84a720b5642025-05-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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