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BOA VIDA Calvida ZINC OXIDE 20 g/100mL Cream, 148 mL — NDC 62654-0145-05 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

BOA VIDA Calvida ZINC OXIDE 20 g/100mL Cream, 148 mL — NDC 62654-145-05 (Billing 62654-0145-05)

by Central Solutions Inc · 148 mL in 1 BOTTLE, PLASTIC

This is a package of 148 mL of BOA VIDA Calvida ZINC OXIDE 20 g/100mL Cream from Central Solutions Inc, marketed since Nov 2011 and currently FDA-listed.

NDC 62654-0145-05
🏷️ FDA NDC (as labeled) 62654-145-05 billing pads the product segment with a zero
This package
Contains148 mL Pack sizes2 compare ↓
Product page 62654-0145-04 Also comes in: 118 ml 62654-145-04
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

NDC database record

One package, one record: these facts belong to NDC 62654-145-05 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
62654 labeler · 145 product · 05 package
Package marketed since
Nov 1, 2011
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 6265414505 7
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Zinc Oxide (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0212-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0206-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0202-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0207-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0209-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0208-2026
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) 62654-145-05
Product NDC 62654-145
11-digit billing NDC 62654014505
RxCUI 417425
UNII SOI2LOH54Z
Application # M016
SPL Set ID 48eb2031-bc80-45d5-b8b3-cc08fcab64f1
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2011-11-01
Route TOPICAL
Dosage form CREAM
Substance ZINC OXIDE
Quick answers
  • RxCUI (RxNorm): 417425
Why two NDCs? The FDA registers this code as 62654-145-05 — 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 → 62654-0145-05. 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.

Clinical

🧪 What is this product?

Boa Vida Calvida is a topical cream containing zinc oxide, an ingredient commonly used in skin care products for its protective and soothing properties. This product is marketed as an over-the-counter monograph drug, meaning it follows FDA's established safety and use guidelines for this category rather than being individually reviewed. Zinc oxide is typically used to help protect and calm irritated or sensitive skin when applied to the affected area.

Supplement & herbal interactions

Some supplements/herbs that may interact with Zinc oxide (OTC drug) — tap one for details:

Dimethylsulfoxide (dmso)Moderate Turpentine OilModerate AlchemillaMinor
🌿 Every supplement checked against Zinc oxide (OTC drug) (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.
Try another pack size: 118 ml
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
62654-0145-04 62654-145-04 Main listing 118 mL in 1 BOTTLE, PLASTIC 2011-11-01 — Active
62654-0145-05 You're viewing this 148 mL in 1 BOTTLE, PLASTIC 2011-11-01 — Active

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This package contains 148 mL — 148 ml in 1 bottle, plastic.
How does this package differ from NDC 62654-0145-04?
Both are BOA VIDA Calvida ZINC OXIDE 20 g/100mL Cream — the drug itself is identical. This page's package is the 148 mL one, while NDC 62654-0145-04 is the 118 ml package.
What NDC number is used to bill for this package of BOA VIDA Calvida ZINC OXIDE 20 g/100mL 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
Medpride 20 g/100g 52410-3040-03 Shield 28 g — — FDA listed —
BOA VIDA Calvida 20 g/100mLthis 62654-0145-05 Central 148 ml — — FDA listed —
Surface SPF 50 3oz Tinted mineral sunscreen with Water Resistance 20 g/100mL 72344-0112-03 Surface 88 ml — — FDA listed —
Solara Suncare - Clean Freak Spf-30 Naturally Scented 20 g/100mL 73054-0102-11 SOLARA 1 tube — — FDA listed —
Rio Radiance SPF 50 BodyLotion 20 g/100mL 83982-4838-00 SOL 1 tube — — FDA listed —
Thrive Daily Sunscreen For Sensitive Skin SPF 30 20 g/100mL 84138-0002-02 Thrive 1 bottle — — FDA listed —
Spf-30 Bb 20 g/100mL 69090-0100-01 ZION 110 ml — — FDA listed —
Native Mineral Sunscreen Broad Spectrum SPF 30 Unscented 20 g/100mL 69423-0550-14 The 147 ml — — Discontinued —
Solara Suncare - Fortune Teller Spf-30 20 g/100mL 73054-0120-11 SOLARA 1 tube — — FDA listed —
Babyganics Kids Sheer Blend SPF50 Mineral Sunscreen 20 g/100mL 59062-2203-03 KAS 89 ml — — FDA listed —
Sunceutical SPF 50 Mineral Body Cream 20 g/100mL 70157-0368-02 Baxter 1 jar — — FDA listed —
SPF 50 Mineral Sunscreen Face and Body 20 g/100mL 85865-0002-01 Toddle 50 ml — — FDA listed —
Sheer Mineral Sunscreen 20 g/100mL 84009-0816-01 Plant 1 tube — — FDA listed —
Native Mineral Sunscreen Broad Spectrum SPF 30 Tropical Breeze 20 g/100mL 84126-0605-14 The 147 ml — — FDA listed —
Ava Isa Sun Lip Sun Whip Strawberry Zinnia 20 g/100mL 71644-0010-10 Cyberderm 1 tube — — FDA listed —
Solara Suncare - Glow Getter Spf-30 Naturally Scented 20 g/100mL 73054-0103-11 SOLARA 1 tube — — FDA listed —
Solara Suncare - Time Traveler Spf-30 Unscented 20 g/100mL 73054-0105-11 SOLARA 1 tube — — FDA listed —
Native Mineral Suncare Daily Face Broad Spectrum SPF 30 Unscented 20 g/100mL 84126-0157-50 The 1 tube — — FDA listed —
Thrive Daily Defense Sunscreen Balm SPF30 20 g/100mL 84138-0001-02 Thrive 1 bottle — — FDA listed —
Surface Sun SPF 50 Mineral 20 g/100mL 72344-0110-03 Surface 88 ml — — FDA listed —
ARAMORE MULTI-DEFENSE SUNSCREEN - AM Broad Spectrum SPF 30 20 g/100mL 83127-0101-11 New 50 ml — — FDA listed —
Native Mineral Suncare Broad Spectrum SPF 30 Unscented 20 g/100mL 84126-0156-14 The 147 ml — — FDA listed —
Babyganics Sheer Blend SPF50 Mineral Sunscreen 20 g/100mL 59062-2202-01 KAS 50 ml — — FDA listed —
Native Mineral Face Broad Spectrum SPF 30 Unscented 20 g/100mL 69423-0548-50 The 50 ml — — Discontinued —
Native Facial Care Brightening Facial Moisturizer Broad Spectrum SPF 30 20 g/100mL 69423-0621-50 The 1 bottle — — FDA listed —
Native Mineral Sunscreen Broad Spectrum SPF 30 Sweet Peach and Nectar 20 g/100mL 69423-0731-14 The 147 ml — — FDA listed —
Sunceutical SPF 50 Mineral Glow Serum 20 g/100mL 70157-0367-02 Baxter 1 jar — — FDA listed —
Sunceutical SPF 50 Mineral Face Cream 20 g/100mL 70157-0369-02 Baxter 1 jar — — FDA listed —
Ava Isa Sun Lip Sun Whip Clear Sunshine 20 g/100mL 71644-0009-10 Cyberderm 1 tube — — FDA listed —
Mineral Defense Sport Antioxidant Face Sunscreen Spf-50 20 g/100mL 73054-0107-11 SOLARA 1 tube — — FDA listed —
Silk Mineral SPF 50 Sunscreen Face 20 g/100mL 70157-0026-01 Baxter 50 ml — — FDA listed —
Ava Isa Sun Lip Sun Whip Watermelon Lily 20 g/100mL 71644-0011-10 Cyberderm 1 tube — — FDA listed —
Native Daily Face Mineral Sunscreen Broad Spectrum SPF 30 Coconut and Pineapple 20 g/100mL 84126-0112-50 The 50 ml — — FDA listed —
Native Mineral Suncare Broad Spectrum SPF 30 Coconut and Pineapple 20 g/100mL 84126-0155-14 The 147 ml — — FDA listed —
Sol de Janiero Rio Radiance SPF 50 Body 20 g/100mL 66163-4838-01 Cosmetic 1 bottle — — FDA listed —
Native Mineral Face Broad Spectrum SPF 30 Coconut and Pineapple 20 g/100mL 69423-0549-50 The 50 ml — — Discontinued —
Solara Suncare - Clean Freak Spf-30 Unscented 20 g/100mL 73054-0101-11 SOLARA 1 tube — — FDA listed —
Bliss Block Star Sheer Liquid Daily Sunscreen SPF 50 SPF-50 20 g/100mL 67038-0203-60 Bliss 1 bottle — — FDA listed —
First Aid Beauty FAB Mineral Sunscreen Broad Spectrum SPF 30 20 g/100mL 69423-0622-50 The 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

🏛️
2011
On the market since
Nov 2011
📍
2026
Currently FDA-listed
15 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 1C6V77QF41
    Cholecalciferol is vitamin D3, a fat-soluble vitamin added to medicines as a nutritional supplement or active ingredient fortification. It helps the body absorb calcium and support bone health.
  • UNII 8470G57WFM
    Corn oil is a vegetable oil extracted from corn kernels. It's used in medicines as a solvent to dissolve active ingredients and help the body absorb them, and sometimes as a lubricant in capsules.
  • UNII H5RIZ3MPW4
    A chemical preservative used to prevent bacterial and fungal growth in medicines. It helps extend shelf life and maintain product safety during storage and use.
  • UNII 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • UNII 2865993309
    Ethylhexyl palmitate is an oily chemical made from palm oil and alcohol. It acts as an emollient and skin-conditioning agent in topical medicines, helping the product spread smoothly and keeping skin soft.
  • 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 4CG9F9W01Q
    A synthetic fatty acid ester used as an emollient and skin-conditioning agent in topical medicines. It helps soften the product texture and improves how it spreads and absorbs into the skin.
  • UNII ZF94AP8MEY
    Hydrogenated castor oil is a processed plant oil made by adding hydrogen to castor oil. It's used as a binder to help hold tablet ingredients together and as a lubricant to prevent sticking during manufacturing.
  • UNII 8CRQ2TH63M
    Isopropyl palmitate is an oily liquid derived from palm oil. It acts as an emollient and lubricant in medicines, helping soften the skin or improve how the product spreads and flows.
  • 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 T5L8T28FGP
    Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
  • UNII 820DPX33S7
    A synthetic emulsifier derived from glycerin and fatty acids. It helps mix oil and water-based ingredients together and keeps them evenly blended throughout the product.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII Q7RNT1G37V
    A plant-based ingredient derived from cacao tree seeds, used as a natural fat or cocoa butter substitute. It serves as a binder and filler in solid dosage forms and helps with texture and consistency in tablets or capsules.
  • UNII R0ZB2556P8
    Tocopherol is a form of vitamin E derived from plant oils. It acts as an antioxidant in medicines to prevent oils and fats from breaking down and spoiling during storage.
  • UNII 1D1K0N0VVC
    A fat-soluble form of vitamin A used as a colorant and nutritional fortification ingredient. It gives products a yellow or orange tint and increases vitamin A content in the formula.
  • 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 2ZA36H0S2V
    Beeswax is a natural wax produced by honeybees. In medicines, it works as a coating agent and thickener to control how fast the drug dissolves and improve the product's texture and appearance.

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

The official label also statesInactive Ingredients Purified Water, Polyglyceryl-4 Isostearate and Cetyl PEG/PPG-10/1 Dimethicone and Hexyl Laurate, Mineral Oil, Isopropyl Palmitate, Ethylhexyl Palmitate, Theobroma Grandiflorum Seed (Cupuacu Butter), Calamine, Glycerin, Cetyl Dimethicone, Dimethicone, SD Alcohol 40-B, Sodium Chloride, Diazolidinyl Urea, Menthol, Hydrogenated Castor Oil, Beeswax, Tocopherol (Vitamin E), Methyl Paraben, Zea Mays Oil and Retinyl Palmitate (Vitamin A) and Cholecalciferol (Vitamin D3)

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

LabelerCentral Solutions Inc
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code62654
First marketedNov 2011
Product typeHuman Otc Drug
Portfolio14 products on file

More NDCs from Central Solutions Inc labeler code 62654

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 📦 Storage and Handling 🧪 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 20 words ▾

Uses Helps treat and prevent diaper rash Protects minor skin irritation due to diaper rash and helps seal out wetness

⏱️ Dosage and Administration 49 words ▾

Directions For Diaper Rash: Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry. Apply product liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged. For Skin Protection: Apply liberally as needed.

⚠️ Warnings 72 words ▾

Warnings For External Use Only Do not use on deep or puncture wounds on animal bites on serious burns When using this product do not get into eyes Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 8 words ▾

Other Information Protect from freezing. Avoid excessive heat

🧪 Active Ingredient 6 words ▾

Active Ingredients Zinc Oxide 20% (w/w)

🧪 Inactive Ingredients 58 words ▾

Inactive Ingredients Purified Water, Polyglyceryl-4 Isostearate and Cetyl PEG/PPG-10/1 Dimethicone and Hexyl Laurate, Mineral Oil, Isopropyl Palmitate, Ethylhexyl Palmitate, Theobroma Grandiflorum Seed (Cupuacu Butter), Calamine, Glycerin, Cetyl Dimethicone, Dimethicone, SD Alcohol 40-B, Sodium Chloride, Diazolidinyl Urea, Menthol, Hydrogenated Castor Oil, Beeswax, Tocopherol (Vitamin E), Methyl Paraben, Zea Mays Oil and Retinyl Palmitate (Vitamin A) and Cholecalciferol (Vitamin D3)

🎯 Purpose 3 words ▾

Purpose Skin protectant

📄 Do Not Use 14 words ▾

Do not use on deep or puncture wounds on animal bites on serious burns

📄 When Using This Product 9 words ▾

When using this product do not get into eyes

📄 Stop Use and Ask a Doctor If 25 words ▾

Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days

📄 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.

📄 Package Label / Principal Display Panel 21 words ▾

BOA VIDA Calvida protectant shield helps treat minor skin irritation Formulated with Cupuacu Butter 5 fl oz. (148 mL) container label

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 BOA VIDA Calvida (this brand).

Top reported reactions

Macular Degeneration460
Pyrexia306
Nausea290
Pain282
Malaise261
Weight Decreased236
Therapeutic Product Effect Incomplete214

Reporter sex

1,941 reports
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 272 82
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 Central Solutions 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 118 ml (62654-0145-04). 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?
Central Solutions 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.
← 62654-0144-04 · Central 62654-0146-02 · Central →
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.