Lanacane

Product NDC
63824-810
11-digit product format
638240810
Labeler code
63824
Product ID
63824-810_27093f0a-7535-4869-8ef2-82c7c8c04095
Type
HUMAN OTC DRUG
Nonproprietary name
Benzethonium chloride and Benzocaine
Dosage form
CREAM
Route
TOPICAL
Labeler
RB Health (US) LLC
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2012-09-28
Marketing end
0000-00-00
Substance
BENZETHONIUM CHLORIDE; BENZOCAINE
Active strength
2 mg/g; mg/g
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63824-810-01GM - Gram63824-8107f7b3b8d-0ca6-47a5-858a-633d50b0f01212014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Benzethonium chlorideACTIVE INGREDIENTPH41D05744LANACANE MAXIMUM STRENGTH ANTI-ITCH (BENZETHONIUM CHLORIDE AND BENZOCAINE) CREAM [RECKITT BENCKISER LLC]3
BenzocaineACTIVE INGREDIENTU3RSY48JW5LANACANE MAXIMUM STRENGTH ANTI-ITCH (BENZETHONIUM CHLORIDE AND BENZOCAINE) CREAM [RECKITT BENCKISER LLC]3
BenzethoniumACTIVE MOIETY1VU15B70BPLANACANE MAXIMUM STRENGTH ANTI-ITCH (BENZETHONIUM CHLORIDE AND BENZOCAINE) CREAM [RECKITT BENCKISER LLC]3
BenzocaineACTIVE MOIETYU3RSY48JW5LANACANE MAXIMUM STRENGTH ANTI-ITCH (BENZETHONIUM CHLORIDE AND BENZOCAINE) CREAM [RECKITT BENCKISER LLC]3
.alpha.-tocopherol acetate, dl-INACTIVE INGREDIENTWR1WPI7EW8LANACANE MAXIMUM STRENGTH ANTI-ITCH (BENZETHONIUM CHLORIDE AND BENZOCAINE) CREAM [RECKITT BENCKISER LLC]3
acetylated lanolin alcoholsINACTIVE INGREDIENTSNN716810PLANACANE MAXIMUM STRENGTH ANTI-ITCH (BENZETHONIUM CHLORIDE AND BENZOCAINE) CREAM [RECKITT BENCKISER LLC]3
aloeINACTIVE INGREDIENTV5VD430YW9LANACANE MAXIMUM STRENGTH ANTI-ITCH (BENZETHONIUM CHLORIDE AND BENZOCAINE) CREAM [RECKITT BENCKISER LLC]3
cetyl acetateINACTIVE INGREDIENT4Q43814HXSLANACANE MAXIMUM STRENGTH ANTI-ITCH (BENZETHONIUM CHLORIDE AND BENZOCAINE) CREAM [RECKITT BENCKISER LLC]3
cetyl alcoholINACTIVE INGREDIENT936JST6JCNLANACANE MAXIMUM STRENGTH ANTI-ITCH (BENZETHONIUM CHLORIDE AND BENZOCAINE) CREAM [RECKITT BENCKISER LLC]3
cholecalciferolINACTIVE INGREDIENT1C6V77QF41LANACANE MAXIMUM STRENGTH ANTI-ITCH (BENZETHONIUM CHLORIDE AND BENZOCAINE) CREAM [RECKITT BENCKISER LLC]3
corn oilINACTIVE INGREDIENT8470G57WFMLANACANE MAXIMUM STRENGTH ANTI-ITCH (BENZETHONIUM CHLORIDE AND BENZOCAINE) CREAM [RECKITT BENCKISER LLC]3
dimethiconeINACTIVE INGREDIENT92RU3N3Y1OLANACANE MAXIMUM STRENGTH ANTI-ITCH (BENZETHONIUM CHLORIDE AND BENZOCAINE) CREAM [RECKITT BENCKISER LLC]3
glycerinINACTIVE INGREDIENTPDC6A3C0OXLANACANE MAXIMUM STRENGTH ANTI-ITCH (BENZETHONIUM CHLORIDE AND BENZOCAINE) CREAM [RECKITT BENCKISER LLC]3
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE4LANACANE MAXIMUM STRENGTH ANTI-ITCH (BENZETHONIUM CHLORIDE AND BENZOCAINE) CREAM [RECKITT BENCKISER LLC]3
isopropyl myristateINACTIVE INGREDIENT0RE8K4LNJSLANACANE MAXIMUM STRENGTH ANTI-ITCH (BENZETHONIUM CHLORIDE AND BENZOCAINE) CREAM [RECKITT BENCKISER LLC]3
methylparabenINACTIVE INGREDIENTA2I8C7HI9TLANACANE MAXIMUM STRENGTH ANTI-ITCH (BENZETHONIUM CHLORIDE AND BENZOCAINE) CREAM [RECKITT BENCKISER LLC]3
mineral oilINACTIVE INGREDIENTT5L8T28FGPLANACANE MAXIMUM STRENGTH ANTI-ITCH (BENZETHONIUM CHLORIDE AND BENZOCAINE) CREAM [RECKITT BENCKISER LLC]3
PEG-100 stearateINACTIVE INGREDIENTYD01N1999RLANACANE MAXIMUM STRENGTH ANTI-ITCH (BENZETHONIUM CHLORIDE AND BENZOCAINE) CREAM [RECKITT BENCKISER LLC]3
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHLANACANE MAXIMUM STRENGTH ANTI-ITCH (BENZETHONIUM CHLORIDE AND BENZOCAINE) CREAM [RECKITT BENCKISER LLC]3
pyrithione zincINACTIVE INGREDIENTR953O2RHZ5LANACANE MAXIMUM STRENGTH ANTI-ITCH (BENZETHONIUM CHLORIDE AND BENZOCAINE) CREAM [RECKITT BENCKISER LLC]3
sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58XLANACANE MAXIMUM STRENGTH ANTI-ITCH (BENZETHONIUM CHLORIDE AND BENZOCAINE) CREAM [RECKITT BENCKISER LLC]3
stearamidopropyl PG-dimonium chloride phosphateINACTIVE INGREDIENTW6000VEI5YLANACANE MAXIMUM STRENGTH ANTI-ITCH (BENZETHONIUM CHLORIDE AND BENZOCAINE) CREAM [RECKITT BENCKISER LLC]3
vitamin A palmitateINACTIVE INGREDIENT1D1K0N0VVCLANACANE MAXIMUM STRENGTH ANTI-ITCH (BENZETHONIUM CHLORIDE AND BENZOCAINE) CREAM [RECKITT BENCKISER LLC]3
waterINACTIVE INGREDIENT059QF0KO0RLANACANE MAXIMUM STRENGTH ANTI-ITCH (BENZETHONIUM CHLORIDE AND BENZOCAINE) CREAM [RECKITT BENCKISER LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63824-810LANACANE MAXIMUM STRENGTH ANTI-ITCH (BENZETHONIUM CHLORIDE AND BENZOCAINE) CREAM [RB HEALTH (US) LLC]7Legacy NDC20231130_96eb2dcc-4653-452a-9abd-fe92114a14ad.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63824-810-01638240810011 TUBE in 1 CARTON (63824-810-01) > 28 g in 1 TUBE1 tube2012-09-280000-00-00NoNoCurrent