Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
Dologesic Roll-On Lidocaine Hcl 4 g/100mL Liquid, 60 mL — NDC 54859-513-02 (Billing 54859-0513-02)
by Llorens Pharmaceutical International Division, Inc. · 60 mL in 1 BOTTLE
This is a package of 60 mL of Dologesic Roll-On Lidocaine Hcl 4 g/100mL Liquid from Llorens Pharmaceutical International Division, Inc., marketed since May 2018 and currently FDA-listed. It is this product's only package size.
NDC 54859-0513-02
🏷️ FDA NDC (as labeled)
54859-513-02
billing pads the product segment with a zero
🗂️ 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 54859-513-02 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 54859 labeler · 513 product · 02 package
- Package marketed since
- May 1, 2018
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Billing quantity
- 60 mL per package
- Barcode (UPC)
- 0354859513021
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
54859-513-02
Product NDC
54859-513
11-digit billing NDC
54859051302
NCPDP billing unit
ML — per mL (volume)
RxCUI
1987647
UNII
V13007Z41A
UPC
0354859513021
Application #
M017
SPL Set ID
81546810-85a8-45fe-b9e6-cdd02cc4c080
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
2018-05-01
Route
TOPICAL
Dosage form
LIQUID
Substance
LIDOCAINE HYDROCHLORIDE
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
GPI-14
90850060100940
GPI class
Dologesic Pain Relief Roll-On
GCN Seq No
080206
GCN
46917
HICL code
001478
Ingredient (HICL)
Lidocaine Hcl
HIC1 code
Q
Therapeutic class — broad (HIC1)
Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code
Q5
Therapeutic class — intermediate (HIC2)
Agents Acting Principally On The Skin
HIC3 code
Q5H
Therapeutic class — specific (HIC3)
Topical Local Anesthetics
AHFS code
72:00.00.00
AHFS class
Local Anesthetics
FDB label name
DOLOGESIC PAIN RLF 4% ROLL-ON
FDB brand name
Dologesic Pain Relief
Legend status
O — Over-the-counter (OTC) drug or device
Quick answers
- GSN (GCN sequence number): 080206
- GCN: 46917
- GPI-14 (Medi-Span): 90850060100940
- HICL (First Databank): 001478
- AHFS class code: 72:00.00.00
- RxCUI (RxNorm): 1987647
Why two NDCs?
The FDA registers this code as 54859-513-02 — 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 → 54859-0513-02. 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 3, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
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.
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Label name DOLOGESIC PAIN RLF 4% ROLL-ON Ingredient Lidocaine Hcl
📗 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?
Patient education
Supplement & herbal interactions
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.
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 3, 2026
💬 Questions about Lidocaine Hcl?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per mL | Per 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.
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 4, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 54859-0513-02 You're viewing this Main listing | 60 mL in 1 BOTTLE | 2018-05-01 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Walgreens Pain Relieving with Turmeric Analgesic 40 mg/mL 00363-1222-01 | Walgreen | 1 bottle | — | — | FDA listed | — |
| Walgreens Pain Relieving with Lavender Analgesic 40 mg/mL 00363-1225-01 | Walgreen | 1 bottle | — | — | FDA listed | — |
| Walgreen Pain Relieving Fragrance Free 4 g/100g 00363-7790-25 | WALGREENS | 1 bottle | — | — | FDA listed | — |
| TopCare Pain Relief Maximum Strength 4 g/100g 36800-0529-25 | TOPCO | 1 bottle | — | — | FDA listed | — |
| Aspercreme with Lidocaine No-Mess Applicator 4 g/100mL 41167-0581-00 | Chattem, | 1 bottle | — | — | FDA listed | — |
| Aspercreme with Lidocaine Essential Oils Rosemary Mint 4 g/100mL 41167-0598-07 | Chattem, | 1 bottle | — | — | FDA listed | — |
| Aspercreme with lidocaine No-Mess Applicator Two Pack 4 g/100mL 41167-0599-09 | Chattem, | 2 bottles | — | — | FDA listed | — |
| Icy Hot Lidocaine No-Mess 4 g/100g 41167-1711-00 | Chattem, | 42.5 g | — | — | FDA listed | — |
| Meijer Odor Free Analgesic Pain Relieving Topical Analgesic 40 mg/mL 41250-0351-01 | Meijer | 1 cylinder | — | — | FDA listed | — |
| Good Sense Pain Relief Roll On 4 g/100g 50804-0187-02 | Geiss, | 71 g | — | — | FDA listed | — |
| Dologesic Roll-On 4 g/100mLthis 54859-0513-02 | Llorens | 60 ml | — | — | FDA listed | — |
| Theraworx Pain Relief Roll- On- Lidocaine 40 mg/mL 61594-0028-00 | AVADIM | 1 bottle | — | — | FDA listed | — |
| Theraworx Pain Relief Roll-On with Lidocaine for Diabetics 40 mg/mL 61594-0030-00 | AVADIM | 74 ml | — | — | FDA listed | — |
| Theraworx PM Nighttime Maximum Strength Pain Relief 40 mg/mL 61594-0044-00 | AVADIM | 1 bottle | — | — | FDA listed | — |
| Bactine Max Lidocaine Roll-on 2.5oz 4 g/100g 65197-0840-25 | WellSpring | 1 bottle | — | — | FDA listed | — |
| pain relief roll-on 4 g/100mL 69452-0393-63 | Bionpharma | 1 bottle | — | — | FDA listed | — |
| Lipoflavonoid Ear Pain Kids Relief Drops 4 g/100mL 69693-0902-04 | Clarion | 12.4 ml | — | — | FDA listed | — |
| IceQuake Lidocaine Analgesic 4 g/100mL 69822-0430-03 | Southern | 74 ml | — | — | FDA listed | — |
| Lidocaine Pain Relief Roll-On 4 g/100mL 69842-0029-97 | CVS | 1 bottle | — | — | FDA listed | — |
| Leader Lidocaine 4 g/100mL 70000-0099-01 | CARDINAL | 1 bottle | — | — | FDA listed | — |
| Meijer Pain Relieving Max Strength with Lavender Essential Oil Analgesic 40 mg/mL 79481-0019-01 | Meijer | 1 cylinder | — | — | FDA listed | — |
| DOCTORS TOUCH Erase The Pain Lidocaine 40 mg/mL 80045-0400-00 | DOCTOR'S | 90 ml | — | — | FDA listed | — |
| Thera Plus Max Strength Lidocaine Pain Relief Liquid 40 mg/mL 80684-0098-00 | Fourstar | 74 ml | — | — | FDA listed | — |
| QUALITY CHOICE Maximum Strength Lidocaine Pain Relief Roll On 4 g/100g 83324-0226-71 | CHAIN | 1 bottle | — | — | FDA listed | — |
| AUVON Pain Relief Roll-on 4 g/100mL 83391-0004-01 | SHENZHEN | 74 ml | — | — | FDA listed | — |
| Aspercreme Lidocaine No-Mess plus Lavender 4 g/100mL 41167-0568-05 | Chattem, | 1 bottle | — | — | 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
🏛️
2018
On the market since
May 2018
📍
2026
Currently FDA-listed
8 years listed
🔒
·
Generic approved (availability unconfirmed)
see note
🔒Generic approved by FDA, but pharmacy availability is not confirmed
The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.
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.
- FDA Orange Book · refreshed Oct 3, 2026
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 5TJD82A1ET
A cooling crystalline substance made synthetically that is added to medicines as a fragrance, flavoring agent, and mild local irritant to produce a cooling or warming sensation on the skin or mucous membranes.
-
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 ND2M416302
Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
-
UNII L7T10EIP3A
A cooling compound from mint plants used as a flavoring agent and to create a fresh sensation in medicines. It helps mask bitter tastes and improve how the product feels in the mouth.
-
UNII A2I8C7HI9T
Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
-
UNII Z8IX2SC1OH
Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
-
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.
-
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.
8 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesInactive ingredients camphor, glycerin, isopropyl alcohol, menthol, methylparaben, propylparaben, purified water and xantham 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.- FDA label on DailyMed · label index refreshed Oct 3, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
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
LabelerLlorens Pharmaceutical International Division, Inc.
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code54859
First marketedMay 2018
Product typeHuman Otc Drug
Portfolio12 products on file
More NDCs from Llorens Pharmaceutical International Division, I... labeler code 54859
- Tusnel Diabetic Dextromethorphan, Guaifenesin 10 mg/5mL; 100 mg/5mL Liquid NDC 54859-505-04
- Tusnel SF Dextromethorphan HBr, Guaifenesin 10 mg/5mL; 100 mg/5mL Liquid NDC 54859-506-04
- Tusnel EX Guaifenesin 100 mg/5mL Liquid NDC 54859-507-04
- Triponel Dextromethorphan HBr, Phenylephrine HCl, Triprolidine HCl 15 mg/5mL; 5 mg/5mL; 1.25 mg/5mL Liquid NDC 54859-508-16
- Tusnel Cough Suppressant Expectorant Dextromethorphan HBr, Guaifenesin 10 mg/5mL; 100 mg/5mL Liquid NDC 54859-509-16
- Llorens Care Tussin Guaifenesin 100 mg/5mL Liquid NDC 54859-510-16
- Triponel Dextromethorphan HBr, Pseufoephedrine HCl, Triprolidine HCl 15 mg/5mL; 30 mg/5mL; 30 mg/5mL Liquid NDC 54859-514-16
- Tusnel DM Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl 20 mg/5mL; 400 mg/5mL; 10 mg/5mL Liquid NDC 54859-517-16
- Tusnel Pediatric Dextromethorphan, Guiafenesin, Pseudoephedrine HCl 5 mg/5mL; 50 mg/5mL; 15 mg/5mL Liquid NDC 54859-544-04
- Tusnel DM Pediatric Dextromethorphan, Guiafenesin, Pseudoephedrine HCl 25 mg/mL; 7.5 mg/mL; 2.5 mg/mL Solution/ Drops NDC 54859-603-02
- Tusnel Pediatric DM Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl 5 mg/5mL; 75 mg/5mL; 2.5 mg/5mL Liquid NDC 54859-604-16
- Tusnel Pediatric Drops Guaifenesin, Phenylephrine HCl 25 mg/mL; 1.25 mg/mL Solution/ Drops NDC 54859-605-01
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 openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
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
🤰 If Pregnant or Breast-Feeding
📄 Keep Out of Reach of Children
📄 Questions or Comments
📄 Package Label / Principal Display Panel
🎯 Indications and Usage ▾
Use Temporarily relieves minor pains
⏱️ Dosage and Administration ▾
Directions Adults and children over 12 years of age Apply generously to the affected area as needed every 6-8 hours, not to exceed 3 application in a 24 hour period. Not for use in children under 12 years of age.
⚠️ Warnings ▾
Warnings For external use only Do not use on large areas of the body or on cut, irritated or swollen skin on puncture wounds for more than one week without consulting a doctor When using this product use only as directed. Read and follow all directions and warnings on this label. do not allow contact with eyes do not bandage or apply local heat (such as heating pads) to the area of use. Stop use and ask doctor if condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days
🧪 Active Ingredient ▾
Active Ingredient Lidocaine HCL, USP 4%
🧪 Inactive Ingredients ▾
Inactive ingredients camphor, glycerin, isopropyl alcohol, menthol, methylparaben, propylparaben, purified water and xantham gum.
🎯 Purpose ▾
Purpose Topical Anesthetic
🤰 If Pregnant or Breast-Feeding ▾
If pregnant or breast-feeding, ask a doctor before use.
📄 Keep Out of Reach of Children ▾
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
📄 Questions or Comments ▾
Questions Llorens Pharmaceutical International Division, Inc. Miami Fl 33147
📄 Package Label / Principal Display Panel ▾
DologesicRollOn
No label section mentions that — try another word, or open the full label on DailyMed below.
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 HCl Viscous (matched by generic name) — the program that covers self-administered drugs. 4 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 HCl Viscous. CMS lists 5 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
$2.02M
Claims incl. refills
110.4K
Beneficiaries
87.1K
Spend / beneficiary
$23.19
Spend / claim
$18.30
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 Dologesic Roll-On (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 33%
Female · 67%
Unknown · 0%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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 Llorens Pharmaceutical International Division, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Llorens Pharmaceutical International Division, 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.
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.