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Skin Mercy Intense Recovery Cream colloidal oatmeal 1 g/100mL Cream — NDC 80921-0001-50 package photo

Skin Mercy Intense Recovery Cream colloidal oatmeal 1 g/100mL Cream

by Cultskin Apothecary, Inc. · 1 TUBE in 1 CARTON (80921-001-50) / 50 mL in 1 TUBE
NDC 80921-0001-50
🏷️ FDA NDC (as labeled) 80921-001-50 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) 80921-001-50
Product NDC 80921-001
11-digit billing NDC 80921000150
RxCUI 240651
UNII 8PI54V663Y
Application # M016
SPL Set ID 468f21c6-2d6f-1654-e063-6394a90ab2f5
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 2026-01-02
Marketing end 2027-04-01
Route TOPICAL
Dosage form CREAM
Substance OATMEAL
Why two NDCs? The FDA registers this code as 80921-001-50 — 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 → 80921-0001-50. 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

LabelerCultskin Apothecary, Inc.
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code80921
First marketedJan 2026
Product typeHuman Otc Drug
Portfolio2 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?

Skin Mercy Intense Recovery Cream is a topical cream containing colloidal oatmeal, marketed as an over-the-counter skin protectant under FDA's OTC monograph rules. Oatmeal in this form is typically used to help soothe and protect irritated or dry skin. This product is applied directly to the skin surface and is commonly found in moisturizing and skin-care preparations intended for general skin comfort.

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 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 24WE03BX2T
    Levomenol is a naturally derived alcohol compound used as a skin-conditioning and anti-inflammatory agent in topical formulations. It helps soothe and protect the skin while improving product texture and absorption.
  • UNII 114P5I43UJ
    A hydrocarbon oil derived from petroleum, containing 13 to 15 carbon atoms per molecule. It serves as a lubricant and glidant in tablets and capsules to reduce friction during manufacturing and improve powder flow.
  • UNII 7J5R5W72QM
    C9-12 alkane is a clear, colorless liquid hydrocarbon mixture derived from petroleum. In medicines, it serves as a solvent, lubricant, or component in liquid formulations to help dissolve or suspend active ingredients.
  • 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 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 GSA2TXZ34G
    A synthetic polymer made from castor oil and a chemical linker, used as a coating or binder in medications to control how and when the active ingredient is released in the body.
  • 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 58B69Q84JO
    A plant-derived emulsifier made from olive oil and fatty alcohols. It helps blend oil and water ingredients together and stabilizes the product's texture in creams, lotions, and similar formulations.
  • UNII 8D9H4QU99H
    A synthetic fatty acid ester derived from coconut oil, used as an emulsifier and solubilizer to help mix oil and water-based ingredients and improve how the body absorbs certain drugs.
  • UNII 1F2S8T535O
    A synthetic polymer made from fatty acids and a chemical compound that binds ingredients together. It works as a binder and film-former in solid dosage forms, helping hold tablets together and coat their surface.
  • 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 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 BKJ0J3D1BP
    A plant-derived ingredient from sunflower flowers, used as a natural colorant and flavoring agent in medicines. It may help provide color or mild taste to the product.
  • UNII 9KJL21T0QJ
    Linoleic acid is an omega-6 fatty acid derived from plant oils. It serves as an emulsifier and skin conditioning agent in topical formulations, helping ingredients mix smoothly and improving product texture.
  • UNII 3HH93SL2H9
    A plant-derived oil made from meadowfoam seeds. It acts as an emollient and lubricant in medicines, helping soften formulations and improve how ingredients mix together.
  • UNII 412ZHA4T4Y
    A plant-derived oil extracted from meadowfoam seeds. It acts as an emollient and skin-conditioning agent, helping soften and smooth the product texture while improving how it spreads on skin.
  • UNII N8F53B3R4R
    A synthetic humectant and solvent derived from propane. It draws and holds moisture in the formulation, helping keep the medicine stable and improving texture or flow in liquid and semi-solid products.
  • UNII R60QEP13IC
    Rice bran is a natural powder made from the outer layer of rice grains. It's used in medicines as a filler and flow agent to add bulk and help the product mix and flow smoothly during manufacturing.
  • 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 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 IJ67X351P9
    A natural plant extract from rosemary leaves used as a preservative to help prevent oils and fats in the medicine from spoiling or becoming rancid during storage.
  • UNII 129R0X862G
    A plant-derived fat extracted from Shorea stenoptera seeds, used as an emollient and lubricant in topical formulations to soften the skin and improve product spreadability and texture.
  • UNII 88496G1ERL
    Sodium phytate is a plant-derived salt used in medications as a chelating agent and preservative. It helps stabilize formulations and may improve how the body absorbs certain minerals in the medicine.
  • UNII 05I15JNI2J
    A synthetic polymer that absorbs and holds moisture. Used in tablets and capsules as a super-disintegrant to help the medicine break apart quickly when swallowed, allowing faster drug release.
  • UNII MDL271E3GR
    Sorbitan olivate is an emulsifier derived from sorbitol and olive oil. It helps blend water and oil ingredients together to maintain consistent texture and appearance throughout the medicine.
  • 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 3YYE6VJS0P
    A compound derived from licorice root extract combined with stearyl alcohol. It acts as an emollient and skin-conditioning agent that helps soften and smooth the product's texture while providing a protective barrier on the skin or mucous membranes.
  • UNII RQ58K8571Z
    A plant extract from Tasmanian pepper berry used as a flavoring agent to add taste and aroma to the medicine.
  • 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 2P6O7CFW5K
    Triheptanoin is a synthetic fat made from glycerol and seven-carbon fatty acids. It's used as a caloric supplement and carrier in certain formulations to deliver active ingredients and provide nutritional support.
  • 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.

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

The official label also statesWater, Glycerin, Squalane, Caprylic/Capric Triglyceride, Limnanthes Alba (Meadowfoam) Seed Oil, C13-15 Alkane, Cetearyl Olivate, Sorbitan Olivate, Cetearyl Alcohol, Shorea Stenoptera Seed Butter, Meadowfoam Estolide, Dimethicone, Coco-Caprylate/Caprate, Methylpropanediol, Allantoin, Panthenol, Triheptanoin, Linoleic Acid, Phytosterols, Phospholipids, Oryza Sativa (Rice) Bran Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Helianthus Annuus (Sunflower) Extract, Tocopherol, Phenoxyethanol, Caprylyl Glycol, Sodium Polyacrylate, C9-12 Alkane, Dilinoleic Acid/Butanediol Copolymer, Bisabolol, Stearyl Glycyrrhetinate, Sodium Phytate, Tasmannia Lanceolata Fruit/Leaf Extract, Castor Oil/IPDI Copolymer

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
Baby Eczema Therapy 10 mg/g 00363-0986-28 Walgreen 141 g — — Discontinued —
Walgreens Eczema Relief Body Skin Protectant 10 mg/g 00363-8395-01 Walgreen 226 g — — FDA listed —
Eucerin Eczema Relief Body 1 g/100g 10356-0365-02 Beiersdorf 7 g — — FDA listed —
Eucerin Eczema Relief Flare Up Treatment 1 g/100g 10356-0371-07 Beiersdorf 57 g — — FDA listed —
Eczema Soothing Moisturizing Cream 10 mg/g 11344-0965-98 Nice-Pak 207 g — — FDA listed —
SOOTHE Moisturizing Rescue Cream .01 g/mL 14222-2430-01 Rodan 1 tube — — FDA listed —
Colloidal oatmeal 10 mg/g 37808-0128-28 H 141 g — — FDA listed —
CeraVe Developed With Dermatologist Baby Eczema Relief Cream 10 mg/mL 49967-0536-01 L'Oreal 148 ml — — FDA listed —
KIEHLS SINCE 1851 Ultra Facial Meltdown Recovery 10 mg/mL 49967-0571-01 LOreal 1 tube — — FDA listed —
La Roche Posay Laboratoire Dermatologique Lipikar Eczema Soothing Relief 10 mg/mL 49967-0621-01 L'Oreal 1 tube — — Discontinued —
CeraVe Developed with Dermatologists Eczema Relief Creamy 10 mg/mL 49967-0951-01 L'Oreal 236 ml — — FDA listed —
Derma-e Eczema Relief .01 g/g 51326-0870-04 Topiderm, 1 jar — — FDA listed —
Eczema 10 mg/mL 52915-0120-02 ORGANIC 57 ml — — FDA listed —
Renew Intensive Skin Therapy Targeted Eczema Treatment .5 g/50mL 54473-0410-01 Melaleuca 50 ml — — FDA listed —
Eczema Hand Relief 1 g/100g 61328-0010-00 Skinfix, 90 g — — FDA listed —
Skinfix Hand Repair 1 g/100mL 61328-0106-11 Skinfix, 30 ml — — FDA listed —
Skin Soothing Cream - Nut Free 1 mg/g 62742-4194-01 Allure 113.5 g — — FDA listed —
Baby Eczema Therapy 10 mg/g 64024-0601-34 Aldi, 227 g — — FDA listed —
Avene XERACALM Eczema Calming Relief Balm 1 g/100g 64760-0777-01 Pierre 100 g — — FDA listed —
Honest Eczema Cream 1 g/100g 69366-0504-19 The 200 g — — FDA listed —
Olay Ultimate Sensitive Colloidal Oatmeal Skin Protectant Moisturizer Fragrance Free 1 g/100g 69423-0743-48 The 1 jar — — FDA listed —
La Roche Posay Laboratoire Dermatologique Lipikar Eczema Relief 10 mg/mL 69625-0620-02 COSMETIQUE 200 ml — — FDA listed —
CVS Eczema Relief Skin Protectant 10 mg/g 69842-0388-01 CVS 226 g — — FDA listed —
Aveeno Baby Eczema Therapy Moisturizing 10 mg/g 69968-0404-01 Kenvue 14 g — — FDA listed —
Aveeno Eczema Therapy Itch Relief Balm 10 mg/g 69968-0419-01 Kenvue 312 g — — FDA listed —
Aveeno Eczema Therapy daily moisturizing 10 mg/g 69968-0421-01 Kenvue 14 g — — FDA listed —
Aveeno Baby Eczema Therapy Nighttime Balm 10 mg/g 69968-0540-01 Kenvue 312 g — — FDA listed —
Aveeno Calm Plus Restore Skin Therapy Balm 10 mg/g 69968-0755-02 Kenvue 1 tube — — FDA listed —
Aveeno Eczema Therapy Nighttime Itch Relief Balm 10 mg/g 69968-0772-01 Kenvue 312 g — — FDA listed —
Aveeno Eczema Therapy Daily Moisturizing 10 mg/mL 69968-0774-02 Kenvue 354 ml — — FDA listed —
Aveeno Baby Eczema Therapy Moisturizing 10 mg/g 69968-0901-02 Kenvue 341 g — — FDA listed —
Aveeno Baby Eczema Therapy Moisturizing Cream Clubtray 69968-0921-09 Kenvue 1 kit — — FDA listed —
Aveeno Baby Eczema Therapy Moisturizing 10 mg/mL 69968-0923-02 Kenvue 354 ml — — FDA listed —
Eczema Relief Cream 1 g/100g 71521-0025-15 Lavior 15 g — — FDA listed —
DERMA SANTE Anti Eczema Cream 10 mg/mL 71970-0324-00 Hope 1 tube — — FDA listed —
Evereden Healing Eczema Treatment 1 g/100mL 72113-0106-03 Eden 1 tube — — FDA listed —
Mountain Ice Eczema 10 mg/g 72793-0400-01 Mountainside 118 g — — FDA listed —
LMNOOP Eczema Relief Cream 1 g/100g 73076-0128-01 Shenzhen 50 g — — FDA listed —
LMNOOP Baby Eczema Relief Cream 1 g/100g 73076-0141-02 Shenzhen 100 g — — FDA listed —
LMNOOP Urticaria Cream 1 g/100g 73076-0142-02 Shenzhen 100 g — — FDA listed —
iShancare Anti-itch Cream 1 g/100g 73076-0145-01 Shenzhen 10 g — — FDA listed —
LMNOOP Antifungal Cream 1 g/100g 73076-0147-01 Shenzhen 50 g — — FDA listed —
LMNOOP Itch Relief Cream 1 g/100g 73076-0148-01 Shenzhen 50 g — — FDA listed —
iShancare Baby Eczema Cream 1 g/100g 73076-0152-02 Shenzhen 100 g — — FDA listed —
iShancare Seborrheic Dermatitis Cream 1 g/100g 73076-0153-01 Shenzhen 50 g — — FDA listed —
LMNOOP Tinea Treatment 1 g/100g 73076-0200-01 Shenzhen 50 g — — FDA listed —
LMNOOP Athletes Foot Cream 1 g/100g 73076-0201-01 Shenzhen 50 g — — FDA listed —
LMNOOP Seborrheic Dermatitis Treatment 1 g/100g 73076-0203-01 Shenzhen 50 g — — FDA listed —
LMNOOP Feminine Cream 1 g/100g 73076-0205-01 Shenzhen 50 g — — FDA listed —
LMNOOP Vaginal Antifungal Cream 1 g/100g 73076-0208-01 Shenzhen 1 applicator — — FDA listed —
LMNOOP Eczema Relief Cream 1 g/100g 73076-0209-03 Shenzhen 100 g — — FDA listed —
Yimimde Tinea Corporis Cream 1 g/100g 73076-0307-03 Shenzhen 100 g — — FDA listed —
Yimimde Masculine Care Cream 1 g/100g 73076-0308-02 Shenzhen 56 g — — FDA listed —
HOMWIS Urticaria Relief Cream 1 g/100g 73076-0506-02 Shenzhen 50 g — — FDA listed —
Colloidal oatmeal 10 mg/g 79481-6601-01 Meijer, 141 g — — FDA listed —
Colloidal oatmeal 10 mg/g 79481-9965-01 Meijer, 207 g — — FDA listed —
Skin Mercy Intense Recovery Cream 1 g/100mLthis 80921-0001-50 Cultskin 1 tube — — FDA listed —
Skin Mercy Recovery Cream 1 g/100mL 80921-0002-50 Cultskin 1 tube — — FDA listed —
Barrier Build Skin Protectant Cream 1 g/100mL 81110-0800-02 ILIA, 1 jar — — FDA listed —
M3 NATURALS Eczema Cream 10 mg/mL 81985-0186-01 M3 118 ml — — FDA listed —
CeraVe Developed with Dermatologists Eczema Relief Moisturizing 10 mg/mL 82046-0040-01 L'Oreal 236 ml — — FDA listed —
THERAPLEX Eczema Therapy 10 mg/g 82280-0425-00 THERAPLEX, 170.1 g — — FDA listed —
THERAPLEX Eczema Therapy Moisturizing Skin Protectant with Colloidal Oatmeal 10 mg/g 82280-0618-00 THERAPLEX, 85.05 g — — FDA listed —
THERAPLEX Eczema Therapy 10 mg/g 82280-0816-00 THERAPLEX, 170.1 g — — FDA listed —
Prequel Barrier Cream 1 g/100g 82800-0009-01 The 296 g — — Discontinued —
DERMOIA Manuka Honey Eczema Cream 10 mg/mL 83524-0407-00 TREASUREWISE 120 ml — — FDA listed —
Puriya Eczema Cream 1 g/100g 84711-0002-04 IPC 113 g — — FDA listed —
Serawise Eczema Rescue 10 mg/mL 85050-0575-00 DrAnaMaria.com 1 jar — — FDA listed —
Soteri Skin Long-Term Eczema Relief Cream 1 g/100mL 85265-0103-01 Soteri 1 bottle — — FDA listed —
Eczema Cream 1 g/100mL 85303-0001-01 Kyte 100 ml — — FDA listed —
Tagrid Eczema Cream Colloidal Oatmeal 1% 1 g/100g 85384-0024-01 TAGRID 56.7 g — — FDA listed —
RoyceDerm Eczema Relief Cream 1.13 g/113g 85424-0010-01 RoyceDerm 113 g — — FDA listed —
Eczema Therapy .96 g/96g 85951-0010-01 SilverCeuticals 1 g — — FDA listed —
Radlive Active Defense Nano-Silver Cream .96 g/96g 85951-0200-34 SilverCeuticals 1 g — — FDA listed —
Neurexa 10 mg/mL 87110-0004-01 METHODIQ 1 tube — — FDA listed —
Baby Eczema Moisturizing Cream 1 g/100g 87781-0003-01 Foshan 80 g — — FDA listed —
Cetaphil Baby Eczema Soothing 1 g/100mL 00299-4140-05 Galderma 147 ml — — FDA listed —
Cetaphil Eczema Soothing Moisturizer 1 g/100mL 00299-4128-00 Galderma 296 ml — — FDA listed —
Dove DermaSeries Eczema Relief Soothing Body 1 g/100mL 64942-1503-01 Conopco, 50 ml — — 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

🏛️
2026
On the market since
Jan 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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 Skin Mercy Intense Recovery Cream (this brand).

Top reported reactions

Rash2
Anaemia1
Aplastic Anaemia1
Asthenia1
Bile Duct Stenosis1
Cholangiocarcinoma1
Death1

Age at onset

Adult2

Reporter sex

0 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
80921-0001-50 You're viewing this 1 TUBE in 1 CARTON (80921-001-50) / 50 mL in 1 TUBE 2026-01-02 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 ✓ 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 80921-001-50, 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: 80921-0001-50, written without dashes as 80921000150. 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 80921-0001-50, the first segment (80921) is the labeler code FDA assigned to Cultskin Apothecary, Inc.; the middle segment (0001) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (50) 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 it is currently marketed — but Cultskin Apothecary, Inc. has reported a marketing end date of 2027-04-01, after which this package is expected to stop being marketed. The directory data on this page refreshes weekly.
Who lists this product with the FDA?
Cultskin Apothecary, 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 15 words ▾

Uses Temporarily protects and helps relieve minor skin irritation and itching due to: eczema rashes

⏱️ Dosage and Administration 4 words ▾

Directions Apply as needed

⚠️ Warnings 58 words ▾

Warnings For external use only When using this product 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 Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 5 words ▾

Active ingredient Colloidal Oatmeal 1%

🧪 Inactive Ingredients 73 words ▾

Inactive ingredients Water, Glycerin, Squalane, Caprylic/Capric Triglyceride, Limnanthes Alba (Meadowfoam) Seed Oil, C13-15 Alkane, Cetearyl Olivate, Sorbitan Olivate, Cetearyl Alcohol, Shorea Stenoptera Seed Butter, Meadowfoam Estolide, Dimethicone, Coco-Caprylate/Caprate, Methylpropanediol, Allantoin, Panthenol, Triheptanoin, Linoleic Acid, Phytosterols, Phospholipids, Oryza Sativa (Rice) Bran Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Helianthus Annuus (Sunflower) Extract, Tocopherol, Phenoxyethanol, Caprylyl Glycol, Sodium Polyacrylate, C9-12 Alkane, Dilinoleic Acid/Butanediol Copolymer, Bisabolol, Stearyl Glycyrrhetinate, Sodium Phytate, Tasmannia Lanceolata Fruit/Leaf Extract, Castor Oil/IPDI Copolymer

🎯 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 ↗
← 80883-0097-00 · Miracle 80921-0002-50 · Cultskin →
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.