Home › NDC Lookup › Ingredients › Lidocaine › 73287-0026-01
Hempvana Maximum Strength Pain Relief Topical Anesthetic Lidocaine 5 g/100g Cream — NDC 73287-0026-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Hempvana Maximum Strength Pain Relief Topical Anesthetic Lidocaine 5 g/100g Cream — NDC 73287-026-01 (Billing 73287-0026-01)

by Telebrands Corp · 1 JAR in 1 CARTON / 85 g in 1 JAR

This is a package of Hempvana Maximum Strength Pain Relief Topical Anesthetic Lidocaine 5 g/100g Cream from Telebrands Corp, marketed since Feb 2023 and currently FDA-listed. It is this product's only package size.

NDC 73287-0026-01
🏷️ FDA NDC (as labeled) 73287-026-01 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 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 →

NDC database record

One package, one record: these facts belong to NDC 73287-026-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
73287 labeler · 026 product · 01 package
Package marketed since
Feb 17, 2023
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0097298054587
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Lidocaine (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
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) 73287-026-01
Product NDC 73287-026
11-digit billing NDC 73287002601
RxCUI 1534792
UNII 98PI200987
UPC 0097298054587
Application # M015
SPL Set ID f525075a-d7ee-dad0-e053-2a95a90a6f3f
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 2023-02-17
Route TOPICAL
Dosage form CREAM
Substance LIDOCAINE
Quick answers
  • RxCUI (RxNorm): 1534792
Why two NDCs? The FDA registers this code as 73287-026-01 — 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 → 73287-0026-01. 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
73287-0026-01 You're viewing this Main listing 1 JAR in 1 CARTON / 85 g in 1 JAR 2023-02-17 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Lidocaine 50 mg/g 58980-0823-30 STRATUS 1 tube — — FDA listed —
Adellina Tattoo Numbing Cream 5 g/100g 60771-0010-01 Guangzhou 50 g — — Discontinued —
Adellina Numbing Cream 5 g/100mL 60771-0011-01 Guangzhou 44 ml — — FDA listed —
Lipocaine 5 5 g/100g 63135-0811-04 ESBA 113 g — — FDA listed —
Microcaine Topical Analgesic 50 mg/g 67194-0022-01 Unit 15 g — — FDA listed —
Hempvana Maximum Strength Pain Relief Topical Anesthetic 5 g/100gthis 73287-0026-01 Telebrands 1 jar — — FDA listed —
Lidocaine 5 g/100mL 73581-0022-06 YYBA 170 ml — — FDA listed —
Lidocaine Numbing Cream 50 mg/mL 73581-0105-55 Yyba 156 ml — — FDA listed —
Lidocaine 5 g/100mL 73581-0114-01 YYBA 30 ml — — FDA listed —
Numbing Cream 5 g/100mL 82929-0011-01 Sainite 1 bottle — — FDA listed —
Healcome Lidocaine Numbing Cream 5 g/100g 83364-0024-01 YITONGBADA 1 bottle — — FDA listed —
Pressy Tattoo Numbing Cream 5 g/100g 83887-0008-01 Changsha 60 g — — Discontinued —
Tattoo Numbing Cream 5 g/100mL 83887-0009-01 Changsha 60 ml — — Discontinued —
Lidocaine 5% 5 g/100g 84007-0335-01 Medhome 30 g — — FDA listed —
Signature Lidocaine Pain Relief Cream 50 mg/g 84019-0043-01 Shengnan 30 g — — FDA listed —
ElixirLidoFast .05 g/g 84546-0010-01 ELIXIR 1 tube — — FDA listed —
VTROUY Tattoo Numbing Cream 5 g/100g 85150-0004-01 Guangzhou 50 g — — FDA listed —
Dr.pabu Numbing 5 g/100g 85248-0177-01 Jiangxi 50 g — — FDA listed —
Tattoo numbing 3 g/60g 85342-0002-01 Guangzhou 60 g — — Discontinued —
Arlun LIDOCAINE Cream 5 g/100g 87408-0021-01 Guangzhou 1 bottle — — FDA listed —
Lidocaine 5 g/100g 00362-0221-10 Septodont, 50 g — AT FDA listed —
Bloop Fissure Healing Anorectal Topical 5 g/100g 83838-0153-01 Three 1 tube — — FDA listed —
Adellina Lidocaine Numbing Cream Topical Anorectal Cream 5 g/100g 83566-0612-02 Guangdong 50 g — — FDA listed —
Numb and Number Anorectal Cream 5 g/100g 68848-0002-01 Dermtech 54 g — — FDA listed —
RWWXII Deep Numbing Cream(Anorectal Hemorrhoidal Cream) 5 g/100g 60771-0027-01 Guangzhou 50 g — — FDA listed —
Hemorrhoid Pain Relief 5 g/100g 73287-0028-01 Telebrands 1 jar — — FDA listed —
Bunnies Bum Hemorrhoidal Numbing 5 g/100g 84308-0159-01 FloCal 28 g — — FDA listed —
Gniby LIDOCAINE ANORECTAL HEMORRHOIDAL Numbing 5 g/100g 87152-0003-01 Putian 50 g — — FDA listed —
Acolye Numbing Cream Anorectal(Hemorrhoidal) Cream 5 g/100g 60771-0028-01 Guangzhou 50 g — — FDA listed —
Adellina Lidocaine Numbing Cream Anorectal(Hemorrhoidal) Cream 5 g/100g 60771-0041-01 Guangzhou 60 g — — FDA listed —
RectoProtect 5 g/100g 71399-0050-01 Akron 5 g — — FDA listed —
Zensa 5 g/100g 69805-0786-01 Alera 1 tube — — FDA listed —
MyDerm Medical 5 Lidocaine Numbing Roll-On 5 g/100g 72667-0285-01 Inspec 89 g — — FDA listed —
ETADERM Numbing Cream 5 g/100g 84180-0001-01 NUEPHASE 44 g — — FDA listed —
Curist Lidocaine Numbing Relief 5 g/100g 72559-0012-08 Little 170 g — — FDA listed —
Curist Hemorrhoid Relief 5 g/100g 72559-0018-15 Little 1 tube — — Discontinued —
Acolye Numbing Cream Anorectal(Hemorrhoidal) Cream 5 g/100g 60771-0029-01 Guangzhou 60 g — — FDA listed —
Numb 520 5 g/100g 63742-0027-01 Clinical 1 bottle — — FDA listed —
Adellina Lidocaine Numbing Cream Topical Anorectal Cream 5 g/100g 83566-0614-01 Guangdong 60 g — — FDA listed —
Zmztuhua Numbing Cream 5 g/100g 87298-0050-01 Guangzhou 60 g — — FDA listed —
Acolye Numbing Cream Anorectal(Hemorrhoidal) Cream 5 g/100g 83566-0615-01 Guangdong 50 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
Feb 2023
📍
2026
Currently FDA-listed
3 years 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.

💡 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 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 3XUS85K0RA
    Butylene glycol is a clear liquid derived from petroleum or plants that acts as a humectant, solvent, and preservative booster in medicines. It helps keep formulations stable, dissolve active ingredients, and maintain moisture in topical products.
  • UNII 69VJ1LPN1S
    Cannabis sativa seed oil is a plant-based oil derived from hemp seeds. It's used in medicines as a carrier or emollient to help deliver active ingredients and improve product texture and absorption.
  • 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 59TL3WG5CO
    A synthetic polymer made by crosslinking acrylic acid with allyl sucrose. It thickens liquids, forms gels, and helps control how fast the medicine is released in your 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 8NLQ36F6MM
    Edetate disodium anhydrous is a chemical compound that binds to metal ions in a medicine. It's used as a stabilizer to prevent unwanted chemical reactions and help keep the drug product effective during storage.
  • UNII EG3PA2K3K5
    Ethylhexyl stearate is a waxy oil made from stearic acid and ethylhexyl alcohol. In medicines, it acts as an emollient and thickener to improve texture and help the product spread smoothly on skin or dissolve properly.
  • UNII 147D247K3P
    Ethylhexylglycerin is a synthetic preservative used to prevent bacteria and mold from growing in medicines and personal care products. It helps keep the product safe and stable throughout its 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 KEH0A3F75J
    Hexylene glycol is a clear liquid alcohol used as a solvent and preservative in medicines. It helps dissolve other ingredients and keeps the product stable during storage.
  • 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 YD01N1999R
    A waxy substance made from polyethylene glycol and stearic acid. It helps mix oil and water-based ingredients together and serves as an emulsifier and solubilizer in liquid and semi-solid medicines.
  • 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 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 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 R9N3379M4Z
    Sunflower seed is a plant-derived ingredient used as a filler and source of oil in medications. It helps add bulk to the formulation and may serve as a natural binding or lubricating component.
  • UNII 856YO1Z64F
    Turmeric is a natural spice derived from the turmeric plant root. It serves as a colorant in medicines, giving products a yellow or golden appearance, and may also provide mild flavoring.
  • 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.

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

The official label also statesWater/Aqua/Eau, Ethylhexyl Stearate, Butylene Glycol, Dimethicone, Stearic Acid, Caprylic/Capric Triglyceride, Cannabis Saliva (Hemp) Seed Oil, Glyceryl Stearate, PEG-100 Stearate, Cetearyl Alcohol, Helianthus Annuus (Sunflower) Seed Oil, Curcuma Longa (Turmeric) Root Extract, Allantoin, Glycerin, Tocopheryl Acetate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Sodium Hydroxide, Disodium EDTA

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

LabelerTelebrands Corp
FDA applicationM015 (OTC MONOGRAPH DRUG)
Labeler code73287
First marketedFeb 2023
Product typeHuman Otc Drug
Portfolio23 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.

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 16 words ▾

Uses For the temporary relief of local and anorectal discomfort associated with anorectal disorder or inflammation.

⏱️ Dosage and Administration 58 words ▾

Directions Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth, before application of this product to affected area. Apply to the affected area up to 6 times a day Children under 12 years of age: consult a doctor.

⚠️ Warnings 149 words ▾

Warnings For external use only Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use. When using this product do not exceed the recommended daily dosage unless directed by a doctor. use only as directed. Read and follow all directions and warnings on this label. do not put this product into the rectum by using finger or any mechanical device or applicator.

Stop use and ask a doctor if condition worsens or does not improve within 7 days in case of bleeding symptom being treated does not subside or if redness, irritation, sweeling, pain, or other symptoms develop or increase. Certain persons can develop allergic reactions to ingredients in this product. If pregnant or breast-feeding , ask a health professional before use.

Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 11 words ▾

Other information Do not use if seal is broken or missing

🧪 Active Ingredient 4 words ▾

Active ingredient Lidocaine 5%

🧪 Inactive Ingredients 51 words ▾

Inactive ingredients Water/Aqua/Eau, Ethylhexyl Stearate, Butylene Glycol, Dimethicone, Stearic Acid, Caprylic/Capric Triglyceride, Cannabis Saliva (Hemp) Seed Oil, Glyceryl Stearate, PEG-100 Stearate, Cetearyl Alcohol, Helianthus Annuus (Sunflower) Seed Oil, Curcuma Longa (Turmeric) Root Extract, Allantoin, Glycerin, Tocopheryl Acetate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Sodium Hydroxide, Disodium EDTA

🎯 Purpose 4 words ▾

Purpose Lidocaine 5%...........Local Anesthetic

📄 When Using This Product 47 words ▾

When using this product do not exceed the recommended daily dosage unless directed by a doctor. use only as directed. Read and follow all directions and warnings on this label. do not put this product into the rectum by using finger or any mechanical device or applicator.

📄 Stop Use and Ask a Doctor If 49 words ▾

Stop use and ask a doctor if condition worsens or does not improve within 7 days in case of bleeding symptom being treated does not subside or if redness, irritation, sweeling, pain, or other symptoms develop or increase. Certain persons can develop allergic reactions to ingredients in this product.

🤰 If Pregnant or Breast-Feeding 11 words ▾

If pregnant or breast-feeding , ask a health professional before use.

📄 Keep Out of Reach of Children 21 words ▾

Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away.

📄 Questions or Comments 7 words ▾

Questions? Call (855) 877-4503 (M-F, 9am-5pm EST)

📄 Package Label / Principal Display Panel 27 words ▾

Hempvana Maximum Strength Pain Relief Topical Anesthetic Cream 5% Lidocaine anorectal cream +Hemp Seed Oil For Moisturization Odor Free! Net Wt. 3 oz (85 g) 1 2

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.

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 Telebrands Corp. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Telebrands Corp 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.
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.