JBA Omelia

Product NDC
13411-857
11-digit product format
134110857
Labeler code
13411
Product ID
13411-857_31a6113c-0abc-0412-e063-6394a90ac49a
Type
HUMAN OTC DRUG
Nonproprietary name
Sea Buckthorn extract,Maca (Lepidium meyenii) extract,Tongkat Ali (Eurycoma longifolia) Peptides
Dosage form
CAPSULE
Route
ORAL
Labeler
Advanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticals
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2024-08-19
Substance
HIPPOPHAE RHAMNOIDES WHOLE; LEPIDIUM MEYENII ROOT; EURYCOMA LONGIFOLIA ROOT
Active strength
380; 120; 20 mg/1; mg/1; mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HIPPOPHAE RHAMNOIDES WHOLE380 mg/1
LEPIDIUM MEYENII ROOT120 mg/1
EURYCOMA LONGIFOLIA ROOT20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
YAA7TG74X6Internal UNII lookup
HP7119212TInternal UNII lookup
43B8E2HG8BInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ae63fe31-f602-4171-abed-a7212864d064Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13411-857-15JBA Omelia15 in 1 BOTTLECAPSULE152
13411-857-30JBA Omelia30 in 1 BOTTLECAPSULE302
13411-857-60JBA Omelia60 in 1 BOTTLECAPSULE602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13411-857JBA OMELIA (SEA BUCKTHORN EXTRACT,MACA (LEPIDIUM MEYENII) EXTRACT,TONGKAT ALI (EURYCOMA LONGIFOLIA) PEPTIDES) CAPSULE [ADVANCED PHARMACEUTICAL SERVICES, INC. DBA AFFORDABLE QUALITY PHARMACEUTICALS]2Current NDC, 3 package rows20250402_ae63fe31-f602-4171-abed-a7212864d064.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
JBA OmeliaSEA BUCKTHORN EXTRACT,MACA (LEPIDIUM MEYENII) EXTRACT,TONGKAT ALI (EURYCOMA LONGIFOLIA) PEPTIDESAdvanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticalsae63fe31-f602-4171-abed-a7212864d0642025-03-31WarningsExact identifier
ndc (product): 13411-857

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
13411-857-151341108571515 CAPSULE in 1 BOTTLE (13411-857-15) 15 capsule2024-08-19NoNoCurrent
13411-857-301341108573030 CAPSULE in 1 BOTTLE (13411-857-30) 30 capsule2024-08-19NoNoCurrent
13411-857-601341108576060 CAPSULE in 1 BOTTLE (13411-857-60) 60 capsule2024-08-19NoNoCurrent