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Lipocaine 5 Lidocaine 5% 5 g/100g Cream — NDC 63135-0811-30 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Lipocaine 5 Lidocaine 5% 5 g/100g Cream — NDC 63135-811-30 (Billing 63135-0811-30)

by ESBA LABORATORIES INC. · 1 TUBE in 1 CARTON / 30 g in 1 TUBE

This is a package of Lipocaine 5 Lidocaine 5% 5 g/100g Cream from ESBA LABORATORIES INC., marketed since Mar 2019 and currently FDA-listed.

NDC 63135-0811-30
🏷️ FDA NDC (as labeled) 63135-811-30 billing pads the product segment with a zero
This package
Contains30 g in 1 tube Pack sizes2 compare ↓
Product page 63135-0811-04 Also comes in: 113 g 63135-811-04
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 63135-811-30 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
63135 labeler · 811 product · 30 package
Package marketed since
Mar 18, 2019
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC)
0606604811303
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 63135-811-30
Product NDC 63135-811
11-digit billing NDC 63135081130
NCPDP billing unit GM — per gram (weight)
RxCUI 1534792, 2120175
UNII 98PI200987
UPC 0606604811303
Application # M015
SPL Set ID 849d6e28-a6b8-7f49-e053-2a91aa0a497d
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 2019-03-18
Route TOPICAL
Dosage form CREAM
Substance LIDOCAINE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 89200025003720
GPI class Lipocaine 5
Quick answers
  • GPI-14 (Medi-Span): 89200025003720
  • RxCUI (RxNorm): 1534792
Why two NDCs? The FDA registers this code as 63135-811-30 — 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 → 63135-0811-30. 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 →

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.

Pricing

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

Price systemPer gPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 113 g
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
63135-0811-04 63135-811-04 Main listing 113 g in 1 TUBE 2019-03-18 — Active
63135-0811-30 You're viewing this 1 TUBE in 1 CARTON / 30 g in 1 TUBE 2019-03-18 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 tube in 1 carton / 30 g in 1 tube.
What NDC number is used to bill for this package of Lipocaine 5 Lidocaine 5% 5 g/100g Cream?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
RectaSmoothe 5 g/100g 69315-0301-30 Leading 1 tube $0.458 — Discontinued —
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/100gthis 63135-0811-30 ESBA 1 tube — — 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/100g 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 —
Rite Aid Rectal Care 5 g/100g 11822-0265-01 Rite 1 tube — — FDA listed —
Topicaine 5 5 g/100g 63135-0581-04 ESBA 113 g — — FDA listed —
Curist Lidocaine Relief 5 g/100g 72559-0024-32 Little 57 g — — FDA listed —
Lubricaine 5 5 g/100g 63135-0924-04 ESBA 113 g — — FDA listed —
Formula 2 Skin Care 5 g/100g 72839-0265-00 Derma 28 g — — FDA listed —
Hempvana Maximum Strength Pain Relief Topical Anesthetic Platinum 5 g/100g 73287-0040-01 Telebrands 1 jar — — FDA listed —
Anecream 5 5 g/100g 24357-0702-15 Focus 1 tube — — FDA listed —
Doctor Butlers Hemorrhoid and Fissure External Pain Formula 5 g/100g 70942-0121-01 Beyond 28 g — — FDA listed —
Lidocaine anorectal cream 5 g/100g 85833-0001-04 EveryMarket 1 jar — — FDA listed —
Rectal Care Cream Revivol 5 g/100g 72839-0141-01 Derma 28 g — — FDA listed —
Moshe Numbing Hemorrhoidal 5 g/100g 72839-0218-01 Derma 42.5 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

🏛️
2019
On the market since
Mar 2019
📍
2026
Currently FDA-listed
7 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

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.

  • 0.5 g / 100 g UNII WR1WPI7EW8
    A synthetic form of vitamin E used as an antioxidant. It prevents oils and fats in the medicine from breaking down and becoming rancid, helping keep the product stable during storage.
  • 0.5 g / 100 g UNII S347WMO6M4
    Beta-sitosterol is a plant-derived sterol (waxy substance from vegetable oils and seeds). In medicines, it acts as an emulsifier or thickening agent to help blend oil and water-based ingredients and improve texture.
  • 0.01 g / 100 g 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.
  • 0.01 g / 100 g UNII ZY81Z83H0X
    Aloe vera leaf is a plant extract derived from the aloe plant. It is used in medicines as a natural moisturizer and skin-soothing agent in topical formulations.
  • 0.12 g / 100 g UNII UPY805K99W
    A synthetic compound derived from caprylic acid that works as a preservative and antimicrobial agent to help prevent bacterial and fungal growth in the medicine.
  • 0.25 g / 100 g UNII 936JST6JCN
    Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
  • 5 g / 100 g UNII 5ZA2S6B08X
    Cetyl palmitate is a waxy substance made from natural fats. It works as a binder and thickener to help hold the medicine together and control how it dissolves in your body.
  • 0.48 g / 100 g 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.
  • 0.6 g / 100 g UNII TM2TZD4G4A
    A plant-derived oily substance used as an emulsifier and solubilizer in medicines. It helps blend water and oil-based ingredients together and improves how the body absorbs certain active drugs.
  • 0.25 g / 100 g UNII Q613OCQ44Y
    Isostearyl alcohol is a fatty alcohol derived from plant or petroleum sources. It acts as an emollient and thickener in formulations, helping to soften the product and improve texture and stability.
  • 0.01 g / 100 g UNII 834K0WOS5G
    A natural fat extracted from sunflower seeds. It acts as an emulsifier and lubricant in medicines, helping mix ingredients that don't normally blend together and allowing the product to flow smoothly during manufacturing.
  • 2 g / 100 g UNII 33X4X4B90S
    Sucrose distearate is an emulsifier made from sugar and stearic acid. It helps mix oil and water-based ingredients together and improves the texture and stability of the medicine.
  • 2 g / 100 g UNII 274KW0O50M
    Sucrose stearate is a compound made from sugar and stearic acid (a fatty substance). It works as an emulsifier and surfactant to help mix oils and water-based ingredients together in the medicine.
  • 10 g / 100 g UNII 8Z96QXD6UM
    Triethyl citrate is a clear liquid derived from citric acid. It acts as a plasticizer and solvent in tablet coatings and film formulations, helping the coating remain flexible and adhere properly to the medicine.
  • 71.77 g / 100 g 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.
  • 1.5 g / 100 g UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

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

The official label also statesAllantoin, Aloe Barbadensis Leaf Extract, Beta-Sitosterol, Caprylhydroxamic Acid, Cetyl Alcohol, Cetyl Palmitate, Glycerin, Glyceryl Caprylate, Isostearyl Alcohol, Lecithin, Purified Water, Sucrose Distearate, Sucrose Stearate, Tocopheryl Acetate, Triethylcitrate, Xanthan Gum.

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

LabelerESBA LABORATORIES INC.
FDA applicationM015 (OTC MONOGRAPH DRUG)
Labeler code63135
First marketedMar 2019
Product typeHuman Otc Drug
Portfolio5 products on file

More NDCs from ESBA LABORATORIES INC. labeler code 63135

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 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 12 words ▾

Use For temporary relief of pain and itching due to anorectal disorders.

⏱️ Dosage and Administration 57 words ▾

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

⚠️ Warnings 103 words ▾

Warnings For external use only. When using this product: avoid contact with eyes do not use in large quantities, particularly over raw surfaces or blistered areas do not put in rectum do not exceed recommended dosage unless directed by a doctor. Stop use and ask a doctor if: allergic reaction occurs rectal bleeding occurs condition worsens or does not improve within 7 days symptoms clear up and return within a few days redness, irritation, swelling, pain or other symptoms begin or increase.

Keep out of the reach of children: If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

🧪 Active Ingredient 4 words ▾

Active ingredient: Lidocaine 5%

🧪 Inactive Ingredients 32 words ▾

Inactive ingredients: Allantoin, Aloe Barbadensis Leaf Extract, Beta-Sitosterol, Caprylhydroxamic Acid, Cetyl Alcohol, Cetyl Palmitate, Glycerin, Glyceryl Caprylate, Isostearyl Alcohol, Lecithin, Purified Water, Sucrose Distearate, Sucrose Stearate , Tocopheryl Acetate, Triethylcitrate, Xanthan Gum.

🎯 Purpose 3 words ▾

Purpose Topical Anesthetic

📄 When Using This Product 36 words ▾

When using this product: avoid contact with eyes do not use in large quantities, particularly over raw surfaces or blistered areas do not put in rectum do not exceed recommended dosage unless directed by a doctor.

📄 Stop Use and Ask a Doctor If 41 words ▾

Stop use and ask a doctor if: allergic reaction occurs rectal bleeding occurs condition worsens or does not improve within 7 days symptoms clear up and return within a few days redness, irritation, swelling, pain or other symptoms begin or increase.

📄 Keep Out of Reach of Children 21 words ▾

Keep out of the reach of children: If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

📄 Other Information 28 words ▾

Other information: Store at room temperature 20-25oC (68-77oF). Child-Resistant Cap: push down and turn to open Available in 1 Oz (30 g) and 4 Oz (113 g) tubes

📄 Questions or Comments 20 words ▾

Questions Call toll-free in USA & Canada 800-677-9299 9 am - 5 pm (EST) M - F or visit www.esbalabs.com

📄 Package Label / Principal Display Panel 48 words ▾

Label on tube and outer carton Lipocaine 5 tube 113 grams label Lipocaine 5 tube 30 grams label Outer carton of Lipocaine 5 - 30 g tube Lipocaine 5- tube 113 grams label Label Lipocaine 5 - 30 g tube Outer carton Lipocaine 5 - 30 g tube

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

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 5% — the ingredient across all brands.

Top reported reactions

Nausea42
Pain30
Headache28
Dizziness26
Fatigue24
Vomiting24
Hypotension22

Age at onset

Infant1
Child1
Adult26
Elderly14

Reporter sex

556 reports
Male · 42%
Female · 57%
Unknown · 1%

Serious outcomes

Hospitalization181
Life-threatening59
Death43
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 35 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.

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 ESBA LABORATORIES INC.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 113 g (63135-0811-04). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
ESBA LABORATORIES 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.
← 63135-0727-04 · ESBA 63135-0924-04 · ESBA →
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.