FDA.reportPublic FDA data

Acne Toner

Product NDC
49825-130
11-digit product format
498250130
Labeler code
49825
Product ID
49825-130_e1a609b0-d5e6-40e9-9021-efa39188bb5b
Type
HUMAN OTC DRUG
Nonproprietary name
Salicylic Acid
Dosage form
CREAM
Route
TOPICAL
Labeler
Bioelements, Inc.
Application
part333D
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-06-17
Marketing end
0000-00-00
Substance
SALICYLIC ACID
Active strength
1 g/100mL
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49825-130-022020-01-31C16284748780-19d75b9d0-c223-f424-e053-dadaa90a57ceAcne Toner
49825-130-042020-01-31C16284748780-19d75b9d0-c223-f424-e053-dadaa90a57ceAcne Toner

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49825-130-01Acne TonerBiolements88 mL in 1 BOTTLECREAM882
49825-130-02Acne TonerBiolements1 in 1 CARTONCREAM12
49825-130-03Acne TonerBiolements236 mL in 1 BOTTLECREAM2362
49825-130-04Acne TonerBiolements1 in 1 CARTONCREAM12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZACNE TONER BIOLEMENTS (SALICYLIC ACID) CREAM [BIOELEMENTS, INC.]2
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZACNE TONER BIOLEMENTS (SALICYLIC ACID) CREAM [BIOELEMENTS, INC.]2
ELEMIINACTIVE INGREDIENTC13XI009KOACNE TONER BIOLEMENTS (SALICYLIC ACID) CREAM [BIOELEMENTS, INC.]2
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PACNE TONER BIOLEMENTS (SALICYLIC ACID) CREAM [BIOELEMENTS, INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXACNE TONER BIOLEMENTS (SALICYLIC ACID) CREAM [BIOELEMENTS, INC.]2
GRAPEFRUITINACTIVE INGREDIENTO82C39RR8CACNE TONER BIOLEMENTS (SALICYLIC ACID) CREAM [BIOELEMENTS, INC.]2
GRAPEFRUIT OILINACTIVE INGREDIENTYR377U58W9ACNE TONER BIOLEMENTS (SALICYLIC ACID) CREAM [BIOELEMENTS, INC.]2
HAMAMELIS VIRGINIANA LEAFINACTIVE INGREDIENTT07U1161SVACNE TONER BIOLEMENTS (SALICYLIC ACID) CREAM [BIOELEMENTS, INC.]2
HEXYLENE GLYCOLINACTIVE INGREDIENTKEH0A3F75JACNE TONER BIOLEMENTS (SALICYLIC ACID) CREAM [BIOELEMENTS, INC.]2
HONEYINACTIVE INGREDIENTY9H1V576FHACNE TONER BIOLEMENTS (SALICYLIC ACID) CREAM [BIOELEMENTS, INC.]2
KIWI FRUITINACTIVE INGREDIENT71ES77LGJCACNE TONER BIOLEMENTS (SALICYLIC ACID) CREAM [BIOELEMENTS, INC.]2
LAVANDIN OILINACTIVE INGREDIENT9RES347CKGACNE TONER BIOLEMENTS (SALICYLIC ACID) CREAM [BIOELEMENTS, INC.]2
LAVANDULA ANGUSTIFOLIA FLOWERINACTIVE INGREDIENT19AH1RAF4MACNE TONER BIOLEMENTS (SALICYLIC ACID) CREAM [BIOELEMENTS, INC.]2
LEMONINACTIVE INGREDIENT24RS0A988OACNE TONER BIOLEMENTS (SALICYLIC ACID) CREAM [BIOELEMENTS, INC.]2
LIME (CITRUS)INACTIVE INGREDIENT8CZS546954ACNE TONER BIOLEMENTS (SALICYLIC ACID) CREAM [BIOELEMENTS, INC.]2
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UACNE TONER BIOLEMENTS (SALICYLIC ACID) CREAM [BIOELEMENTS, INC.]2
ORANGEINACTIVE INGREDIENT5EVU04N5QUACNE TONER BIOLEMENTS (SALICYLIC ACID) CREAM [BIOELEMENTS, INC.]2
ORANGE OILINACTIVE INGREDIENTAKN3KSD11BACNE TONER BIOLEMENTS (SALICYLIC ACID) CREAM [BIOELEMENTS, INC.]2
PAPAYAINACTIVE INGREDIENTKU94FIY6JBACNE TONER BIOLEMENTS (SALICYLIC ACID) CREAM [BIOELEMENTS, INC.]2
PENTYLENE GLYCOLINACTIVE INGREDIENT50C1307PZGACNE TONER BIOLEMENTS (SALICYLIC ACID) CREAM [BIOELEMENTS, INC.]2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TACNE TONER BIOLEMENTS (SALICYLIC ACID) CREAM [BIOELEMENTS, INC.]2
PINEAPPLEINACTIVE INGREDIENT2A88ZO081OACNE TONER BIOLEMENTS (SALICYLIC ACID) CREAM [BIOELEMENTS, INC.]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IACNE TONER BIOLEMENTS (SALICYLIC ACID) CREAM [BIOELEMENTS, INC.]2
TETRAHEXYLDECYL ASCORBATEINACTIVE INGREDIENT9LBV3F07AZACNE TONER BIOLEMENTS (SALICYLIC ACID) CREAM [BIOELEMENTS, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RACNE TONER BIOLEMENTS (SALICYLIC ACID) CREAM [BIOELEMENTS, INC.]2
WINE GRAPEINACTIVE INGREDIENT3GOV20705GACNE TONER BIOLEMENTS (SALICYLIC ACID) CREAM [BIOELEMENTS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49825-130ACNE TONER BIOLEMENTS (SALICYLIC ACID) CREAM [BIOELEMENTS, INC.]2Legacy NDC, 4 package rows20130619_1966e710-fded-4d6b-a9cc-978cd6ace4a5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
248684salicylic acid 0.5 % Topical CreamPSN1966e710-fded-4d6b-a9cc-978cd6ace4a52
248684salicylic acid 5 MG/ML Topical CreamSCD1966e710-fded-4d6b-a9cc-978cd6ace4a52
248684salicylic acid 0.5 % Topical CreamSY1966e710-fded-4d6b-a9cc-978cd6ace4a52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
49825-130-014982501300188 mL in 1 BOTTLE88 mlHistorical
49825-130-02498250130021 in 1 CARTONHistorical
49825-130-0349825013003236 mL in 1 BOTTLE236 mlHistorical
49825-130-04498250130041 in 1 CARTONHistorical