FDA.reportPublic FDA data

Synalar

Product NDC
43538-910
11-digit product format
435380910
Labeler code
43538
Product ID
43538-910_ba6591f7-ccd9-4269-a18f-d269f2714345
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluocinolone acetonide
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Medimetriks Pharmaceuticals, Inc.
Application
NDA013960
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
Rxcui1191256, 1191260

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
43538-910-122023-11-13C16284748780-10191ceaa-6fc6-198a-e063-dbdaa90aec3eSYNALAR ® (fluocinolone acetonide) Ointment, 0.025%
43538-910-992023-11-13C16284748780-10191ceaa-6fc6-198a-e063-dbdaa90aec3eSYNALAR ® (fluocinolone acetonide) Ointment, 0.025%
43538-910-122023-07-28C16284748780-10191ceaa-6fc6-198a-e063-dbdaa90aec3eSYNALAR ® (fluocinolone acetonide) Ointment, 0.025%
43538-910-992023-07-28C16284748780-10191ceaa-6fc6-198a-e063-dbdaa90aec3eSYNALAR ® (fluocinolone acetonide) Ointment, 0.025%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43538-910-12Synalar120 g in 1 TUBEOINTMENT12010
43538-910-12Synalar1 in 1 CARTONOINTMENT110
43538-910-99Synalar3 g in 1 TUBEOINTMENT310
43538-910-99Synalar6 in 1 CARTONOINTMENT610

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43538-910-12GM - Gram43538-9105aeb8de2-777f-4450-887a-cc79ac780c2d12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
fluocinolone acetonideACTIVE INGREDIENT0CD5FD6S2MSYNALAR (FLUOCINOLONE ACETONIDE) OINTMENT SYNALAR (FLUOCINOLONE ACETONIDE ) KIT [MEDIMETRIKS PHARMACEUTICALS, INC.]2
fluocinolone acetonideACTIVE MOIETY0CD5FD6S2MSYNALAR (FLUOCINOLONE ACETONIDE) OINTMENT SYNALAR (FLUOCINOLONE ACETONIDE ) KIT [MEDIMETRIKS PHARMACEUTICALS, INC.]2
petrolatumINACTIVE INGREDIENT4T6H12BN9USYNALAR (FLUOCINOLONE ACETONIDE) OINTMENT SYNALAR (FLUOCINOLONE ACETONIDE ) KIT [MEDIMETRIKS PHARMACEUTICALS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43538-910SYNALAR (FLUOCINOLONE ACETONIDE) OINTMENT [MEDIMETRIKS PHARMACEUTICALS, INC.]10Current NDC, Legacy NDC, 4 package rows20231130_d2d155cf-a635-4ab7-87de-34e90b9a74cd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1191256fluocinolone acetonide 0.025 % Topical OintmentPSNd2d155cf-a635-4ab7-87de-34e90b9a74cd10
1191260SYNALAR 0.025 % Topical OintmentPSNd2d155cf-a635-4ab7-87de-34e90b9a74cd10
1191260fluocinolone acetonide 0.00025 MG/MG Topical Ointment [Synalar]SBDd2d155cf-a635-4ab7-87de-34e90b9a74cd10
1191256fluocinolone acetonide 0.00025 MG/MG Topical OintmentSCDd2d155cf-a635-4ab7-87de-34e90b9a74cd10
1191256fluocinolone acetonide 0.025 % Topical OintmentSYd2d155cf-a635-4ab7-87de-34e90b9a74cd10
1191260Synalar 0.00025 MG/MG Topical OintmentSYd2d155cf-a635-4ab7-87de-34e90b9a74cd10
1191260Synalar 0.025 % Topical OintmentSYd2d155cf-a635-4ab7-87de-34e90b9a74cd10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43538-910-12435380910121 TUBE in 1 CARTON (43538-910-12) / 120 g in 1 TUBE1 tube2012-09-270000-00-00NoNoCurrent
43538-910-99435380910996 TUBE in 1 CARTON (43538-910-99) / 3 g in 1 TUBE6 tube2012-09-270000-00-00NoNoCurrent