Zinc oxide

Product NDC
87879-004
Requested package NDC
87879-004-02
11-digit product format
878790004
Labeler code
87879
Product ID
87879-004_573e257f-236a-e6fc-e063-6294a90af57d
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc oxide
Dosage form
GRANULE
Route
TOPICAL
Labeler
Shaanxi Shuvita Biotech Co., Ltd
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-07-22
Substance
ZINC OXIDE
Active strength
100 kg/100kg
NDC exclude flag
No
Listing certified through
2027-12-31
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
Zinc oxide
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE100 kg/100kg

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
573e262b-7fc9-1188-e063-6394a90afd8fAvailable on FDA.report

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
Zinc oxideZINC OXIDEShaanxi Shuvita Biotech Co., Ltd573e262b-7fc9-1188-e063-6394a90afd8f2026-07-22WarningsExact identifier
ndc (package): 87879-004-02
ndc (product): 87879-004
ndc11 (package): 87879000402

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87879-004-028787900040260 POUCH in 1 POUCH (87879-004-02) / 25 kg in 1 POUCH (87879-004-01) 60 pouch2026-07-22NoNoCurrent