Softlips
- Product NDC
- 10742-3051
- 11-digit product format
- 107423051
- Labeler code
- 10742
- Product ID
- 10742-3051_43fde22f-2a7f-7b72-e063-6294a90a3254
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- dimethicone, octinoxate, octisalate, oxybenzone
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- The Mentholatum Company
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 1997-11-19
- 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
- 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 |
|---|
| 10742-3051-1 | SoftlipsVanilla | 2 g in 1 TUBE | OINTMENT | 2 | | 8 |
| 10742-3051-1 | SoftlipsVanilla | 1 in 1 BLISTER PACK | OINTMENT | 1 | | 8 |
| 10742-3051-2 | SoftlipsVanilla | 2 g in 1 TUBE | OINTMENT | 2 | | 8 |
| 10742-3051-3 | SoftlipsVanilla | 3 in 1 BLISTER PACK | OINTMENT | 3 | | 8 |
| 10742-3051-3 | SoftlipsVanilla | 2 g in 1 TUBE | OINTMENT | 2 | | 8 |
| 10742-3051-9 | SoftlipsVanilla | 2 g in 1 TUBE | OINTMENT | 2 | | 8 |
| 10742-3051-9 | SoftlipsVanilla | 2 in 1 BLISTER PACK | OINTMENT | 2 | | 8 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DIMETHICONE | ACTIVE INGREDIENT | 92RU3N3Y1O | SOFTLIPS VANILLA (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) OINTMENT [THE MENTHOLATUM COMPANY] | 3 | |
| OCTINOXATE | ACTIVE INGREDIENT | 4Y5P7MUD51 | SOFTLIPS VANILLA (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) OINTMENT [THE MENTHOLATUM COMPANY] | 3 | |
| OCTISALATE | ACTIVE INGREDIENT | 4X49Y0596W | SOFTLIPS VANILLA (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) OINTMENT [THE MENTHOLATUM COMPANY] | 3 | |
| OXYBENZONE | ACTIVE INGREDIENT | 95OOS7VE0Y | SOFTLIPS VANILLA (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) OINTMENT [THE MENTHOLATUM COMPANY] | 3 | |
| DIMETHICONE | ACTIVE MOIETY | 92RU3N3Y1O | SOFTLIPS VANILLA (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) OINTMENT [THE MENTHOLATUM COMPANY] | 3 | |
| OCTINOXATE | ACTIVE MOIETY | 4Y5P7MUD51 | SOFTLIPS VANILLA (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) OINTMENT [THE MENTHOLATUM COMPANY] | 3 | |
| OCTISALATE | ACTIVE MOIETY | 4X49Y0596W | SOFTLIPS VANILLA (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) OINTMENT [THE MENTHOLATUM COMPANY] | 3 | |
| OXYBENZONE | ACTIVE MOIETY | 95OOS7VE0Y | SOFTLIPS VANILLA (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) OINTMENT [THE MENTHOLATUM COMPANY] | 3 | |
| .ALPHA.-TOCOPHEROL | INACTIVE INGREDIENT | H4N855PNZ1 | SOFTLIPS VANILLA (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) OINTMENT [THE MENTHOLATUM COMPANY] | 3 | |
| BUTYLATED HYDROXYTOLUENE | INACTIVE INGREDIENT | 1P9D0Z171K | SOFTLIPS VANILLA (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) OINTMENT [THE MENTHOLATUM COMPANY] | 3 | |
| CERESIN | INACTIVE INGREDIENT | Q1LS2UJO3A | SOFTLIPS VANILLA (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) OINTMENT [THE MENTHOLATUM COMPANY] | 3 | |
| CETYL ALCOHOL | INACTIVE INGREDIENT | 936JST6JCN | SOFTLIPS VANILLA (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) OINTMENT [THE MENTHOLATUM COMPANY] | 3 | |
| ETHYLHEXYL PALMITATE | INACTIVE INGREDIENT | 2865993309 | SOFTLIPS VANILLA (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) OINTMENT [THE MENTHOLATUM COMPANY] | 3 | |
| MENTHOL | INACTIVE INGREDIENT | L7T10EIP3A | SOFTLIPS VANILLA (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) OINTMENT [THE MENTHOLATUM COMPANY] | 3 | |
| MYRISTYL ALCOHOL | INACTIVE INGREDIENT | V42034O9PU | SOFTLIPS VANILLA (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) OINTMENT [THE MENTHOLATUM COMPANY] | 3 | |
| MYRISTYL LACTATE | INACTIVE INGREDIENT | 1D822OC34X | SOFTLIPS VANILLA (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) OINTMENT [THE MENTHOLATUM COMPANY] | 3 | |
| MYRISTYL LAURATE | INACTIVE INGREDIENT | 58U0NZN2BT | SOFTLIPS VANILLA (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) OINTMENT [THE MENTHOLATUM COMPANY] | 3 | |
| MYRISTYL MYRISTATE | INACTIVE INGREDIENT | 4042ZC00DY | SOFTLIPS VANILLA (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) OINTMENT [THE MENTHOLATUM COMPANY] | 3 | |
| PETROLATUM | INACTIVE INGREDIENT | 4T6H12BN9U | SOFTLIPS VANILLA (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) OINTMENT [THE MENTHOLATUM COMPANY] | 3 | |
| SQUALANE | INACTIVE INGREDIENT | GW89575KF9 | SOFTLIPS VANILLA (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) OINTMENT [THE MENTHOLATUM COMPANY] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10742-3051 | SOFTLIPS VANILLA (DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE) OINTMENT [THE MENTHOLATUM COMPANY] | 7 | Current NDC, Legacy NDC, 7 package rows | 20241215_8dff782f-7201-4ad9-94d2-672058f817b8.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 10742-3051-1 | 10742305101 | 1 TUBE in 1 BLISTER PACK (10742-3051-1) / 2 g in 1 TUBE | 1 tube | 1997-11-19 | 0000-00-00 | No | No | Current |
| 10742-3051-2 | 10742305102 | 2 g in 1 TUBE (10742-3051-2) | 2 g | 1997-11-19 | 0000-00-00 | No | No | Current |
| 10742-3051-3 | 10742305103 | 3 TUBE in 1 BLISTER PACK (10742-3051-3) / 2 g in 1 TUBE | 3 tube | 2020-03-02 | 0000-00-00 | No | No | Current |
| 10742-3051-9 | 10742305109 | 2 TUBE in 1 BLISTER PACK (10742-3051-9) / 2 g in 1 TUBE | 2 tube | 1997-11-19 | 0000-00-00 | No | No | Current |