Home NDC 69546-201 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 Ingredient Strength SALICYLIC ACID 1.5 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination O414PZ4LPZ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 416212 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69546-201-02 Zitlox Salicylic Acne 15 mL in 1 BOTTLE, PUMP GEL 15 2 69546-201-02 Zitlox Salicylic Acne 1 in 1 CARTON GEL 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69546-201 ZITLOX SALICYLIC ACNE (SALICYLIC ACID) GEL [ASA UNIVERSAL INC. DBA: SONAGE] 2 Current NDC, Legacy NDC, 2 package rows 20250108_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 55 of 55 · 1,088 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Replenix Acne Gly-Sal 2-2 Foaming Cleanser SALICYLIC ACID Topiderm, Inc. 811dbf95-2b39-45c5-99a2-33c3c9d19570 2019-12-19 Warnings Exact identifier application number: M006 REPLENIX ACNE SOLUTIONS WASH BENZOYL PEROXIDE Topiderm, Inc. 8dc2d27d-3cc4-4874-b4c2-32607849b205 2019-12-17 Warnings Exact identifier application number: M006 REPLENIX ACNE Solution BENZOYL PEROXIDE WASH BENZOYL PEROXIDE Topiderm, Inc. 235e9dd5-13f2-4078-9807-1d87fd9e6cba 2019-12-17 Warnings Exact identifier application number: M006 Replenix Acne BENZOYL PEROXIDE Topiderm, Inc 03d4c298-8f44-41f7-b086-96ae836152bb 2019-10-31 Warnings Exact identifier application number: M006 Replenix Acne BENZOYL PEROXIDE Topiderm, Inc. c12f9005-a549-4447-9beb-df7126f77df1 2019-10-31 Warnings Exact identifier application number: M006 Gly-Sal 10-2 Pads SALICYLIC ACID Topiderm, Inc. b39e845d-4c40-4f9e-9cb5-a8386f326652 2019-10-23 Warnings Exact identifier application number: M006 Gly-Sal 5-2 Pads SALICYLIC ACID Topiderm, Inc. e73bd26c-cdc2-47ab-94e8-3bc49a9b19e8 2019-10-22 Warnings Exact identifier application number: M006 SKIN MEDICA Purifying Foaming Wash SALICYLIC ACID Allergan, Inc. 064d9e2b-077f-4229-b653-666fc5479ae2 2013-03-01 Warnings Exact identifier application number: M006
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 69546-201-02 69546020102 1 BOTTLE, PUMP in 1 CARTON (69546-201-02) / 15 mL in 1 BOTTLE, PUMP 2022-06-30 0000-00-00 No No Current