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Superscreen Daytime Mineral Sunscreen Zinc Oxide 160 mg/g Cream, 1.5 g — NDC 85449-208-15 (Billing 85449-0208-15)

by MCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY · 1.5 g in 1 PACKET

This is a package of 1.5 g of Superscreen Daytime Mineral Sunscreen Zinc Oxide 160 mg/g Cream from MCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY, marketed since Oct 2024 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 85449-0208-15
🏷️ FDA NDC (as labeled) 85449-208-15 billing pads the product segment with a zero
This package
Contains1.5 g Pack sizes2 compare ↓
Main listing for product 85449-208 · Also comes in: 50 g 85449-208-50
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 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 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) 85449-208-15
Product NDC 85449-208
11-digit billing NDC 85449020815
UNII SOI2LOH54Z
Application # M020
SPL Set ID 35805e66-18e6-0e45-e063-6294a90afe58
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-10-23
Route TOPICAL
Dosage form CREAM
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 85449-208-15 — 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 → 85449-0208-15. 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?

Superscreen Daytime Mineral Sunscreen is a topical cream containing zinc oxide, a mineral ingredient commonly used in sunscreen products to help protect skin from ultraviolet (UV) radiation. Zinc oxide functions as a physical UV filter that sits on the skin surface and reflects UV rays. This product is marketed as an over-the-counter monograph drug, meaning it is made and sold under FDA's established rules for sunscreen products rather than through individual drug approval.

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: 50 g
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
85449-0208-50 85449-208-50 50 g in 1 BOTTLE, PUMP 2023-11-08 — Active
85449-0208-15 You're viewing this Main listing 1.5 g in 1 PACKET Sample 2024-10-23 — Active

Pack size FAQ

What quantity is in this package?
This package contains 1.5 g — 1.5 g in 1 packet.
How does this package differ from NDC 85449-0208-50?
Both are Superscreen Daytime Mineral Sunscreen Zinc Oxide 160 mg/g Cream — the drug itself is identical. This page's package is the 1.5 g one, while NDC 85449-0208-50 is the 50 g package.
What NDC number is used to bill for this package of Superscreen Daytime Mineral Sunscreen Zinc Oxide 160 mg/g 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
Skin Apeel Ageless Defense SPF 40 Broad Spectrum 160 mg/g 83628-0208-50 Skin 50 g — — FDA listed —
Illuminating Daily SPF 40 Lightly Tinted 160 mg/g 85302-0208-50 Face 50 g — — FDA listed —
Matte Invisible Mineral Sunscreen 160 mg/g 85306-0208-50 INTEGRATIVE 50 g — — FDA listed —
Matte Invisible Mineral Sunscreen Non-Tinted 160 mg/g 85306-0226-50 INTEGRATIVE 50 g — — FDA listed —
Replenishing Mineral Sunscreen 160 mg/g 85330-0208-50 Skin 50 g — — FDA listed —
Florida Babe Everyday Tinted Replenishing Daily Protection 160 mg/g 85337-0208-15 Tichy 1.5 g — — FDA listed —
Daily Replenish mineral sunscreen 160 mg/g 85367-0208-50 PURE 50 g — — FDA listed —
Nourish Non-Tinted Mineral Sunscreen 160 mg/g 85387-0226-50 Fern 50 g — — FDA listed —
Daily Protection 40 160 mg/g 85392-0208-50 2301 50 g — — FDA listed —
Canopy SPF 40 Tinted 160 mg/g 85399-0208-50 BORREGO 50 g — — FDA listed —
Bio H Plus Daily Defense And Revitalize 160 mg/g 85403-0208-15 BIOHEALTH 1.5 g — — FDA listed —
SPF 101 Non-Tinted 160 mg/g 85415-0226-50 The 50 g — — FDA listed —
Tinted Replenishing Daily Protection 160 mg/g 85513-0208-50 THE 50 g — — FDA listed —
Daily Restore 160 mg/g 85556-0208-15 TYRLIN 1.5 g — — FDA listed —
Sacred Glow 160 mg/g 85583-0208-50 IRIA 50 g — — FDA listed —
Skin Shield Plus 160 mg/g 85596-0208-50 LAURA 50 g — — FDA listed —
Hydra Tint 160 mg/g 85649-0208-50 PATRICIA 50 g — — FDA listed —
Auset Tinted Replenishing Daily Protection 160 mg/g 85725-0208-50 SHAYLA 50 g — — FDA listed —
Daily Repair Moisturizing Non Tinted 160 mg/g 85738-0226-15 Skintique 1.5 g — — FDA listed —
Tinted Mineral Sunscreen 160 mg/g 85747-0208-50 WECARE 50 g — — FDA listed —
Radiance 160 mg/g 85768-0226-15 L.S. 1.5 g — — FDA listed —
Replenishing Daily Protection Tinted 160 mg/g 87149-0208-15 SOLUTIONS 1.5 g — — FDA listed —
Replenishing Daily Protection Non-Tinted 160 mg/g 87149-0226-50 SOLUTIONS 50 g — — FDA listed —
Easy Everything Sunscreen 160 mg/g 87670-0208-50 VLT 50 g — — FDA listed —
Emme Diane Pure Protection Tinted Antioxidant Sunscreen 160 mg/g 81377-0208-50 Emme 50 g — — FDA listed —
Parasol Daily Mineral Sunscreen Non-Tinted 160 mg/g 85373-0226-50 Bodi 50 g — — FDA listed —
Replenishing Tinted Sunscreen 160 mg/g 85418-0208-50 Beauty 50 g — — FDA listed —
Everyday Mineral Tinted Sunscreen 160 mg/g 85441-0208-50 Atlanta 50 g — — FDA listed —
Daily Mineral Protection 160 mg/g 85452-0226-15 Charisma 1.5 g — — FDA listed —
Serum Lightly Tinted 160 mg/g 85459-0208-15 PANDA 1.5 g — — FDA listed —
Daily Skin Protection Sunscreen Tinted 160 mg/g 85479-0208-50 SKINPLUSBYOROYO 50 g — — FDA listed —
Tinted Mineral Defense SPF 40 160 mg/g 85591-0208-50 JOSEPHINA 50 g — — FDA listed —
Daily Shade Dewy Glow Tinted 160 mg/g 85712-0208-15 BLISS 1.5 g — — FDA listed —
Morning Replenish 160 mg/g 85714-0208-50 KATHY 50 g — — FDA listed —
Daily Repair Moisturizing Tinted 160 mg/g 85738-0208-50 Skintique 50 g — — FDA listed —
Daily Tinted Antioxidant Mineral Sunscreen 160 mg/g 85936-0208-50 MONIKA 50 g — — FDA listed —
AM Shield plus 160 mg/g 87271-0226-50 Grace 50 g — — FDA listed —
Tizo Photoceutical Am Replenish - Tinted 160 mg/g 58892-0101-50 Fallien 1 tube — — FDA listed —
Proceuticals Private Label by TiZO non-tinted replenishing daily protection 160 mg/g 58892-0226-50 Fallien 50 g — — FDA listed —
Matte Shield Spf 160 mg/g 85291-0208-50 ACNE 50 g — — FDA listed —
Sunscreen Plus Untinted 160 mg/g 85329-0226-15 Lily 1.5 g — — FDA listed —
Tinted Sunscreen 160 mg/g 85331-0208-50 Scottsdale 53 g — — FDA listed —
Tinted Replenishing Daily Protection 160 mg/g 85377-0208-15 MANTRA 1.5 g — — FDA listed —
Tinted Mineral Sunscreen Plus Primer CPlusE Glow 160 mg/g 85400-0208-50 Simply 50 g — — FDA listed —
Restore Plus Defense Acne Safe Facial Mineral Sunscreen Lightly Tinted 160 mg/g 85404-0208-50 NY 50 g — — FDA listed —
SPF 101 Lightly Tinted 160 mg/g 85415-0208-50 The 50 g — — FDA listed —
Mineral Sunscreen Moisturizing Non-Tinted 160 mg/g 85431-0226-50 Cutis 50 g — — FDA listed —
Fair Skin Anti-Aging 160 mg/g 85466-0208-50 DERMOPERFECTION 53 g — — FDA listed —
Non-Tinted Replenishing Daily Protection 160 mg/g 85513-0226-50 THE 50 g — — FDA listed —
Mint Condition 160 mg/g 85533-0208-15 Mint 1.5 g — — FDA listed —
flawless photo finish 160 mg/g 85575-0208-50 NEXTEX 50 g — — FDA listed —
Tinted Restorative Moisturizer 160 mg/g 85582-0208-50 SKINERGIX 50 g — — FDA listed —
Face Love 160 mg/g 85629-0208-50 CLARITY 50 g — — FDA listed —
Magic Veil 160 mg/g 85861-0208-15 THE 1.5 g — — FDA listed —
Non-Tinted Daily Mineral Shield 160 mg/g 85896-0226-50 SIGNATURE 50 g — — FDA listed —
Protect and Renew 160 mg/g 85971-0208-50 ENSO 50 g — — FDA listed —
Shield And Protect 160 mg/g 69487-0226-50 TRILOGY 50 g — — FDA listed —
Parasol Daily Mineral Sunscreen 160 mg/g 85373-0208-50 Bodi 50 g — — FDA listed —
Anti Aging Daily Protection 160 mg/g 85450-0208-50 LEVERRIER, 50 g — — FDA listed —
Replenish SPF 40 160 mg/g 85555-0208-50 ELIZA 50 g — — FDA listed —
Protection E And C Lightly Tinted 160 mg/g 85563-0208-50 CLEAR 50 g — — FDA listed —
D Fend Daily 160 mg/g 85599-0226-50 CLEAN 50 g — — FDA listed —
Tinted Daily Protection Sunscreen 160 mg/g 85711-0208-50 Kemmi 50 g — — FDA listed —
Everyday Mineral Sunscreen 160 mg/g 85889-0208-15 MYRENE 1.5 g — — FDA listed —
Solar Shield Primer SPF 40 160 mg/g 85944-0208-15 BRIGHT 1.5 g — — FDA listed —
Mineral Sunscreen 160 mg/g 87121-0208-50 ISIS 50 g — — FDA listed —
TiZO Photoceutical AM Replenish Non-Tinted 160 mg/g 58892-0107-50 Fallien 1 tube — — FDA listed —
Shield And Protect Tinted 160 mg/g 69487-0208-50 TRILOGY 50 g — — FDA listed —
Lightly Tinted Mineral Block Sunscreen 160 mg/g 85301-0208-15 Tucson 1.5 g — — FDA listed —
Sunscreen Plus Tinted 160 mg/g 85329-0208-15 Lily 1.5 g — — FDA listed —
Healthy Mineral Sunscreen No Shine plus Tint 160 mg/g 85338-0208-50 Zen 50 g — — FDA listed —
Replenishing Daily Protection 160 mg/g 85394-0208-50 The 50 g — — FDA listed —
Shield Mineral Sunscreen Non Tinted 160 mg/g 85417-0226-50 SMOOTHE 50 g — — FDA listed —
208 160 mg/g 85443-0208-50 PETER 53 g — — FDA listed —
Superscreen Daytime Mineral Sunscreen 160 mg/gthis 85449-0208-15 MCRAE 1.5 g — — FDA listed —
Restore And Replenish 160 mg/g 85730-0208-50 BELLAGENA 50 g — — FDA listed —
Recoverie Mineral Matte 160 mg/g 85299-0226-50 Clear 50 g — — FDA listed —
Dermablue Daily Replenishing 160 mg/g 85300-0208-50 Dermablue, 50 g — — FDA listed —
Replenish 160 mg/g 85318-0208-50 Maloney 50 g — — FDA listed —
Satin Tint 160 mg/g 85334-0208-15 Brent 1.5 g — — FDA listed —
bare skin smooth mineral tint 160 mg/g 85425-0208-50 Skin 50 g — — FDA listed —
Mineral Sunscreen Moisturizing Lightly Tinted 160 mg/g 85431-0208-50 Cutis 50 g — — FDA listed —
Protector Solar Tinted Spf Sunscreen 160 mg/g 85438-0208-50 The 50 g — — FDA listed —
Glow 160 mg/g 85457-0208-50 GODDESSLYNNEBODYANDSKIN 50 g — — FDA listed —
Tinted Replenishing SPF40 160 mg/g 85508-0208-50 RSL89 50 g — — FDA listed —
Tinted Replenishing Daily Protection 160 mg/g 85611-0208-15 SKINPLICITY 1.5 g — — FDA listed —
Non Tinted Replenishing Daily Protection 160 mg/g 85625-0226-50 LUNDQUIST 50 g — — FDA listed —
Non-Tinted Mineral Sunscreen 160 mg/g 85747-0226-15 WECARE 1.5 g — — FDA listed —
Antioxidant SPF 160 mg/g 85339-0208-50 Teton 50 g — — FDA listed —
Sunshield Moisturizing Sunscreen and Antioxidant 160 mg/g 85340-0208-15 Oculofacial 1.5 g — — FDA listed —
Skin Defense Matte Tinted Sunscreen 160 mg/g 85366-0208-50 Gentlehomme 50 g — — FDA listed —
Tinted Replenishing Daily Protection 160 mg/g 85467-0208-50 Tory 50 g — — FDA listed —
Daydream Beyond Screen 160 mg/g 85491-0208-50 ULTRAVIOLET 50 g — — FDA listed —
Ultra Silk Protection Sunscreen 160 mg/g 85564-0208-50 SKINFINITY 50 g — — FDA listed —
Tinted Replenishing Daily Protection 160 mg/g 85589-0208-50 Natur 50 g — — FDA listed —
Hydrating Antioxidant Sunscreen tinted 160 mg/g 85641-0208-15 KRISTI 1.5 g — — FDA listed —
CoTZ Face Moisture 160 mg/g 58892-0360-42 Fallien 1 tube — — FDA listed —
Replenishing Daily Protection Sunscreen Invisible 160 mg/g 81679-0208-50 KATHLEEN 50 g — — FDA listed —
Advanced Light Perfecting Sunscreen 160 mg/g 85351-0208-15 ADVANCED 1.5 g — — FDA listed —
Mineral Tinted SPF40 with ceramides 160 mg/g 85360-0208-50 Spalina 50 g — — FDA listed —
Tinted Daily Replenishing Protection 160 mg/g 85362-0208-50 Goldberg, 50 g — — FDA listed —
Am Restore 160 mg/g 85364-0208-15 Minder 1.5 g — — FDA listed —
Shield Mineral Sunscreen Tinted 160 mg/g 85417-0208-50 SMOOTHE 50 g — — FDA listed —
Age Defying Sunscreen 160 mg/g 85458-0226-50 GINAMARIE 50 g — — FDA listed —
Antioxidant Mineral Sunscreen Plus Primer Lightly Tinted 160 mg/g 85520-0208-50 True 50 g — — FDA listed —
GLOW UP Ageless Daily Protection Sunscreen 160 mg/g 85752-0208-15 CLEAN 15 g — — FDA listed —
Solar Shield Tinted 160 mg/g 85890-0208-15 DENISE 1.5 g — — FDA listed —
Anti-Aging Tinted Sunscreen 160 mg/g 85921-0208-50 KARINA 50 g — — FDA listed —
Morning Replenish 160 mg/g 85313-0208-50 Restore 50 g — — FDA listed —
Replenishing Daily Sunscreen 160 mg/g 85374-0208-50 BABYFACE 50 g — — FDA listed —
Replenishing Daily Protection Tinted 160 mg/g 85451-0208-50 MY 53 g — — FDA listed —
Tinted Replenishing Daily Protection 160 mg/g 85679-0208-50 HELTON 50 g — — FDA listed —
Tinted BB Cream 160 mg/g 85863-0208-50 Eco 50 g — — FDA listed —
Non-Tinted Replenishing Daily Protection 160 mg/g 87122-0226-50 MADRE 50 g — — FDA listed —
Proceuticals Private Label by TiZO tinted replenishing daily protection 160 mg/g 58892-0208-50 Fallien 50 g — — FDA listed —
Illuminating Daily SPF40 Non-Tinted 160 mg/g 85302-0226-50 Face 50 g — — FDA listed —
Replenishing Daily Protection NT 160 mg/g 85451-0226-50 MY 53 g — — FDA listed —
Restore Tinted Moisturizing 160 mg/g 85503-0208-50 SKIN 50 g — — FDA listed —
Tinted Replenishing Daily Protection 160 mg/g 85805-0208-50 OLGA 50 g — — FDA listed —
Tinted Daily Mineral Shield 160 mg/g 85896-0208-50 SIGNATURE 50 g — — FDA listed —
Replenishing Daily Protection Tinted 160 mg/g 87003-0208-50 YUMA 50 g — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2024
On the market since
Oct 2024
📍
2026
Currently FDA-listed
2 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
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

LabelerMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code85449
First marketedOct 2024
Product typeHuman Otc Drug
Portfolio4 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.
📄 Package Label / Principal Display Panel
📄 Package Label / Principal Display Panel 2 words ▾

Package 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 Zinc Oxide — the ingredient across all brands.

Top reported reactions

Macular Degeneration460
Nausea365
Pyrexia351
Pain348
Malaise289
Weight Decreased284
Constipation257

Reporter sex

3,195 reports

Serious outcomes

Death290
Disabling63
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 365 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 MCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY. 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 50 g (85449-0208-50). 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?
MCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY 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.
← 85449-0203-15 · MCRAE 85450-0208-50 · LEVERRIER, →
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.