Controlling balm with tea tree oil

Product NDC
35192-018
11-digit product format
351920018
Labeler code
35192
Product ID
35192-018_ef1e799a-3c8b-7410-e053-2a95a90a30d0
Type
HUMAN OTC DRUG
Nonproprietary name
SALICYLIC ACID
Dosage form
EMULSION
Route
TOPICAL
Labeler
CA-BOTANA INTERNATIONAL
Application
part358H
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-11-09
Marketing end
0000-00-00
Substance
SALICYLIC ACID
Active strength
2 mg/237mg
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZCONTROLLING BALM WITH TEA TREE OIL (SALICYLIC ACID) EMULSION [CA-BOTANA INTERNATIONAL]1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZCONTROLLING BALM WITH TEA TREE OIL (SALICYLIC ACID) EMULSION [CA-BOTANA INTERNATIONAL]1
.ALPHA.,.ALPHA.-DIMETHYLBENZYL ALCOHOLINACTIVE INGREDIENTJE030BGE05CONTROLLING BALM WITH TEA TREE OIL (SALICYLIC ACID) EMULSION [CA-BOTANA INTERNATIONAL]1
1,2-DIOLEOYL-SN-GLYCERO-3-PHOSPHOCHOLINEINACTIVE INGREDIENTH026DM5V6UCONTROLLING BALM WITH TEA TREE OIL (SALICYLIC ACID) EMULSION [CA-BOTANA INTERNATIONAL]1
ACAIINACTIVE INGREDIENT46AM2VJ0AWCONTROLLING BALM WITH TEA TREE OIL (SALICYLIC ACID) EMULSION [CA-BOTANA INTERNATIONAL]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MCONTROLLING BALM WITH TEA TREE OIL (SALICYLIC ACID) EMULSION [CA-BOTANA INTERNATIONAL]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XCONTROLLING BALM WITH TEA TREE OIL (SALICYLIC ACID) EMULSION [CA-BOTANA INTERNATIONAL]1
ARGANIA SPINOSA LEAFINACTIVE INGREDIENT51XV5WTF7ECONTROLLING BALM WITH TEA TREE OIL (SALICYLIC ACID) EMULSION [CA-BOTANA INTERNATIONAL]1
CAMELLIA SINENSIS FLOWERINACTIVE INGREDIENT9I2BJY2J17CONTROLLING BALM WITH TEA TREE OIL (SALICYLIC ACID) EMULSION [CA-BOTANA INTERNATIONAL]1
CHAMOMILEINACTIVE INGREDIENTFGL3685T2XCONTROLLING BALM WITH TEA TREE OIL (SALICYLIC ACID) EMULSION [CA-BOTANA INTERNATIONAL]1
CINNAMONINACTIVE INGREDIENT5S29HWU6QBCONTROLLING BALM WITH TEA TREE OIL (SALICYLIC ACID) EMULSION [CA-BOTANA INTERNATIONAL]1
COPPERINACTIVE INGREDIENT789U1901C5CONTROLLING BALM WITH TEA TREE OIL (SALICYLIC ACID) EMULSION [CA-BOTANA INTERNATIONAL]1
COPPER GLUCONATEINACTIVE INGREDIENTRV823G6G67CONTROLLING BALM WITH TEA TREE OIL (SALICYLIC ACID) EMULSION [CA-BOTANA INTERNATIONAL]1
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PCONTROLLING BALM WITH TEA TREE OIL (SALICYLIC ACID) EMULSION [CA-BOTANA INTERNATIONAL]1
GINKGOINACTIVE INGREDIENT19FUJ2C58TCONTROLLING BALM WITH TEA TREE OIL (SALICYLIC ACID) EMULSION [CA-BOTANA INTERNATIONAL]1
GLATIRAMER ACETATEINACTIVE INGREDIENT5M691HL4BOCONTROLLING BALM WITH TEA TREE OIL (SALICYLIC ACID) EMULSION [CA-BOTANA INTERNATIONAL]1
GLYCINEINACTIVE INGREDIENTTE7660XO1CCONTROLLING BALM WITH TEA TREE OIL (SALICYLIC ACID) EMULSION [CA-BOTANA INTERNATIONAL]1
HAMAMELIS VIRGINIANA BARKINACTIVE INGREDIENTIH3063S9MYCONTROLLING BALM WITH TEA TREE OIL (SALICYLIC ACID) EMULSION [CA-BOTANA INTERNATIONAL]1
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4THCONTROLLING BALM WITH TEA TREE OIL (SALICYLIC ACID) EMULSION [CA-BOTANA INTERNATIONAL]1
HYPERICUM PERFORATUMINACTIVE INGREDIENTXK4IUX8MNBCONTROLLING BALM WITH TEA TREE OIL (SALICYLIC ACID) EMULSION [CA-BOTANA INTERNATIONAL]1
JUNIPERUS COMMUNIS FRUITINACTIVE INGREDIENTO84B5194RLCONTROLLING BALM WITH TEA TREE OIL (SALICYLIC ACID) EMULSION [CA-BOTANA INTERNATIONAL]1
LACTIC ACIDINACTIVE INGREDIENT33X04XA5ATCONTROLLING BALM WITH TEA TREE OIL (SALICYLIC ACID) EMULSION [CA-BOTANA INTERNATIONAL]1
LAVENDER OILINACTIVE INGREDIENTZBP1YXW0H8CONTROLLING BALM WITH TEA TREE OIL (SALICYLIC ACID) EMULSION [CA-BOTANA INTERNATIONAL]1
LEMON OILINACTIVE INGREDIENTI9GRO824LLCONTROLLING BALM WITH TEA TREE OIL (SALICYLIC ACID) EMULSION [CA-BOTANA INTERNATIONAL]1
MALPIGHIA EMARGINATA SEEDINACTIVE INGREDIENT1X7L93686MCONTROLLING BALM WITH TEA TREE OIL (SALICYLIC ACID) EMULSION [CA-BOTANA INTERNATIONAL]1
MELALEUCA ALTERNIFOLIA LEAFINACTIVE INGREDIENTG43C57162KCONTROLLING BALM WITH TEA TREE OIL (SALICYLIC ACID) EMULSION [CA-BOTANA INTERNATIONAL]1
OLEA EUROPAEA LEAFINACTIVE INGREDIENTMJ95C3OH47CONTROLLING BALM WITH TEA TREE OIL (SALICYLIC ACID) EMULSION [CA-BOTANA INTERNATIONAL]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TCONTROLLING BALM WITH TEA TREE OIL (SALICYLIC ACID) EMULSION [CA-BOTANA INTERNATIONAL]1
PINUS TAEDA BARKINACTIVE INGREDIENT9I1F994SVGCONTROLLING BALM WITH TEA TREE OIL (SALICYLIC ACID) EMULSION [CA-BOTANA INTERNATIONAL]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHCONTROLLING BALM WITH TEA TREE OIL (SALICYLIC ACID) EMULSION [CA-BOTANA INTERNATIONAL]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4CONTROLLING BALM WITH TEA TREE OIL (SALICYLIC ACID) EMULSION [CA-BOTANA INTERNATIONAL]1
PROPYLENE GLYCOL, (R)-INACTIVE INGREDIENT602HN5L69HCONTROLLING BALM WITH TEA TREE OIL (SALICYLIC ACID) EMULSION [CA-BOTANA INTERNATIONAL]1
PUNICA GRANATUM FLOWERINACTIVE INGREDIENTD9B634V4GPCONTROLLING BALM WITH TEA TREE OIL (SALICYLIC ACID) EMULSION [CA-BOTANA INTERNATIONAL]1
ROSA CANINA FLOWERINACTIVE INGREDIENT81MCR2UQ6QCONTROLLING BALM WITH TEA TREE OIL (SALICYLIC ACID) EMULSION [CA-BOTANA INTERNATIONAL]1
ROSEMARYINACTIVE INGREDIENTIJ67X351P9CONTROLLING BALM WITH TEA TREE OIL (SALICYLIC ACID) EMULSION [CA-BOTANA INTERNATIONAL]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ICONTROLLING BALM WITH TEA TREE OIL (SALICYLIC ACID) EMULSION [CA-BOTANA INTERNATIONAL]1
SODIUM PYRROLIDONE CARBOXYLATEINACTIVE INGREDIENT469OTG57A2CONTROLLING BALM WITH TEA TREE OIL (SALICYLIC ACID) EMULSION [CA-BOTANA INTERNATIONAL]1
VITIS VINIFERA FLOWERING TOPINACTIVE INGREDIENT6TG3V35HTVCONTROLLING BALM WITH TEA TREE OIL (SALICYLIC ACID) EMULSION [CA-BOTANA INTERNATIONAL]1
WATERINACTIVE INGREDIENT059QF0KO0RCONTROLLING BALM WITH TEA TREE OIL (SALICYLIC ACID) EMULSION [CA-BOTANA INTERNATIONAL]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECONTROLLING BALM WITH TEA TREE OIL (SALICYLIC ACID) EMULSION [CA-BOTANA INTERNATIONAL]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35192-018CONTROLLING BALM WITH TEA TREE OIL (SALICYLIC ACID) EMULSION [CA-BOTANA INTERNATIONAL]14Legacy NDC20241209_65d71c3e-30ea-40db-9fdb-5d60c079a37d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35192-018-0735192001807237 mg in 1 BOTTLE (35192-018-07) 237 mg2017-11-020000-00-00NoNoCurrent