FDA.reportPublic FDA data

Tretinoin Cream

Product NDC
62032-417
11-digit product format
620320417
Labeler code
62032
Product ID
62032-417_c96be1f7-0c29-4bc7-ac51-c3da8b4788fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tretinoin
Dosage form
CREAM
Route
TOPICAL
Labeler
Obagi Cosmeceuticals LLC
Application
NDA017340
Marketing category
NDA
Marketing start
1973-01-26
Substance
TRETINOIN
Active strength
1 mg/g
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 Cream
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRETINOIN1 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5688UTC01R
Rxcui106302, 106303, 198300

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62032-417-202025-02-11C16284748780-12cef2736-5adc-d83d-e063-dadaa90ab31fTRETINOIN CREAM
62032-417-202025-01-30C16284748780-12cef2736-5adc-d83d-e063-dadaa90ab31fTRETINOIN CREAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62032-417-20Tretinoin Cream1 in 1 CARTONCREAM113
62032-417-20Tretinoin Cream20 g in 1 TUBECREAM2013

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRETINOINACTIVE INGREDIENT5688UTC01RTRETINOIN CREAM (TRETINOIN) CREAM [OMP, INC.]4
TRETINOINACTIVE MOIETY5688UTC01RTRETINOIN CREAM (TRETINOIN) CREAM [OMP, INC.]4
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KTRETINOIN CREAM (TRETINOIN) CREAM [OMP, INC.]4
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSTRETINOIN CREAM (TRETINOIN) CREAM [OMP, INC.]4
POLYOXYL 40 STEARATEINACTIVE INGREDIENT13A4J4NH9ITRETINOIN CREAM (TRETINOIN) CREAM [OMP, INC.]4
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BTRETINOIN CREAM (TRETINOIN) CREAM [OMP, INC.]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTRETINOIN CREAM (TRETINOIN) CREAM [OMP, INC.]4
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YTRETINOIN CREAM (TRETINOIN) CREAM [OMP, INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RTRETINOIN CREAM (TRETINOIN) CREAM [OMP, INC.]4
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEETRETINOIN CREAM (TRETINOIN) CREAM [OMP, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62032-417TRETINOIN CREAM (TRETINOIN) CREAM [OBAGI COSMECEUTICALS LLC]13Current NDC, Legacy NDC, 2 package rows20250213_745cc3ce-60b4-4479-a055-316817567949.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106302tretinoin 0.025 % Topical CreamPSN745cc3ce-60b4-4479-a055-31681756794913
106303tretinoin 0.05 % Topical CreamPSN745cc3ce-60b4-4479-a055-31681756794913
198300tretinoin 0.1 % Topical CreamPSN745cc3ce-60b4-4479-a055-31681756794913
106302tretinoin 0.25 MG/ML Topical CreamSCD745cc3ce-60b4-4479-a055-31681756794913
106303tretinoin 0.5 MG/ML Topical CreamSCD745cc3ce-60b4-4479-a055-31681756794913
198300tretinoin 1 MG/ML Topical CreamSCD745cc3ce-60b4-4479-a055-31681756794913
106302tretinoin 0.025 % Topical CreamSY745cc3ce-60b4-4479-a055-31681756794913
106303tretinoin 0.05 % Topical CreamSY745cc3ce-60b4-4479-a055-31681756794913
198300tretinoin 0.1 % Topical CreamSY745cc3ce-60b4-4479-a055-31681756794913

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62032-417-20620320417201 TUBE in 1 CARTON (62032-417-20) / 20 g in 1 TUBE1 tube1973-01-260000-00-00NoNoCurrent