HYDROCORTISONE 0.5% / HYDROQUINONE 4% / TRETINOIN 0.025%

Product NDC
72934-6101
11-digit product format
729346101
Labeler code
72934
Product ID
72934-6101_874c4086-18fb-436b-e053-2a95a90afda2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROCORTISONE 0.5% / HYDROQUINONE 4% / TRETINOIN 0.025%
Dosage form
EMULSION
Route
TOPICAL
Labeler
Sincerus Florida, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2019-05-01
Marketing end
0000-00-00
Substance
HYDROCORTISONE; HYDROQUINONE; TRETINOIN
Active strength
1 g/100g; g/100g; g/100g
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE],Retinoid [EPC],Retinoids [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2Product name120250325
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8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
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bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1Product name220150218
02657a3f-1489-66ea-f740-5ab9524e57d7Product name120140508
0a8118e4-08c6-b395-9ddc-d3e425e0493aProduct name120140508
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72934-6101-22021-01-29C16284748780-1ba0f9c33-2635-a910-e053-dadaa90a0b85HYDROCORTISONE 0.5% / HYDROQUINONE 4% / TRETINOIN 0.025%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72934-6101-2HYDROCORTISONE 0.5% / HYDROQUINONE 4% / TRETINOIN 0.025%30 g in 1 BOTTLE, PUMPEMULSION301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72934-6101-2GM - Gram72934-6101be428469-a236-4023-aca1-9e3ad168fee012020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72934-6101HYDROCORTISONE 0.5% / HYDROQUINONE 4% / TRETINOIN 0.025% EMULSION [SINCERUS FLORIDA, LLC]1Legacy NDC, 1 package rows20190501_874c4086-18fa-436b-e053-2a95a90afda2.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
72934-6101-27293461010230 g in 1 BOTTLE, PUMP30 gHistorical