FDA.reportPublic FDA data

Synalar

Product NDC
43538-900
11-digit product format
435380900
Labeler code
43538
Product ID
43538-900_890554e0-30dd-4f2c-a469-f8822ca89cab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluocinolone acetonide
Dosage form
CREAM
Route
TOPICAL
Labeler
Medimetriks Pharmaceuticals, Inc.
Application
NDA012787
Marketing category
NDA
Marketing start
2012-09-27
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
Synalar
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0CD5FD6S2M
Rxcui1191315, 1191319

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43538-900-122023-12-08C16284748780-10191ceaa-6b3c-198a-e063-dbdaa90aec3eSYNALAR ® (fluocinolone acetonide) Cream, 0.025%
43538-900-992023-12-08C16284748780-10191ceaa-6b3c-198a-e063-dbdaa90aec3eSYNALAR ® (fluocinolone acetonide) Cream, 0.025%
43538-900-122023-07-28C16284748780-10191ceaa-6b3c-198a-e063-dbdaa90aec3eSYNALAR ® (fluocinolone acetonide) Cream, 0.025%
43538-900-992023-07-28C16284748780-10191ceaa-6b3c-198a-e063-dbdaa90aec3eSYNALAR ® (fluocinolone acetonide) Cream, 0.025%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43538-900-12Synalar120 g in 1 TUBECREAM1208
43538-900-12Synalar1 in 1 CARTONCREAM18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43538-900-12GM - Gram43538-90051933d34-4801-441f-aba6-1fcd680370fc12013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
fluocinolone acetonideACTIVE INGREDIENT0CD5FD6S2MSYNALAR (FLUOCINOLONE ACETONIDE) CREAM SYNALAR (FLUOCINOLONE ACETONIDE) KIT [MEDIMETRIKS PHARMACEUTICALS, INC.]1
fluocinolone acetonideACTIVE MOIETY0CD5FD6S2MSYNALAR (FLUOCINOLONE ACETONIDE) CREAM SYNALAR (FLUOCINOLONE ACETONIDE) KIT [MEDIMETRIKS PHARMACEUTICALS, INC.]1
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLSYNALAR (FLUOCINOLONE ACETONIDE) CREAM SYNALAR (FLUOCINOLONE ACETONIDE) KIT [MEDIMETRIKS PHARMACEUTICALS, INC.]1
butylated hydroxytolueneINACTIVE INGREDIENT1P9D0Z171KSYNALAR (FLUOCINOLONE ACETONIDE) CREAM SYNALAR (FLUOCINOLONE ACETONIDE) KIT [MEDIMETRIKS PHARMACEUTICALS, INC.]1
cetyl alcoholINACTIVE INGREDIENT936JST6JCNSYNALAR (FLUOCINOLONE ACETONIDE) CREAM SYNALAR (FLUOCINOLONE ACETONIDE) KIT [MEDIMETRIKS PHARMACEUTICALS, INC.]1
edetate disodiumINACTIVE INGREDIENT7FLD91C86KSYNALAR (FLUOCINOLONE ACETONIDE) CREAM SYNALAR (FLUOCINOLONE ACETONIDE) KIT [MEDIMETRIKS PHARMACEUTICALS, INC.]1
methylparabenINACTIVE INGREDIENTA2I8C7HI9TSYNALAR (FLUOCINOLONE ACETONIDE) CREAM SYNALAR (FLUOCINOLONE ACETONIDE) KIT [MEDIMETRIKS PHARMACEUTICALS, INC.]1
mineral oilINACTIVE INGREDIENTT5L8T28FGPSYNALAR (FLUOCINOLONE ACETONIDE) CREAM SYNALAR (FLUOCINOLONE ACETONIDE) KIT [MEDIMETRIKS PHARMACEUTICALS, INC.]1
polyoxyl 20 cetostearyl etherINACTIVE INGREDIENTYRC528SWUYSYNALAR (FLUOCINOLONE ACETONIDE) CREAM SYNALAR (FLUOCINOLONE ACETONIDE) KIT [MEDIMETRIKS PHARMACEUTICALS, INC.]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3SYNALAR (FLUOCINOLONE ACETONIDE) CREAM SYNALAR (FLUOCINOLONE ACETONIDE) KIT [MEDIMETRIKS PHARMACEUTICALS, INC.]1
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHSYNALAR (FLUOCINOLONE ACETONIDE) CREAM SYNALAR (FLUOCINOLONE ACETONIDE) KIT [MEDIMETRIKS PHARMACEUTICALS, INC.]1
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1YSYNALAR (FLUOCINOLONE ACETONIDE) CREAM SYNALAR (FLUOCINOLONE ACETONIDE) KIT [MEDIMETRIKS PHARMACEUTICALS, INC.]1
waterINACTIVE INGREDIENT059QF0KO0RSYNALAR (FLUOCINOLONE ACETONIDE) CREAM SYNALAR (FLUOCINOLONE ACETONIDE) KIT [MEDIMETRIKS PHARMACEUTICALS, INC.]1
white waxINACTIVE INGREDIENT7G1J5DA97FSYNALAR (FLUOCINOLONE ACETONIDE) CREAM SYNALAR (FLUOCINOLONE ACETONIDE) KIT [MEDIMETRIKS PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43538-900SYNALAR (FLUOCINOLONE ACETONIDE) CREAM [MEDIMETRIKS PHARMACEUTICALS, INC.]8Current NDC, Legacy NDC, 2 package rows20240719_5af2e4c1-082b-48a0-aae7-72d4a68cbb2d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1191315fluocinolone acetonide 0.025 % Topical CreamPSN5af2e4c1-082b-48a0-aae7-72d4a68cbb2d8
1191319SYNALAR 0.025 % Topical CreamPSN5af2e4c1-082b-48a0-aae7-72d4a68cbb2d8
1191319fluocinolone acetonide 0.25 MG/ML Topical Cream [Synalar]SBD5af2e4c1-082b-48a0-aae7-72d4a68cbb2d8
1191315fluocinolone acetonide 0.25 MG/ML Topical CreamSCD5af2e4c1-082b-48a0-aae7-72d4a68cbb2d8
1191315fluocinolone acetonide 0.025 % Topical CreamSY5af2e4c1-082b-48a0-aae7-72d4a68cbb2d8
1191319Synalar 0.025 % Topical CreamSY5af2e4c1-082b-48a0-aae7-72d4a68cbb2d8
1191319Synalar 0.25 MG/ML Topical CreamSY5af2e4c1-082b-48a0-aae7-72d4a68cbb2d8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43538-900-12435380900121 TUBE in 1 CARTON (43538-900-12) / 120 g in 1 TUBE1 tube2012-09-270000-00-00NoNoCurrent
43538-900-99435380900996 TUBE in 1 CARTON (43538-900-99) > 3 g in 1 TUBE6 tube2012-09-270000-00-00NoNoCurrent