FDA.reportPublic FDA data

Fluocinolone Acetonide

Product NDC
0713-0224
11-digit product format
007130224
Labeler code
0713
Product ID
0713-0224_0abbbbe6-b694-1260-e063-6294a90a6f81
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluocinolone Acetonide
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Cosette Pharmaceuticals, Inc.
Application
ANDA089524
Marketing category
ANDA
Marketing start
1988-07-26
Substance
FLUOCINOLONE ACETONIDE
Active strength
.25 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fluocinolone Acetonide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUOCINOLONE ACETONIDE.25 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0CD5FD6S2M
Rxcui1191256, 1191302, 1191315

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0adb2af5-1ecf-4df5-912b-16ae89228294Product name620240829
65f6255d-41cc-425f-ba54-b1bea4947886Product name520210930
5ba208e4-886f-44da-e218-ab4f4cad2c49Product name520190612
e5a2793f-318b-72fd-b734-c44ecc6f6748Product name220190213
9e453f34-aacb-44d5-a119-c0e3dc1fca2aProduct name120160622
7df2570a-c555-4d82-9189-9247c722b62cProduct name120150402
85490a6b-2306-6bf2-c51b-eb63537dc2daProduct name120140508
a78a3633-fd06-b0af-63b3-c714de3b3bfaProduct name120140508
b2d0a9c2-fd0c-a9b4-ae41-f6a4eef4fbf6Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0713-0224-15Fluocinolone Acetonide1 in 1 CARTONOINTMENT118
0713-0224-15Fluocinolone Acetonide15 g in 1 TUBEOINTMENT1518
0713-0224-60Fluocinolone Acetonide60 g in 1 TUBEOINTMENT6018
0713-0224-60Fluocinolone Acetonide1 in 1 CARTONOINTMENT118

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0713-0224-15GM - Gram0713-0224e09f210f-f738-4227-8bd3-af086e5e371112012-07-24
0713-0224-60GM - Gram0713-0224e6e6744e-a068-48c0-a753-745afb19db0112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Fluocinolone AcetonideACTIVE INGREDIENT0CD5FD6S2MFLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) CREAM FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) OINTMENT [G&W LABORATORIES, INC.]10
Fluocinolone AcetonideACTIVE MOIETY0CD5FD6S2MFLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) CREAM FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) OINTMENT [G&W LABORATORIES, INC.]10
Cetyl AlcoholINACTIVE INGREDIENT936JST6JCNFLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) CREAM FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) OINTMENT [G&W LABORATORIES, INC.]10
Isopropyl PalmitateINACTIVE INGREDIENT8CRQ2TH63MFLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) CREAM FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) OINTMENT [G&W LABORATORIES, INC.]10
Lanolin AlcoholsINACTIVE INGREDIENT884C3FA9HEFLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) CREAM FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) OINTMENT [G&W LABORATORIES, INC.]10
Light Mineral OilINACTIVE INGREDIENTN6K5787QVPFLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) CREAM FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) OINTMENT [G&W LABORATORIES, INC.]10
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TFLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) CREAM FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) OINTMENT [G&W LABORATORIES, INC.]10
Mineral OilINACTIVE INGREDIENTT5L8T28FGPFLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) CREAM FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) OINTMENT [G&W LABORATORIES, INC.]10
PetrolatumINACTIVE INGREDIENT4T6H12BN9UFLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) CREAM FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) OINTMENT [G&W LABORATORIES, INC.]10
Polyoxyl 40 StearateINACTIVE INGREDIENT13A4J4NH9IFLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) CREAM FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) OINTMENT [G&W LABORATORIES, INC.]10
Polysorbate 60INACTIVE INGREDIENTCAL22UVI4MFLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) CREAM FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) OINTMENT [G&W LABORATORIES, INC.]10
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) CREAM FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) OINTMENT [G&W LABORATORIES, INC.]10
Propylene Glycol StearateINACTIVE INGREDIENTMZM1I680W0FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) CREAM FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) OINTMENT [G&W LABORATORIES, INC.]10
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHFLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) CREAM FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) OINTMENT [G&W LABORATORIES, INC.]10
Sorbic AcidINACTIVE INGREDIENTX045WJ989BFLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) CREAM FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) OINTMENT [G&W LABORATORIES, INC.]10
Sorbitan MonostearateINACTIVE INGREDIENTNVZ4I0H58XFLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) CREAM FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) OINTMENT [G&W LABORATORIES, INC.]10
WaterINACTIVE INGREDIENT059QF0KO0RFLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) CREAM FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE) OINTMENT [G&W LABORATORIES, INC.]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0713-0224FLUOCINOLONE ACETONIDE CREAM FLUOCINOLONE ACETONIDE OINTMENT [COSETTE PHARMACEUTICALS, INC.]18Current NDC, Legacy NDC, 4 package rows20231123_de5b78ab-ff79-3e0f-cad4-ecab11ebbdcd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1191302fluocinolone acetonide 0.01 % Topical CreamPSNde5b78ab-ff79-3e0f-cad4-ecab11ebbdcd18
1191315fluocinolone acetonide 0.025 % Topical CreamPSNde5b78ab-ff79-3e0f-cad4-ecab11ebbdcd18
1191256fluocinolone acetonide 0.025 % Topical OintmentPSNde5b78ab-ff79-3e0f-cad4-ecab11ebbdcd18
1191256fluocinolone acetonide 0.00025 MG/MG Topical OintmentSCDde5b78ab-ff79-3e0f-cad4-ecab11ebbdcd18
1191302fluocinolone acetonide 0.1 MG/ML Topical CreamSCDde5b78ab-ff79-3e0f-cad4-ecab11ebbdcd18
1191315fluocinolone acetonide 0.25 MG/ML Topical CreamSCDde5b78ab-ff79-3e0f-cad4-ecab11ebbdcd18
1191302fluocinolone acetonide 0.01 % Topical CreamSYde5b78ab-ff79-3e0f-cad4-ecab11ebbdcd18
1191315fluocinolone acetonide 0.025 % Topical CreamSYde5b78ab-ff79-3e0f-cad4-ecab11ebbdcd18
1191256fluocinolone acetonide 0.025 % Topical OintmentSYde5b78ab-ff79-3e0f-cad4-ecab11ebbdcd18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0713-0224-15007130224151 TUBE in 1 CARTON (0713-0224-15) / 15 g in 1 TUBE1 tube1988-07-260000-00-00NoNoCurrent
0713-0224-60007130224601 TUBE in 1 CARTON (0713-0224-60) / 60 g in 1 TUBE1 tube1988-07-260000-00-00NoNoCurrent