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 37 of 70 · 1,386 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OraLabs SPF 15 Lip BalmAVOBENZONE, OCTINOXATE, PETROLATUMOraLabs3ac8569f-4b11-4536-8919-234f79bbd7fc2025-04-22WarningsExact identifier
unii: 4T6H12BN9U
ChapIce SPF 30 Lip BalmAVOBENZONE, OCTISALATE, HOMOSALATE, PETROLATUMOraLabsc7094485-a19f-41b7-88b8-d6d472adbff12025-04-22WarningsExact identifier
unii: 4T6H12BN9U
Mineral OilMINERAL OILAmerisourceBergen (Good Neighbor Pharmacy) 46122581f81a0-7488-4c90-b33e-06c6301a4fd22025-04-17WarningsExact identifier
unii: T5L8T28FGP
Petroleum JellyPETROLATUMWalgreens69bdd508-7c33-42c5-9a08-e56cf3eaebf32025-04-11WarningsExact identifier
unii: 4T6H12BN9U
BODY ACTION PRODUCTS Anal Glide ExtraBENZOCAINEPRODUCT MAX GROUP INC282ac8d3-2caf-42de-b347-450e9c7a9e502025-04-03WarningsExact identifier
unii: U3RSY48JW5
Eye WashWATERCMC Group Inc.6158a1f5-a6bc-4a3e-9d1d-0a310d9dc5612025-04-02WarningsExact identifier
unii: 059QF0KO0R
hemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLBionpharma Inc.1790da99-2a22-e2a2-e063-6394a90ac36f2025-03-31WarningsExact identifier
unii: 4T6H12BN9U
unii: T5L8T28FGP
St. Paul Brands VerestorVITAMIN C,VITAMIN E,NATTOKINASE,PHYTOSTEROL,DOKUDAMI LEAF,RUTIN,BETA-CAROTENEAdvanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticals0e0b6c75-0ae8-4ef4-ab86-0f3be5ca63d12025-03-31WarningsExact identifier
unii: H4N855PNZ1
VaselineBABY HEALING JELLYConopco Inc. d/b/a Unileverbca3176f-86fe-5969-e053-2995a90a24192025-03-31WarningsExact identifier
unii: 4T6H12BN9U
Strovite One CapletsVITAMIN A, CALCIUM PANTOTHENATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL SUCCINATE, D-, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, BIOTIN, CYANOCOBALAMIN, SELENIUM, MAGNESIUM OXIDE, ZINC OXIDE, CUPRIC SULFATE, MANGANESE, CHROMIUM, .ALPHA.-LIPOIC ACID, AND LUTEINExeltis USA, Inc.b9b71fa4-89c7-4f5b-8174-950649434ba52025-03-20Warnings, Adverse reactionsExact identifier
unii: 1C6V77QF41
Vitafol Fe PlusDOCONEXENT, NIACINAMIDE, .ALPHA.-TOCOPHEROL ACETATE, DL-, CHOLECALCIFEROL, BETA CAROTENE, ASCORBIC ACID, THIAMINE MONONITRATE, RIBOFLAVIN, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, IRON, ZINC OXIDE, CUPRIC OXIDE, POTASSIUM IODIDE, MAGNESIUM OXIDE, FOLIC ACID, AND LEVOMEFOLATE CALCIUMExeltis USA, Inc.3927b074-d72a-4d8c-9f7e-15c42a8309452025-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 1C6V77QF41
Vitafol OnePRENATAL SUPPLEMENT WITH DHAExeltis USA, Inc.42a5cafd-a2c0-4ac2-99c9-708642f007162025-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: H4N855PNZ1
Dr. Butler Hemorrhoid and PerinealMINERAL OIL 59.8%,PETROLATUM 36%Beyond Health P.A.d17b6f16-6893-ce0a-e053-2a95a90aa23a2025-03-19WarningsExact identifier
unii: T5L8T28FGP
Mineral OilMINERAL OILKesin Pharma Corporation30a11cc9-e407-23b7-e063-6294a90a7d6e2025-03-18WarningsExact identifier
unii: T5L8T28FGP
DEBACHERE Butt Balm After Play Care Multi Symptoms ReliefBENZOCAINE, BENZALKONIUM CHLORIDEDE.BACHERE USA LLCf469b446-58a0-4be3-884f-d622b9d074f82025-03-17WarningsExact identifier
unii: U3RSY48JW5
Vitafol UltraDOCONEXENT, NIACINAMIDE, .ALPHA.-TOCOPHEROL ACETATE, DL-, CHOLECALCIFEROL, .BETA.-CAROTENE, ASCORBIC ACID, THIAMINE MONONITRATE, RIBOFLAVIN, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, IRON, ZINC OXIDE, CUPRIC OXIDE, POTASSIUM IODIDE, MAGNESIUM OXIDE, FOLIC ACID, AND LEVOMEFOLATE CALCIUMExeltis USA, Inc.40fa2c3a-f41f-434c-91de-5150a18d3e4b2025-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 1C6V77QF41
Se-Natal 19 ChewableVITAMINS AND MINERALSSeton Pharmaceuticalsa54dd642-8884-415a-a082-cd9fb544e4002025-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 1C6V77QF41
AddiclenzASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, BETA VULGARIS, BISPHENOL A, BOLDO, CHELIDONIUM MAJUS, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PETROSELINUM SATIVUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, TARAXACUM OFFICINALE, ZINCUM METALLICUMDeseret Biologicals, Inc.25036c26-1c21-4e5a-b4db-b8e1774583412025-03-11WarningsExact identifier
unii: A2I8C7HI9T
Winco Medicated Lip BalmPETROLATUMWincoc81cd9f7-f23a-4873-8542-1926497d39ce2025-03-07WarningsExact identifier
unii: 4T6H12BN9U
AD Skin ProtectantAD SKIN PROTECTANTWellSpring Pharmaceutical Corporationd26f1312-2e1b-4106-bc48-a336d4e034ad2025-03-07WarningsExact identifier
unii: 4T6H12BN9U

Reported adverse events (FAERS/openFDA)#

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