burn gel
- Product NDC
- 82953-045
- 11-digit product format
- 829530045
- Labeler code
- 82953
- Product ID
- 82953-045_3227b643-a99e-6716-e063-6294a90a73b7
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- melaleuca alternifolia (tea tree) leaf oil
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Cosmuses Cosmetics (Ningbo) Co., Ltd.
- Application
- M004
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-04-06
- Substance
- MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL
- Active strength
- 1 g/100g
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- burn gel
- Brand name suffix
- 01
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL | 1 g/100g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | VIF565UC2G |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82953-045-01 | burn gel01 | 0.85 g in 1 POUCH | GEL | 0.85 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82953-045 | BURN GEL 01 (MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL) GEL [COSMUSES COSMETICS (NINGBO) CO., LTD.] | 1 | Current NDC, 1 package rows | 20250408_3227bdc9-9323-68eb-e063-6294a90a29d2.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 82953-045-01 | 82953004501 | .85 g in 1 POUCH (82953-045-01) | 2025-04-06 | No | No | Historical |