ALBOTHYL

Product NDC
72988-0035
Requested package NDC
72988-0035-1
11-digit product format
729880035
Labeler code
72988
Product ID
72988-0035_001d54ef-148b-e55a-e063-6294a90a7c40
Type
HUMAN OTC DRUG
Nonproprietary name
Policresulen Solution
Dosage form
LIQUID
Route
ORAL
Labeler
Lydia Co., Ltd.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2023-01-23
Substance
POLICRESULEN
Active strength
720 mg/g
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
ALBOTHYL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POLICRESULEN720 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6I19M5GB0GInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f2ea4e1b-a3d7-d063-e053-2a95a90a6d0bAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72988-0035-1ALBOTHYL5 g in 1 BOTTLELIQUID53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72988-0035ALBOTHYL (POLICRESULEN SOLUTION) LIQUID [LYDIA CO., LTD.]3Current NDC, 1 package rows20230819_f2ea4e1b-a3d7-d063-e053-2a95a90a6d0b.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
ALBOTHYLPOLICRESULEN SOLUTIONLydia Co., Ltd.f2ea4e1b-a3d7-d063-e053-2a95a90a6d0b2023-07-10WarningsExact identifier
ndc (package): 72988-0035-1
ndc (product): 72988-0035
ndc11 (package): 72988003501

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72988-0035-1729880035015 g in 1 BOTTLE (72988-0035-1) 5 g2023-01-23NoNoCurrent