Cream
- Product NDC
- 61354-115
- 11-digit product format
- 613540115
- Labeler code
- 61354
- Product ID
- 61354-115_08a1e862-b55b-fb84-e063-6294a90a016a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Zinc Oxide
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Oxygen Development LLC
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-10-26
- Substance
- ZINC OXIDE
- Active strength
- 21.76 mg/100mg
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- 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.
Brand, Generic, Manufacturer table| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|
| Cream | ZINC OXIDE | Oxygen Development LLC | 08a1e862-b55a-fb84-e063-6294a90a016a | 2023-10-26 | Warnings | Exact identifier |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings
Warnings For external use only.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cream
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ZINC OXIDE | 21.76 mg/100mg |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | SOI2LOH54Z |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 61354-115-01 | Cream | 100 mg in 1 TUBE | CREAM | 100 | | 1 |
| 61354-115-02 | Cream | 1 in 1 CARTON | CREAM | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61354-115 | CREAM (ZINC OXIDE) CREAM [OXYGEN DEVELOPMENT LLC] | 1 | Current NDC, 2 package rows | 20231030_08a1e862-b55a-fb84-e063-6294a90a016a.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 61354-115-01 | 61354011501 | 100 mg in 1 TUBE | 100 mg | | | | Historical |
| 61354-115-02 | 61354011502 | 1 TUBE in 1 CARTON (61354-115-02) / 100 mg in 1 TUBE (61354-115-01) | 1 tube | 2023-10-26 | No | No | Current |