FDA.reportPublic FDA data

Acne Toner

Product NDC
49825-136
Requested package NDC
49825-136-02
11-digit product format
498250136
Labeler code
49825
Product ID
49825-136_67bc2122-1734-41d6-bf1e-88ced54c0198
Type
HUMAN OTC DRUG
Nonproprietary name
Salicylic Acid
Dosage form
LIQUID
Route
TOPICAL
Labeler
Bioelements
Application
part358B
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-04-10
Marketing end
0000-00-00
Substance
SALICYLIC ACID
Active strength
1 g/.5mL
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage49825-13649825-136-02DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
49825-136-022025-01-08Acne Toner
49825-136-042025-01-08Acne Toner
49825-136-022024-01-30Acne Toner
49825-136-042024-01-30Acne Toner

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZACNE TONER ACNE CLEARING SYSTEM (SALICYLIC ACID) LIQUID [BIOELEMENTS]4
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZACNE TONER ACNE CLEARING SYSTEM (SALICYLIC ACID) LIQUID [BIOELEMENTS]4
CITRUS MAXIMA FRUIT RIND OILINACTIVE INGREDIENT8U3877WD44ACNE TONER ACNE CLEARING SYSTEM (SALICYLIC ACID) LIQUID [BIOELEMENTS]4
ELEMIINACTIVE INGREDIENTC13XI009KOACNE TONER ACNE CLEARING SYSTEM (SALICYLIC ACID) LIQUID [BIOELEMENTS]4
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PACNE TONER ACNE CLEARING SYSTEM (SALICYLIC ACID) LIQUID [BIOELEMENTS]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXACNE TONER ACNE CLEARING SYSTEM (SALICYLIC ACID) LIQUID [BIOELEMENTS]4
HEXYLENE GLYCOLINACTIVE INGREDIENTKEH0A3F75JACNE TONER ACNE CLEARING SYSTEM (SALICYLIC ACID) LIQUID [BIOELEMENTS]4
HONEYINACTIVE INGREDIENTY9H1V576FHACNE TONER ACNE CLEARING SYSTEM (SALICYLIC ACID) LIQUID [BIOELEMENTS]4
KIWI FRUITINACTIVE INGREDIENT71ES77LGJCACNE TONER ACNE CLEARING SYSTEM (SALICYLIC ACID) LIQUID [BIOELEMENTS]4
LAVANDIN OILINACTIVE INGREDIENT9RES347CKGACNE TONER ACNE CLEARING SYSTEM (SALICYLIC ACID) LIQUID [BIOELEMENTS]4
LAVANDULA ANGUSTIFOLIA FLOWERING TOPINACTIVE INGREDIENT9YT4B71U8PACNE TONER ACNE CLEARING SYSTEM (SALICYLIC ACID) LIQUID [BIOELEMENTS]4
LEMONINACTIVE INGREDIENT24RS0A988OACNE TONER ACNE CLEARING SYSTEM (SALICYLIC ACID) LIQUID [BIOELEMENTS]4
LIME (CITRUS)INACTIVE INGREDIENT8CZS546954ACNE TONER ACNE CLEARING SYSTEM (SALICYLIC ACID) LIQUID [BIOELEMENTS]4
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UACNE TONER ACNE CLEARING SYSTEM (SALICYLIC ACID) LIQUID [BIOELEMENTS]4
ORANGEINACTIVE INGREDIENT5EVU04N5QUACNE TONER ACNE CLEARING SYSTEM (SALICYLIC ACID) LIQUID [BIOELEMENTS]4
ORANGE OILINACTIVE INGREDIENTAKN3KSD11BACNE TONER ACNE CLEARING SYSTEM (SALICYLIC ACID) LIQUID [BIOELEMENTS]4
PAPAYAINACTIVE INGREDIENTKU94FIY6JBACNE TONER ACNE CLEARING SYSTEM (SALICYLIC ACID) LIQUID [BIOELEMENTS]4
PENTYLENE GLYCOLINACTIVE INGREDIENT50C1307PZGACNE TONER ACNE CLEARING SYSTEM (SALICYLIC ACID) LIQUID [BIOELEMENTS]4
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TACNE TONER ACNE CLEARING SYSTEM (SALICYLIC ACID) LIQUID [BIOELEMENTS]4
PINEAPPLEINACTIVE INGREDIENT2A88ZO081OACNE TONER ACNE CLEARING SYSTEM (SALICYLIC ACID) LIQUID [BIOELEMENTS]4
POLYOXYL 40 HYDROGENATED CASTOR OILINACTIVE INGREDIENT7YC686GQ8FACNE TONER ACNE CLEARING SYSTEM (SALICYLIC ACID) LIQUID [BIOELEMENTS]4
PUMMELOINACTIVE INGREDIENTET1TN5W71XACNE TONER ACNE CLEARING SYSTEM (SALICYLIC ACID) LIQUID [BIOELEMENTS]4
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IACNE TONER ACNE CLEARING SYSTEM (SALICYLIC ACID) LIQUID [BIOELEMENTS]4
TETRAHEXYLDECYL ASCORBATEINACTIVE INGREDIENT9LBV3F07AZACNE TONER ACNE CLEARING SYSTEM (SALICYLIC ACID) LIQUID [BIOELEMENTS]4
TRIDECETH-9INACTIVE INGREDIENTX9HD79I514ACNE TONER ACNE CLEARING SYSTEM (SALICYLIC ACID) LIQUID [BIOELEMENTS]4
WATERINACTIVE INGREDIENT059QF0KO0RACNE TONER ACNE CLEARING SYSTEM (SALICYLIC ACID) LIQUID [BIOELEMENTS]4
WINE GRAPEINACTIVE INGREDIENT3GOV20705GACNE TONER ACNE CLEARING SYSTEM (SALICYLIC ACID) LIQUID [BIOELEMENTS]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49825-136ACNE TONER ACNE CLEARING SYSTEM (SALICYLIC ACID) LIQUID [BIOELEMENTS, INC.]9Legacy NDC20250110_ec0a568a-c6c1-44e4-81b0-1140cc83048f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49825-136-02498250136021 BOTTLE in 1 BOX (49825-136-02) > 88 mL in 1 BOTTLE (49825-136-01) 1 bottle2015-04-100000-00-00NoNoCurrent