Home NDC 42851-038 ZO Skin Health Pigment Control Creme Hydroquinone
Product NDC 42851-038
11-digit product format 428510038
Labeler code 42851
Product ID 42851-038_dd82a6af-aa21-98ba-e053-2995a90a5540
Type HUMAN OTC DRUG
Nonproprietary name Hydroquinone
Dosage form LOTION
Route TOPICAL
Labeler ZO Skin Health, Inc.
Application part358A
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2018-11-07
Marketing end 0000-00-00
Substance HYDROQUINONE
Active strength 20 mg/mL
Pharmacologic classes Depigmenting Activity [PE], Melanin Synthesis Inhibitor [EPC], Melanin Synthesis Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 · 21 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 42851-038-80 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 42851-038-80 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 42851-038-80 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 42851-038-80 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 42851-038-80 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 42851-038-80 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 42851-038-80 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 42851-038-80 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 42851-038-80 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 42851-038-80 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 42851-038-80 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 42851-038-80 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…
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 42851-038-80 ZO Skin Health Pigment Control Creme Hydroquinone 1 in 1 CARTON LOTION 1 2 42851-038-80 ZO Skin Health Pigment Control Creme Hydroquinone 80 mL in 1 BOTTLE, PLASTIC LOTION 80 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42851-038 ZO SKIN HEALTH PIGMENT CONTROL CREME HYDROQUINONE (HYDROQUINONE) LOTION [ZO SKIN HEALTH, INC.] 2 Legacy NDC, 2 package rows 20220426_d9285ffa-6114-4798-9b16-169d2bb67355.zip
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 42851-038-80 42851003880 1 BOTTLE, PLASTIC in 1 CARTON (42851-038-80) > 80 mL in 1 BOTTLE, PLASTIC 2018-11-07 0000-00-00 No No Current