HYDROQUINONE 4%

Product NDC
42192-151
11-digit product format
421920151
Labeler code
42192
Product ID
42192-151_f57301e6-8034-4bad-9e6f-8ced5571c494
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroquinone
Dosage form
CREAM
Route
TOPICAL
Labeler
Acella Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2014-09-10
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

Additional Listing Data#

Finished product
Yes
Brand name base
HYDROQUINONE 4%
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROQUINONE40 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiXV74C1N1AE
Rxcui197795

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
85490a6b-2306-6bf2-c51b-eb63537dc2daProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42192-151-01HYDROQUINONE 4%28.35 g in 1 TUBECREAM28.354
42192-151-01HYDROQUINONE 4%1 in 1 CARTONCREAM14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42192-151-01GM - Gram42192-15138065cf9-863b-4013-9640-af16064cb88912014-09-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROQUINONEACTIVE INGREDIENTXV74C1N1AEHYDROQUINONE 4% (HYDROQUINONE) CREAM [ACELLA PHARMACEUTICALS, LLC]1
HYDROQUINONEACTIVE MOIETYXV74C1N1AEHYDROQUINONE 4% (HYDROQUINONE) CREAM [ACELLA PHARMACEUTICALS, LLC]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MHYDROQUINONE 4% (HYDROQUINONE) CREAM [ACELLA PHARMACEUTICALS, LLC]1
C13-14 ISOPARAFFININACTIVE INGREDIENTE4F12ROE70HYDROQUINONE 4% (HYDROQUINONE) CREAM [ACELLA PHARMACEUTICALS, LLC]1
CAPRYLOYL GLYCINEINACTIVE INGREDIENT8TY5YO42NJHYDROQUINONE 4% (HYDROQUINONE) CREAM [ACELLA PHARMACEUTICALS, LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXHYDROQUINONE 4% (HYDROQUINONE) CREAM [ACELLA PHARMACEUTICALS, LLC]1
GLYCOLIC ACIDINACTIVE INGREDIENT0WT12SX38SHYDROQUINONE 4% (HYDROQUINONE) CREAM [ACELLA PHARMACEUTICALS, LLC]1
JOJOBA OILINACTIVE INGREDIENT724GKU717MHYDROQUINONE 4% (HYDROQUINONE) CREAM [ACELLA PHARMACEUTICALS, LLC]1
KOJIC ACIDINACTIVE INGREDIENT6K23F1TT52HYDROQUINONE 4% (HYDROQUINONE) CREAM [ACELLA PHARMACEUTICALS, LLC]1
LAURETH-7INACTIVE INGREDIENTZ95S6G8201HYDROQUINONE 4% (HYDROQUINONE) CREAM [ACELLA PHARMACEUTICALS, LLC]1
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62HYDROQUINONE 4% (HYDROQUINONE) CREAM [ACELLA PHARMACEUTICALS, LLC]1
POLYACRYLAMIDE (CROSSLINKED; 0.01-0.2 MOLE PERCENT BISACRYLAMIDE)INACTIVE INGREDIENTRHA9LWJ494HYDROQUINONE 4% (HYDROQUINONE) CREAM [ACELLA PHARMACEUTICALS, LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IHYDROQUINONE 4% (HYDROQUINONE) CREAM [ACELLA PHARMACEUTICALS, LLC]1
SQUALANEINACTIVE INGREDIENTGW89575KF9HYDROQUINONE 4% (HYDROQUINONE) CREAM [ACELLA PHARMACEUTICALS, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RHYDROQUINONE 4% (HYDROQUINONE) CREAM [ACELLA PHARMACEUTICALS, LLC]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEHYDROQUINONE 4% (HYDROQUINONE) CREAM [ACELLA PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42192-151HYDROQUINONE 4% (HYDROQUINONE) CREAM [ACELLA PHARMACEUTICALS, LLC]4Current NDC, Legacy NDC, 2 package rows20240116_595dfc50-ee6f-41b5-ab5b-4c293aee342b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197795hydroquinone 4 % Topical CreamPSN595dfc50-ee6f-41b5-ab5b-4c293aee342b4
197795hydroquinone 40 MG/ML Topical CreamSCD595dfc50-ee6f-41b5-ab5b-4c293aee342b4
197795hydroquinone 4 % Topical CreamSY595dfc50-ee6f-41b5-ab5b-4c293aee342b4
197795hydroquinone 4 % Topical CreamPSNe07e4206-4231-285d-e053-2995a90af37a1
197795hydroquinone 40 MG/ML Topical CreamSCDe07e4206-4231-285d-e053-2995a90af37a1
197795hydroquinone 4 % Topical CreamSYe07e4206-4231-285d-e053-2995a90af37a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42192-151-01421920151011 TUBE in 1 CARTON (42192-151-01) / 28.35 g in 1 TUBE1 tube2014-09-100000-00-00NoNoCurrent