FDA.reportPublic FDA data

Tretinoin

Product NDC
43478-243
11-digit product format
434780243
Labeler code
43478
Product ID
43478-243_a61787f3-f3c8-4ea7-b659-f1ba1655336b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tretinoin
Dosage form
CREAM
Route
TOPICAL
Labeler
Rouses Point
Application
ANDA075264
Marketing category
ANDA
Marketing start
1998-12-24
Marketing end
2019-04-01
Substance
TRETINOIN
Active strength
0 mg/g
Pharmacologic classes
Retinoid [EPC],
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

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
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
e3af9708-3004-7392-4046-5311eaa8bab5Product name320221128
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
503b047e-e62d-4745-9011-522b13bc701bProduct name120181206
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
7d41caa2-0b5d-9b03-ab8d-84271de26ef4Product name220170314
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
50ca9ff5-82dd-9971-4f2c-5845a76a8572Product name220150818
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
0a8118e4-08c6-b395-9ddc-d3e425e0493aProduct name120140508
233bcb0a-cf40-b0a1-b346-c83ac2f43579Product name120140508
85490a6b-2306-6bf2-c51b-eb63537dc2daProduct name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43478-243-20GM - Gram43478-243049078f2-14ec-4f4f-a11c-c3cec97550d012012-07-24
43478-243-45GM - Gram43478-243836eb77e-5ba9-46f1-94bd-053bd1c5b5c412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOL, UNSPECIFIED FORMACTIVE INGREDIENTL7T10EIP3ADERMAWERX ZMT PAK (ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, AND TRETINOIN) KIT [PATCHWERX LABS, INC.]1
TRETINOINACTIVE INGREDIENT5688UTC01RDERMAWERX ZMT PAK (ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, AND TRETINOIN) KIT [PATCHWERX LABS, INC.]1
TRETINOINACTIVE INGREDIENT5688UTC01RTRETINOIN CREAM TRETINOIN GEL [REBEL DISTRIBUTORS CORP]1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZDERMAWERX ZMT PAK (ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, AND TRETINOIN) KIT [PATCHWERX LABS, INC.]1
MENTHOL, UNSPECIFIED FORMACTIVE MOIETYL7T10EIP3ADERMAWERX ZMT PAK (ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, AND TRETINOIN) KIT [PATCHWERX LABS, INC.]1
TRETINOINACTIVE MOIETY5688UTC01RTRETINOIN CREAM TRETINOIN GEL [REBEL DISTRIBUTORS CORP]1
TRETINOINACTIVE MOIETY5688UTC01RDERMAWERX ZMT PAK (ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, AND TRETINOIN) KIT [PATCHWERX LABS, INC.]1
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZDERMAWERX ZMT PAK (ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, AND TRETINOIN) KIT [PATCHWERX LABS, INC.]1
BRUCINE SULFATEINACTIVE INGREDIENTKY7O12XPOQTRETINOIN CREAM TRETINOIN GEL [REBEL DISTRIBUTORS CORP]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KDERMAWERX ZMT PAK (ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, AND TRETINOIN) KIT [PATCHWERX LABS, INC.]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KTRETINOIN CREAM TRETINOIN GEL [REBEL DISTRIBUTORS CORP]1
CHLOROTHYMOLINACTIVE INGREDIENTLJ25TI0CVTDERMAWERX ZMT PAK (ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, AND TRETINOIN) KIT [PATCHWERX LABS, INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DERMAWERX ZMT PAK (ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, AND TRETINOIN) KIT [PATCHWERX LABS, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDERMAWERX ZMT PAK (ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, AND TRETINOIN) KIT [PATCHWERX LABS, INC.]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PTRETINOIN CREAM TRETINOIN GEL [REBEL DISTRIBUTORS CORP]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSDERMAWERX ZMT PAK (ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, AND TRETINOIN) KIT [PATCHWERX LABS, INC.]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSTRETINOIN CREAM TRETINOIN GEL [REBEL DISTRIBUTORS CORP]1
LANOLININACTIVE INGREDIENT7EV65EAW6HDERMAWERX ZMT PAK (ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, AND TRETINOIN) KIT [PATCHWERX LABS, INC.]1
PHENOLINACTIVE INGREDIENT339NCG44TVDERMAWERX ZMT PAK (ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, AND TRETINOIN) KIT [PATCHWERX LABS, INC.]1
POLYOXYL 40 STEARATEINACTIVE INGREDIENT13A4J4NH9ITRETINOIN CREAM TRETINOIN GEL [REBEL DISTRIBUTORS CORP]1
POLYOXYL 40 STEARATEINACTIVE INGREDIENT13A4J4NH9IDERMAWERX ZMT PAK (ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, AND TRETINOIN) KIT [PATCHWERX LABS, INC.]1
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QODERMAWERX ZMT PAK (ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, AND TRETINOIN) KIT [PATCHWERX LABS, INC.]1
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BDERMAWERX ZMT PAK (ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, AND TRETINOIN) KIT [PATCHWERX LABS, INC.]1
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BTRETINOIN CREAM TRETINOIN GEL [REBEL DISTRIBUTORS CORP]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTRETINOIN CREAM TRETINOIN GEL [REBEL DISTRIBUTORS CORP]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APDERMAWERX ZMT PAK (ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, AND TRETINOIN) KIT [PATCHWERX LABS, INC.]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YTRETINOIN CREAM TRETINOIN GEL [REBEL DISTRIBUTORS CORP]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YDERMAWERX ZMT PAK (ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, AND TRETINOIN) KIT [PATCHWERX LABS, INC.]1
TERT-BUTYL ALCOHOLINACTIVE INGREDIENTMD83SFE959TRETINOIN CREAM TRETINOIN GEL [REBEL DISTRIBUTORS CORP]1
THYMOLINACTIVE INGREDIENT3J50XA376EDERMAWERX ZMT PAK (ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, AND TRETINOIN) KIT [PATCHWERX LABS, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RTRETINOIN CREAM TRETINOIN GEL [REBEL DISTRIBUTORS CORP]1
WATERINACTIVE INGREDIENT059QF0KO0RDERMAWERX ZMT PAK (ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, AND TRETINOIN) KIT [PATCHWERX LABS, INC.]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEETRETINOIN CREAM TRETINOIN GEL [REBEL DISTRIBUTORS CORP]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEDERMAWERX ZMT PAK (ZINC OXIDE, MENTHOL, UNSPECIFIED FORM, AND TRETINOIN) KIT [PATCHWERX LABS, INC.]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106302tretinoin 0.025 % Topical CreamPSN4af7484c-53e8-4ccb-a387-f20efb7a0bea6
106303tretinoin 0.05 % Topical CreamPSN4af7484c-53e8-4ccb-a387-f20efb7a0bea6
198300tretinoin 0.1 % Topical CreamPSN4af7484c-53e8-4ccb-a387-f20efb7a0bea6
106302tretinoin 0.25 MG/ML Topical CreamSCD4af7484c-53e8-4ccb-a387-f20efb7a0bea6
106303tretinoin 0.5 MG/ML Topical CreamSCD4af7484c-53e8-4ccb-a387-f20efb7a0bea6
198300tretinoin 1 MG/ML Topical CreamSCD4af7484c-53e8-4ccb-a387-f20efb7a0bea6
106302tretinoin 0.025 % Topical CreamSY4af7484c-53e8-4ccb-a387-f20efb7a0bea6
106303tretinoin 0.05 % Topical CreamSY4af7484c-53e8-4ccb-a387-f20efb7a0bea6
198300tretinoin 0.1 % Topical CreamSY4af7484c-53e8-4ccb-a387-f20efb7a0bea6
1946481Calmoseptine 15.7 % / 0.44 % / 24 % / 20.6 % Topical OintmentPSN24682288-1be4-42af-e054-00144ff88e881
1946476lanolin 15.7 % / menthol 0.44 % / petrolatum 24 % / zinc oxide 20.6 % Topical OintmentPSN24682288-1be4-42af-e054-00144ff88e881
106302tretinoin 0.025 % Topical CreamPSNf5ce22e8-1a9b-408c-86ae-4084b7afeca11
106302tretinoin 0.025 % Topical CreamPSN24682288-1be4-42af-e054-00144ff88e881
313451tretinoin 0.025 % Topical GelPSNf5ce22e8-1a9b-408c-86ae-4084b7afeca11
106303tretinoin 0.05 % Topical CreamPSNf5ce22e8-1a9b-408c-86ae-4084b7afeca11
1946481lanolin 0.157 MG/MG / menthol 0.0044 MG/MG / petrolatum 0.24 MG/MG / zinc oxide 0.206 MG/MG Topical Ointment [Calmoseptine]SBD24682288-1be4-42af-e054-00144ff88e881
1946476lanolin 0.157 MG/MG / menthol 0.0044 MG/MG / petrolatum 0.24 MG/MG / zinc oxide 0.206 MG/MG Topical OintmentSCD24682288-1be4-42af-e054-00144ff88e881
313451tretinoin 0.00025 MG/MG Topical GelSCDf5ce22e8-1a9b-408c-86ae-4084b7afeca11
106302tretinoin 0.25 MG/ML Topical CreamSCD24682288-1be4-42af-e054-00144ff88e881
106302tretinoin 0.25 MG/ML Topical CreamSCDf5ce22e8-1a9b-408c-86ae-4084b7afeca11
106303tretinoin 0.5 MG/ML Topical CreamSCDf5ce22e8-1a9b-408c-86ae-4084b7afeca11
1946481Calmoseptine Ointment (lanolin 0.157 MG/MG / menthol 0.0044 MG/MG / petrolatum 0.24 MG/MG / zinc oxide 0.206 MG/MG) Topical OintmentSY24682288-1be4-42af-e054-00144ff88e881
1946481Calmoseptine OIntment (lanolin 15.7 % / menthol 0.44 % / petrolatum 24 % / zinc oxide 20.6 % ) Topical OintmentSY24682288-1be4-42af-e054-00144ff88e881
1946476Lanolin 0.157 MG/MG / Menthol 0.0044 MG/MG / Petrolatum 0.24 MG/MG / ZNO 0.206 MG/MG Topical OintmentSY24682288-1be4-42af-e054-00144ff88e881
1946481Lanolin 0.157 MG/MG / Menthol 0.0044 MG/MG / Petrolatum 0.24 MG/MG / ZNO 0.206 MG/MG Topical Ointment [Calmoseptine]SY24682288-1be4-42af-e054-00144ff88e881
1946476lanolin 15.7 % / menthol 0.44 % / petrolatum 24 % / zinc oxide 20.6 % Topical OintmentSY24682288-1be4-42af-e054-00144ff88e881
106302tretinoin 0.025 % Topical CreamSY24682288-1be4-42af-e054-00144ff88e881
106302tretinoin 0.025 % Topical CreamSYf5ce22e8-1a9b-408c-86ae-4084b7afeca11
313451tretinoin 0.025 % Topical GelSYf5ce22e8-1a9b-408c-86ae-4084b7afeca11
106303tretinoin 0.05 % Topical CreamSYf5ce22e8-1a9b-408c-86ae-4084b7afeca11