FDA.reportPublic FDA data

Esokalli Testosterone Booster Oral Dissolving Film

Product NDC
84778-085
11-digit product format
847780085
Labeler code
84778
Product ID
84778-085_3dcadf2b-8896-9183-e063-6394a90a27d2
Type
HUMAN OTC DRUG
Nonproprietary name
Esokalli Testosterone Booster Oral Dissolving Film
Dosage form
FILM, SOLUBLE
Route
TOPICAL
Labeler
Guangzhou Yixin Cross-border E-commerce Co., Ltd.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-08-24
Substance
TADALAFIL; VARDENAFIL
Active strength
40; 20 mg/100mg; mg/100mg
Pharmacologic classes
Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA], Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Esokalli Testosterone Booster Oral Dissolving Film
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TADALAFIL40 mg/100mg
VARDENAFIL20 mg/100mg

Harmonized Identifiers#

Field, Values table
FieldValues
Unii742SXX0ICT, UCE6F4125H

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b90b74cb-f6c8-3798-d11c-73b8768b278aProduct name820250317
0fe0157c-95a7-4870-ae64-de9f3fa874aeProduct name120250227
20ae0006-d78c-4dba-9e3e-6ae424841903Product name120250127
b86a08b7-54cc-440b-ad4a-3e530ccd8324Product name620230421
7a02e74a-2844-42af-84a8-96bae57351cfProduct name120230313
928d249c-35c3-4d88-a9ef-cf2f2e31b96fProduct name120220706
f2f15561-f1f1-39f4-fff4-873c88c535cdProduct name420210224
9c8b57d3-6030-411c-8a17-97b4b8f0ea17Product name320200708

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84778-085-01Esokalli Testosterone Booster Oral Dissolving Film60 mg in 1 PATCHFILM, SOLUBLE604
84778-085-01Esokalli Testosterone Booster Oral Dissolving Film1 in 1 BOXFILM, SOLUBLE14
84778-085-02Esokalli Testosterone Booster Oral Dissolving Film2 in 1 BOXFILM, SOLUBLE24
84778-085-02Esokalli Testosterone Booster Oral Dissolving Film60 mg in 1 PATCHFILM, SOLUBLE604
84778-085-03Esokalli Testosterone Booster Oral Dissolving Film60 mg in 1 PATCHFILM, SOLUBLE604
84778-085-03Esokalli Testosterone Booster Oral Dissolving Film4 in 1 BOXFILM, SOLUBLE44
84778-085-04Esokalli Testosterone Booster Oral Dissolving Film8 in 1 BOXFILM, SOLUBLE84
84778-085-04Esokalli Testosterone Booster Oral Dissolving Film60 mg in 1 PATCHFILM, SOLUBLE604

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84778-085-01847780085011 PATCH in 1 BOX (84778-085-01) / 60 mg in 1 PATCH1 patch2025-08-24NoNoHistorical
84778-085-02847780085022 PATCH in 1 BOX (84778-085-02) / 60 mg in 1 PATCH2 patch2025-08-24NoNoHistorical
84778-085-03847780085034 PATCH in 1 BOX (84778-085-03) / 60 mg in 1 PATCH4 patch2025-08-24NoNoHistorical
84778-085-04847780085048 PATCH in 1 BOX (84778-085-04) / 60 mg in 1 PATCH8 patch2025-08-24NoNoHistorical