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La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Soothing Therapeutic Multipurpose Dimethicone 10 mg/mL Cream — NDC 49967-0744-01 package photo

La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Soothing Therapeutic Multipurpose Dimethicone 10 mg/mL Cream

by L'Oreal USA Products Inc · 1 TUBE in 1 CARTON (49967-744-01) / 40 mL in 1 TUBE
NDC 49967-0744-01
🏷️ FDA NDC (as labeled) 49967-744-01 billing pads the product segment with a zero
This package
Contains40 mL in 1 tube Pack sizes4 compare ↓
Also comes in: 3 mL 49967-0744-02 1 ml 49967-0744-03 100 mL 49967-0744-04
OTC On market Non-controlled
🗂️ Data synced Sep 17, 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

⚠️
Other active recalls for Dimethicone (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jun 11, 2026 — Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification. (BioMed Laboratories, LLC.) · FDA recall D-0663-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 49967-744-01
Product NDC 49967-744
11-digit billing NDC 49967074401
UNII 92RU3N3Y1O
UPC 3606000437449
Application # M016
SPL Set ID 805cd262-2689-4818-8fed-ddefacbdde23
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 2021-03-15
Route TOPICAL
Dosage form CREAM
Substance DIMETHICONE
Why two NDCs? The FDA registers this code as 49967-744-01 — 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 → 49967-0744-01. 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

LabelerL'Oreal USA Products Inc
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code49967
First marketedMar 2021
Product typeHuman Otc Drug
Portfolio197 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?

This is an over-the-counter topical cream containing dimethicone, a silicone-based ingredient marketed under FDA's monograph rules for skin care products. Dimethicone is commonly used in creams and balms as a skin protectant and to help soften and soothe dry or irritated skin. The product is applied directly to the skin surface and is typically intended for general moisturizing and protective purposes.

Supplement & herbal interactions

Some supplements/herbs that may interact with Dimethicone — tap one for details:

Dimethylsulfoxide (dmso)Moderate Turpentine OilModerate AlchemillaMinor
🌿 Every supplement checked against Dimethicone (3 interactions) — ranked by severity →
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 K71M6R9N7E
    A waxy substance made from glycol and stearic acid. It works as a lubricant and binder to help the medicine hold together and move smoothly through manufacturing equipment.
  • UNII S95658MI3W
    A carbohydrate derived from starch that acts as a binder and filler in tablets and capsules. It helps hold ingredients together and adds bulk to the medicine so it's easier to manufacture and handle.
  • UNII 5QB0T2IUN0
    Aluminum hydroxide is a white powder mineral compound used as an antacid ingredient in some formulations. It works as a buffer and pH regulator to help neutralize stomach acid in the medicine.
  • UNII 3XUS85K0RA
    Butylene glycol is a clear liquid derived from petroleum or plants that acts as a humectant, solvent, and preservative booster in medicines. It helps keep formulations stable, dissolve active ingredients, and maintain moisture in topical products.
  • UNII 8TY5YO42NJ
    Capryloyl glycine is a mild, skin-conditioning ingredient made from a natural fatty acid and the amino acid glycine. In medicines, it acts as a surfactant and preservative booster, helping the product spread evenly and resist contamination.
  • UNII 7M867G6T1U
    Centella asiatica is a plant extract used in medicines as a skin-conditioning or soothing ingredient. It helps maintain product stability and may support skin comfort in topical formulations.
  • UNII V2W71V8T0X
    A silicone-based compound that mixes oil and water together. Used in formulations as an emulsifier to help blend ingredients and improve texture and stability of creams, lotions, and other topical products.
  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII 7D1YQ9Y5EZ
    Hydrogenated polybutene is a thick, wax-like ingredient made by chemically processing petroleum. It acts as a binder and lubricant, helping hold tablet ingredients together and allowing pills to slide smoothly during manufacturing and packaging.
  • UNII 5307V7XW8I
    A beneficial bacterium added to certain medicines and supplements. It acts as a probiotic ingredient, helping maintain or restore healthy gut bacteria balance in formulations designed for digestive wellness.
  • UNII CQ2F5O6YIY
    A natural compound extracted from Centella asiatica plant used as an active skin-conditioning ingredient. It functions as a humectant and skin protectant to improve moisture retention and support skin barrier function in topical formulations.
  • UNII DE08037SAB
    Magnesium sulfate is a mineral salt that acts as an osmotic agent in medications. It draws water into the intestines to soften stool or is used as a filler and processing aid in some solid dosage forms.
  • UNII 7CVR7L4A2D
    A starch-derived carbohydrate produced by breaking down corn, potato, or tapioca starch. It functions as a filler and binder to give the medicine bulk and texture, and sometimes as a mild sweetener or texture enhancer in powders and tablets.
  • UNII 9YY2F980SV
    Manganese gluconate is a mineral compound that combines manganese with gluconic acid. It may be used as a nutritional supplement or processing aid in formulations.
  • UNII PHA4727WTP
    Mannose is a simple sugar derived from natural sources. In medicines, it acts as a filler, binder, and sweetener to help form tablets and improve taste.
  • UNII WV9CM0O67Z
    Panthenol is a humectant and skin-conditioning agent derived from pantothenic acid. It's added to medicines to help retain moisture and soothe skin irritation.
  • UNII 255PIF62MS
    A synthetic antioxidant compound used to prevent oils and fats in medications from breaking down or becoming rancid during storage. It helps maintain the medicine's stability and shelf life.
  • UNII 50C1307PZG
    Pentylene glycol is a humectant and preservative helper derived from petroleum or plant sources. It draws moisture into the product and helps prevent bacterial growth, keeping medicines stable during storage.
  • UNII HIE492ZZ3T
    Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
  • UNII 820DPX33S7
    A synthetic emulsifier derived from glycerin and fatty acids. It helps mix oil and water-based ingredients together and keeps them evenly blended throughout the product.
  • UNII M9S7HX36CT
    A natural plant extract from the polymnia root, used as a humectant and natural sweetening agent. It helps retain moisture in the formulation and may enhance flavor or texture.
  • UNII 5965N8W85T
    Propanediol is a clear liquid organic compound derived from vegetable sources or synthesized chemically. It acts as a humectant to retain moisture, a solvent to dissolve active ingredients, and a preservative booster in liquid medications and supplements.
  • UNII K49155WL9Y
    Shea butter is a fat extracted from shea tree nuts. It's used in medicines as an emollient and lubricant to soften the product, improve texture, and help ingredients blend smoothly together.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • UNII R0ZB2556P8
    Tocopherol is a form of vitamin E derived from plant oils. It acts as an antioxidant in medicines to prevent oils and fats from breaking down and spoiling during storage.
  • UNII 06YD7896S3
    A waxy, fatty substance derived from stearic acid. It acts as a thickener and texture modifier in medicines, helping control how quickly the drug dissolves and improving the product's firmness and consistency.
  • UNII YA22H34H9Q
    A chelating agent derived from sodium and organic compounds. It binds to metal ions in the formulation to improve stability and prevent unwanted chemical reactions that could degrade the medicine.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII U6WSN5SQ1Z
    Zinc gluconate is a form of zinc, a mineral, combined with gluconic acid. It's used as a supplement ingredient to provide zinc content in the formulation.

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

The official label also stateswater, hydrogenated polyisobutene, dimethicone, glycerin, butyrospermum parkii (shea) butter, panthenol, zea mays (corn) starch, propanediol, butylene glycol, cetyl PEG/PPG-10/1 dimethicone, trihydroxystearin, centella asiatica leaf extract, polymnia sonchifolia root juice, zinc gluconate, madecassoside, manganese gluconate, alpha-glucan oligosaccharide, silica, aluminum hydroxide, magnesium sulfate, mannose, capryloyl glycine, vitreoscilla ferment, citric acid, trisodium ethylenediamine disuccinate, lactobacillus, acetylated glycol stearate, maltodextrin, pentylene glycol, polyglyceryl-4 isostearate, tocopherol, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, phenoxyethanol, titanium dioxide

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.
Try another pack size: 3 mL 1 ml 100 mL
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
TheraSeal 1.7 g/170.1g 00187-1660-06 Bausch 1 tube — — FDA listed —
Cetaphil Cracked Skin Repair Balm 10 mg/g 00299-4115-00 Galderma 1 tube — — FDA listed —
Cracked Heel Repair Balm 10 mg/g 20276-0042-00 Delta 1 tube — — FDA listed —
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Soothing Therapeutic Multipurpose 10 mg/mLthis 49967-0744-01 L'Oreal 1 tube — — FDA listed —
CeraVe Developed with Dermatologists Therapeutic Hand 10 mg/g 49967-0925-01 L'Oreal 1 bottle — — Discontinued —
Quad Wash 1 g/100g 67777-0225-02 Dynarex 24 tubes — — FDA listed —
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Therapeutic Multipurpose 10 mg/mL 69625-0743-01 Cosmetique 1 tube — — FDA listed —
Workmans Friend Superior Barrier Skin 1 g/100mL 71810-0101-01 SolvChem, 29.5 ml — — FDA listed —
Tommie Copper Foot 1 g/100g 72562-0222-01 Tommie 28 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

🏛️
2021
On the market since
Mar 2021
📍
2026
Currently FDA-listed
5 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 La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Soothing Therapeutic Multipurpose (this brand).

Top reported reactions

Vomiting56
Diarrhoea52
Abdominal Pain49
Pyrexia48
Nausea47
Pneumonia41
Decreased Appetite35

Age at onset

Child5
Adolescent5
Adult59
Elderly63

Reporter sex

677 reports
Male · 49%
Female · 51%
Unknown · 0%

Serious outcomes

Hospitalization409
Death131
Life-threatening60
Disabling14
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 114 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
49967-0744-01 You're viewing this 1 TUBE in 1 CARTON (49967-744-01) / 40 mL in 1 TUBE 2021-03-15 Active
49967-0744-02 1 TUBE in 1 CARTON (49967-744-02) / 3 mL in 1 TUBE 2021-03-15 Active
49967-0744-03 1 mL in 1 PACKET (49967-744-03) 2021-03-15 Active
49967-0744-04 1 TUBE in 1 CARTON (49967-744-04) / 100 mL in 1 TUBE 2023-01-01 Active

Pack size FAQ

What quantity is in NDC 49967-0744-01?
NDC 49967-0744-01 is listed by the FDA — 1 tube in 1 carton / 40 ml in 1 tube.
What NDC number is used to bill for this package of La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Soothing Therapeutic Multipurpose Dimethicone 10 mg/mL Cream?
Bill NDC 49967-0744-01 — the 11-digit billing format is 49967074401. 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) ✓ 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 49967-744-01, 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: 49967-0744-01, written without dashes as 49967074401. 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 49967-0744-01, the first segment (49967) is the labeler code FDA assigned to L'Oreal USA Products Inc; the middle segment (0744) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 L'Oreal USA Products Inc. 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 (49967-0744-02), 1 ml (49967-0744-03), 1 tube (49967-0744-04). 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?
L'Oreal USA Products 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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 40 words ▾

Uses temporarily protects and helps relieve chafed, chapped or cracked skin helps protect from the drying effects of wind and cold weather helps treat and prevent diaper rash protects chafed skin due to diaper rash and helps seal out wetness

⏱️ Dosage and Administration 45 words ▾

Directions apply as needed For diaper rash: change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry apply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

⚠️ Warnings 6 words ▾

Warnings F or external use only

📦 Storage and Handling 7 words ▾

Other information ● store at room temperature

🧪 Active Ingredient 4 words ▾

Active ingredient Dimethicone 1%

🧪 Inactive Ingredients 69 words ▾

Inactive ingredients water, hydrogenated polyisobutene, dimethicone, glycerin, butyrospermum parkii (shea) butter, panthenol, zea mays (corn) starch, propanediol, butylene glycol, cetyl PEG/PPG-10/1 dimethicone, trihydroxystearin, centella asiatica leaf extract, polymnia sonchifolia root juice, zinc gluconate, madecassoside, manganese gluconate, alpha-glucan oligosaccharide, silica, aluminum hydroxide, magnesium sulfate, mannose, capryloyl glycine, vitreoscilla ferment, citric acid, trisodium ethylenediamine disuccinate, lactobacillus, acetylated glycol stearate, maltodextrin, pentylene glycol, polyglyceryl-4 isostearate, tocopherol, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, phenoxyethanol, titanium dioxide

🎯 Purpose 3 words ▾

Purpose Skin protectant

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 49967-0736-01 · L'Oreal 49967-0754-01 · L'Oreal →
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.