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CVS Hemorrhoidal Lidocaine 5 Rapid Pain Relief with 10 Finger Cots Kit — NDC 51316-204-01 (Billing 51316-0204-01)

by CVS PHARMACY, INC · 1 KIT in 1 KIT * 30 g in 1 TUBE

This is a package of CVS Hemorrhoidal Lidocaine 5 Rapid Pain Relief with 10 Finger Cots Kit from CVS PHARMACY, INC, marketed since Nov 2025 and currently FDA-listed. It is this product's only package size.

NDC 51316-0204-01
🏷️ FDA NDC (as labeled) 51316-204-01 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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
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) 51316-204-01
Product NDC 51316-204
11-digit billing NDC 51316020401
RxCUI 1366789
UPC 0050428031230
Application # M015
SPL Set ID caef51a8-76e9-42b3-a160-c54f62b47de1
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-11-30
Dosage form KIT
Quick answers
  • RxCUI (RxNorm): 1366789
Why two NDCs? The FDA registers this code as 51316-204-01 — 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 → 51316-0204-01. 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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
51316-0204-01 You're viewing this Main listing 1 KIT in 1 KIT * 30 g in 1 TUBE 2025-11-30 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Leader Maximum Strength Hemorrhoidal Relief 50 mg/g 70000-0650-01 Cardinal 1 tube $0.399 — Availability likely —
lidocaine 50 mg/g 75834-0333-30 Nivagen 30 g $0.399 — Availability likely —
Lidocaine 5% 5 g/100g 24689-0124-01 Apnar 1 tube $0.426 — FDA listed —
RectaSmoothe 5 g/100g 69315-0301-30 Leading 1 tube $0.458 — Discontinued —
Lidocaine Anorectal 50 mg/g 39328-0025-15 Patrin 1 tube $1.249 — Availability likely —
Walgreens Anorectal Lidocaine Cream 50 mg/g 00363-5722-28 Walgreens 1 tube — — FDA listed —
Lmx5 50 mg/g 00496-0883-15 Ferndale 15 g — — FDA listed —
Recticare 50 mg/g 00496-0892-15 Ferndale 15 g — — FDA listed —
Oxify 50 mg/g 11383-0002-06 Weeks 170 g — — FDA listed —
Oxify 50 mg/g 11383-0003-06 Weeks 170 g — — FDA listed —
Rite Aid Rectal Care 5 g/100g 11822-0265-01 Rite 1 tube — — FDA listed —
Anecream 5 5 g/100g 24357-0702-15 Focus 1 tube — — FDA listed —
CVS Hemorrhoidal Lidocaine 5 Rapid Pain Relief with 10 Finger Cotsthis 51316-0204-01 CVS 1 kit — — FDA listed —
Maximum Strength Hemorrhoidal Relief 50 mg/g 51316-0226-00 CVS 1 tube — — FDA listed —
MAXIMUM STRENGTH HEMORRHOIDAL RELIEF with Finger Cots 50 mg/g 51316-0229-00 CVS 1 tube — — FDA listed —
HemAway 1.5 g/30g 54473-0336-01 Melaleuca, 1 tube — — FDA listed —
Family Wellness Anorectal Lidocaine 50 mg/g 55319-0826-28 FAMILY 1 tube — — FDA listed —
Lidonumb .05 g/g 57237-0353-15 Rising 1 tube — — FDA listed —
RWWXII Deep Numbing Cream(Anorectal Hemorrhoidal Cream) 5 g/100g 60771-0027-01 Guangzhou 50 g — — FDA listed —
Acolye Numbing Cream Anorectal(Hemorrhoidal) Cream 5 g/100g 60771-0028-01 Guangzhou 50 g — — FDA listed —
Acolye Numbing Cream Anorectal(Hemorrhoidal) Cream 5 g/100g 60771-0029-01 Guangzhou 60 g — — FDA listed —
Adellina Lidocaine Numbing Cream Anorectal(Hemorrhoidal) Cream 5 g/100g 60771-0041-01 Guangzhou 60 g — — FDA listed —
Numb 520 5 g/100g 63742-0027-01 Clinical 1 bottle — — FDA listed —
Numb Master 50 mg/g 63742-0032-01 Clinical 1 bottle — — FDA listed —
Numb520 50 mg/g 63742-0033-01 Clinical 1 bottle — — FDA listed —
Numb25 50 mg/g 63742-0035-01 Clinical 38 g — — FDA listed —
Quick Numb 50 mg/g 63742-0333-01 Clinical 35.43 g — — FDA listed —
Numb and Number Anorectal Cream 5 g/100g 68848-0002-01 Dermtech 54 g — — FDA listed —
Rectal Care Cream 5 g/100g 69168-0484-02 Allegiant 1 tube — — FDA listed —
RectaEase Hemorrhoid Relief Cream 50 mg/g 69396-0070-01 Trifecta 1 tube — — FDA listed —
Retalief Lidocaine 5 .05 g/g 69618-0075-78 Reliable 1 tube — — FDA listed —
Zensa 5 g/100g 69805-0786-01 Alera 1 tube — — FDA listed —
Dr. Numb 1.5 g/30g 69903-0001-30 Shinpharma 1 tube — — FDA listed —
Dr. Numb .5 g/10g 69903-0004-10 Shinpharma 1 tube — — FDA listed —
Dr. Numb 5 g/100mL 69903-0006-02 Shinpharma 60 ml — — FDA listed —
Numbskin Maximum Strength Pain Reliever 5 g/100mL 69903-0008-30 Shinpharma 60 ml — — FDA listed —
Doctor Butlers Hemorrhoid and Fissure External Pain Formula 5 g/100g 70942-0121-01 Beyond 28 g — — FDA listed —
RectoProtect 5 g/100g 71399-0050-01 Akron 5 g — — FDA listed —
Curist Lidocaine Numbing Relief 5 g/100g 72559-0012-08 Little 170 g — — FDA listed —
Curist Lidocaine Relief 5 g/100g 72559-0024-32 Little 57 g — — FDA listed —
Numb 520 50 mg/g 72654-0033-02 Ebanel 125 g — — FDA listed —
Numb25 50 mg/g 72654-0035-01 Ebanel 38 g — — FDA listed —
Numb25 50 mg/g 72654-0036-02 Ebanel 125 g — — 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 —
Formula 2 Skin Care 5 g/100g 72839-0265-00 Derma 28 g — — FDA listed —
Hemorrhoid Relief Cream 50 mg/g 73492-0712-28 ALAINA 1 tube — — FDA listed —
Equate Hemorrhoid Relief 50 mg/g 79903-0109-30 WALMART, 1 tube — — FDA listed —
Lidocaine cream 5 g/100g 80489-0949-01 OL 1 tube — — FDA listed —
PUREGEN LABS Maximum Strength Lidocaine 50 mg/g 80513-0813-06 Advanced 170 g — — FDA listed —
SIMPLY VITAL HEMORRHOID and ANORECTAL RELIEF 50 mg/mL 82460-0262-00 ALPHA 30 ml — — FDA listed —
Lidocaine 5% Cream 50 mg/g 82461-0420-30 Medcore 1 tube — — FDA listed —
HemRid Anorectal Cream 50 mg/g 82620-0001-01 KKA 1 tube — — FDA listed —
Adellina Lidocaine Numbing Cream Topical Anorectal Cream 5 g/100g 83566-0612-02 Guangdong 50 g — — FDA listed —
Lidocaine Numbing Cream .05 g/g 83602-0311-36 Guangzhou 1 jar — — FDA listed —
DR REAL NUMB Topical Anorectal 50 mg/g 83800-0430-00 FUZZYLULU 1 tube — — FDA listed —
Bloop Fissure Healing Anorectal Topical 5 g/100g 83838-0153-01 Three 1 tube — — FDA listed —
Dr. Care Numbing Cream 50 mg/g 84019-0038-01 Shengnan 30 g — — FDA listed —
Signature numbing cream 50 mg/g 84019-0039-01 Shengnan 10 g — — FDA listed —
Dr Wellskin Numbing Cream 50 mg/g 84019-0040-01 Shengnan 30 g — — FDA listed —
Signature numbing cream 50 mg/g 84019-0041-01 Shengnan 30 g — — FDA listed —
ETADERM Numbing Cream 5 g/100g 84180-0001-01 NUEPHASE 44 g — — FDA listed —
Bunnies Bum Hemorrhoidal Numbing 5 g/100g 84308-0159-01 FloCal 28 g — — FDA listed —
VBBV Anorectal(Hemorrhoidal) Creams 5 g/100mL 84867-0020-01 Jiashen 60 ml — — FDA listed —
Jakwork Numbing Cream 5 g/100g 85150-0001-01 Guangzhou 50 g — — FDA listed —
PUVIDA NUMBING Cream Anorectal (Hemorrhoidal) Cream 5 g/100g 85248-0224-01 Jiangxi 50 g — — FDA listed —
Treatonic 5% Lidocaine Cream 3 g/60g 85569-0014-01 100 60 g — — FDA listed —
Lidocaine anorectal cream 5 g/100g 85833-0001-04 EveryMarket 1 jar — — FDA listed —
Nupharmisto NumbMD LIDOCAINE cream anorectal (hemorrhoidal) 4 g/80g 85833-0002-01 EveryMarket 80 g — — FDA listed —
Nupharmisto NumbMD 5% Lidocaine cream 4 g/80g 85833-0003-01 EveryMarket 80 g — — FDA listed —
Nupharmisto NumbMD Lidocaine Cream 4 g/80g 85833-0004-01 EveryMarket 80 g — — FDA listed —
Nupharmisto NumbMD Lidocaine Cream 4 g/80g 85833-0005-01 EveryMarket 80 g — — FDA listed —
NumbMD Lidocaine Cream Anorectal(hemorrhoidal) 3 g/60g 85833-0006-01 EveryMarket 60 g — — FDA listed —
Gniby - LIDOCAINE ANORECTAL HEMORRHOIDAL 5 g/100g 87152-0002-01 Putian 50 g — — FDA listed —
Gniby LIDOCAINE ANORECTAL HEMORRHOIDAL Numbing 5 g/100g 87152-0003-01 Putian 50 g — — FDA listed —
tuiwaro LIDOCAINE Cream 5 g/100g 87408-0020-01 Guangzhou 1 bottle — — FDA listed —
Oudetas Lidocaine Cream 5 g/100g 87408-0022-01 Guangzhou 1 bottle — — FDA listed —
Numb Fast Hemorrhoidal 50 mg/mL 87459-0906-00 Oasis 1 tube — — FDA listed —
LidoPure Patch 59088-0712-00 PureTek 1 kit — — FDA listed —
Lidoxryl 59088-0722-00 PureTek 1 kit — — FDA listed —
Relivyx Plus 72835-0555-02 V2 1 kit — — FDA listed —
Dr. Scholls Blister Pain Relief Complete 73469-0487-08 Scholl's 1 patch — — FDA listed —
Dr. Scholls Blister Pain Relief Complete 73469-0488-02 Scholl's 1 patch — — FDA listed —
DermacinRx PHN Pak 59088-0807-00 PureTek 1 kit — — FDA listed —
Elemar Patch 72835-0502-02 V2 1 kit — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2025
On the market since
Nov 2025
📍
2026
Currently FDA-listed
1 year 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.

From the label’s inactive-ingredient sectionaloe vera oil, benzyl alcohol, carbomer homopolymer, cholesterol, isopropyl myristate, mineral oil, polysorbate 80, propylene glycol, purified water, sodium hydroxide, vitamin E

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

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

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerCVS PHARMACY, INC
FDA applicationM015 (OTC MONOGRAPH DRUG)
Labeler code51316
First marketedNov 2025
Product typeHuman Otc Drug
Portfolio104 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 ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 15 words ▾

Uses helps relieve the pain, itching and burning associated with hemorrhoids and other anorectal disorders.

⏱️ Dosage and Administration 81 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 and older: apply externally to the affected area up to 6 times a day. children under 12 years of age: consult a doctor To use finger cots: Roll one finger cot over finger. Gently squeeze cream onto finger cot. Smooth a layer of the cream over affected area.

⚠️ Warnings 124 words ▾

Warnings For external use only. When using this product avoid contact with the eyes do not exceed the recommended daily dosage unless directed by a doctor do not put into the rectum by using fingers or any mechanical device or applicator Stop use and ask a doctor if rectal bleeding occurs condition worsens or does not improve within 7 days allergic reaction occurs to ingredients in this product symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase symptoms clear up and return within a few days If pregnant or breastfeeding ask a health professional before use.

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

🧪 Active Ingredient 8 words ▾

Active ingredient Lidocaine 5% w/w Purpose Local anesthetic

🧪 Inactive Ingredients 24 words ▾

Inactive ingredients aloe vera oil, benzyl alcohol, carbomer homopolymer, cholesterol, isopropyl myristate, mineral oil, polysorbate 80, propylene glycol, purified water, sodium hydroxide, vitamin E

🎯 Purpose 3 words ▾

Purpose Local anesthetic

📄 When Using This Product 36 words ▾

When using this product avoid contact with the eyes do not exceed the recommended daily dosage unless directed by a doctor do not put into the rectum by using fingers or any mechanical device or applicator

📄 Stop Use and Ask a Doctor If 54 words ▾

Stop use and ask a doctor if rectal bleeding occurs condition worsens or does not improve within 7 days allergic reaction occurs to ingredients in this product symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase symptoms clear up and return within a few days

🤰 If Pregnant or Breast-Feeding 10 words ▾

If pregnant or breastfeeding ask a health professional before use.

📄 Keep Out of Reach of Children 19 words ▾

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

📄 Questions or Comments 9 words ▾

Questions? 1-800-639-3803 Weekdays 9 AM to 4 PM EST

📄 Package Label / Principal Display Panel 6 words ▾

Package Labeling: Outer Package Inner Package

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 CVS Hemorrhoidal Lidocaine 5 Rapid Pain Relief with 10 Finger Cots (this brand).

Top reported reactions

Pain3,169
Fatigue3,039
Nausea3,029
Headache2,802
Dyspnoea2,167
Pneumonia2,002
Diarrhoea1,965

Age at onset

Neonate144
Infant62
Child363
Adolescent258
Adult4,906
Elderly3,132

Reporter sex

48,649 reports
Male · 37%
Female · 63%
Unknown · 0%
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 5,398 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 Kit / multi-component package

Kit / multi-component package

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

What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
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 CVS PHARMACY, INC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
CVS PHARMACY, 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.
← 51316-0203-01 · CVS 51316-0205-10 · CVS →
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.