Softlips
- Product NDC
- 10742-8478
- 11-digit product format
- 107428478
- Labeler code
- 10742
- Product ID
- 10742-8478_2979b07a-c0f7-37df-e063-6394a90ae1ff
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- dimethicone, octinoxate, octisalate, oxybenzone
- Dosage form
- STICK
- Route
- TOPICAL
- Labeler
- The Mentholatum Company
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2020-06-01
- Substance
- DIMETHICONE; OCTINOXATE; OCTISALATE; OXYBENZONE
- Active strength
- 20; 75; 30; 30 mg/g; mg/g; mg/g; mg/g
- Pharmacologic classes
- Skin Barrier Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Softlips
- Brand name suffix
- Vanilla Watermelon
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DIMETHICONE | 20 mg/g |
| OCTINOXATE | 75 mg/g |
| OCTISALATE | 30 mg/g |
| OXYBENZONE | 30 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 92RU3N3Y1O, 4Y5P7MUD51, 4X49Y0596W, 95OOS7VE0Y |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 10742-8478-1 | SoftlipsVanilla Watermelon | 3 in 1 BLISTER PACK | STICK | 3 | | 3 |
| 10742-8478-1 | SoftlipsVanilla Watermelon | 2 g in 1 TUBE | STICK | 2 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10742-8478 | SOFTLIPS VANILLA WATERMELON (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) STICK [THE MENTHOLATUM COMPANY] | 3 | Current NDC, Legacy NDC, 2 package rows | 20241219_1fbe85a2-4cd7-45bd-85a2-83bbf75c5f97.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 10742-8478-1 | 10742847801 | 3 TUBE in 1 BLISTER PACK (10742-8478-1) / 2 g in 1 TUBE | 3 tube | 2020-06-01 | 0000-00-00 | No | No | Current |