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 10 of 70 · 1,400 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BiteMDINSECT BITE RELIEFWisconsin Pharmacal Company4f860c1e-a638-4923-e063-6294a90ae7e22026-04-15WarningsExact identifier
unii: U3RSY48JW5
PRENATE EnhanceASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, BIOTIN, CALCIUM CARBONATE, FERROUS FUMARATE, MAGNESIUM OXIDE, LACTIC ACID AND DOCONEXENTAvion Pharmaceuticals, LLCcf10de09-6ed5-4a66-84fa-2da4f668bbe62026-04-14Boxed warning, Adverse reactionsExact identifier
unii: 1C6V77QF41
Sting Relief SwabBENZOCAINE4 Visions LLC4f76a8c5-fde6-eee0-e063-6394a90a09f82026-04-14WarningsExact identifier
unii: U3RSY48JW5
MultitamFOLIC ACIDPureTek Corporationcee15842-4a9e-c6ba-e053-2a95a90aebc52026-04-13Warnings, Adverse reactionsExact identifier
unii: 1C6V77QF41
Petroleum JellyWHITE PETROLATUMWAL-MART STORES INC00faa772-53f3-9276-e063-6394a90a2dab2026-04-07WarningsExact identifier
unii: 4T6H12BN9U
PetroleumWHITE PETROLATUMCVS Pharmacy, Inc.4dc08832-e610-4e62-a6af-cadaa339e39e2026-04-06Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
PetroleumWHITE PETROLATUMAmazon.com Services LLC616ef87d-1518-46aa-8e12-9a1b678d49802026-04-06Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
Health-Tec Topical AnestheticBENZOCAINEDental Health Products, Inc.5eb437c5-a2af-4c0d-b7b9-9ab7d093db852026-04-06WarningsExact identifier
unii: U3RSY48JW5
Jack BlackAVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUMJack Black L.L.C.4baade5c-e759-d98f-e063-6394a90aa0562026-04-03WarningsExact identifier
unii: 4T6H12BN9U
KIDS TOOTHPASTE, FOR CAVITY PROTECTIONKIDS TOOTHPASTE FOR CAVITY PROTECTIONShulisa (Foshan) Daily ChemicalIndustry Co., Ltd4e8fab9e-f05c-5e2f-e063-6294a90aecf92026-04-03WarningsExact identifier
unii: 059QF0KO0R
Health-Tec Topical AnestheticBENZOCAINEDental Health Products, Inc.c3fb6705-c647-4fe6-9aca-29735d01d8ea2026-04-02WarningsExact identifier
unii: U3RSY48JW5
Critic-Aid ClearPETROLATUMColoplast Corpa92c18f7-52b2-43e4-bae3-2bab9de226712026-03-31WarningsExact identifier
unii: 4T6H12BN9U
HemorrhoidalLIDOCAINE, MINERAL OIL, PHENYLEPHRINE HCL, WHITE PETROLATUMWalgreens Co3d213ba8-3cbe-11c4-e063-6394a90ae0162026-03-30WarningsExact identifier
unii: T5L8T28FGP
Critic Aid ClearPETROLATUMColoplast Corp0b6da97e-519b-4579-9895-f4ede5c48b472026-03-27WarningsExact identifier
unii: 4T6H12BN9U
Baza ClearPETROLATUMColoplast Corp69d9f456-1a35-4146-8366-c0285648a1722026-03-27WarningsExact identifier
unii: 4T6H12BN9U
Vitamin A DLANOLIN, PETROLATUMTopco Associates LLC5126fdf6-5df5-474b-bc0d-3a82dea61abb2026-03-26Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
Advanced HealingPETROLATUMAmazon.com Services LLCcdf1bd12-ac59-4f06-be0f-ef6eb3caeeff2026-03-26Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
Benzocaine 20%BENZOCAINE 20%PAI Holdings, LLC dba PAI Pharma7fbce9a5-00dc-4a4a-8709-ab752bdf2f592026-03-25WarningsExact identifier
unii: U3RSY48JW5
D-CerinMOISTURIZERDynarex Corporation7ea47a7e-12af-9290-e053-2a91aa0a065f2026-03-24WarningsExact identifier
unii: 4T6H12BN9U
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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