FDA.reportPublic FDA data

Retin-A

Product NDC
0187-5160
11-digit product format
001875160
Labeler code
0187
Product ID
0187-5160_18a7b6d8-e3c4-676f-e063-6294a90a0498
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tretinoin
Dosage form
CREAM
Route
TOPICAL
Labeler
Bausch Health US, LLC
Application
NDA019049
Marketing category
NDA
Marketing start
1988-10-30
Substance
TRETINOIN
Active strength
.25 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
Retin-A
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRETINOIN.25 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5688UTC01R
Rxcui106302, 106303, 198300, 208328, 208330, 208331, 208334, 313450, 313451, 701305

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
0187-5160-20Retin-A1 in 1 CARTONCREAM115
0187-5160-20Retin-A20 g in 1 TUBECREAM2015
0187-5160-45Retin-A1 in 1 CARTONCREAM115
0187-5160-45Retin-A45 g in 1 TUBECREAM4515

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0187-5160-20GM - Gram0187-516019997273-15e2-4749-b8e9-d506cb8cf4a212015-04-03
0187-5160-45GM - Gram0187-51601ce78cae-bd20-4347-9b36-ceadb3521f4d12014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TretinoinACTIVE INGREDIENT5688UTC01RRETIN-A (TRETINOIN) CREAM RETIN-A (TRETINOIN) GEL [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
TretinoinACTIVE MOIETY5688UTC01RRETIN-A (TRETINOIN) CREAM RETIN-A (TRETINOIN) GEL [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
AlcoholINACTIVE INGREDIENT3K9958V90MRETIN-A (TRETINOIN) CREAM RETIN-A (TRETINOIN) GEL [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
Butylated HydroxytolueneINACTIVE INGREDIENT1P9D0Z171KRETIN-A (TRETINOIN) CREAM RETIN-A (TRETINOIN) GEL [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PRETIN-A (TRETINOIN) CREAM RETIN-A (TRETINOIN) GEL [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
Isopropyl MyristateINACTIVE INGREDIENT0RE8K4LNJSRETIN-A (TRETINOIN) CREAM RETIN-A (TRETINOIN) GEL [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
Polyoxyl 40 StearateINACTIVE INGREDIENT13A4J4NH9IRETIN-A (TRETINOIN) CREAM RETIN-A (TRETINOIN) GEL [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
Sorbic AcidINACTIVE INGREDIENTX045WJ989BRETIN-A (TRETINOIN) CREAM RETIN-A (TRETINOIN) GEL [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
Stearic AcidINACTIVE INGREDIENT4ELV7Z65APRETIN-A (TRETINOIN) CREAM RETIN-A (TRETINOIN) GEL [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
Stearyl AlcoholINACTIVE INGREDIENT2KR89I4H1YRETIN-A (TRETINOIN) CREAM RETIN-A (TRETINOIN) GEL [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
WaterINACTIVE INGREDIENT059QF0KO0RRETIN-A (TRETINOIN) CREAM RETIN-A (TRETINOIN) GEL [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
Xanthan GumINACTIVE INGREDIENTTTV12P4NEERETIN-A (TRETINOIN) CREAM RETIN-A (TRETINOIN) GEL [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0187-5160RETIN-A (TRETINOIN) CREAM RETIN-A (TRETINOIN) GEL [BAUSCH HEALTH US, LLC]15Current NDC, Legacy NDC, 4 package rows20240518_9556d73d-c573-4e0a-9feb-764ce2d1107b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
208334Retin-A 0.01 % Topical GelPSN9556d73d-c573-4e0a-9feb-764ce2d1107b15
208328Retin-A 0.025 % Topical CreamPSN9556d73d-c573-4e0a-9feb-764ce2d1107b15
701305Retin-A 0.025 % Topical GelPSN9556d73d-c573-4e0a-9feb-764ce2d1107b15
208330Retin-A 0.05 % Topical CreamPSN9556d73d-c573-4e0a-9feb-764ce2d1107b15
208331Retin-A 0.1 % Topical CreamPSN9556d73d-c573-4e0a-9feb-764ce2d1107b15
313450tretinoin 0.01 % Topical GelPSN9556d73d-c573-4e0a-9feb-764ce2d1107b15
106302tretinoin 0.025 % Topical CreamPSN9556d73d-c573-4e0a-9feb-764ce2d1107b15
313451tretinoin 0.025 % Topical GelPSN9556d73d-c573-4e0a-9feb-764ce2d1107b15
106303tretinoin 0.05 % Topical CreamPSN9556d73d-c573-4e0a-9feb-764ce2d1107b15
198300tretinoin 0.1 % Topical CreamPSN9556d73d-c573-4e0a-9feb-764ce2d1107b15
208334tretinoin 0.0001 MG/MG Topical Gel [Retin-A]SBD9556d73d-c573-4e0a-9feb-764ce2d1107b15
701305tretinoin 0.00025 MG/MG Topical Gel [Retin-A]SBD9556d73d-c573-4e0a-9feb-764ce2d1107b15
208328tretinoin 0.25 MG/ML Topical Cream [Retin-A]SBD9556d73d-c573-4e0a-9feb-764ce2d1107b15
208330tretinoin 0.5 MG/ML Topical Cream [Retin-A]SBD9556d73d-c573-4e0a-9feb-764ce2d1107b15
208331tretinoin 1 MG/ML Topical Cream [Retin-A]SBD9556d73d-c573-4e0a-9feb-764ce2d1107b15
313450tretinoin 0.0001 MG/MG Topical GelSCD9556d73d-c573-4e0a-9feb-764ce2d1107b15
313451tretinoin 0.00025 MG/MG Topical GelSCD9556d73d-c573-4e0a-9feb-764ce2d1107b15
106302tretinoin 0.25 MG/ML Topical CreamSCD9556d73d-c573-4e0a-9feb-764ce2d1107b15
106303tretinoin 0.5 MG/ML Topical CreamSCD9556d73d-c573-4e0a-9feb-764ce2d1107b15
198300tretinoin 1 MG/ML Topical CreamSCD9556d73d-c573-4e0a-9feb-764ce2d1107b15
208334Retin-A 0.0001 MG/MG Topical GelSY9556d73d-c573-4e0a-9feb-764ce2d1107b15
701305Retin-A 0.00025 MG/MG Topical GelSY9556d73d-c573-4e0a-9feb-764ce2d1107b15
208334Retin-A 0.01 % Topical GelSY9556d73d-c573-4e0a-9feb-764ce2d1107b15
208328Retin-A 0.025 % Topical CreamSY9556d73d-c573-4e0a-9feb-764ce2d1107b15
701305Retin-A 0.025 % Topical GelSY9556d73d-c573-4e0a-9feb-764ce2d1107b15
208330Retin-A 0.05 % Topical CreamSY9556d73d-c573-4e0a-9feb-764ce2d1107b15
208331Retin-A 0.1 % Topical CreamSY9556d73d-c573-4e0a-9feb-764ce2d1107b15
208328Retin-A 0.25 MG/ML Topical CreamSY9556d73d-c573-4e0a-9feb-764ce2d1107b15
208330Retin-A 0.5 MG/ML Topical CreamSY9556d73d-c573-4e0a-9feb-764ce2d1107b15
208331Retin-A 1 MG/ML Topical CreamSY9556d73d-c573-4e0a-9feb-764ce2d1107b15
313450tretinoin 0.01 % Topical GelSY9556d73d-c573-4e0a-9feb-764ce2d1107b15
106302tretinoin 0.025 % Topical CreamSY9556d73d-c573-4e0a-9feb-764ce2d1107b15
313451tretinoin 0.025 % Topical GelSY9556d73d-c573-4e0a-9feb-764ce2d1107b15
106303tretinoin 0.05 % Topical CreamSY9556d73d-c573-4e0a-9feb-764ce2d1107b15
198300tretinoin 0.1 % Topical CreamSY9556d73d-c573-4e0a-9feb-764ce2d1107b15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0187-5160-20001875160201 TUBE in 1 CARTON (0187-5160-20) / 20 g in 1 TUBE1 tube1988-10-300000-00-00NoNoCurrent
0187-5160-45001875160451 TUBE in 1 CARTON (0187-5160-45) / 45 g in 1 TUBE1 tube1988-10-300000-00-00NoNoCurrent