FDA.reportPublic FDA data

Acne Solution

Manufacturer
Biometics Co.,Ltd.
Effective date
2014-04-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:39:09

Label at a glance#

ProductAcne Solution
Active ingredientsalicylic acid
Label structure1 sections

Label contents#

Full prescribing information#

Acne Solution

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
199308salicylic acid 0.5 % Topical SolutionPSN1
199308salicylic acid 5 MG/ML Topical SolutionSCD1
199308salicylic acid 0.5 % Topical SolutionSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62818-101-022020-01-31C16284748780-19d75b9d1-2a93-f424-e053-dadaa90a57ceAcne Solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62818-101-01Acne Solution40 g in 1 BOTTLESOLUTION401
62818-101-02Acne Solution1 in 1 BOXSOLUTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62818-101ACNE SOLUTION (SALICYLIC ACID) SOLUTION [BIOMETICS CO.,LTD.]1Legacy NDC, 2 package rows20140501_3e7c306d-9927-4e7a-901f-abed8184fae4.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
salicylic acidACTIVE INGREDIENTO414PZ4LPZ1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZ1
ALLANTOININACTIVE INGREDIENT344S277G0Z1
BROUSSONETIA PAPYRIFERA WHOLEINACTIVE INGREDIENT0QW22BU6781
CAMELLIA SINENSIS WHOLEINACTIVE INGREDIENTC5M4585ZBZ1
CAPSICUM ANNUUM WHOLEINACTIVE INGREDIENT7FKZ3QQQ1F1
CENTELLA ASIATICAINACTIVE INGREDIENT7M867G6T1U1
CETYL HYDROXYETHYLCELLULOSE (350000 MW)INACTIVE INGREDIENTT7SWE4S2TT1
CITRUS PARADISI SEEDINACTIVE INGREDIENT12F08874Y71
CORYLUS AVELLANA POLLEN EXTRACTINACTIVE INGREDIENTCR2J49TL6L1
CUPRESSUS SEMPERVIRENS LEAF OILINACTIVE INGREDIENTM7QUY89S4O1
CYMBOPOGON MARTINI WHOLEINACTIVE INGREDIENT267NPH931L1
EUCOMMIA ULMOIDES WHOLEINACTIVE INGREDIENT21176878UY1
GERANIUM OIL, ALGERIAN TYPEINACTIVE INGREDIENT5Q1I94P4WG1
LAVANDULA ANGUSTIFOLIA WHOLEINACTIVE INGREDIENT51217XIL5L1
LOTUS CORNICULATUS FLOWER VOLATILE OILINACTIVE INGREDIENTW11376RO0T1
MELALEUCA ALTERNIFOLIA LEAFINACTIVE INGREDIENTG43C57162K1
MORUS ALBA WHOLEINACTIVE INGREDIENTC4228R0MX21
OLIVE OILINACTIVE INGREDIENT6UYK2W1W1E1
PAEONIA SUFFRUTICOSA ROOTINACTIVE INGREDIENT7M7E9A2C8J1
PHELLODENDRON AMURENSE BARKINACTIVE INGREDIENTPBG27B754G1
PROPOLIS WAXINACTIVE INGREDIENT6Y8XYV2NOF1
ROSMARINUS OFFICINALIS WHOLEINACTIVE INGREDIENTEA3289138M1
SAURURUS CHINENSIS WHOLEINACTIVE INGREDIENT6DRV3D37XS1
VITIS VINIFERA SEEDINACTIVE INGREDIENTC34U15ICXA1
waterINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62818-10162818-101-01, 62818-101-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
salicylic acidO414PZ4LPZACTIB
water059QF0KO0RIACT
SAURURUS CHINENSIS WHOLE6DRV3D37XSIACT
CAMELLIA SINENSIS WHOLEC5M4585ZBZIACT
BROUSSONETIA PAPYRIFERA WHOLE0QW22BU678IACT
MORUS ALBA WHOLEC4228R0MX2IACT
EUCOMMIA ULMOIDES WHOLE21176878UYIACT
PHELLODENDRON AMURENSE BARKPBG27B754GIACT
VITIS VINIFERA SEEDC34U15ICXAIACT
LOTUS CORNICULATUS FLOWER VOLATILE OILW11376RO0TIACT
CORYLUS AVELLANA POLLEN EXTRACTCR2J49TL6LIACT
ALLANTOIN344S277G0ZIACT
CENTELLA ASIATICA7M867G6T1UIACT
CAPSICUM ANNUUM WHOLE7FKZ3QQQ1FIACT
ROSMARINUS OFFICINALIS WHOLEEA3289138MIACT
OLIVE OIL6UYK2W1W1EIACT
CITRUS PARADISI SEED12F08874Y7IACT
PAEONIA SUFFRUTICOSA ROOT7M7E9A2C8JIACT
PROPOLIS WAX6Y8XYV2NOFIACT
CETYL HYDROXYETHYLCELLULOSE (350000 MW)T7SWE4S2TTIACT
LAVANDULA ANGUSTIFOLIA WHOLE51217XIL5LIACT
MELALEUCA ALTERNIFOLIA LEAFG43C57162KIACT
GERANIUM OIL, ALGERIAN TYPE5Q1I94P4WGIACT
CYMBOPOGON MARTINI WHOLE267NPH931LIACT
CUPRESSUS SEMPERVIRENS LEAF OILM7QUY89S4OIACT

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 6 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALLANTOINALLANTOIN344S277G0ZGEL / TOPICAL8 mgExact identifier — unii candidate
OLIVE OILOLIVE OIL6UYK2W1W1ECAPSULE / ORALNAExact identifier — unii candidate
5 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ESOAP / TOPICALNAExact identifier — unii candidate
5 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ELOTION / TOPICAL32468 mgExact identifier — unii candidate
5 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ESOLUTION / TOPICAL0.6 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ESOLUTION / ORAL425 mg/1mlExact identifier — unii candidate
5 equally ranked IID candidates

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
041856fa-1f3e-4a4b-ba5a-f9326e9c620d3e7c306d-9927-4e7a-901f-abed8184fae42014-04-16WarningsExact identifier
spl id: 041856fa-1f3e-4a4b-ba5a-f9326e9c620d
spl set id: 3e7c306d-9927-4e7a-901f-abed8184fae4

Reported adverse events (FAERS/openFDA)#

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