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CVS Health Concealing Acne Treatment Maximum Strength Adult Acne Treatment Benzoyl Peroxide 100 mg/g Cream — NDC 51316-0047-16 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

CVS Health Concealing Acne Treatment Maximum Strength Adult Acne Treatment Benzoyl Peroxide 100 mg/g Cream — NDC 51316-047-16 (Billing 51316-0047-16)

by CVS PHARMACY · 1 TUBE in 1 CARTON / 28 g in 1 TUBE

This is a package of CVS Health Concealing Acne Treatment Maximum Strength Adult Acne Treatment Benzoyl Peroxide 100 mg/g Cream from CVS PHARMACY, marketed since May 2019 and currently FDA-listed. It is this product's only package size.

NDC 51316-0047-16
🏷️ FDA NDC (as labeled) 51316-047-16 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 Benzoyl Peroxide (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Feb 24, 2025 — Chemical Contamination: Presence of benzene. (Denison Pharmaceuticals, LLC) · FDA recall D-0273-2025
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) 51316-047-16
Product NDC 51316-047
11-digit billing NDC 51316004716
RxCUI 106315
UNII W9WZN9A0GM
Application # M006
SPL Set ID fa402202-1750-e6eb-e053-6294a90a4e63
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-05-17
Route TOPICAL
Dosage form CREAM
Substance BENZOYL PEROXIDE
Quick answers
  • RxCUI (RxNorm): 106315
Why two NDCs? The FDA registers this code as 51316-047-16 — 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 → 51316-0047-16. 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 Peroxides class.

Drug family (ATC) Peroxides
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

📖 What it is MedlinePlus · NLM

Benzoyl peroxide is used to treat mild to moderate acne.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Most products are for acne. They dry up pimples and help prevent new ones. Epsolay is a prescription cream for rosacea bumps in adults. The Folliculitis Treatment Cream products ar...
  • For many acne products, start with once a day. You can move up to two or three times daily if your skin tolerates it. If you get dryness or peeling, cut back to once daily or every...
  • Redness, dryness, peeling, itching, and stinging or burning are the usual ones. Using less often can help. Using another acne product at the same time makes irritation more likely.
  • Stop if irritation gets severe. Stop right away and get help if you have hives, swelling or trouble breathing. Those can be signs of a serious allergic reaction.
📖 Read our full Benzoyl Peroxide guide →

Supplement & herbal interactions

Some supplements/herbs that may interact with Benzoyl Peroxide — tap one for details:

Dimethylsulfoxide (dmso)Moderate Turpentine OilModerate AlchemillaMinor
🌿 Every supplement checked against Benzoyl Peroxide (3 interactions) — ranked by severity →
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
51316-0047-16 You're viewing this Main listing 1 TUBE in 1 CARTON / 28 g in 1 TUBE 2019-05-17 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Rugby Benzoyl Peroxide Wash Acne Medication 100 mg/g 00536-1474-42 Rugby 237 g $0.047 — Availability likely —
Rugby Benzoyl Peroxide Wash Acne Medication 100 mg/g 00536-1351-42 Rugby 237 g $0.047 — Discontinued —
Rugby Benzoyl Peroxide Acne Medication 100 mg/g 00536-1459-25 Rugby 1 tube $0.231 — Availability likely —
Walgreens Maximum Strength Tinted Acne Spot Treatment Cream 100 mg/g 00363-0256-51 WALGREEN 1 tube — — FDA listed —
Oxy Maximum Strength Rapid Spot Treatment 100 mg/g 10742-1002-01 The 1 tube — — FDA listed —
Oxy Maximum Strength Acne Cream Cleanser 100 mg/mL 10742-1003-01 The 148 ml — — FDA listed —
OXY Rapid Spot Treatment Maximum Action 100 mg/g 10742-1301-01 The 1 tube — — FDA listed —
Meijer Invisible Acne Acne medication 100 mg/g 41250-0348-01 Meijer 1 tube — — FDA listed —
ZO Skin Health Acne Control Benzoyl Peroxide 100 mg/mL 42851-0087-60 ZO 1 tube — — FDA listed —
CVS Health Concealing Acne Treatment Maximum Strength Adult Acne Treatment 100 mg/gthis 51316-0047-16 CVS 1 tube — — FDA listed —
Clarity Clear Skin Solutions Acne Spot Treatment 1.5 g/15mL 54473-0402-01 Melaleuca, 15 ml — — FDA listed —
Modesa Acne Treatment 10 g/100g 55621-0017-01 Zhejiang 1 tube — — FDA listed —
Dermaclear Spot Treatment 100 mg/g 62742-4075-04 Allure 1 bottle — — FDA listed —
Clearasil Rapid Rescue Spot Treatment 10 g/100g 63824-0433-01 Reckitt 1 tube — — FDA listed —
Clearasil Stubborn Acne Control 5in1 Spot Treatment 10 g/100g 63824-0438-01 Reckitt 1 tube — — FDA listed —
Age Intervention Duality 10 g/100g 65113-2372-02 G.S. 28 g — — FDA listed —
Age Intervention Duality Md 10 g/100g 65113-2373-02 G.S. 28 g — — FDA listed —
Face Reality 10% Advanced Acne Med 100 mg/mL 70707-0158-01 Face 1 tube — — FDA listed —
Terminator 10 100 mg/mL 80861-0002-01 AcneFree, 1 tube — — FDA listed —
Caring mill Acne Treatment 100 mg/g 81522-0951-01 FSA 28 g — — FDA listed —
Replenix Acne 100 mg/g 51326-0412-57 Topiderm, 57 g — — FDA listed —
111 Medco Benzoyl Peroxide 100 mg/g 72811-0137-11 111 113 g — — FDA listed —
PanOxyl Acne Clearing Spot Treatment 100 mg/g 00316-0298-01 Crown 1 tube — — FDA listed —
Clean and Clear Persa-Gel 10 100 mg/g 69968-0212-01 Kenvue 1 tube — — FDA listed —
Rugby Benzoyl Peroxide Wash Acne Medication 100 mg/g 75376-0474-42 Guangzhou 237 g — — FDA listed —
OXY Advanced Care Soothing Cream Acne Cleanser 100 mg/g 10742-1206-01 The 3 g — — FDA listed —
Acne Treatment 100 mg/g 30142-0877-10 The 1 tube — — FDA listed —
Acne Cleanser 100 mg/g 41250-0264-56 Meijer, 141 g — — FDA listed —
Acne Treatment 100 mg/g 49035-0229-10 Walmart 1 tube — — FDA listed —
Walgreens Acne Control Cleanser Acne Medication 100 mg/g 00363-3602-01 Walgreen 142 g — — FDA listed —
Daily Acne Control Cleanser 100 mg/g 72288-0264-56 Amazon.com 141 g — — FDA listed —
Acne Treatment 100 mg/g 76162-0229-10 Topco 1 tube — — FDA listed —
Rugby Benzoyl Peroxide Acne Medication 100 mg/g 75376-0459-25 Guangzhou 1 tube — — FDA listed —
Oxy Advanced Care Rapid Spot Treatment 100 mg/g 10742-1201-01 The 1 tube — — FDA listed —
Acne Treatment 100 mg/g 72288-0229-10 Amazon.com 1 tube — — FDA listed —
Daily Acne Control Cleanser 100 mg/g 76162-0264-28 Topco 141 g — — FDA listed —
Signature Care Acne Medication 100 mg/g 21130-0730-17 SAFEWAY, 1 tube — — FDA listed —
Acne Cleanser 100 mg/g 49035-0264-56 Walmart, 141 g — — FDA listed —
PanOxyl 100 mg/g 00316-0228-01 Crown 1 tube — — Discontinued —
Walgreens Acne Foaming Wash Acne Medication 100 mg/g 00363-1522-01 Walgreen 156 g — — FDA listed —
CVS Health Acne Control Cleanser Acne Medication 100 mg/g 69842-0571-02 CVS 141 g — — FDA listed —
Meijer Maximum Strength Foaming Acne Face Wash Acne Medication 100 mg/g 79481-0022-01 Meijer 1 tube — — FDA listed —
Equate Acne Wash Acne medication 100 mg/g 79903-0061-01 Wal-Mart 1 tube — — FDA listed —
Target Up And Up Acne Medication 100 mg/g 11673-0088-17 TARGET 1 tube — — FDA listed —
Acne Treatment 100 mg/g 11822-7701-03 Rite 1 tube — — FDA listed —
Neutrogena Rapid Clear Stubborn Acne Spot 100 mg/g 69968-0043-01 Kenvue 1 tube — — FDA listed —
Oxy Advanced Care Rapid Spot Treatment 100 mg/g 10742-1205-01 The 2 g — — FDA listed —
Walgreens Maximum Strength Acne Gel 100 mg/g 00363-0266-51 WALGREEN 1 tube — — FDA listed —
Clean and Clear persa-gel 10 Maximum Strength 100 mg/g 69968-0720-01 Kenvue 1 tube — — FDA listed —
Replenix BP Acne 100 mg/g 51326-0841-20 Topiderm, 57 g — — FDA listed —
Oxy 10 Vanishing 100 mg/g 10742-8353-01 The 1 bottle — — FDA listed —
Oxy 10 Tinted 100 mg/g 10742-8354-01 The 1 bottle — — FDA listed —
Meijer Acne Treatment Acne medication 100 mg/g 41250-0347-01 Meijer 1 tube — — FDA listed —
Zitfree Acne Treatment 100 mg/g 67234-0035-01 Natureplex, 1 tube — — FDA listed —
Walgreens Maximum Strength Acne Treatment Acne medication 100 mg/g 00363-8798-01 Walgreen 1 tube — — FDA listed —
Walgreens Maximum Strength Acne Treatment 100 mg/g 00363-1363-17 WALGREEN 1 tube — — 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
May 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.

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

  • UNII 5QB0T2IUN0
    Aluminum hydroxide is a white powder mineral compound used as an antacid ingredient in some formulations. It works as a buffer and pH regulator to help neutralize stomach acid in the medicine.
  • UNII A3N5ZCN45C
    Bentonite is a naturally occurring clay mineral used in medicines as a binder and absorbent. It helps hold tablet ingredients together and can absorb moisture or unwanted substances in the formulation.
  • UNII Z135WT9208
    Carbomer is a synthetic polymer that forms a thick, gel-like consistency. It's used in medicines as a thickener and stabilizer to improve texture and keep ingredients evenly mixed throughout the product.
  • UNII 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 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 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • UNII 258491E1RZ
    A waxy substance made from glycerin and stearic acid, commonly used as an emulsifier to help blend oil and water ingredients together in medicines. It also helps thicken and stabilize the product's texture.
  • UNII 0RE8K4LNJS
    Isopropyl myristate is an oily liquid made from coconut or palm oil. It's used in medicines as an emollient and penetration enhancer to help the medicine absorb through skin or improve spreadability in topical products.
  • 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 WZH3C48M4T
    Potassium hydroxide is a strong alkaline chemical used in medicines to adjust and maintain the pH level of liquid formulations, helping keep the product stable and the active ingredients effective.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and 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 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • 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.

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

The official label also statesWater, Bentonite, Isopropyl Myristate, Propylene Glycol, Glyceryl Stearate, PEG-100 Stearate, Phenoxyethanol, Carbomer, Silica, Aluminum Hydroxide, Stearic Acid, Ethylhexylglycerin, Potassium Hydroxide, Titanium Dioxide, Iron Oxides

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

LabelerCVS PHARMACY
FDA applicationM006 (OTC MONOGRAPH DRUG)
Labeler code51316
First marketedMay 2019
Product typeHuman Otc Drug
Portfolio550 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 📄 Do Not Use 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 6 words ▾

Uses for the treatment of acne

⏱️ Dosage and Administration 92 words ▾

Directions Clean the skin thoroughly before applying this product Cover the entire affected area with a thin layer one to three times daily Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two to three times daily if needed or as directed by a doctor If bothersome dryness or peeling occurs, reduce application to once a day or every other day If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

⚠️ Warnings 5 words ▾

Warnings For external use only

🧪 Active Ingredient 5 words ▾

Active Ingredient Benzoyl peroxide 10%

🧪 Inactive Ingredients 26 words ▾

Inactive Ingredients Water, Bentonite, Isopropyl Myristate, Propylene Glycol, Glyceryl Stearate, PEG-100 Stearate, Phenoxyethanol, Carbomer, Silica, Aluminum Hydroxide, Stearic Acid, Ethylhexylglycerin, Potassium Hydroxide, Titanium Dioxide, Iron Oxides

🎯 Purpose 3 words ▾

Purpose Acne Medication

📄 Do Not Use 14 words ▾

Do not use if you have very sensitive skin are sensitive to benzoyl peroxide

📄 When Using This Product 94 words ▾

When using this product: avoid unnecessary sun exposure and use a sunscreen avoid contact with the eyes, lips, and mouth avoid contact with hair and dyed fabrics which may be bleached by this product skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration. skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

📄 Stop Use and Ask a Doctor If 9 words ▾

Stop use and ask doctor if irritation becomes severe.

📄 Keep Out of Reach of Children 20 words ▾

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

📄 Package Label / Principal Display Panel 3 words ▾

Label CVS33170K2 CVS33170A2

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 Epsolay (matched by generic name) — the program that covers self-administered drugs. 1 manufacturer.
⚠️ 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 Epsolay. 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
$60.9K
Claims incl. refills
82
Beneficiaries
63
Spend / beneficiary
$967.04
Spend / claim
$742.97
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 CVS PHARMACY. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
CVS PHARMACY 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.
← 51316-0044-01 · CVS 51316-0049-01 · 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.