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 36 of 70 · 1,386 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineral OilMINERAL OILATLANTIC BIOLOGICALS CORP.960502ae-2468-406e-8799-cacb01f2727e2025-05-23WarningsExact identifier
unii: T5L8T28FGP
First Aid Only Antiseptic First AidBENZALKONIUM CHLORIDEAcme United Corporation35d06b38-55dd-e306-e063-6394a90aaf262025-05-23WarningsExact identifier
unii: U3RSY48JW5
Insecticides/Pest/Food Additives DetoxBOLDO, CARDUUS MARIANUS, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDr. Donna Restivo DCb5778211-0e3e-44ef-bd65-a76a68cf15042025-05-23WarningsExact identifier
unii: A2I8C7HI9T
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC9e1f7462-a052-4db4-bc59-cce437b695d02025-05-20WarningsExact identifier
unii: U3RSY48JW5
CobalefolVITAMINV2 Pharma LLC7d409065-112d-4bc7-bae6-d558aeb7c0e42025-05-16WarningsExact identifier
unii: 1C6V77QF41
MultivitaminMULTIVITAMINPureTek Corporation353453e2-1f60-24ea-e063-6394a90a251e2025-05-15Warnings, Adverse reactionsExact identifier
unii: 1C6V77QF41
Prenate PixieASCORBIC ACID, BIOTIN, CHOLECALCIFEROL, CYANOCOBALAMIN, LEVOMEFOLATE CALCIUM, FOLIC ACID, FERROUS ASPARTO GLYCINATE, POTASSIUM IODIDE, PYRIDOXINE HYDROCHLORIDE, .ALPHA.-TOCOPHEROL ACETATE, DL-, DOCOSAHEXAENOIC ACID, AND BLUEBERRYAvion Pharmaceuticals, LLCfe0a737e-4f28-40d8-b4a7-090edf86a8232025-05-14Boxed warning, Adverse reactionsExact identifier
unii: 1C6V77QF41
Eyesaline Emergency EyewashSTERILE EYESALINE EYEWASHHoneywell Safety Products USA, Inc.2d567518-4c54-7448-e063-6294a90a3e642025-05-14WarningsExact identifier
unii: 059QF0KO0R
NESTABS Prenatal Multi-vitamin/Mineral SupplementMULTI-VITAMIN/MINERAL SUPPLEMENT WITH SODIUM ASCORBATE, CHOLECALCIFEROL, DI-ALPHA-TOCOPHERYL ACETATE, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HCL, FOLIC ACID, CYANOCOBALAMIN, CALCIUM FORMATE, CALCIUM CARBONATE, FERROUS (II) BIS-GLYCINATE CHELATE, POTASSIUM IODIDE, ZINC OXIDE, AND CHOLINE BITARTRATEWOMENS CHOICE PHARMACEUTICALS LLC61945c85-3c9a-4b57-a8e1-79dd0469a0422025-05-13Boxed warning, WarningsExact identifier
unii: A7E6112E4N
unii: 1C6V77QF41
LANOZEM HEMORRHOIDALMENTHOL, PETROLATUMSod-e Biotech Ltd34901e83-8f24-8460-e063-6394a90a27442025-05-07WarningsExact identifier
unii: 4T6H12BN9U
ChapIce Moisture SPF 15 Lip BalmOXYBENZONE, OCTINOXATE, PETROLATUMOraLabs1fcc1d6e-71b8-4f2f-8794-b3d013ad4ea72025-05-07WarningsExact identifier
unii: 4T6H12BN9U
Prenatal Vitamins Plus Low IronPRENATAL WITH FERROUS FUMARATE AND FOLIC ACIDA-S Medication Solutionsed793721-e869-43de-9d6e-6dc9c8230e362025-05-07Boxed warningExact identifier
unii: 1C6V77QF41
Climax Shield DelayBENZOCAINEPRODUCT MAX GROUP INC9c720cdc-f753-47ce-95ff-3b26e461a0ab2025-05-05WarningsExact identifier
unii: U3RSY48JW5
Perfect 10 Soothing RecoveryPETROLATUMTopiderm, Inc.e3a4f038-d084-4d77-bd35-13f41856a6152025-04-30WarningsExact identifier
unii: 4T6H12BN9U
OraLabs ChapIce Original PetrolatumPETROLATUMOraLabs54729693-f0e2-48ad-881a-a07986ed823b2025-04-30WarningsExact identifier
unii: 4T6H12BN9U
Sunfrog Ultra SPF 30 Lip BalmOCTINOXATE, OCTOCRYLENE, OXYBENZONE, OCTISALATE, PETROLEUM JELLYOraLabs61299626-bf60-40e8-a2d3-4d4a99d8d15c2025-04-30WarningsExact identifier
unii: 4T6H12BN9U
ChapIce Moisture SPF 15 Lip BalmOXYBENZONE, OCTINOXATE, PETROLATUMNavajo Manufacturing Company Inc.60ce1a8c-180a-161e-e053-2991aa0ae9812025-04-29WarningsExact identifier
unii: 4T6H12BN9U
OraLabs ChapIce Cherry PetrolatumPETROLATUMOraLabsf0d9d01e-bfdf-4e33-abfb-f683d414d8082025-04-29WarningsExact identifier
unii: 4T6H12BN9U
Nestabs ONEVITAMIN C, VITAMIN D, VITAMIN E, VITAMIN B6, FOLATE, VITAMIN B12, IRON, ZINC, MAGNESIUM, DHAWomens Choice Pharmaceuticals, LLC9b71b219-91ae-46b2-8fb5-d3d118d738732025-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 1C6V77QF41
SPF 45 - Lip BalmAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, PETROLATUMOraLabsafd10abe-1e8b-4df8-9d8c-ef15266c510c2025-04-22WarningsExact identifier
unii: 4T6H12BN9U

Reported adverse events (FAERS/openFDA)#

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