Tretinoin

Product NDC
68682-800
11-digit product format
686820800
Labeler code
68682
Product ID
68682-800_465e7164-5e77-4a2b-ae94-6ea7966af0e5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tretinoin
Dosage form
GEL
Route
TOPICAL
Labeler
Oceanside Pharmaceuticals
Application
NDA022070
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2007-07-26
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
68682-800-45Tretinoin1 in 1 PACKAGEGEL16
68682-800-45Tretinoin45 g in 1 TUBEGEL456

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68682-800-45GM - Gram68682-8000e5a13e3-0925-468a-be55-a501a0643a9712015-11-12

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
butylparabenINACTIVE INGREDIENT3QPI1U3FV8TRETINOIN GEL [OCEANSIDE PHARMACEUTICALS]1
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT4Q93RCW27ETRETINOIN GEL [OCEANSIDE PHARMACEUTICALS]1
ethylparabenINACTIVE INGREDIENT14255EXE39TRETINOIN GEL [OCEANSIDE PHARMACEUTICALS]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXTRETINOIN GEL [OCEANSIDE PHARMACEUTICALS]1
hyaluronate sodiumINACTIVE INGREDIENTYSE9PPT4THTRETINOIN GEL [OCEANSIDE PHARMACEUTICALS]1
isobutylparabenINACTIVE INGREDIENT0QQJ25X58GTRETINOIN GEL [OCEANSIDE PHARMACEUTICALS]1
methylparabenINACTIVE INGREDIENTA2I8C7HI9TTRETINOIN GEL [OCEANSIDE PHARMACEUTICALS]1
octoxynol-9INACTIVE INGREDIENT7JPC6Y25QSTRETINOIN GEL [OCEANSIDE PHARMACEUTICALS]1
phenoxyethanolINACTIVE INGREDIENTHIE492ZZ3TTRETINOIN GEL [OCEANSIDE PHARMACEUTICALS]1
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHTRETINOIN 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
68682-800TRETINOIN GEL [OCEANSIDE PHARMACEUTICALS]5Current NDC, Legacy NDC, 2 package rows20240423_febda58b-c9ee-4b95-bee7-dca5f2645f98.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
245723tretinoin 0.05 % Topical GelPSNfebda58b-c9ee-4b95-bee7-dca5f2645f986
245723tretinoin 0.0005 MG/MG Topical GelSCDfebda58b-c9ee-4b95-bee7-dca5f2645f986
245723tretinoin 0.05 % Topical GelSYfebda58b-c9ee-4b95-bee7-dca5f2645f986

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68682-800-45686820800451 TUBE in 1 PACKAGE (68682-800-45) / 45 g in 1 TUBE1 tube2007-07-260000-00-00NoNoCurrent