FDA.reportPublic FDA data

Zitlox Salicylic Acne

Product NDC
69546-201
11-digit product format
695460201
Labeler code
69546
Product ID
69546-201_11a394cf-9646-4dc7-8315-d5329b0d08d9
Type
HUMAN OTC DRUG
Nonproprietary name
Salicylic Acid
Dosage form
GEL
Route
TOPICAL
Labeler
ASA Universal Inc. dba: SONAGE
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-06-30
Substance
SALICYLIC ACID
Active strength
1.5 g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Zitlox Salicylic Acne
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID1.5 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
O414PZ4LPZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
416212Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4b833d7a-f957-4e65-be5b-177149314958Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69546-201-02Zitlox Salicylic Acne15 mL in 1 BOTTLE, PUMPGEL152
69546-201-02Zitlox Salicylic Acne1 in 1 CARTONGEL12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69546-201ZITLOX SALICYLIC ACNE (SALICYLIC ACID) GEL [ASA UNIVERSAL INC. DBA: SONAGE]2Current NDC, Legacy NDC, 2 package rows20250108_4b833d7a-f957-4e65-be5b-177149314958.zip

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 16 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Proactiv Renewing CleanserBENZOYL PEROXIDEAlchemee, LLC85c22f3a-b6c5-44a2-959c-532c6456ec302026-01-07WarningsExact identifier
application number: M006
Proactiv Repairing TreatmentBENZOYL PEROXIDEAlchemee, LLC9bbf6db0-ff80-44d2-b81b-40080ca46b922026-01-07WarningsExact identifier
application number: M006
Proactiv Deep Cleansing WashSALICYLIC ACIDTHE PROACTIV COMPANY LLC4a2bd12d-f166-43cf-b175-d20affc805262026-01-07WarningsExact identifier
application number: M006
Proactiv Advanced Daily Oil ControlSALICYLIC ACIDAlchemee, LLC945be4e4-1ca2-41df-b3c8-da7b8fe38bc42026-01-07WarningsExact identifier
application number: M006
Proactiv Skin Purifying MaskSULFURTHE PROACTIV COMPANY LLC9f0eb12b-4da1-4498-9ffb-de8235264d9b2026-01-07WarningsExact identifier
application number: M006
Proactiv Blackhead DissolvingSALICYLIC ACIDAlchemee, LLC822c64b9-59bd-4625-b4bf-294d54c96e102026-01-07WarningsExact identifier
application number: M006
Proactivplus Skin Smoothing ExfoliatorBENZOYL PEROXIDEAlchemee, LLCb56b63d6-5635-4fd4-9517-8b08c3cbf9aa2026-01-07WarningsExact identifier
application number: M006
Proactivplus Smoothing BHA CleanserSALICYLIC ACIDAlchemee, LLC14b9a54c-9993-385e-e063-6394a90a27de2026-01-07WarningsExact identifier
application number: M006
Proactiv Blemish Control Body CreamSALICYLIC ACIDAlchemee, LLC164d2c7f-5f1e-d0a8-e063-6294a90a95f22026-01-07WarningsExact identifier
application number: M006
Proactiv Redness Correcting TreatmentSALICYLIC ACIDAlchemee, LLC25ca582d-158f-2c97-e063-6394a90a56582026-01-07WarningsExact identifier
application number: M006
Proactiv Acne Clearing BodySALICYLIC ACIDAlchemee, LLC22559e3a-3ca4-fb38-e063-6394a90ada9e2026-01-07WarningsExact identifier
application number: M006
Proactiv MD KitMD KITAlchemee, LLC1d142dba-145c-fb33-e063-6394a90a88b62026-01-07WarningsExact identifier
application number: M006
Proactiv Clean Beginner BundleCLEAN KITAlchemee, LLC201e1b5e-555a-92c0-e063-6394a90a13602026-01-07WarningsExact identifier
application number: M006
Proactiv Plus KitSOLUTIONS KITAlchemee, LLC1bbe19ff-0bc8-7b8b-e063-6394a90aa7f42026-01-07WarningsExact identifier
application number: M006
Proactiv Solution KitSOLUTIONS KITAlchemee, LLC17f359a0-04a2-d112-e063-6394a90a27352026-01-07WarningsExact identifier
application number: M006
Universal Clarifying PadSALICYLIC ACIDAllure Labs47d3c57c-d6d2-a9e0-e063-6294a90a3b5b2026-01-07WarningsExact identifier
application number: M006
Earths Care Acne Treatment MaskSULFURDLC Laboratories, Inc.f067e85e-0475-4108-ad93-2af7717ead3e2026-01-07WarningsExact identifier
application number: M006
Acne Treatment with SulfurSULFURDLC Laboratories, Inc.aa1f2afe-7b09-4448-b522-e1b23d63d3ef2026-01-07WarningsExact identifier
application number: M006
Joesoef Skincare Anti AcneSULFURPT Galenium Pharmasia Laboratoriesd9b7acd4-f0dd-c28b-e053-2a95a90a4c302026-01-05WarningsExact identifier
application number: M006
PanOxyl Acne Banishing Body (Spray)SALICYLIC ACIDCrown Laboratories, Inc.2305f297-665d-e55f-e063-6394a90aa14e2026-01-05WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416212salicylic acid 1.5 % Topical GelPSN4b833d7a-f957-4e65-be5b-1771493149582
416212salicylic acid 0.015 MG/MG Topical GelSCD4b833d7a-f957-4e65-be5b-1771493149582
416212salicylic acid 1.5 % Topical GelSY4b833d7a-f957-4e65-be5b-1771493149582

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69546-201-02695460201021 BOTTLE, PUMP in 1 CARTON (69546-201-02) / 15 mL in 1 BOTTLE, PUMP2022-06-300000-00-00NoNoCurrent