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TrueLipids Relieve and Protect CL MD White Petrolatum 50 g/100g Ointment, 100 g

by Claridei Laboratories, Inc. · 100 g in 1 TUBE (61387-254-03)
NDC 61387-0254-03
🏷️ FDA NDC (as labeled) 61387-254-03 billing pads the product segment with a zero
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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 61387-254-03
Product NDC 61387-254
11-digit billing NDC 61387025403
RxCUI 1049075
UNII 4T6H12BN9U
UPC 0851714005009
Application # M016
SPL Set ID 27c0af9b-f397-dec3-e063-6394a90aed8b
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2014-03-01
Route TOPICAL
Dosage form OINTMENT
Substance PETROLATUM
Why two NDCs? The FDA registers this code as 61387-254-03 — a 5-3-2 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 product segment → 61387-0254-03. 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

LabelerClaridei Laboratories, Inc.
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code61387
First marketedMar 2014
Product typeHuman Otc Drug
Portfolio3 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?

TrueLipids Relieve and Protect CL MD is a topical ointment containing white petrolatum as its active ingredient. Petrolatum is commonly used in over-the-counter skin care products to help protect and moisturize the skin by forming an occlusive barrier that reduces water loss. This product is marketed as an OTC monograph drug, meaning it follows FDA's established guidelines for this category of skin protectant ointments. The ointment is applied directly to the skin surface.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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.

🧪 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 137SL7IL0Y
    A waxy substance derived from sheep's wool that contains natural sterols. It acts as an emollient and emulsifier, helping blend oil and water-based ingredients together in creams and lotions.
  • UNII WL0328HX19
    A natural plant-based wax derived from candelilla shrub leaves. It acts as a coating agent, hardener, and texture modifier to control how quickly the medicine releases and to improve the tablet or capsule's appearance and stability.
  • UNII 4370DF050B
    Ceramide NP is a waxy, lipid-based substance that mimics natural skin oils. It's used in topical formulations as an emollient and skin-conditioning agent to help soften, smooth, and protect the skin barrier.
  • UNII 4828G836N6
    A plant-derived oil mixture from coconut that acts as an emollient and solvent. It helps dissolve or carry active ingredients and improves how the medicine spreads or absorbs in topical formulations.
  • UNII P540XA09DR
    Enoxolone is a naturally derived compound from licorice root that acts as a skin-soothing and anti-inflammatory agent. In medicines, it helps reduce irritation and supports the healing of mucous membranes or damaged skin.
  • UNII IV0Z586Z4Y
    A synthetic oil derived from isostearic acid, used as an emollient and lubricant in topical formulations to soften the skin and improve the texture and spreadability of creams, lotions, and ointments.
  • UNII C9H2L21V7U
    A fat derived from coconut or palm oil containing shorter fatty acid chains. It serves as a solvent and carrier to help dissolve or suspend active ingredients, improving absorption and stability in liquid formulations.
  • UNII XOF597Q3KY
    A refined form of wax made from petroleum, microcrystalline wax is used in medicines as a coating agent, binder, and hardening ingredient. It helps give tablets and capsules their shape and protective outer layer.
  • UNII I9O0E3H2ZE
    Paraffin is a waxy, petroleum-derived substance used as a coating, lubricant, and hardening agent in tablets and capsules. It helps protect the medicine from moisture and gives pills a smooth finish.
  • UNII GIN46U9Q2Q
    Phytosphingosine is a naturally derived fatty compound that helps stabilize and thicken skincare and cosmetic formulations. It works as an emollient and conditioning agent to improve texture and skin feel in topical products.

10 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesCaprylic/Capric Triglyceride, Coco-Caprylate, Hydrogenated Microcrystalline Wax, Paraffin, Euphorbia Cerifera (Candelilla) Wax, Isostearyl Isostearate, C10-C30 Cholesterol/Lanosterol Esters, Glycyrrhetinic Acid (from Licorice Root), Phytosphingosine, Ceramide NP, Tocopherol.

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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 systemPer gPer 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
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Crash Cream 50 g/100g 61387-0251-01 Claridei 50 g — — FDA listed —
TrueLipids Boo-Boo and Bum Balm CL MD 50 g/100g 61387-0253-01 Claridei 50 g — — FDA listed —
TrueLipids Relieve and Protect CL MD 50 g/100gthis 61387-0254-03 Claridei 100 g — — 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

🏛️
2014
On the market since
Mar 2014
📍
2026
Currently FDA-listed
12 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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for TrueLipids Relieve and Protect CL MD (this brand).

Top reported reactions

Pyrexia49
Diarrhoea39
Febrile Neutropenia31
Pneumonia29
Anaemia28
Nausea25
Platelet Count Decreased25

Age at onset

Infant1
Child4
Adolescent3
Adult32
Elderly51

Reporter sex

503 reports
Male · 57%
Female · 43%
Unknown · 0%

Serious outcomes

Hospitalization355
Death114
Life-threatening71
Disabling19
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 59 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
61387-0254-03 You're viewing this 100 g in 1 TUBE (61387-254-03) 2014-03-01 Active

🧭 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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) ✓ 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 61387-254-03, 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: 61387-0254-03, written without dashes as 61387025403. 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 61387-0254-03, the first segment (61387) is the labeler code FDA assigned to Claridei Laboratories, Inc.; the middle segment (0254) 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 Claridei Laboratories, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Claridei Laboratories, Inc. 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 27 words ▾

Uses Stop use and ask a doctor if: condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days

⏱️ Dosage and Administration 19 words ▾

Directions ​ apply generously to affected areas as needed. For best results, use right after a shower or bath

⚠️ Warnings 25 words ▾

Warnings For external use only When using this product avoid contact with eyes Do not use on: deep or puncture wounds animal bites serious burns

🧪 Active Ingredient 9 words ▾

Active Ingredient Purpose White Petrolatum, USP (50%) Skin Protectant

🧪 Inactive Ingredients 27 words ▾

Inactive Ingredients Caprylic/Capric Triglyceride, Coco-Caprylate, Hydrogenated Microcrystalline Wax, Paraffin, Euphorbia Cerifera (Candelilla) Wax, Isostearyl Isostearate, C10-C30 Cholesterol/Lanosterol Esters, Glycyrrhetinic Acid (from Licorice Root), Phytosphingosine, Ceramide NP, Tocopherol.

🎯 Purpose 32 words ▾

Uses helps relieve, prevent and temporarily protects chafed, chapped, cracked or windburned skin and lips temporarily protects minor: cuts scrapes burns helps protect from the drying effects of wind and cold weather

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 61387-0253-01 · Claridei 61387-0255-02 · Claridei →
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.