FDA.reportPublic FDA data

NDC 28109-010-01 - AcneWorx

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
28109-010
Requested NDC
28109-010-01
Package NDCs from labels
28109-010-01, 28109-010-06
Manufacturer
DermWorx Incorporated | IGI Laboratories, Inc.
Effective date
2010-02-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
AcneWorx® Gentle Moisturizing Clear Acne Treatment Gel (2% Salicylic Acid)DermWorx Incorporated | IGI Laboratories, Inc.2010-02-18HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
28109-010-062019-10-21C16284748780-1956f9ecf-c2a6-621f-e053-dbdaa90a74adAcneWorx® Gentle Moisturizing Clear Acne Treatment Gel (2% Salicylic Acid)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
28109-010-01AcneWorx1 in 1 CARTONGEL11
28109-010-01AcneWorx30 mL in 1 TUBEGEL301
28109-010-06AcneWorx6 in 1 CARTONGEL61

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
28109-010ACNEWORX (SALICYLIC ACID) GEL [DERMWORX INCORPORATED]1Legacy NDC, 3 package rows20100223_43c8f760-7c5c-407c-91ce-674bd13b4ecd.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZACNEWORX (SALICYLIC ACID) GEL [DERMWORX INCORPORATED]1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZACNEWORX (SALICYLIC ACID) GEL [DERMWORX INCORPORATED]1

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 8 of 73 · 1,453 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ANIXIKE WART CORN REMOVER PENSALICYLIC ACID 17% WART CORN REMOVER PENJiangxi Yudexi Pharmaceutical Co., LTD4ac16e3f-7535-4a44-e063-6394a90a75ad2026-07-20WarningsExact identifier
unii: O414PZ4LPZ
Rukada WART REMOVER PatchesSALICYLIC ACID 17% WART REMOVER PATCHESJiangxi Yudexi Pharmaceutical Co., LTD524b5d03-af91-d441-e063-6294a90afc952026-07-20WarningsExact identifier
unii: O414PZ4LPZ
Pureskin Seborrheic Dermatitis and Psoriasis CreamSEBORRHEIC DERMATITIS PSORIASIS CREAMBENLONG HALL LLC36086f7f-8536-417f-a302-37f78288489e2026-07-20WarningsExact identifier
unii: O414PZ4LPZ
Good Molecules Acne Foaming CleanserSALICYLIC ACIDGood Molecules, LLC44fa9eda-0910-7d70-e063-6394a90af3a72026-07-20WarningsExact identifier
unii: O414PZ4LPZ
Good Molecules Acne Foaming CleanserSALICYLIC ACIDGood Moleculesdec189a2-5f93-7c3e-e053-2a95a90af9882026-07-20WarningsExact identifier
unii: O414PZ4LPZ
Komxsum WART REMOVER PATCHESSALICYLIC ACID 1% WART REMOVERJiangxi Yudexi Pharmaceutical Co., LTD4dc1da6f-661b-ae95-e063-6394a90aa4142026-07-20WarningsExact identifier
unii: O414PZ4LPZ
ADVANCED WART REMOVERSALICYLIC ACIDGuangzhou ChuanMa International Trading Co.,Ltd.41bbda9b-5570-764f-e063-6394a90a63152026-07-18WarningsExact identifier
unii: O414PZ4LPZ
FUNGAL NAIL TREATMENT kit .liquid.PSEUDOLARIX AMABILIS BARK 1%GETHSEMANE BRANCH CORPORATION56c93390-ee07-4f78-e063-6394a90add422026-07-17WarningsExact identifier
unii: O414PZ4LPZ
FUNGAL NAIL TREATMENT kit .cream.PSEUDOLARIX AMABILIS BARK 1%GETHSEMANE BRANCH CORPORATION56c9d9fa-09ad-e26a-e063-6394a90a0ed92026-07-17WarningsExact identifier
unii: O414PZ4LPZ
Clean and Clear Essentials Acne TonerSALICYLIC ACIDKenvue Brands LLC06cd03e3-6146-65d8-e063-6294a90a17012026-07-17WarningsExact identifier
unii: O414PZ4LPZ
PCA Skin Acne Control Prebiotic CleanserSALICYLIC ACIDCP Skin Health Group, Inc.56bca675-3e59-815a-e063-6294a90a1d872026-07-16WarningsExact identifier
unii: O414PZ4LPZ
Acne patchesACNE PATCHESShenzhen Hengdasheng Technology Co., Ltd5664b9c4-6ae3-4f64-e063-6294a90a825a2026-07-14WarningsExact identifier
unii: O414PZ4LPZ
Orraya WART REMOVER PatchesSALICYLIC ACID 40% WART REMOVER PATCHESWenzhou Yuyuan Pharmaceutical Co., Ltd.56748fe8-7621-4d0b-e063-6394a90a9a002026-07-12WarningsExact identifier
unii: O414PZ4LPZ
7 Day Spot and Tag Remover PenSALICYLIC ACIDGuangxi Keyun E-commerce Co., Ltd.5675f3cb-6b8f-2ba2-e063-6294a90a3fd62026-07-12WarningsExact identifier
unii: O414PZ4LPZ
NATURAL CURES WART REMOVERSALICYLIC ACID 17% WART REMOVERWenzhou Yuyuan Pharmaceutical Co., Ltd.5650ed83-2572-083b-e063-6294a90a5d692026-07-11WarningsExact identifier
unii: O414PZ4LPZ
THRYLIA TAG WART REMOVERSALICYLIC ACID 17% TAG WART REMOVERWenzhou Yuyuan Pharmaceutical Co., Ltd.56536544-3a0b-36e3-e063-6394a90adf7b2026-07-11WarningsExact identifier
unii: O414PZ4LPZ
SKINARIS TAG WART REMOVERSALICYLIC ACID 17% TAG WART REMOVERWenzhou Yuyuan Pharmaceutical Co., Ltd.56536aab-0a60-16fa-e063-6294a90a39132026-07-11WarningsExact identifier
unii: O414PZ4LPZ
ProBliva Psoriasis Shampoo.SALICYLIC ACID 3%CAVTECH HOLDING LLC563e75f9-a1e2-2796-e063-6294a90aedb42026-07-10WarningsExact identifier
unii: O414PZ4LPZ
PHYLA ACNE PHAGE SERUMSALICYLIC ACIDCOSMAX USA, CORP564abe82-c983-6a98-e063-6394a90a14a02026-07-10WarningsExact identifier
unii: O414PZ4LPZ
GOOD MOLECULE MAXIMUM STRENGHT ACNESALICYLIC ACIDCOSMAX USA, CORP564aafc0-1a06-1cba-e063-6294a90ae7382026-07-10WarningsExact identifier
rxcui: 346298
unii: O414PZ4LPZ

Reported adverse events (FAERS/openFDA)#

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