FDA.reportPublic FDA data

Vita Soluball

Product NDC
84020-0001
Requested package NDC
84020-0001-1
11-digit product format
840200001
Labeler code
84020
Product ID
84020-0001_0fa71049-16a4-c0db-e063-6294a90a7edf
Type
HUMAN OTC DRUG
Nonproprietary name
ascorbic acid, zinc oxide
Dosage form
POWDER
Route
TOPICAL
Labeler
Silexn Technology Co.,Ltd.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2024-01-24
Substance
ZINC OXIDE; ASCORBIC ACID
Active strength
40; 200 mg/1000mg; mg/1000mg
Pharmacologic classes
Ascorbic Acid [CS], Vitamin C [EPC]
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
Vita Soluball
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE40 mg/1000mg
ASCORBIC ACID200 mg/1000mg

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup
PQ6CK8PD0RInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0fa7105d-ee23-d73a-e063-6394a90a34f0Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84020-0001-1Vita Soluball10000 mg in 1 BOTTLEPOWDER100001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84020-0001VITA SOLUBALL (ASCORBIC ACID, ZINC OXIDE) POWDER [SILEXN TECHNOLOGY CO.,LTD.]1Current NDC, 1 package rows20240124_0fa7105d-ee23-d73a-e063-6394a90a34f0.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
Vita SoluballASCORBIC ACID, ZINC OXIDESilexn Technology Co.,Ltd.0fa7105d-ee23-d73a-e063-6394a90a34f02024-01-23WarningsExact identifier
ndc (package): 84020-0001-1
ndc (product): 84020-0001
ndc11 (package): 84020000101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84020-0001-18402000010110000 mg in 1 BOTTLE (84020-0001-1) 10000 mg2024-01-24NoNoCurrent