Home NDC 71399-0400 HYDROQUINONE 4%
Product NDC 71399-0400
11-digit product format 713990400
Labeler code 71399
Product ID 71399-0400_f940dc72-b1bf-4234-944d-71c83f5e878d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydroquinone
Dosage form CREAM
Route TOPICAL
Labeler Akron Pharma Inc
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2024-09-13
Substance HYDROQUINONE
Active strength 40 mg/g
Pharmacologic classes Depigmenting Activity [PE], Melanin Synthesis Inhibitor [EPC], Melanin Synthesis Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
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 · 8 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 2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 71399-0400-1 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 71399-0400-1 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 71399-0400-1 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 71399-0400-1 1332a3947898…d4bfe170f9cd…
Additional Listing Data#
Finished product Yes
Brand name base HYDROQUINONE 4%
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROQUINONE 40 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination XV74C1N1AE Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197795 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 71399-0400-1 HYDROQUINONE 4% 28.35 g in 1 TUBE CREAM 28.35 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71399-0400 HYDROQUINONE 4% (HYDROQUINONE) CREAM [AKRON PHARMA INC] 5 Current NDC, Legacy NDC, 1 package rows 20240927_cbec45c9-4adb-4473-8c09-b1217d0f8ebc.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 Marketing end Sample Exclude flag Status 71399-0400-1 71399040001 28.35 g in 1 TUBE (71399-0400-1) 28.35 g 2024-09-13 0000-00-00 No No Current