FDA.reportPublic FDA data

BENZOCAINE and RESORCINOL

Product NDC
67868-117
11-digit product format
678680117
Labeler code
67868
Product ID
67868-117_d1f9eabc-99ec-4daa-a999-47aaca7d1aa0
Type
HUMAN OTC DRUG
Nonproprietary name
BENZOCAINE and RESORCINOL
Dosage form
CREAM
Route
TOPICAL
Labeler
Pharma Pac, LLC
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2009-05-19
Marketing end
0000-00-00
Substance
BENZOCAINE; RESORCINOL
Active strength
200 mg/g; mg/g
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67868-117-902019-10-29C16284748780-1960f7f55-c551-8e05-e053-dbdaa90a074adrug facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67868-117-90BENZOCAINE and RESORCINOL28 g in 1 TUBECREAM287

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZOCAINEACTIVE INGREDIENTU3RSY48JW5BENZOCAINE AND RESORCINOL CREAM [PHARMA PAC, LLC]7
RESORCINOLACTIVE INGREDIENTYUL4LO94HKBENZOCAINE AND RESORCINOL CREAM [PHARMA PAC, LLC]7
BENZOCAINEACTIVE MOIETYU3RSY48JW5BENZOCAINE AND RESORCINOL CREAM [PHARMA PAC, LLC]7
RESORCINOLACTIVE MOIETYYUL4LO94HKBENZOCAINE AND RESORCINOL CREAM [PHARMA PAC, LLC]7
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XBENZOCAINE AND RESORCINOL CREAM [PHARMA PAC, LLC]7
ALPHA-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1BENZOCAINE AND RESORCINOL CREAM [PHARMA PAC, LLC]7
CARBOMER HOMOPOLYMER TYPE CINACTIVE INGREDIENT4Q93RCW27EBENZOCAINE AND RESORCINOL CREAM [PHARMA PAC, LLC]7
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNBENZOCAINE AND RESORCINOL CREAM [PHARMA PAC, LLC]7
CORN OILINACTIVE INGREDIENT8470G57WFMBENZOCAINE AND RESORCINOL CREAM [PHARMA PAC, LLC]7
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4BENZOCAINE AND RESORCINOL CREAM [PHARMA PAC, LLC]7
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSBENZOCAINE AND RESORCINOL CREAM [PHARMA PAC, LLC]7
ISOPROPYL PALMITATEINACTIVE INGREDIENT8CRQ2TH63MBENZOCAINE AND RESORCINOL CREAM [PHARMA PAC, LLC]7
ISOPROPYL STEARATEINACTIVE INGREDIENT43253ZW1MZBENZOCAINE AND RESORCINOL CREAM [PHARMA PAC, LLC]7
LANOLIN ALCOHOLSINACTIVE INGREDIENT884C3FA9HEBENZOCAINE AND RESORCINOL CREAM [PHARMA PAC, LLC]7
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TBENZOCAINE AND RESORCINOL CREAM [PHARMA PAC, LLC]7
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPBENZOCAINE AND RESORCINOL CREAM [PHARMA PAC, LLC]7
POLYOXYL 100 STEARATEINACTIVE INGREDIENTYD01N1999RBENZOCAINE AND RESORCINOL CREAM [PHARMA PAC, LLC]7
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BENZOCAINE AND RESORCINOL CREAM [PHARMA PAC, LLC]7
SODIUM SULFITEINACTIVE INGREDIENTVTK01UQK3GBENZOCAINE AND RESORCINOL CREAM [PHARMA PAC, LLC]7
TRISODIUM HEDTAINACTIVE INGREDIENTK3E0U7O8KIBENZOCAINE AND RESORCINOL CREAM [PHARMA PAC, LLC]7
VITAMIN AINACTIVE INGREDIENT81G40H8B0TBENZOCAINE AND RESORCINOL CREAM [PHARMA PAC, LLC]7
VITAMIN DINACTIVE INGREDIENT9VU1KI44GPBENZOCAINE AND RESORCINOL CREAM [PHARMA PAC, LLC]7
WATERINACTIVE INGREDIENT059QF0KO0RBENZOCAINE AND RESORCINOL CREAM [PHARMA PAC, LLC]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67868-117BENZOCAINE AND RESORCINOL CREAM [PHARMA PAC, LLC]7Legacy NDC, 1 package rows20110719_6cf1ab7b-8d16-4d41-a3bb-92ba603d3f7e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
67868-117-906786801179028 g in 1 TUBE28 gHistorical