HomeNDC LookupIngredientsColloidal Oatmeal › 85423-0087-11
First Aid Beauty Face and Body Bestsellers Kit colloidal oatmeal Kit — NDC 85423-0087-11 package photo

First Aid Beauty Face and Body Bestsellers Kit colloidal oatmeal Kit

by JCS Global Distribution, Inc. · 1 KIT in 1 KIT (85423-087-11) * 113 g in 1 JAR (84126-203-11) * 60 DISC in 1 JAR * 170.1 g in 1 BOTTLE, PUMP * 56.7 g in 1 TUBE
NDC 85423-0087-11
🏷️ FDA NDC (as labeled) 85423-087-11 billing pads the product segment with a zero
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 →

🆔 Identity & classification

FDA NDC (as labeled) 85423-087-11
Product NDC 85423-087
11-digit billing NDC 85423008711
Application # M016
SPL Set ID 5b25fc41-82d9-094a-e063-6394a90acb6d
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-08-14
Route TOPICAL
Dosage form KIT
Why two NDCs? The FDA registers this code as 85423-087-11 — 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 → 85423-0087-11. 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

LabelerJCS Global Distribution, Inc.
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code85423
First marketedAug 2026
Product typeHuman Otc Drug
Portfolio4 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 a topical kit containing colloidal oatmeal, an over-the-counter skin care product marketed under FDA's monograph rules for its category. Colloidal oatmeal is commonly used in skin care products to help soothe and moisturize the skin. This kit is a multi-product bundle designed for general face and body care rather than treatment of a specific medical condition.

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.

From the label’s inactive-ingredient sectionWater, stearic acid, glycerin, C12-15 alkyl benzoate, caprylic/capric triglyceride,glyceryl stearate, glyceryl stearate SE,cetearylalcohol, dimethicone, squalane,hydrogenated shea butter,phenoxyethanol, caprylyl glycol,xanthan gum, allantoin, sodium hydroxide, tetrasodium EDTA, chrysanthemum parthenium (feverfew) extract, camellia sinensis leaf extract, glycyrrhiza glabra (licorice) root extract, ceramide NP, eucalyptus globulus leaf oil

This is label-wide narrative text, not a normalized exact-product ingredient list. A label can cover multiple strengths or packages.

Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer 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
Eczema Care Moisturizing 3 oz. 10 mg/mL 57337-0101-01 Rejoice 85 ml FDA listed
MG217 Baby Eczema .02 g/g 68093-5105-01 Wisconsin 170 g FDA listed
MG217 Eczema Face .02 g/g 68093-7245-01 Wisconsin 170 g FDA listed
Cetaphil Baby Eczema Soothing 1 g/100mL 00299-4140-05 Galderma 147 ml FDA listed
EczemaHoneyBodyLotion 1 g/100g 62742-4234-01 Allure 226.79 g FDA listed
Babo Botanicals Sensitive Baby Healing 10 mg/g 79265-8655-01 Babo 1 jar FDA listed
MATYS Baby ECZEMA RELIEF .1 g/100g 72827-0103-05 Matys 106 g FDA listed
Colloidal oatmeal 10 mg/g 79481-9965-01 Meijer, 207 g FDA listed
First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant .5 g/100g 84126-0203-11 The 113 g FDA listed
Everyday Eczema 2 g/100g 54136-0181-25 Better 244 g FDA listed
Badger After-BUG Balm 10 g/100g 62206-0297-00 W.S. 1 tube FDA listed
Eczema Relief Cream 1 g/100g 71521-0025-15 Lavior 15 g FDA listed
Evereden Intensive Eczema Balm 2 g/100g 72113-0109-21 Eden 1 jar FDA listed
Baby Eczema Therapy 1 mg/g 76162-0601-28 Topco 141 g FDA listed
Colloidal oatmeal 10 mg/g 79481-6601-01 Meijer, 141 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
Gold Bond Medicated eczema relief 20 mg/g 84714-0567-01 Gold 155 g FDA listed
Pipette Eczema 10 mg/mL 84723-0004-02 Pipette 1 bottle FDA listed
First Aid Beauty Dry Skin Rescue Kit 5x Hydration Power 85423-0203-56 JCS 1 kit FDA listed
Eczema Therapy .96 g/96g 85951-0010-01 SilverCeuticals 1 g FDA listed
Pink Eczema Cream .5 g/100g 87043-0012-02 MOOGOO 100 g FDA listed
Baby Eczema Moisturizing Cream 1 g/100g 87781-0003-01 Foshan 80 g FDA listed
Triderma Eczema Fast Healing Face And Body 1.5 g/100g 10738-0054-20 Genuine 1 tube FDA listed
TCX Skincare 2 g/100g 49449-0100-01 Theraceutix, 59 g FDA listed
Nizoral Eczema Relief Cream 2 g/100g 55505-0223-33 Kramer 1 bottle FDA listed
Eczema Dermatitis Relief Balm 5 g/100g 61328-0112-20 Skinfix, 50 g FDA listed
AL0043600 Alba Botanica VE Herbal Healing Body .4 g/100g 61995-2436-09 The 907 g FDA listed
Skin Soothing Cream - Nut Free 1 mg/g 62742-4194-01 Allure 113.5 g FDA listed
Cetaphil Eczema Rapid Relief Cream 2 g/100g 00299-4144-00 Galderma 227 g FDA listed
The Indigo Calming 20 mg/mL 69417-0140-03 TATCHA 1 jar Discontinued
First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant Cranberry Pomegranate .5 g/100g 69423-0565-39 The 396.8 g FDA listed
Olay Ultimate Sensitive Colloidal Oatmeal Skin Protectant Moisturizer Fragrance Free 1 g/100g 69423-0743-48 The 1 jar FDA listed
Aveeno Baby Eczema Therapy Moisturizing Cream Clubtray 69968-0921-09 Kenvue 1 kit FDA listed
Mountain Ice Eczema 10 mg/g 72793-0400-01 Mountainside 118 g FDA listed
Psoriasis Body Wash 5 g/100mL 83004-0027-01 Rida 473 ml FDA listed
The Zoeun Omega Serum .007 g/100mL 83636-0115-01 Sturgeonbio 50 ml 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
Walgreens Eczema 10 mg/g 00363-0258-86 WALGREEN 207 g FDA listed
Honest Eczema Balm 1 g/100g 69366-0503-20 The 1 jar Discontinued
Honest Eczema Cream 1 g/100g 69366-0504-19 The 200 g FDA listed
Aveeno Calm Plus Restore Skin Therapy Balm 10 mg/g 69968-0755-02 Kenvue 1 tube FDA listed
Aveeno Eczema Therapy Rescue Relief Treatment Gel Cream 20 mg/g 69968-1003-02 Kenvue 44 g FDA listed
Colloidal Oatmeal 10 mg/g 79903-0438-05 Walmart 141 g FDA listed
Childs Farm Eczema Moisturizing Cream 15 mg/mL 83244-0001-01 Childs 250 ml FDA listed
The Zoeun Skin Eye Cream .007 g/100mL 83636-0116-01 Sturgeonbio 50 ml FDA listed
The Zoeun Skin Nourishing Cream .007 g/100mL 83636-0118-01 Sturgeonbio 50 ml FDA listed
First Aid Beauty FAB Ultra Repair Skin Protectant Candy Cane .5 g/100g 84126-0100-56 The 56.7 g FDA listed
Gold Bond Eczema Relief Medicated Hand Cream 2 g/100g 84714-0668-00 Gold 85 g FDA listed
First Aid Beauty Sensitive Skin Bestsellers Kit 85423-0262-56 JCS 1 kit FDA listed
Eczema Soothing Moisturizing Cream 10 mg/g 11344-0965-98 Nice-Pak 207 g FDA listed
Eczema Relief 10 mg/11g 55910-0653-34 Old 226 g FDA listed
Eczema Hand Relief 1 g/100g 61328-0010-00 Skinfix, 90 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 Body Skin Protectant .5 g/100g 69423-0726-28 The 283.5 g FDA listed
Aveeno Eczema Therapy Daily Moisturizing 10 mg/mL 69968-0774-02 Kenvue 354 ml FDA listed
CeraVe Developed with Dermatologists Eczema Relief Moisturizing 10 mg/mL 82046-0040-01 L'Oreal 236 ml 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 Skin Protectant Sparkling Grapefruit .5 g/100g 84126-0210-39 The 396.8 g FDA listed
Gold Bond Eczema Relief Medicated Skin Protectant Cream 2 g/100g 84714-0669-01 Gold 121 g FDA listed
Triderma Baby Stubborn Eczema Itch Relief 1.5 g/100g 10738-0069-20 Genuine 1 tube FDA listed
Eczema Itch Relief Wash and Shampo 15 mg/mL 10738-0162-23 Genuine 355 ml FDA listed
Gold Bond Medicated eczema relief 20 mg/g 41167-0567-01 Chattem, 155 g FDA listed
Skin Soothing Cream 1 mg/g 62742-4190-01 Allure 113.5 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
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
Aveeno Eczema Therapy Rescue Relief Treatment 20 mg/mL 69968-0802-01 Kenvue 14 ml FDA listed
Atopis Eczema Therapy Cream .5 g/100g 71570-0001-01 Bionona 1 bottle FDA listed
Colloidal oatmeal 10.4 mg/g 72288-0965-98 Amazon.com 207 g FDA listed
Neurexa 10 mg/mL 87110-0004-01 METHODIQ 1 tube FDA listed
First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant .5 g/100g 10637-1901-01 Port 28.3 g FDA listed
Dermatitis Face Balm 5 g/100g 61328-0121-12 Skinfix, 13.5 g FDA listed
Cetaphil Eczema Soothing Moisturizer 1 g/100mL 00299-4128-00 Galderma 296 ml FDA listed
Mustela Stelatopia Intense Eczema Relief Skin Protectant 10 mg/mL 64768-7024-01 Expanscience 30 ml FDA listed
Earth Mama Eczema Cream 50 mg/g 72812-0151-01 Earth 85 g FDA listed
The Zoeun Skin Total Care Cream .007 g/100mL 83636-0122-01 Sturgeonbio 50 ml FDA listed
The Zoeun Skin Sturgeon Gel .007 g/100mL 83636-0123-01 Sturgeonbio 150 ml 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 Cream Intense Hydration Skin Protectant Cucumber Melon .5 g/100g 84126-0102-39 The 396.8 g FDA listed
First Aid Beauty Dry Skin Rescue Kit 84126-0220-01 The 1 kit FDA listed
Tagrid Eczema Cream Colloidal Oatmeal 1% 1 g/100g 85384-0024-01 TAGRID 56.7 g FDA listed
Gold Bond Eczema Relief Medicated Hand Cream 2 g/100g 41167-0668-00 Chattem, 85 g FDA listed
Gold Bond Eczema Relief Medicated Skin Protectant Cream 2 g/100g 41167-0669-01 Chattem, 121 g FDA listed
Baby Eczema Therapy 10.4 kg/g 55910-0803-28 Old 141 g FDA listed
Extra Strength Body 2 g/100mL 61328-0119-28 Skinfix, 236 ml FDA listed
Baby Eczema Therapy 10 mg/g 64024-0601-34 Aldi, 227 g FDA listed
Sarna 20 mg/mL 00316-0256-17 Crown 5 ml FDA listed
Colloidal oatmeal 10 mg/g 69842-0214-28 CVS 141 g FDA listed
Aveeno Eczema Therapy Nighttime Itch Relief Balm 10 mg/g 69968-0772-01 Kenvue 312 g FDA listed
Eczema 1.25 g/100g 72609-0704-04 Smith 113 g FDA listed
All Over 1 g/100g 73088-0302-02 Tubby 57 g 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
Colloidal oatmeal 10 mg/g 37808-0128-28 H 141 g FDA listed
Baby Eczema Therapy 10 mg/g 00363-0986-28 Walgreen 141 g Discontinued
OKeeffes Skin Repair Body Cream Eczema Relief 2 g/100g 71564-0010-98 The 198 g FDA listed
Skin Mercy Intense Recovery Cream 1 g/100mL 80921-0001-50 Cultskin 1 tube FDA listed
Barrier Build Skin Protectant Cream 1 g/100mL 81110-0800-02 ILIA, 1 jar 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 Skin Protectant Chai Cinnamon .5 g/100g 84126-0212-39 The 396.8 g FDA listed
First Aid Beauty Sensitive Skin Bestsellers Kit 84126-0262-01 The 1 kit FDA listed
Whipped Gel 1 mg/100g 84293-0010-02 OCEAN 50 g FDA listed
Puriya Eczema Cream 1 g/100g 84711-0002-04 IPC 113 g FDA listed
Soothing Moisturizing 10.4 mg/g 49035-0965-98 Walmart 207 g FDA listed
KIEHLS SINCE 1851 Ultra Facial Meltdown Recovery 10 mg/mL 49967-0571-01 LOreal 1 tube FDA listed
Calming Itch and Irritation 2 g/100g 54136-0183-24 Better 239 g FDA listed
Renew Intensive Skin Therapy Targeted Eczema Treatment .5 g/50mL 54473-0410-01 Melaleuca 50 ml FDA listed
MG217 Eczema Body .02 g/g 68093-5106-01 Wisconsin 170 g FDA listed
Colloidal oatmeal 10.4 mg/g 69842-0276-98 CVS 207 g FDA listed
Evereden Healing Eczema Treatment 1 g/100mL 72113-0106-03 Eden 1 tube FDA listed
Skin Mercy Recovery Cream 1 g/100mL 80921-0002-50 Cultskin 1 tube FDA listed
Our Eczema Remedy 1.8 g/100g 84073-0100-02 Fewer 1 tube 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 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 Sugar Cookie .5 g/100g 84126-0211-39 The 396.8 g FDA listed
Radlive Active Defense Nano-Silver Cream .96 g/96g 85951-0200-34 SilverCeuticals 1 g FDA listed
Eczema Fast Healing Body Wash 15 mg/mL 10738-0205-63 Genuine 473 ml FDA listed
Avene XERACALM Eczema Calming Relief Balm 1 g/100g 64760-0777-01 Pierre 100 g FDA listed
Dove DermaSeries Eczema Relief Soothing Body 1 g/100mL 64942-1503-01 Conopco, 50 ml FDA listed
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 Skin Protectant Pink Grapefruit .5 g/100g 69423-0567-34 The 340.2 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
Gladskin Eczemact Eczema .2 mg/mL 73105-0003-00 Micreos 1 bottle 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 Sensitive Skin Bestsellers Kit 85423-0094-56 JCS 1 kit FDA listed
Eczema Skin Relief Cream 2 g/100g 51316-0860-01 CVS 227 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
EczeNourish Eczema and Psoriasis Soothing Oat 1 g/100g 51642-0074-42 Vanguard 99 g FDA listed
Aveeno Eczema Therapy Cream 10 mg/g 69968-1006-02 Kenvue 354 g FDA listed
FIRST AID BEAUTY FAB ULTRA REPAIR SKIN PROTECTANT Kit 84126-0912-01 The 1 kit FDA listed
First Aid Beauty Face and Body Bestsellers Kit 84126-0911-01 The 1 kit FDA listed
First Aid Beauty Face and Body Bestsellers Kitthis 85423-0087-11 JCS 1 kit 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
Aug 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
85423-0087-11 You're viewing this 1 KIT in 1 KIT (85423-087-11) * 113 g in 1 JAR (84126-203-11) * 60 DISC in 1 JAR * 170.1 g in 1 BOTTLE, PUMP * 56.7 g in 1 TUBE 2026-08-14 Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product Kit / multi-component package

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

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 85423-087-11, 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: 85423-0087-11, written without dashes as 85423008711. 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 85423-0087-11, the first segment (85423) is the labeler code FDA assigned to JCS Global Distribution, Inc.; the middle segment (0087) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (11) 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 JCS Global Distribution, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
JCS Global Distribution, 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.
📄 FDA label 19 words

No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.