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Numbing Cream LIDOCAINE 40 mg/g Cream, 50 g — NDC 85569-0001-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Numbing Cream LIDOCAINE 40 mg/g Cream, 50 g — NDC 85569-001-01 (Billing 85569-0001-01)

by 100 KARMA INC · 50 g in 1 CARTON

This is a package of 50 g of Numbing Cream LIDOCAINE 40 mg/g Cream from 100 KARMA INC, marketed since Jun 2025 and currently FDA-listed. It is this product's only package size.

NDC 85569-0001-01
🏷️ FDA NDC (as labeled) 85569-001-01 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed 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

NDC database record

One package, one record: these facts belong to NDC 85569-001-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
85569 labeler · 001 product · 01 package
Package marketed since
Jun 9, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0860013342302
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Lidocaine (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Aug 31, 2026 — Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stability station, at (25¿C,60%RH). (SUN PHARMA /TARO) · FDA recall D-0848-2026
Class III · Apr 20, 2023 — Labeling: Typographical error on the upper left-hand side of the box and individual patch label that has the incorrect dosage form stating, each tablet contains instead of each adhesive patch contains. (Bryant Ranch Prepack, Inc.) · FDA recall D-0556-2023
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 85569-001-01
Product NDC 85569-001
11-digit billing NDC 85569000101
RxCUI 1421893
UNII 98PI200987
UPC 0860013342302
Application # M017
SPL Set ID 35884644-d017-eda3-e063-6394a90a1f6c
Established class (EPC) Amide Local Anesthetic; Antiarrhythmic
Physiologic effect Local Anesthesia
Chemical class Amides
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-06-09
Route TOPICAL
Dosage form CREAM
Substance LIDOCAINE
Quick answers
  • RxCUI (RxNorm): 1421893
Why two NDCs? The FDA registers this code as 85569-001-01 — 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 → 85569-0001-01. 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.

RxNorm drug class

This medicine belongs to the Antiarrhythmic class.

Pharmacologic class Antiarrhythmic, Amide Local Anesthetic
Drug family (ATC) Antiarrhythmics, class Ib, Local anesthetics, Anesthetics for topical use
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.

Clinical

📗 Our plain-language guide HelloPharmacist
  • Lidocaine numbs the area where it is used. Clinicians inject it for procedures. Skin products are used for pain, itching, minor burns, insect bites, hemorrhoid discomfort, and in s...
  • Clean and dry the skin first, then apply as your product’s directions say. Wash your hands afterward. Don’t exceed the number of uses on the label. Ask a doctor before using a prod...
  • No. Heat can increase how much lidocaine your body absorbs. Don’t bandage tightly either. Also avoid using other topical pain products at the same time.
  • Can I use a heating pad with a lidocaine patch?
📖 Read our full Lidocaine guide →
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.

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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
85569-0001-01 You're viewing this Main listing 50 g in 1 CARTON 2025-06-09 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Rugby Lidocaine 4 g/100g 00536-1357-95 Rugby 1 tube $0.428 — Availability likely —
Lidocaine 4% Topical Anesthetic Cream 4 g/100g 83720-0523-01 Oncor 1 tube $0.490 — Availability likely —
4 Lidocaine Topical Anesthetic 40 mg/g 00536-1267-20 RUGBY 15 g $0.635 — Availability likely —
Lidocaine 40 mg/g 39328-0024-15 Patrin 1 tube $0.635 — Availability likely —
Numbing Pain Relief 4 g/100g 00363-6261-07 Walgreen 1 applicator — — FDA listed —
Lmx4 40 mg/g 00496-0882-05 Ferndale 5 g — — FDA listed —
Lidocaine 40 mg/g 10135-0672-96 Marlex 1 tube — — FDA listed —
Anecream 4 g/100g 24357-0701-06 Focus 5 tubes — — FDA listed —
Meijer Analgesic Lidocaine Topical Analgesic 40 mg/g 41250-0518-01 Meijer 1 bottle — — FDA listed —
Lidocaine 4 g/100g 42291-0399-30 AvKARE 1 tube — — FDA listed —
Pain free IV 4 g/100mL 54723-0008-01 Sambria 4 ml — — FDA listed —
Painless Tattoo 2 4 g/100mL 54723-0016-01 Sambria 4 ml — — FDA listed —
NeuroMed Topical Anesthetic 7 40 mg/g 54723-0300-04 Sambria 4 g — — FDA listed —
Family Wellness Pain Relief with Lidocaine 40 mg/g 55319-0822-50 FAMILY 1 tube — — FDA listed —
Lidocaine 40 mg/g 58980-0824-05 Stratus 1 tube — — FDA listed —
Burn Relief Professional Bio-Kool 4 g/100g 61566-0201-04 Kool-Down 113 g — — FDA listed —
Desert Harvest RELEVEUM 40 mg/mL 69145-0201-04 Desert 118 ml — — FDA listed —
Lidocaine Anesthetic Cream 4 g/100g 69375-0005-30 Nationwide 1 tube — — FDA listed —
Tylenol Precise Warming Pain Relieving 40 mg/g 69968-0794-04 Kenvue 1 tube — — FDA listed —
Tylenol Precise Pain Relieving 40 mg/g 69968-0795-04 Kenvue 1 tube — — FDA listed —
Blue-Emu Lidocaine Pain Relief Cream 40 mg 69993-0350-03 Kingsway 1 tube — — FDA listed —
Lidocaine Cream, 4% 4 g/100g 71085-0075-19 IPG 119 g — — FDA listed —
Deeveeant Numb 40 mg/g 71383-0014-02 Valekista 1 tube — — FDA listed —
MediNumb 40 mg/g 71383-0024-02 Valekista 1 tube — — FDA listed —
Asper Flex 4 g/100g 71399-0049-01 Akron 15 g — — FDA listed —
Lidocaine 4% 4 g/100g 71800-0026-06 Innovida 58.5 g — — FDA listed —
Lidozall 4 g/100g 72835-0004-20 V2 20 packets — — FDA listed —
Lidocaine 4% Topical Anesthetic Cream 4.27 g/100g 73715-0001-01 Mohnark 30 g — — Discontinued —
Meijer Pain Relief Cream 4 g/100g 79481-0048-02 Meijer 76.5 g — — FDA listed —
Lidocaine 40 mg/g 80425-0351-01 Advanced 1 tube — — FDA listed —
Lidocaine 4% Cream 40 mg/g 82461-0419-30 Medcore 1 tube — — FDA listed —
AUVON Pain Relief Cream 4 g/100g 83391-0009-01 SHENZHEN 57 g — — FDA listed —
RelaxInk LIDOCAINE 4 g/100g 83714-0004-01 Hambli 1 tube — — FDA listed —
ELAIMEI Numbing Cream 4 g/100mL 83804-0005-01 Shenzhen 1 bottle — — FDA listed —
Tktalker Numbing 4 g/100g 83804-0113-01 Shenzhen 50 g — — FDA listed —
Dcsily Numbing Cream 4 g/100g 83818-0034-01 Shenzhen 50 g — — FDA listed —
4% TATTOO Numb Cream 100 mg/g 84019-0030-01 Shengnan 30 g — — FDA listed —
Signature Pain Relief Cream 40 mg/g 84019-0044-01 Shengnan 30 g — — FDA listed —
Nekvnro LIDOCAINE 4% Tattoo numbing cream set 4 g/100g 84844-0018-01 Guoyu 2 tubes — — Discontinued —
VBBV Tattoo Numbing 40 mg/mL 84867-0014-01 Jiashen 60 ml — — FDA listed —
Black Cobra Tattoo Numbing Cream 4% Lidocaine .04 g/g 84938-0002-01 Foshan 20 g — — FDA listed —
Jakwork Numbing Cream 4 g/100g 85150-0007-01 Guangzhou 50 g — — FDA listed —
Healmusz Numbing 4 g/100g 85248-0032-01 Jiangxi 50 g — — FDA listed —
Nieapf NUMBING 4 g/100g 85248-0046-01 Jiangxi 65 g — — FDA listed —
Subleef NUMBING 4 g/100g 85248-0052-01 Jiangxi 30 g — — FDA listed —
Sylvirene Numbing 4 g/100g 85248-0070-01 Jiangxi 50 g — — FDA listed —
ANIXIKE Numbing 4 g/100g 85248-0088-01 Jiangxi 30 g — — FDA listed —
Dermfree Numbing 4 g/100g 85248-0121-01 Jiangxi 50 g — — FDA listed —
ANIXIKE Numbing 4 g/100g 85248-0166-01 Jiangxi 30 g — — FDA listed —
YYSDMVY NUMBING Cream 4 g/100g 85248-0209-01 Jiangxi 60 g — — FDA listed —
Tattoo numbing cream 4 g/100g 85284-0001-01 BLOOMWELL 50 g — — FDA listed —
Topical Cream 4 g/100g 85284-0002-01 BLOOMWELL 50 g — — Discontinued —
Numbing Cream 4 g/100g 85284-0003-01 BLOOMWELL 50 g — — Discontinued —
numbing cream MAXIMUM STRENGTH 4 g/100g 85284-0006-01 BLOOMWELL 50 g — — Discontinued —
Veiurkiu External Analgesic Cream 4 g/100g 85284-0011-01 BLOOMWELL 50 g — — FDA listed —
Numbing Cream 40 mg/gthis 85569-0001-01 100 50 g — — FDA listed —
Numbing Cream 4 mg/100mL 85569-0002-01 100 50 ml — — FDA listed —
SCHOELIF Numbing Cream 4 g/100g 85817-0001-01 Guangzhou 50 g — — FDA listed —
Aouiv 4% Lidocaine Numbing Cream 4 g/100g 85817-0003-01 Guangzhou 60 g — — FDA listed —
Numbing Creams 4 g/100g 85881-0001-01 Yongchun 50 g — — FDA listed —
Black Cobra 4% Lidocaine Numbing Cream 40 mg/g 85924-0001-02 BLACKCOBRASUPPLY, 1 tube — — Discontinued —
Swiftalyn Numbing Cream 4 g/100g 87013-0002-01 GENUINE 50 g — — FDA listed —
Morovan 4 g/100g 87800-2624-01 HONG 1 can — — FDA listed —
Greencaine Blast 40 mg/g 69747-0040-01 ALMA 113 g — — FDA listed —
Bed Bug Instant Bite Relief 40 mg/g 70466-0001-01 P.F. 1 tube — — FDA listed —
BENGAY Tropical Jasmine 40 mg/g 69968-0614-03 Kenvue 1 tube — — FDA listed —
Hush Anesthetic 40 mg/g 49947-0002-02 HUSH 56.7 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

🏛️
2025
On the market since
Jun 2025
📍
2026
Currently FDA-listed
1 year listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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.

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.

🧪 Avoiding an ingredient? See Lidocaine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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

  • UNII 9E8X80D2L0
    A synthetic form of vitamin E used as an antioxidant and preservative in medications. It helps prevent the active ingredients from degrading when exposed to oxygen or light.
  • UNII OZ0E5Y15PZ
    A plant extract from arnica flowers, used as a flavoring agent or fragrance component in medicines. It may also provide mild soothing properties to certain topical formulations.
  • UNII LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • UNII Z135WT9208
    Carbomer is a synthetic polymer that forms a thick, gel-like consistency. It's used in medicines as a thickener and stabilizer to improve texture and keep ingredients evenly mixed throughout the product.
  • UNII 344821WD61
    Emu oil is a natural fat derived from emu birds, used in some medicines as an emollient and penetration enhancer to help active ingredients absorb through the skin and soften the formulation.
  • UNII 1DI56QDM62
    A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • 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.

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

The official label also statesCarbomer 934, Emu Oil, Arnica, Lecithin (Soybean), Propylene Glycol, Tocopheryl Acetate, Benzyl Alcohol, Aqua.

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.

Manufacturer & labeler

Labeler100 KARMA INC
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code85569
First marketedJun 2025
Product typeHuman Otc Drug
Portfolio15 products on file

More NDCs from 100 KARMA INC labeler code 85569

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.

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 📄 Do Not Use 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Other Information 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 21 words ▾

For the temporary relief of pain and itching, associated with minor skin irritations, minor burns, sunburn, minor cuts, scrapes, insect bites.

⏱️ Dosage and Administration 47 words ▾

For adults: Cleanse the affected area with mild soap and warm water, and rinse thoroughly. Gently dry the area with toilet tissue or a soft cloth before applying the product. Apply up to 4 times a day. For children under 12 years of age: Consult a doctor.

⚠️ Warnings 118 words ▾

For external use only Do not use this product if Pregnant or breastfeeding, ask a health professional before use. If there is any allergic reaction to this product. In case of accidental overdose, get medical help, or contact the poison control center immediately.

Only take the recommended daily dosage unless otherwise instructed by a doctor. Some individuals may experience allergic reactions to the ingredients contained in this product. Stop using and ask a doctor If discomfort persists for 7 days.

The symptoms being treated do not subside or if redness irritation swelling, pain, or other symptoms develop or increase. Keep out of reach of children Avoid contact with eyes. In case of accidental ingestion, seek medical attention immediately.

🧪 Active Ingredient 2 words ▾

4% lidocaine

🧪 Inactive Ingredients 14 words ▾

Carbomer 934, Emu Oil, Arnica, Lecithin (Soybean), Propylene Glycol, Tocopheryl Acetate, Benzyl Alcohol, Aqua.

🎯 Purpose 2 words ▾

topical analgesic

📄 Do Not Use 39 words ▾

Do not use this product if Pregnant or breastfeeding, ask a health professional before use. If there is any allergic reaction to this product. In case of accidental overdose, get medical help, or contact the poison control center immediately.

📄 When Using This Product 25 words ▾

Only take the recommended daily dosage unless otherwise instructed by a doctor. Some individuals may experience allergic reactions to the ingredients contained in this product.

📄 Stop Use and Ask a Doctor If 31 words ▾

Stop using and ask a doctor If discomfort persists for 7 days. The symptoms being treated do not subside or if redness irritation swelling, pain, or other symptoms develop or increase.

📄 Keep Out of Reach of Children 19 words ▾

Keep out of reach of children Avoid contact with eyes. In case of accidental ingestion, seek medical attention immediately.

📄 Other Information 7 words ▾

Store at 59°-86°F (15°-30°C). Avoid direct sunlight.

📄 Package Label / Principal Display Panel 2 words ▾

numbing cream

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Lidocaine (matched by generic name) — the program that covers self-administered drugs. 17 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Lidocaine. CMS lists 8 products for this generic; we show the highest-spend one. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$53.12M
Claims incl. refills
593.7K
Beneficiaries
367.9K
Spend / beneficiary
$144.39
Spend / claim
$89.46
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

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 LIDOCAINE — the ingredient across all brands.

Top reported reactions

Pain5,185
Nausea4,963
Fatigue4,867
Headache4,439
Product Quality Issue3,919
Dyspnoea3,654
Product Adhesion Issue3,514

Age at onset

Neonate191
Infant95
Child490
Adolescent342
Adult7,266
Elderly4,622

Reporter sex

96,029 reports
Male · 33%
Female · 66%
Unknown · 0%

Serious outcomes

Hospitalization26,845
Life-threatening6,104
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 8,778 3,353
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.

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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 100 KARMA INC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
100 KARMA 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.
← 85568-0006-01 · HORSTER 85569-0002-01 · 100 →
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.