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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N012787-002SYNALARFLUOCINOLONE ACETONIDE0.025%CREAM / TOPICALATRLD, RS, Approved before 1982
N012787-004SYNALARFLUOCINOLONE ACETONIDE0.01%CREAM / TOPICALATRLD, RS, Approved before 1982
N012787-005SYNALARFLUOCINOLONE ACETONIDE0.025%CREAM / TOPICALATRLD, RS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
N012787-002AT
N012787-004AT
N012787-005AT

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N012787-002SYNALAR0.025%CREAM / TOPICALATRLD, RS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N012787-004SYNALAR0.01%CREAM / TOPICALATRLD, RS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N012787-005SYNALAR0.025%CREAM / TOPICALATRLD, RS, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N012787-002SYNALAR0.025%CREAM / TOPICALATRLD, RS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N012787-004SYNALAR0.01%CREAM / TOPICALATRLD, RS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N012787-005SYNALAR0.025%CREAM / TOPICALATRLD, RS, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N012787-002SYNALAR0.025%CREAM / TOPICALATRLD, RS, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N012787-004SYNALAR0.01%CREAM / TOPICALATRLD, RS, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N012787-005SYNALAR0.025%CREAM / TOPICALATRLD, RS, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N012787-002SYNALAR0.025%CREAM / TOPICALATRLD, RS, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N012787-004SYNALAR0.01%CREAM / TOPICALATRLD, RS, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N012787-005SYNALAR0.025%CREAM / TOPICALATRLD, RS, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N012787-002SYNALAR0.025%CREAM / TOPICALATRLD, RS, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N012787-004SYNALAR0.01%CREAM / TOPICALATRLD, RS, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N012787-005SYNALAR0.025%CREAM / TOPICALATRLD, RS, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N012787-002SYNALAR0.025%CREAM / TOPICALATRLD, RS, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N012787-004SYNALAR0.01%CREAM / TOPICALATRLD, RS, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N012787-005SYNALAR0.025%CREAM / TOPICALATRLD, RS, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N012787-002SYNALAR0.025%CREAM / TOPICALATRLD, RS, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N012787-004SYNALAR0.01%CREAM / TOPICALATRLD, RS, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N012787-005SYNALAR0.025%CREAM / TOPICALATRLD, RS, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N012787-002SYNALAR0.025%CREAM / TOPICALATRLD, RS, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N012787-004SYNALAR0.01%CREAM / TOPICALATRLD, RS, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N012787-005SYNALAR0.025%CREAM / TOPICALATRLD, RS, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N012787-002SYNALAR0.025%CREAM / TOPICALATRLD, RS, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N012787-004SYNALAR0.01%CREAM / TOPICALATRLD, RS, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N012787-005SYNALAR0.025%CREAM / TOPICALATRLD, RS, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N012787-002SYNALAR0.025%CREAM / TOPICALATRLD, RS, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N012787-004SYNALAR0.01%CREAM / TOPICALATRLD, RS, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N012787-005SYNALAR0.025%CREAM / TOPICALATRLD, RS, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N012787-002SYNALAR0.025%CREAM / TOPICALATRLD, RS, Approved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N012787-004SYNALAR0.01%CREAM / TOPICALATRLD, RS, Approved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N012787-005SYNALAR0.025%CREAM / TOPICALATRLD, RS, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N012787-002SYNALAR0.025%CREAM / TOPICALATRLD, RS, Approved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N012787-004SYNALAR0.01%CREAM / TOPICALATRLD, RS, Approved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N012787-005SYNALAR0.025%CREAM / TOPICALATRLD, RS, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N012787-002SYNALAR0.025%CREAM / TOPICALATRLD, RS, Approved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N012787-004SYNALAR0.01%CREAM / TOPICALATRLD, RS, Approved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N012787-005SYNALAR0.025%CREAM / TOPICALATRLD, RS, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05N012787-002SYNALAR0.025%CREAM / TOPICALATRLD, RS, Approved before 19828072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N012787-002AT1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N012787-004AT1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N012787-005AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N012787-002AT131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N012787-004AT131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N012787-005AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08N012787-002AT16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N012787-004AT16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N012787-005AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N012787-002AT1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N012787-004AT1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N012787-005AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N012787-002AT1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N012787-004AT1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N012787-005AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N012787-002AT103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N012787-004AT103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N012787-005AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N012787-002AT12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N012787-004AT12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N012787-005AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N012787-002AT15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N012787-004AT15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N012787-005AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N012787-002AT1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N012787-004AT1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N012787-005AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N012787-002AT1d06236e962d9…
2024-10-29 15:01 UTC2024-10N012787-004AT1d06236e962d9…
2024-10-29 15:01 UTC2024-10N012787-005AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N012787-002AT179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N012787-004AT179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N012787-005AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N012787-002AT1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N012787-004AT1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N012787-005AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N012787-002AT11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N012787-004AT11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N012787-005AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N012787-002AT18072bd15b7f6…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0CD5FD6S2MInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1191315Internal RxNorm lookup
1191319Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5af2e4c1-082b-48a0-aae7-72d4a68cbb2dAvailable on FDA.report

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#

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
fluocinolone acetonideFLUOCINOLONE ACETONIDEANI Pharmaceuticals, Inc.50e7006d-a51b-49aa-8e1c-330340e7bf822026-02-23Adverse reactionsExact identifier
application applno (NDA): 012787
application number: NDA012787
SynalarFLUOCINOLONE ACETONIDEMedimetriks Pharmaceuticals, Inc.5af2e4c1-082b-48a0-aae7-72d4a68cbb2d2024-07-18Adverse reactionsExact identifier
application applno (NDA): 012787
application number: NDA012787
ndc (product): 43538-900

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