FDA.reportPublic FDA data

FESTAL PLUS

Product NDC
72988-0038
11-digit product format
729880038
Labeler code
72988
Product ID
72988-0038_2130c5e0-13f6-33a5-e063-6394a90aa1e7
Type
HUMAN OTC DRUG
Nonproprietary name
Cellulase AP3 , Pancreatin, Simethicone
Dosage form
TABLET
Route
ORAL
Labeler
Lydia Co., Ltd.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2024-09-01
Substance
DIMETHICONE; PANCRELIPASE
Active strength
30; 315 mg/1; mg/1
Pharmacologic classes
Skin Barrier Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PANCRELIPASE30 mg/1
DIMETHICONE315 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
FQ3DRG0N5KInternal UNII lookup
92RU3N3Y1OInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
212f5059-da04-595d-e063-6394a90acc64Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0b1603b8-969e-b082-f6f5-ad66d8a6ea8aProduct name220200325
19041f15-771b-3d3a-88fc-f5e2d079cd6dProduct name220200325
1987d950-08e4-4b70-adeb-fb67a71142abProduct name220200325
8825ddf7-1520-4680-b0ee-684e2fa73672Product name220200325
267a6f34-90b4-2f48-3063-4f505d06a7beProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72988-0038-1FESTAL PLUS10 in 1 PACKAGETABLET102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72988-0038FESTAL PLUS (CELLULASE AP3 , PANCREATIN, SIMETHICONE) TABLET [LYDIA CO., LTD.]2Current NDC, 1 package rows20240904_212f5059-da04-595d-e063-6394a90acc64.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
FESTAL PLUSCELLULASE AP3 , PANCREATIN, SIMETHICONELydia Co., Ltd.212f5059-da04-595d-e063-6394a90acc642024-09-03WarningsExact identifier
ndc (product): 72988-0038

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72988-0038-17298800380110 TABLET in 1 PACKAGE (72988-0038-1) 10 tablet2024-09-01NoNoCurrent