Retin-A MICRO

Product NDC
0187-5148
11-digit product format
001875148
Labeler code
0187
Product ID
0187-5148_5eacf7df-7bdd-4401-ae28-2319c8757b4a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tretinoin
Dosage form
GEL
Route
TOPICAL
Labeler
Bausch Health US LLC
Application
NDA020475
Marketing category
NDA
Marketing start
2014-01-28
Substance
TRETINOIN
Active strength
.8 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
Retin-A MICRO
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRETINOIN.8 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5688UTC01R
Rxcui313453, 359050, 805370, 805372, 1488045, 1488047, 1987644, 1987646

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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0187-5148-02Retin-A MICRO24 in 1 CARTONGEL2423
0187-5148-02Retin-A MICRO2 g in 1 TUBEGEL223
0187-5148-50Retin-A MICRO1 in 1 CARTONGEL123
0187-5148-50Retin-A MICRO50 g in 1 BOTTLE, PUMPGEL5023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0187-5148-50GM - Gram0187-5148fe249bc2-8c7b-4cc5-8e44-56b2c19c352012014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TretinoinACTIVE INGREDIENT5688UTC01RRETIN-A MICRO (TRETINOIN) GEL [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
TretinoinACTIVE MOIETY5688UTC01RRETIN-A MICRO (TRETINOIN) GEL [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
Benzyl AlcoholINACTIVE INGREDIENTLKG8494WBHRETIN-A MICRO (TRETINOIN) GEL [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
Butylated HydroxytolueneINACTIVE INGREDIENT1P9D0Z171KRETIN-A MICRO (TRETINOIN) GEL [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
Carbomer Homopolymer Type B (Allyl Pentaerythritol Crosslinked)INACTIVE INGREDIENTHHT01ZNK31RETIN-A MICRO (TRETINOIN) GEL [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENTZ135WT9208RETIN-A MICRO (TRETINOIN) GEL [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
CYCLOMETHICONEINACTIVE INGREDIENTNMQ347994ZRETIN-A MICRO (TRETINOIN) GEL [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86KRETIN-A MICRO (TRETINOIN) GEL [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
GlycerinINACTIVE INGREDIENTPDC6A3C0OXRETIN-A MICRO (TRETINOIN) GEL [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
PPG-20 METHYL GLUCOSE ETHER DISTEARATEINACTIVE INGREDIENT0057334FABRETIN-A MICRO (TRETINOIN) GEL [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3RETIN-A MICRO (TRETINOIN) GEL [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
Sorbic AcidINACTIVE INGREDIENTX045WJ989BRETIN-A MICRO (TRETINOIN) GEL [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
TrolamineINACTIVE INGREDIENT9O3K93S3TKRETIN-A MICRO (TRETINOIN) GEL [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
WaterINACTIVE INGREDIENT059QF0KO0RRETIN-A MICRO (TRETINOIN) GEL [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0187-5148RETIN-A MICRO (TRETINOIN) GEL [BAUSCH HEALTH US LLC]18Current NDC, Legacy NDC, 4 package rows20250503_08ab7e0c-1437-455f-815c-98904d96a289.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
805370RETIN-A MICRO 0.04 % Topical GelPSN08ab7e0c-1437-455f-815c-98904d96a28923
1987646RETIN-A MICRO 0.06 % Topical GelPSN08ab7e0c-1437-455f-815c-98904d96a28923
1488047RETIN-A MICRO 0.08 % Topical GelPSN08ab7e0c-1437-455f-815c-98904d96a28923
805372RETIN-A MICRO 0.1 % Topical GelPSN08ab7e0c-1437-455f-815c-98904d96a28923
359050tretinoin 0.04 % Topical GelPSN08ab7e0c-1437-455f-815c-98904d96a28923
1987644tretinoin 0.06 % Topical GelPSN08ab7e0c-1437-455f-815c-98904d96a28923
1488045tretinoin 0.08 % Topical GelPSN08ab7e0c-1437-455f-815c-98904d96a28923
313453tretinoin 0.1 % Topical GelPSN08ab7e0c-1437-455f-815c-98904d96a28923
805370tretinoin 0.0004 MG/MG Topical Gel [Retin-A]SBD08ab7e0c-1437-455f-815c-98904d96a28923
1987646tretinoin 0.0006 MG/MG Topical Gel [Retin-A]SBD08ab7e0c-1437-455f-815c-98904d96a28923
1488047tretinoin 0.0008 MG/MG Topical Gel [Retin-A]SBD08ab7e0c-1437-455f-815c-98904d96a28923
805372tretinoin 0.001 MG/MG Topical Gel [Retin-A]SBD08ab7e0c-1437-455f-815c-98904d96a28923
359050tretinoin 0.0004 MG/MG Topical GelSCD08ab7e0c-1437-455f-815c-98904d96a28923
1987644tretinoin 0.0006 MG/MG Topical GelSCD08ab7e0c-1437-455f-815c-98904d96a28923
1488045tretinoin 0.0008 MG/MG Topical GelSCD08ab7e0c-1437-455f-815c-98904d96a28923
313453tretinoin 0.001 MG/MG Topical GelSCD08ab7e0c-1437-455f-815c-98904d96a28923
805370Retin-A 0.0004 MG/MG Topical GelSY08ab7e0c-1437-455f-815c-98904d96a28923
1987646Retin-A 0.0006 MG/MG Topical GelSY08ab7e0c-1437-455f-815c-98904d96a28923
1488047Retin-A 0.0008 MG/MG Topical GelSY08ab7e0c-1437-455f-815c-98904d96a28923
805372Retin-A 0.001 MG/MG Topical GelSY08ab7e0c-1437-455f-815c-98904d96a28923
805370Retin-A 0.04 % Topical GelSY08ab7e0c-1437-455f-815c-98904d96a28923
1488047Retin-A 0.08 % Topical GelSY08ab7e0c-1437-455f-815c-98904d96a28923
805370Retin-A Micro 0.04 % Topical GelSY08ab7e0c-1437-455f-815c-98904d96a28923
1987646Retin-A Micro 0.06 % Topical GelSY08ab7e0c-1437-455f-815c-98904d96a28923
1488047Retin-A Micro 0.08 % Topical GelSY08ab7e0c-1437-455f-815c-98904d96a28923
805372Retin-A Micro 0.1 % Topical GelSY08ab7e0c-1437-455f-815c-98904d96a28923
359050tretinoin 0.04 % Topical GelSY08ab7e0c-1437-455f-815c-98904d96a28923
1987644tretinoin 0.06 % Topical GelSY08ab7e0c-1437-455f-815c-98904d96a28923
1488045tretinoin 0.08 % Topical GelSY08ab7e0c-1437-455f-815c-98904d96a28923
313453tretinoin 0.1 % Topical GelSY08ab7e0c-1437-455f-815c-98904d96a28923

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0187-5148-020018751480224 TUBE in 1 CARTON (0187-5148-02) / 2 g in 1 TUBE24 tube2014-01-280000-00-00NoNoCurrent
0187-5148-50001875148501 BOTTLE, PUMP in 1 CARTON (0187-5148-50) / 50 g in 1 BOTTLE, PUMP2014-01-280000-00-00NoNoCurrent