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
Listing certified through
2027-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleStatus
87879-004-028787900040260 POUCH in 1 POUCH (87879-004-02) / 25 kg in 1 POUCH (87879-004-01)60 pouch2026-07-220Current