ZO Skin Health Pigment Control Plus Blending Creme Hydroquinone

Product NDC
42851-036
11-digit product format
428510036
Labeler code
42851
Product ID
42851-036_5d6b5713-37eb-8335-e063-6394a90accd1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroquinone
Dosage form
EMULSION
Route
TOPICAL
Labeler
ZO Skin Health, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2018-05-01
Substance
HYDROQUINONE
Active strength
.04 g/mL
Pharmacologic classes
Depigmenting Activity [PE], Melanin Synthesis Inhibitor [EPC], Melanin Synthesis Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage42851-03642851-036-33DDiscontinued by firm2026-11-10

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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
ZO Skin Health Pigment Control Plus Blending Creme Hydroquinone
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROQUINONE.04 g/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
XV74C1N1AEInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c29cbc80-cb97-42d0-b796-ee487b0e85c5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
85490a6b-2306-6bf2-c51b-eb63537dc2daProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42851-036-30ZO Skin Health Pigment Control Plus Blending Creme Hydroquinone30 mL in 1 BOTTLE, PLASTICEMULSION304
42851-036-30ZO Skin Health Pigment Control Plus Blending Creme Hydroquinone1 in 1 CARTONEMULSION14
42851-036-33ZO Skin Health Pigment Control Plus Blending Creme Hydroquinone33 mL in 1 BOTTLE, PLASTICEMULSION334
42851-036-33ZO Skin Health Pigment Control Plus Blending Creme Hydroquinone1 in 1 CARTONEMULSION14
42851-036-80ZO Skin Health Pigment Control Plus Blending Creme Hydroquinone80 mL in 1 BOTTLE, PLASTICEMULSION804
42851-036-80ZO Skin Health Pigment Control Plus Blending Creme Hydroquinone1 in 1 CARTONEMULSION14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42851-036ZO SKIN HEALTH PIGMENT CONTROL PLUS BLENDING CREME HYDROQUINONE (HYDROQUINONE) EMULSION [ZO SKIN HEALTH, INC.]4Current NDC, Legacy NDC, 6 package rows20220423_c29cbc80-cb97-42d0-b796-ee487b0e85c5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1235391hydroquinone 4 % Topical LotionPSN377e151e-ee50-4488-9cc9-3169794e385e6
1235391hydroquinone 40 MG/ML Topical LotionSCD377e151e-ee50-4488-9cc9-3169794e385e6
1235391hydroquinone 4 % Topical EmulsionSY377e151e-ee50-4488-9cc9-3169794e385e6
1235391hydroquinone 4 % Topical LotionSY377e151e-ee50-4488-9cc9-3169794e385e6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42851-036-30428510036301 TUBE in 1 CARTON (42851-036-30) / 30 mL in 1 TUBE1 tube2026-09-010000-00-00NoNoCurrent
42851-036-334285100363333 mL in 1 BOTTLE, PLASTIC33 mlHistorical
42851-036-80428510036801 TUBE in 1 CARTON (42851-036-80) / 80 mL in 1 TUBE1 tube2026-09-010000-00-00NoNoCurrent