Home NDC 83506-001-16 HCS Hydrogen Peroxide 3%
Product NDC 83506-001
Requested package NDC 83506-001-16
11-digit product format 835060001
Labeler code 83506
Product ID 83506-001_4da9c5aa-69bd-41bd-bb82-9efef32752bb
Type HUMAN OTC DRUG
Nonproprietary name Hydrogen Peroxide
Dosage form LIQUID
Route TOPICAL
Labeler Concordance Healthcare Solutions, LLC.
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-08-14
Substance HYDROGEN PEROXIDE
Active strength 3 mL/100mL
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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 83506-001 83506-001-16 I Inactivated by FDA excluded / ndc_excluded.zip ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 83506-001 83506-001-16 I Inactivated by FDA excluded / ndc_excluded.zip 367a005e9d99…383a685ebd0f…
Additional Listing Data#
Finished product Yes
Brand name base HCS Hydrogen Peroxide 3%
Listing expiration 2027-12-31
Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROGEN PEROXIDE 3 mL/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination BBX060AN9V Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 91349 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83506-001-04 HCS Hydrogen Peroxide 3% 118 mL in 1 BOTTLE, PLASTIC LIQUID 118 12 83506-001-08 HCS Hydrogen Peroxide 3% 237 mL in 1 BOTTLE, PLASTIC LIQUID 237 12 83506-001-16 HCS Hydrogen Peroxide 3% 473 mL in 1 BOTTLE, PLASTIC LIQUID 473 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83506-001 HCS HYDROGEN PEROXIDE 3% (HYDROGEN PEROXIDE) LIQUID [CONCORDANCE HEALTHCARE SOLUTIONS, LLC.] 10 Current NDC, 3 package rows 20250101_f854ff4f-1327-4e2a-9389-591b01ba3ee2.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 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83506-001-16 83506000116 473 mL in 1 BOTTLE, PLASTIC (83506-001-16) 473 ml 2023-08-14 No No Current