Softlips Vanilla dimethicone, octinoxate, octisalate, oxybenzone 20 mg/g; 75 mg/g; 30 mg/g; 30 mg/g Ointment
by The Mentholatum Company · 3 TUBE in 1 BLISTER PACK (10742-3051-3) / 2 g in 1 TUBE
NDC 10742-3051-03
🏷️ FDA NDC (as labeled)
10742-3051-3
billing pads the package segment with a zero
This package
Contains2 g in 1 tube
Pack sizes4 compare ↓
OTC
On market
Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
🆔 Identity & classification
FDA NDC (as labeled)
10742-3051-3
Product NDC
10742-3051
11-digit billing NDC
10742305103
UNII
92RU3N3Y1O, 4Y5P7MUD51, 4X49Y0596W, 95OOS7VE0Y
UPC
0310742012187
Application #
M020
SPL Set ID
8dff782f-7201-4ad9-94d2-672058f817b8
Physiologic effect
Skin Barrier Activity
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
1997-11-19
Route
TOPICAL
Dosage form
OINTMENT
Substance
DIMETHICONE; OCTINOXATE; OCTISALATE; OXYBENZONE
Why two NDCs?
The FDA registers this code as 10742-3051-3 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 10742-3051-03. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.
🏭 Manufacturer & labeler
LabelerThe Mentholatum Company
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code10742
First marketedNov 1997
Product typeHuman Otc Drug
Portfolio108 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.
🩺 Clinical
🧪 What is this product?
Softlips Vanilla is a topical lip ointment containing four active ingredients commonly used in sunscreen products. Dimethicone is a silicone that typically functions as a skin protectant and moisturizer. Octinoxate, octisalate, and oxybenzone are UV filters that are commonly used together to help protect skin from ultraviolet radiation. This is an over-the-counter monograph drug, meaning it is marketed under FDA's established category rules for lip protectants and sunscreens.
Patient education
Supplement & herbal interactions
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.
💬 Questions about dimethicone, octinoxate, octisalate, oxybenzone?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
ℹ️
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Softlips Vanilla Watermelon 20 mg/g; 75 mg/g; 30 mg/g; 30 mg/g 10742-8478-01 | The | 3 tubes | — | — | FDA listed | — |
| Softlips Peppermint 20 mg/g; 75 mg/g; 30 mg/g; 30 mg/g 10742-8517-01 | The | 2 cylinders | — | — | FDA listed | — |
| Softlips Peppermint Mocha, Apple Chai Cider, Orange Cranberry 20 mg/g; 75 mg/g; 30 mg/g; 30 mg/g 10742-7010-01 | The | 3 tubes | — | — | FDA listed | — |
| Softlips Vanilla 20 mg/g; 75 mg/g; 30 mg/g; 30 mg/gthis 10742-3051-03 | The | 3 tubes | — | — | FDA listed | — |
| Softlips Raspberry 20 mg/g; 75 mg/g; 30 mg/g; 30 mg/g 10742-8470-01 | The | 1 tube | — | — | FDA listed | — |
| Softlips Cherry 20 mg/g; 75 mg/g; 30 mg/g; 30 mg/g 10742-8512-01 | The | 1 tube | — | — | FDA listed | — |
| Softlips Vanilla, Watermelon, Cherry 20 mg/g; 75 mg/g; 30 mg/g; 30 mg/g 10742-7009-01 | The | 3 tubes | — | — | FDA listed | — |
| Softlips Vanilla Watermelon 20 mg/g; 75 mg/g; 30 mg/g; 30 mg/g 10742-8477-01 | The | 2 tubes | — | — | FDA listed | — |
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.
⏳ Availability & generic status
🏛️
1997
On the market since
Nov 1997
📍
2026
Currently FDA-listed
29 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found
We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 10742-3051-01 | 1 TUBE in 1 BLISTER PACK (10742-3051-1) / 2 g in 1 TUBE | 1997-11-19 | Active |
| 10742-3051-02 | 2 g in 1 TUBE (10742-3051-2) | 1997-11-19 | Active |
| 10742-3051-03 You're viewing this | 3 TUBE in 1 BLISTER PACK (10742-3051-3) / 2 g in 1 TUBE | 2020-03-02 | Active |
| 10742-3051-09 | 2 TUBE in 1 BLISTER PACK (10742-3051-9) / 2 g in 1 TUBE | 1997-11-19 | Active |
Pack size FAQ
What quantity is in NDC 10742-3051-03?
NDC 10742-3051-03 is listed by the FDA — 3 tube in 1 blister pack / 2 g in 1 tube.
What NDC number is used to bill for this package of Softlips Vanilla dimethicone, octinoxate, octisalate, oxybenzone 20 mg/g; 75 mg/g; 30 mg/g; 30 mg/g Ointment?
Bill NDC 10742-3051-03 — the 11-digit billing format is 10742305103. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
🧭 About this NDC listing & data coverage
Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.
Questions about this listing
Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 10742-3051-3, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 10742-3051-03, written without dashes as 10742305103. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 10742-3051-03, the first segment (10742) is the labeler code FDA assigned to The Mentholatum Company; the middle segment (3051) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by The Mentholatum Company. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 1 tube (10742-3051-01), 2 g (10742-3051-02), 2 tubes (10742-3051-09). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
The Mentholatum Company is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
📄 FDA label — Drug Facts FDA SPL
The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage
⏱️ Dosage and Administration
⚠️ Warnings
📦 Storage and Handling
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
🎯 Indications and Usage ▾
Uses helps prevent sunburn temporarily protects chapped or cracked lips
⏱️ Dosage and Administration ▾
Directions apply liberally 15 minutes before sun exposure use a water resistant sunscreen if swimming or sweating reapply at least every 2 hours children under 6 months: ask a doctor
⚠️ Warnings ▾
Warnings Skin Cancer/Skin Aging Alert : Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging. For external use only Do not use on damaged or broken skin When using this product keep out of eyes.
Rinse with water to remove. Stop use and ask a doctor if rash occurs condition worsens symptoms last more than 7 days or clear up and occur again within a few days Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.
📦 Storage and Handling ▾
Other information protect this product from excessive heat and direct sun
🧪 Active Ingredient ▾
Active ingredients Dimethicone 2% Octinoxate 7.5% Octisalate 3% Oxybenzone 3%
🧪 Inactive Ingredients ▾
Inactive ingredients ozokerite, squalane, ethylhexyl palmitate, petrolatum, myristyl myristate, myristyl lactate, cetyl alcohol, myristyl laurate, myristyl alcohol, BHT, flavor, menthol, tocopheryl acetatate [vitamin E]
🎯 Purpose ▾
Purpose Dimethicone - Skin protectant Octinoxate - Sunscreen Octisalate - Sunscreen Oxybenzone - Sunscreen
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published
NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.