Home NDC 84058-130 BENZO DERMA
Product NDC 84058-130
11-digit product format 840580130
Labeler code 84058
Product ID 84058-130_5c165231-b642-52d8-e063-6394a90aad81
Type HUMAN OTC DRUG
Nonproprietary name BENZOIC ACID, SALICYLIC ACID, SULFUR
Dosage form CREAM
Route TOPICAL
Labeler LABORATORIOS H.G. C.A.
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-04-22
Substance SALICYLIC ACID; BENZOIC ACID; SULFUR
Active strength 2.5; 6; 4.6 g/100g; g/100g; g/100g
Pharmacologic classes Ammonium Ion Binding Activity [MoA], Nitrogen Binding Agent [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 84058-130-01 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 84058-130-01 f5e01cc5f278…a2eaf40c39c3…
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 BENZO DERMA
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SALICYLIC ACID 2.5 g/100g BENZOIC ACID 6 g/100g SULFUR 4.6 g/100g
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 84058-130-01 BENZO DERMA 12.5 g in 1 CAN CREAM 12.5 1 84058-130-01 BENZO DERMA 3 in 1 BOX, UNIT-DOSE CREAM 3 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84058-130 MENTOL CHINO CONCENTRATED (METHYL SALICYLATE, MENTHOL) CREAM MENTOL CHINO FORTE (METHYL SALICYLATE, MENTHOL, CAMPHOR) CREAM BENZO DERMA (BENZOIC ACID, SALICYLIC ACID, SULFUR) CREAM [LABORATORIOS H.G. C.A.] 1 Current NDC, 2 package rows 20240423_12652c98-e2a8-21fc-e063-6394a90a94cb.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 40 of 49 · 973 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84058-130-01 84058013001 3 CAN in 1 BOX, UNIT-DOSE (84058-130-01) / 12.5 g in 1 CAN 3 can 2024-04-22 No No Current