FDA.reportPublic FDA data

Tretinoin

Product NDC
62032-413
11-digit product format
620320413
Labeler code
62032
Product ID
62032-413_cf3898ce-f8a0-4e8f-a237-a8d87e3c20a3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tretinoin
Dosage form
GEL
Route
TOPICAL
Labeler
Obagi Cosmeceuticals LLC
Application
NDA022070
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2014-06-19
Substance
TRETINOIN
Active strength
.05 g/100g
Pharmacologic classes
Retinoid [EPC], Retinoids [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tretinoin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRETINOIN.05 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5688UTC01R
Rxcui245723

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b80ad7bc-1b6f-7ef4-1ed0-86cd9f459d60Product name620251124
1426d8f8-b7d5-4053-8554-613df00c0d86Product name220250616
0e7b8bf1-c46c-4de6-b26a-0c50e34364ecProduct name220250521
e3af9708-3004-7392-4046-5311eaa8bab5Product name320221128
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
503b047e-e62d-4745-9011-522b13bc701bProduct name120181206
7d41caa2-0b5d-9b03-ab8d-84271de26ef4Product name220170314
50ca9ff5-82dd-9971-4f2c-5845a76a8572Product name220150818
0a8118e4-08c6-b395-9ddc-d3e425e0493aProduct name120140508
233bcb0a-cf40-b0a1-b346-c83ac2f43579Product name120140508
85490a6b-2306-6bf2-c51b-eb63537dc2daProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62032-413-20Tretinoin20 g in 1 TUBEGEL2010

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRETINOINACTIVE INGREDIENT5688UTC01RTRETINOIN GEL [OMP, INC.]2
TRETINOINACTIVE MOIETY5688UTC01RTRETINOIN GEL [OMP, INC.]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHTRETINOIN GEL [OMP, INC.]2
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KTRETINOIN GEL [OMP, INC.]2
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8TRETINOIN GEL [OMP, INC.]2
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT4Q93RCW27ETRETINOIN GEL [OMP, INC.]2
ETHYLPARABENINACTIVE INGREDIENT14255EXE39TRETINOIN GEL [OMP, INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTRETINOIN GEL [OMP, INC.]2
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4THTRETINOIN GEL [OMP, INC.]2
ISOBUTYLPARABENINACTIVE INGREDIENT0QQJ25X58GTRETINOIN GEL [OMP, INC.]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TTRETINOIN GEL [OMP, INC.]2
OCTOXYNOL-9INACTIVE INGREDIENT7JPC6Y25QSTRETINOIN GEL [OMP, INC.]2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TTRETINOIN GEL [OMP, INC.]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHTRETINOIN GEL [OMP, INC.]2
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKTRETINOIN GEL [OMP, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RTRETINOIN GEL [OMP, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62032-413TRETINOIN GEL [OBAGI COSMECEUTICALS LLC]9Current NDC, Legacy NDC, 1 package rows20210729_c5ee36ac-2ffd-4cca-ad47-b1dae7ebdb3b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
245723tretinoin 0.05 % Topical GelPSNc5ee36ac-2ffd-4cca-ad47-b1dae7ebdb3b10
245723tretinoin 0.0005 MG/MG Topical GelSCDc5ee36ac-2ffd-4cca-ad47-b1dae7ebdb3b10
245723tretinoin 0.05 % Topical GelSYc5ee36ac-2ffd-4cca-ad47-b1dae7ebdb3b10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62032-413-206203204132020 g in 1 TUBE (62032-413-20) 20 g2014-06-190000-00-00NoNoCurrent