FDA.reportPublic FDA data

Tretinoin

Product NDC
68682-513
11-digit product format
686820513
Labeler code
68682
Product ID
68682-513_c4ef7e4d-9c2e-4022-b7ab-b55962c1a58a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tretinoin
Dosage form
GEL
Route
TOPICAL
Labeler
Oceanside Pharmaceuticals
Application
NDA020475
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2013-03-14
Substance
TRETINOIN
Active strength
1 mg/g
Pharmacologic classes
Retinoid [EPC], Retinoids [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tretinoin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRETINOIN1 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5688UTC01R
Rxcui313453, 359050, 1488045

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
68682-513-82Tretinoin1 in 1 CARTONGEL113
68682-513-82Tretinoin20 g in 1 TUBEGEL2013
68682-513-84Tretinoin1 in 1 CARTONGEL113
68682-513-84Tretinoin45 g in 1 TUBEGEL4513
68682-513-85Tretinoin1 in 1 CARTONGEL113
68682-513-85Tretinoin50 g in 1 BOTTLE, PUMPGEL5013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68682-513-82GM - Gram68682-51345d170c4-dae8-48a4-ac00-1d26bc46420f12013-04-01
68682-513-84GM - Gram68682-513337799c1-9c19-48a3-9754-18e6c1aa677112013-04-01
68682-513-85GM - Gram68682-5134fa29b6b-179a-451d-92c7-a130375b62b912013-04-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TretinoinACTIVE INGREDIENT5688UTC01RTRETINOIN GEL [OCEANSIDE PHARMACEUTICALS]1
TretinoinACTIVE MOIETY5688UTC01RTRETINOIN GEL [OCEANSIDE PHARMACEUTICALS]1
Benzyl AlcoholINACTIVE INGREDIENTLKG8494WBHTRETINOIN GEL [OCEANSIDE PHARMACEUTICALS]1
Butylated HydroxytolueneINACTIVE INGREDIENT1P9D0Z171KTRETINOIN GEL [OCEANSIDE PHARMACEUTICALS]1
Carbomer Homopolymer Type BINACTIVE INGREDIENTHHT01ZNK31TRETINOIN GEL [OCEANSIDE PHARMACEUTICALS]1
Carbomer Homopolymer Type B (Allyl Pentaerythritol Crosslinked)INACTIVE INGREDIENTHHT01ZNK31TRETINOIN GEL [OCEANSIDE PHARMACEUTICALS]1
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86KTRETINOIN GEL [OCEANSIDE PHARMACEUTICALS]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXTRETINOIN GEL [OCEANSIDE PHARMACEUTICALS]1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3TRETINOIN GEL [OCEANSIDE PHARMACEUTICALS]1
Sorbic AcidINACTIVE INGREDIENTX045WJ989BTRETINOIN GEL [OCEANSIDE PHARMACEUTICALS]1
TrolamineINACTIVE INGREDIENT9O3K93S3TKTRETINOIN GEL [OCEANSIDE PHARMACEUTICALS]1
WaterINACTIVE INGREDIENT059QF0KO0RTRETINOIN GEL [OCEANSIDE PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68682-513TRETINOIN GEL [OCEANSIDE PHARMACEUTICALS]10Current NDC, Legacy NDC, 6 package rows20240410_d3c528d2-429d-4f37-9ebf-eee8b9fd3050.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359050tretinoin 0.04 % Topical GelPSNd3c528d2-429d-4f37-9ebf-eee8b9fd305013
1488045tretinoin 0.08 % Topical GelPSNd3c528d2-429d-4f37-9ebf-eee8b9fd305013
313453tretinoin 0.1 % Topical GelPSNd3c528d2-429d-4f37-9ebf-eee8b9fd305013
359050tretinoin 0.0004 MG/MG Topical GelSCDd3c528d2-429d-4f37-9ebf-eee8b9fd305013
1488045tretinoin 0.0008 MG/MG Topical GelSCDd3c528d2-429d-4f37-9ebf-eee8b9fd305013
313453tretinoin 0.001 MG/MG Topical GelSCDd3c528d2-429d-4f37-9ebf-eee8b9fd305013
359050tretinoin 0.04 % Topical GelSYd3c528d2-429d-4f37-9ebf-eee8b9fd305013
1488045tretinoin 0.08 % Topical GelSYd3c528d2-429d-4f37-9ebf-eee8b9fd305013
313453tretinoin 0.1 % Topical GelSYd3c528d2-429d-4f37-9ebf-eee8b9fd305013

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68682-513-82686820513821 TUBE in 1 CARTON (68682-513-82) / 20 g in 1 TUBE1 tube2013-03-140000-00-00NoNoCurrent
68682-513-84686820513841 TUBE in 1 CARTON (68682-513-84) / 45 g in 1 TUBE1 tube2013-03-140000-00-00NoNoCurrent
68682-513-85686820513851 BOTTLE, PUMP in 1 CARTON (68682-513-85) / 50 g in 1 BOTTLE, PUMP2013-03-140000-00-00NoNoCurrent