FDA.reportPublic FDA data

SOOLANTRA

Product NDC
0299-3823
11-digit product format
002993823
Labeler code
0299
Product ID
0299-3823_253c7c90-5d85-b1e0-e063-6394a90a7a4b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
IVERMECTIN
Dosage form
CREAM
Route
TOPICAL
Labeler
Galderma Laboratories, L.P.
Application
NDA206255
Marketing category
NDA
Marketing start
2015-01-01
Substance
IVERMECTIN
Active strength
10 mg/g
Pharmacologic classes
Antiparasitic [EPC], Pediculicide [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IVERMECTIN10 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8883YP2R6D
Rxcui1598068, 1598073

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7fd951fe-040a-0b64-2bea-eefc6aa4fc54Product name220250515
5b0ed980-56ce-7dd0-fb86-ff54be67c2e6Product name220200925
eed31638-1288-4eb6-a55c-5fc014dca98dProduct name320200728

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0299-3823-00SOOLANTRA2 g in 1 TUBECREAM28
0299-3823-02SOOLANTRA2 g in 1 TUBECREAM28
0299-3823-02SOOLANTRA1 in 1 BLISTER PACKCREAM18
0299-3823-30SOOLANTRA1 in 1 CARTONCREAM18
0299-3823-30SOOLANTRA30 g in 1 TUBECREAM308
0299-3823-45SOOLANTRA1 in 1 CARTONCREAM18
0299-3823-45SOOLANTRA45 g in 1 TUBECREAM458
0299-3823-60SOOLANTRA1 in 1 CARTONCREAM18
0299-3823-60SOOLANTRA60 g in 1 TUBECREAM608

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0299-3823-30GM - Gram0299-3823615e75f6-77e5-4897-bf41-f98a7783ac0612015-01-05
0299-3823-45GM - Gram0299-3823f07cff3e-f793-4246-9c12-2cb3eae6950f12016-12-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IVERMECTINACTIVE INGREDIENT8883YP2R6DSOOLANTRA (IVERMECTIN) CREAM [GALDERMA LABORATORIES, L.P.]2
IVERMECTINACTIVE MOIETY8883YP2R6DSOOLANTRA (IVERMECTIN) CREAM [GALDERMA LABORATORIES, L.P.]2
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT809Y72KV36SOOLANTRA (IVERMECTIN) CREAM [GALDERMA LABORATORIES, L.P.]2
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNSOOLANTRA (IVERMECTIN) CREAM [GALDERMA LABORATORIES, L.P.]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSOOLANTRA (IVERMECTIN) CREAM [GALDERMA LABORATORIES, L.P.]2
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OSOOLANTRA (IVERMECTIN) CREAM [GALDERMA LABORATORIES, L.P.]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KSOOLANTRA (IVERMECTIN) CREAM [GALDERMA LABORATORIES, L.P.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSOOLANTRA (IVERMECTIN) CREAM [GALDERMA LABORATORIES, L.P.]2
ISOPROPYL PALMITATEINACTIVE INGREDIENT8CRQ2TH63MSOOLANTRA (IVERMECTIN) CREAM [GALDERMA LABORATORIES, L.P.]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TSOOLANTRA (IVERMECTIN) CREAM [GALDERMA LABORATORIES, L.P.]2
OLEYL ALCOHOLINACTIVE INGREDIENT172F2WN8DVSOOLANTRA (IVERMECTIN) CREAM [GALDERMA LABORATORIES, L.P.]2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TSOOLANTRA (IVERMECTIN) CREAM [GALDERMA LABORATORIES, L.P.]2
POLYOXYL 20 CETOSTEARYL ETHERINACTIVE INGREDIENTYRC528SWUYSOOLANTRA (IVERMECTIN) CREAM [GALDERMA LABORATORIES, L.P.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SOOLANTRA (IVERMECTIN) CREAM [GALDERMA LABORATORIES, L.P.]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHSOOLANTRA (IVERMECTIN) CREAM [GALDERMA LABORATORIES, L.P.]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ISOOLANTRA (IVERMECTIN) CREAM [GALDERMA LABORATORIES, L.P.]2
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58XSOOLANTRA (IVERMECTIN) CREAM [GALDERMA LABORATORIES, L.P.]2
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YSOOLANTRA (IVERMECTIN) CREAM [GALDERMA LABORATORIES, L.P.]2
WATERINACTIVE INGREDIENT059QF0KO0RSOOLANTRA (IVERMECTIN) CREAM [GALDERMA LABORATORIES, L.P.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0299-3823SOOLANTRA (IVERMECTIN) CREAM [GALDERMA LABORATORIES, L.P.]8Current NDC, Legacy NDC, 9 package rows20241027_b1d5b166-ab06-4ab5-b0c6-31126238118a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1598068ivermectin 1 % Topical CreamPSNb1d5b166-ab06-4ab5-b0c6-31126238118a8
1598073soolantra 1 % Topical CreamPSNb1d5b166-ab06-4ab5-b0c6-31126238118a8
1598073ivermectin 10 MG/ML Topical Cream [Soolantra]SBDb1d5b166-ab06-4ab5-b0c6-31126238118a8
1598068ivermectin 10 MG/ML Topical CreamSCDb1d5b166-ab06-4ab5-b0c6-31126238118a8
1598068ivermectin 1 % Topical CreamSYb1d5b166-ab06-4ab5-b0c6-31126238118a8
1598073Soolantra 1 % Topical CreamSYb1d5b166-ab06-4ab5-b0c6-31126238118a8
1598073Soolantra 10 MG/ML Topical CreamSYb1d5b166-ab06-4ab5-b0c6-31126238118a8
1598068ivermectin 1 % Topical CreamPSN39fbf2b3-cd2f-4e04-99c4-ca4390fae2bd1
1598068ivermectin 10 MG/ML Topical CreamSCD39fbf2b3-cd2f-4e04-99c4-ca4390fae2bd1
1598068ivermectin 1 % Topical CreamSY39fbf2b3-cd2f-4e04-99c4-ca4390fae2bd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0299-3823-00002993823002 g in 1 TUBE (0299-3823-00) 2 g2019-11-010000-00-00YesNoCurrent
0299-3823-02002993823021 TUBE in 1 BLISTER PACK (0299-3823-02) / 2 g in 1 TUBE1 tube2015-01-010000-00-00YesNoCurrent
0299-3823-30002993823301 TUBE in 1 CARTON (0299-3823-30) / 30 g in 1 TUBE1 tube2015-01-010000-00-00NoNoCurrent
0299-3823-45002993823451 TUBE in 1 CARTON (0299-3823-45) / 45 g in 1 TUBE1 tube2015-01-010000-00-00NoNoCurrent
0299-3823-60002993823601 TUBE in 1 CARTON (0299-3823-60) / 60 g in 1 TUBE1 tube2015-01-010000-00-00NoNoCurrent