Hydroquinone

Product NDC
42582-700
11-digit product format
425820700
Labeler code
42582
Product ID
42582-700_d13853f1-5eb9-49ec-a5ef-5bfa88914d41
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroquinone
Dosage form
CREAM
Route
TOPICAL
Labeler
Bi-Coastal Pharma International LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2011-07-15
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42582-700-012024-01-30C16284748780-19d75b9d0-79b1-f424-e053-dadaa90a57ceHydroquinone USP, 4%
42582-700-012020-03-11C16284748780-19d75b9d0-79b1-f424-e053-dadaa90a57ceHydroquinone USP, 4%
42582-700-012020-01-31C16284748780-19d75b9d0-79b1-f424-e053-dadaa90a57ceHydroquinone USP, 4%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42582-700-01Hydroquinone1 in 1 CARTONCREAM13
42582-700-01Hydroquinone28.35 g in 1 TUBECREAM28.353

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42582-700-01GM - Gram42582-70072ce12cd-b090-4e5c-96d3-66502ef1114412015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HydroquinoneACTIVE INGREDIENTXV74C1N1AEHYDROQUINONE CREAM [BI-COASTAL PHARMA INTERNATIONAL LLC]1
HydroquinoneACTIVE MOIETYXV74C1N1AEHYDROQUINONE CREAM [BI-COASTAL PHARMA INTERNATIONAL LLC]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0HYDROQUINONE CREAM [BI-COASTAL PHARMA INTERNATIONAL LLC]1
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RHYDROQUINONE CREAM [BI-COASTAL PHARMA INTERNATIONAL LLC]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KHYDROQUINONE CREAM [BI-COASTAL PHARMA INTERNATIONAL LLC]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNHYDROQUINONE CREAM [BI-COASTAL PHARMA INTERNATIONAL LLC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KHYDROQUINONE CREAM [BI-COASTAL PHARMA INTERNATIONAL LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXHYDROQUINONE CREAM [BI-COASTAL PHARMA INTERNATIONAL LLC]1
GLYCOLIC ACIDINACTIVE INGREDIENT0WT12SX38SHYDROQUINONE CREAM [BI-COASTAL PHARMA INTERNATIONAL LLC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9THYDROQUINONE CREAM [BI-COASTAL PHARMA INTERNATIONAL LLC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHHYDROQUINONE CREAM [BI-COASTAL PHARMA INTERNATIONAL LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JHYDROQUINONE CREAM [BI-COASTAL PHARMA INTERNATIONAL LLC]1
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CHYDROQUINONE CREAM [BI-COASTAL PHARMA INTERNATIONAL LLC]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YHYDROQUINONE CREAM [BI-COASTAL PHARMA INTERNATIONAL LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RHYDROQUINONE CREAM [BI-COASTAL PHARMA INTERNATIONAL LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42582-700HYDROQUINONE CREAM [BI-COASTAL PHARMA INTERNATIONAL LLC]3Legacy NDC, 2 package rows20220118_d4edbeca-d6ca-42c0-86b7-a7130ba3b963.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197795hydroquinone 4 % Topical CreamPSNd4edbeca-d6ca-42c0-86b7-a7130ba3b9633
197795hydroquinone 40 MG/ML Topical CreamSCDd4edbeca-d6ca-42c0-86b7-a7130ba3b9633
197795hydroquinone 4 % Topical CreamSYd4edbeca-d6ca-42c0-86b7-a7130ba3b9633

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42582-700-01425820700011 TUBE in 1 CARTON (42582-700-01) > 28.35 g in 1 TUBE1 tube2011-07-150000-00-00NoNoCurrent