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 2 of 71 · 1,409 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sting Relief PadBENZOCAINE, ISOPROPYL ALCOHOL CLOTHJINHUA JINGDI MEDICAL SUPPLIES CO., LTD57ccc28b-5f5f-30ec-e063-6294a90a081c2026-09-07WarningsExact identifier
unii: U3RSY48JW5
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMCVS Pharmacy3167c918-a7d3-46a1-a85b-64f9c22916f22026-09-04WarningsExact identifier
unii: 4T6H12BN9U
SurviveX Sting ReliefSTING RELIEF WIPEChangzhou Maokang Medical Products Co., Ltd.5a83b1f1-c8dc-cf07-e063-6394a90a20ca2026-09-03WarningsExact identifier
unii: U3RSY48JW5
Petroleum Skin ProtectantWHITE PETROLATUMYour Military Exchanges1a0aed14-8606-4676-b4b5-23dd415d43ac2026-09-02Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
OilMINERAL OILAtlantic Biologicals Corp.5a82197b-281d-76c0-e063-6294a90a57462026-09-02Warnings, Adverse reactionsExact identifier
unii: T5L8T28FGP
Orajel 4X Medicated Toothache and Gum CreamBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.5a1c82b4-02b3-d456-e063-6294a90a16bb2026-08-31WarningsExact identifier
unii: U3RSY48JW5
Orajel 4X Medicated Toothache and Gum PM CreamBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.5a1cdaf4-3388-280c-e063-6294a90ac70f2026-08-31WarningsExact identifier
unii: U3RSY48JW5
PURE PETROLATUMPETROLATUMVASA COSMETICS PRIVATE LIMITED5a57b197-3e18-b3ab-e063-6394a90aed822026-08-31WarningsExact identifier
unii: 4T6H12BN9U
Orajel 4X Medicated Toothache and GumBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.5a1b4133-0eac-2f8f-e063-6394a90af8f62026-08-28WarningsExact identifier
unii: U3RSY48JW5
HYDROPHORHYDROPHORAkron Pharma Inc.e6099df7-d418-479a-9d2e-ced523585aed2026-08-28WarningsExact identifier
unii: 4T6H12BN9U
Mineral OilMINERAL OILYour Military Exchanges6025dce6-02e8-418c-a248-0b5c33ff60672026-08-28Warnings, Adverse reactionsExact identifier
unii: T5L8T28FGP
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Mirexa MiniMIREXA MINIOncora Pharma, LLCea48f64a-9a70-40df-ba25-0983532730892026-08-25Warnings, Adverse reactionsExact identifier
unii: 1C6V77QF41
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Mineral Oil/White PetrolatumMINERAL OIL/WHITE PETROLATUMYYBA CORP5967ef02-6770-bfd7-e063-6294a90a79042026-08-19WarningsExact identifier
unii: T5L8T28FGP
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
Mineral Oil/White PetrolatumMINERAL OIL/WHITE PETROLATUMYYBA CORP5905b300-6f1f-a61f-e063-6394a90a11232026-08-14WarningsExact identifier
unii: T5L8T28FGP
Mineral oilMINERAL OILEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)92f2147d-b52d-4282-b217-28f6095dca0e2026-08-12WarningsExact identifier
unii: T5L8T28FGP
Gee GasonMALE GENITAL DESENSITIZERMon Gars Boutique Inc58c75e5c-b801-017f-e063-6394a90a1c752026-08-11WarningsExact identifier
unii: U3RSY48JW5
Gingicaine Gel Variety PakGINGICAINE GEL VARIETY PAKGingi-Pak a Division of the Belport62ed4ff3-18f6-5c67-e053-2991aa0a77922026-08-11WarningsExact identifier
unii: U3RSY48JW5

Reported adverse events (FAERS/openFDA)#

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