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First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant Cranberry Pomegranate Colloidal Oatmeal .5 g/100g Cream, 396.8 g — NDC 69423-0565-39 package photo

First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant Cranberry Pomegranate Colloidal Oatmeal .5 g/100g Cream, 396.8 g

by The Procter & Gamble Manufacturing Company · 396.8 g in 1 JAR (69423-565-39)
NDC 69423-0565-39
🏷️ FDA NDC (as labeled) 69423-565-39 billing pads the product segment with a zero
This package
Contains396.8 g Pack sizes2 compare ↓
Also comes in: 56 g 69423-0565-56
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) 69423-565-39
Product NDC 69423-565
11-digit billing NDC 69423056539
RxCUI 1654149
UNII 8PI54V663Y
UPC 0815517025459
Application # M016
SPL Set ID f4464fb2-ba25-16f2-e053-2a95a90a0406
Established class (EPC) Non-Standardized Food Allergenic Extract; Non-Standardized Plant Allergenic Extract
Physiologic effect Increased Histamine Release; Cell-mediated Immunity
Chemical class Allergens; Dietary Proteins; Plant Proteins
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-01-01
Route TOPICAL
Dosage form CREAM
Substance OATMEAL
Why two NDCs? The FDA registers this code as 69423-565-39 — 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 → 69423-0565-39. 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.

🏷️ RxNorm drug class

This medicine belongs to the Non-Standardized Food Allergenic Extract class.

Pharmacologic class Non-Standardized Food Allergenic Extract, Non-Standardized Plant Allergenic Extract
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerThe Procter & Gamble Manufacturing Company
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code69423
First marketedJan 2023
Product typeHuman Otc Drug
Portfolio846 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?

First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant is a topical cream marketed as an over-the-counter monograph drug. The active ingredient is colloidal oatmeal, which is typically used in skin care products to soothe and protect irritated or sensitive skin. This product is intended to be applied directly to the skin surface as a moisturizer and skin protectant.

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 A9EJ3J61HQ
    A synthetic liquid derived from benzoic acid and long-chain alcohols. It functions as a solvent and penetration enhancer in topical formulations, helping active ingredients dissolve and absorb into the skin.
  • UNII 344S277G0Z
    Allantoin is a naturally derived compound that helps soften and soothe skin. In medicines, it works as a skin-conditioning agent and may help support wound healing and reduce irritation in topical formulations.
  • UNII 21C2F5E8RE
    Anise is a plant-derived flavoring from anise seeds with a licorice-like taste. It is added to medicines to improve flavor and make the product more pleasant to take.
  • UNII B423VGH5S9
    A natural fruit ingredient derived from apples, used as a flavoring agent and sweetener to improve taste and palatability of the medicine.
  • UNII 00YIU5438U
    Caprylyl glycol is a clear liquid derived from coconut oil. In medicines, it acts as a humectant to retain moisture, a preservative booster to prevent microbial growth, and a solvent to help dissolve or mix other ingredients.
  • 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 2DMT128M1S
    A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
  • UNII D9108TZ9KG
    Cocoa is a natural powder made from roasted cacao beans. It's used as a flavoring and coloring agent to make medicines taste better and appear brown.
  • UNII 0MVO31Q3QS
    A fruit extract from cranberries used as a natural flavor and coloring agent in medicines. It may also provide antioxidant properties to help preserve the product's stability.
  • UNII 73KDS3BW5E
    A plant oil extracted from cranberry seeds, used in medications as an emollient and emulsifier. It helps blend oil and water-based ingredients together and keeps the product's texture smooth and stable.
  • UNII 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • UNII MP1J8420LU
    A salt derived from edetic acid that binds to trace metals in medicines. It serves as a chelating agent and preservative to prevent metal-catalyzed breakdown of the drug and extend shelf life.
  • 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 230OU9XXE4
    A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
  • UNII FCZ5MH785I
    A waxy substance made from glycerin and stearic acid. It works as an emulsifier to help mix oil and water ingredients together, and as a thickener to give the medicine its proper texture and consistency.
  • UNII 2788Z9758H
    A plant extract from licorice root used as a sweetener, flavoring agent, and natural emulsifier in medicines. It helps improve taste and may aid in keeping ingredients evenly mixed throughout the product.
  • UNII 3582N05Q44
    Grapefruit peel is a plant-derived material from citrus fruit used as a flavoring and coloring agent in medicines. It adds taste and natural color to make the medication more appealing.
  • UNII W2ZU1RY8B0
    A plant extract from green tea leaves. It's used as an antioxidant ingredient to help preserve the medicine and maintain its stability during storage.
  • UNII 72O054U628
    Lemon peel is a natural plant material from citrus fruit used as a flavoring agent and colorant in medicines. It adds tartness and a pale yellow tint to make the medication more pleasant to taste and look at.
  • 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 A389O33LX6
    A plant extract from peppermint leaves used as a flavoring agent to improve taste. It may also provide a cooling or soothing sensory effect in the medicine.
  • UNII ZV095H5633
    A natural flavoring derived from muskmelon fruit. It is used in medicines to add pleasant taste and aroma, making the product more acceptable to take.
  • UNII SF206I8G4P
    A plant extract from passion fruit used in medicines as a natural flavoring agent and to add mild taste appeal to oral formulations.
  • 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 2A88ZO081O
    Pineapple is a tropical fruit extract used as a natural flavoring and coloring agent in medicines. It adds taste and appearance appeal to oral tablets and liquid formulations.
  • UNII 7294Z34NS7
    A plant-derived ingredient from pomegranate fruit seeds. It may serve as a natural colorant, flavoring agent, or antioxidant in the formulation to enhance the product's appearance, taste, or stability.
  • UNII 4N14V5R27W
    A natural flavoring derived from raspberry fruit that gives medicines a pleasant taste. It helps mask bitter or unpleasant flavors to make medications easier to swallow.
  • UNII JWB78P295A
    A plant extract from damask rose flowers used as a natural fragrance, flavoring agent, or coloring component in medicines. It adds pleasant aroma or taste to the product.
  • 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 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII GW89575KF9
    Squalane is a lightweight oil derived from plant sources or synthesized. It acts as an emollient and lubricant in formulations, helping ingredients blend smoothly and improving product texture and spreadability.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • UNII 6GE7Z0761K
    A plant-derived ingredient from feverfew used as a natural flavoring or botanical additive in some formulations. It may contribute mild taste or aroma properties to the medicine.
  • UNII 8Z96QXD6UM
    Triethyl citrate is a clear liquid derived from citric acid. It acts as a plasticizer and solvent in tablet coatings and film formulations, helping the coating remain flexible and adhere properly to the medicine.
  • UNII Q1S51LGQ0G
    A natural essential oil from eastern hemlock tree leaves. It functions as a fragrance, flavoring agent, or preservative in medications to improve taste, aroma, or shelf stability.
  • UNII Q74T35078H
    Vanilla is a flavoring ingredient extracted from vanilla orchid beans. It's added to medicines to improve taste and make them more pleasant to take, especially for children or patients who need liquid formulations.
  • 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 TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

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

The official label also statesWater, stearic acid, glycerin, c12-15 alkyl benzoate, caprylic/capric triglyceride, glyceryl stearate, glyceryl stearate SE, cetearyl alcohol, butyrospermum parkii (shea) butter, dimethicone, squalene, phenoxyethanol, caprylyl glycol. xanthan gum, allantoin, sodium hydroxide, tetrasodium EDTA, chrysanthemum parthenium (feverfew) extract, triethyl citrate, camellia sinensis leaf extract, glycyrrhiza glabra (licorice) root extract, cinnamomum camphora linalooliferum wood extract, citrus limon (lemon) peel extract, punica granatum seed extract, rubus idaeus (raspberry) fruit extract, vaccinium macrocarpon (cranberry) seed oil, ceramide NP, ananas sativus (pineapple) fruit extract, citrus paradisi (grapefruit) peel extract, cucumis melo (melon) fruit extract, passiflora incarnata fruit extract, pimpinella anisum (anise) fruit extract, pyrus malus (apple) fruit extract, rosa damascene flower extract, Theobroma cacao (cocoa) extract, tsuga canadensis oil, vaccinium macrocarpon (cranberry) fruit extract, vanilla planifolia fruit extract

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: 56 g
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
First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant .5 g/100g 10637-1901-01 Port 28.3 g — — FDA listed —
First Aid Beauty FAB Ultra Repair Skin Protectant .5 g/100g 69423-0556-11 The 113.4 g — — Discontinued —
First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant Vanilla .5 g/100g 69423-0563-39 The 396.8 g — — FDA listed —
First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant White Tea and Apricot .5 g/100g 69423-0564-39 The 396.8 g — — FDA listed —
First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant Cranberry Pomegranate .5 g/100gthis 69423-0565-39 The 396.8 g — — FDA listed —
First Aid Beauty FAB Ultra Repair Skin Protectant Pink Grapefruit .5 g/100g 69423-0567-34 The 340.2 g — — FDA listed —
Olay Sensitive Soothing Moisturizer Skin Protectant Fragrance-Free .5 g/100g 69423-0700-15 The 1 jar — — FDA listed —
First Aid Beauty FAB Ultra Repair Skin Protectant Vanilla Cookie .5 g/100g 69423-0708-56 The 56.7 g — — FDA listed —
Atopis Eczema Therapy Cream .5 g/100g 71570-0001-01 Bionona 1 bottle — — FDA listed —
First Aid Beauty FAB Ultra Repair Skin Protectant Birthday Hydration .5 g/100g 84126-0043-56 The 56.7 g — — FDA listed —
First Aid Beauty FAB Ultra Repair Skin Protectant Winter Mint .5 g/100g 84126-0044-56 The 56.7 g — — FDA listed —
First Aid Beauty FAB Ultra Repair Skin Protectant Peppermint Twist .5 g/100g 84126-0046-01 The 2 jars — — FDA listed —
First Aid Beauty FAB Ultra Repair Skin Protectant Vanilla Latte .5 g/100g 84126-0047-56 The 56.7 g — — FDA listed —
First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant Vanilla Cinnamon .5 g/100g 84126-0048-01 The 2 jars — — FDA listed —
First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant Winter Citrus .5 g/100g 84126-0049-01 The 2 jars — — FDA listed —
First Aid Beauty FAB Ultra Repair Skin Protectant Candy Cane .5 g/100g 84126-0100-56 The 56.7 g — — FDA listed —
First Aid Beauty FAB Ultra Repair Cream Intense Hydration Skin Protectant Cucumber Melon .5 g/100g 84126-0102-39 The 396.8 g — — FDA listed —
First Aid Beauty FAB Ultra Repair Cream Intense Hydration Skin Protectant Juicy Peach .5 g/100g 84126-0104-39 The 396.8 g — — FDA listed —
First Aid Beauty FAB Ultra Repair Cream Intense Hydration Skin Protectant Fresh Strawberry .5 g/100g 84126-0105-39 The 396.8 g — — FDA listed —
First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant .5 g/100g 84126-0203-11 The 113 g — — FDA listed —
First Aid Beauty FAB Ultra Repair Skin Protectant Sparkling Grapefruit .5 g/100g 84126-0210-39 The 396.8 g — — FDA listed —
First Aid Beauty FAB Ultra Repair Skin Protectant Sugar Cookie .5 g/100g 84126-0211-39 The 396.8 g — — FDA listed —
First Aid Beauty FAB Ultra Repair Skin Protectant Chai Cinnamon .5 g/100g 84126-0212-39 The 396.8 g — — FDA listed —
First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant Warm Vanilla .5 g/100g 84126-0213-34 The 340.2 g — — FDA listed —
First Aid Beauty Dry Skin Rescue Kit 84126-0220-01 The 1 kit — — FDA listed —
Pink Eczema Cream .5 g/100g 87043-0012-02 MOOGOO 100 g — — FDA listed —
First Aid Beauty FAB Ultra Repair Body Skin Protectant .5 g/100g 69423-0726-28 The 283.5 g — — FDA listed —
First Aid Beauty FAB Ultra Repair Body Skin Protectant Cooling Cucumber .5 g/100g 69423-0727-28 The 283.5 g — — FDA listed —
First Aid Beauty FAB Ultra Repair Skin Protectant Toasted Coconut .5 g/100g 84126-0284-39 The 396.8 g — — FDA listed —
First Aid Beauty FAB Ultra Repair Skin Protectant Frosted Grapefruit .5 g/100g 84126-0282-39 The 396.8 g — — FDA listed —
First Aid Beauty FAB Ultra Repair Skin Protectant Summer Grapefruit .5 g/100g 84126-0281-39 The 396.8 g — — FDA listed —
First Aid Beauty FAB Ultra Repair Cream Skin Protectant Velvet Plum .5 g/100g 84126-0283-39 The 396.8 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

🏛️
2023
On the market since
Jan 2023
📍
2026
Currently FDA-listed
3 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 First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant Cranberry Pomegranate (this brand).

Top reported reactions

Rash2
Anaemia1
Aplastic Anaemia1
Asthenia1
Bile Duct Stenosis1
Cholangiocarcinoma1
Death1

Age at onset

Adult2

Reporter sex

11 reports
Male · 50%
Female · 50%

Serious outcomes

Hospitalization3
Life-threatening1
Death1
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 2 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
69423-0565-39 You're viewing this 396.8 g in 1 JAR (69423-565-39) 2023-01-01 Active
69423-0565-56 56 g in 1 TUBE (69423-565-56) 2023-01-01 Active

Pack size FAQ

What quantity is in NDC 69423-0565-39?
NDC 69423-0565-39 contains 396.8 g — 396.8 g in 1 jar.
What is the difference between NDC 69423-0565-39 and NDC 69423-0565-56?
Both are First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant Cranberry Pomegranate Colloidal Oatmeal .5 g/100g Cream — the drug itself is identical. NDC 69423-0565-39 is the 396.8 g package, while NDC 69423-0565-56 is the 56 g package.
What NDC number is used to bill for this package of First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant Cranberry Pomegranate Colloidal Oatmeal .5 g/100g Cream?
Bill NDC 69423-0565-39 — the 11-digit billing format is 69423056539. 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 69423-565-39, 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: 69423-0565-39, written without dashes as 69423056539. 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 69423-0565-39, the first segment (69423) is the labeler code FDA assigned to The Procter & Gamble Manufacturing Company; the middle segment (0565) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (39) 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 Procter & Gamble Manufacturing 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 1 other package presentation of this same product, including 56 g (69423-0565-56). 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 Procter & Gamble Manufacturing 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 22 words ▾

Uses Temporarily protects and helps relieve minor skin irritation and itching due to eczema, rashes, poison ivy, oak or sumac, insect bites

⏱️ Dosage and Administration 4 words ▾

Directions Apply as needed

⚠️ Warnings 54 words ▾

Warnings For external use only. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Do not get into eyes. Stop use and ask a doctor if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days

🧪 Active Ingredient 5 words ▾

Active ingredients Colloidal Oatmeal 0.5%

🧪 Inactive Ingredients 122 words ▾

Water, stearic acid, glycerin, c12-15 alkyl benzoate, caprylic/capric triglyceride, glyceryl stearate, glyceryl stearate SE, cetearyl alcohol, butyrospermum parkii (shea) butter, dimethicone, squalene, phenoxyethanol, caprylyl glycol. xanthan gum, allantoin, sodium hydroxide, tetrasodium EDTA, chrysanthemum parthenium (feverfew) extract, triethyl citrate, camellia sinensis leaf extract, glycyrrhiza glabra (licorice) root extract, cinnamomum camphora linalooliferum wood extract, citrus limon (lemon) peel extract, punica granatum seed extract, rubus idaeus (raspberry) fruit extract, vaccinium macrocarpon (cranberry) seed oil, ceramide NP, ananas sativus (pineapple) fruit extract, citrus paradisi (grapefruit) peel extract, cucumis melo (melon) fruit extract, passiflora incarnata fruit extract, pimpinella anisum (anise) fruit extract, pyrus malus (apple) fruit extract, rosa damascene flower extract, Theobroma cacao (cocoa) extract, tsuga canadensis oil, vaccinium macrocarpon (cranberry) fruit extract, vanilla planifolia fruit extract

🎯 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 ↗
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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.