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Tinted Minerals 1point8 oz Titanium Dioxide, Zinc Oxide 38 mg/g; 80 mg/g Cream, 1.5 g — NDC 85395-203-15 (Billing 85395-0203-15)

by SPECKTRA6 LLC · 1.5 g in 1 PACKET

This is a package of 1.5 g of Tinted Minerals 1point8 oz Titanium Dioxide, Zinc Oxide 38 mg/g; 80 mg/g Cream from SPECKTRA6 LLC, marketed since Apr 2021 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 85395-0203-15
🏷️ FDA NDC (as labeled) 85395-203-15 billing pads the product segment with a zero
This package
Contains1.5 g Pack sizes2 compare ↓
Main listing for product 85395-203 · Also comes in: 53 g 85395-203-50
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

NDC database record

One package, one record: these facts belong to NDC 85395-203-15 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
85395 labeler · 203 product · 15 package
Package marketed since
Apr 19, 2021
Sample package
Yes — professional sample, not for sale
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 8539520315 2
FDA record last changed
Oct 1, 2026
⚠️
Other active recalls for Titanium Dioxide, Zinc Oxide (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 · Sep 3, 2024 — Microbial Contamination of Non-Sterile Product (Vivier Pharma, Inc.) · FDA recall D-0662-2024
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) 85395-203-15
Product NDC 85395-203
11-digit billing NDC 85395020315
UNII SOI2LOH54Z, 15FIX9V2JP
Application # M020
SPL Set ID 374e53c6-307f-f8e5-e063-6394a90a07ef
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-04-19
Route TOPICAL
Dosage form CREAM
Substance ZINC OXIDE; TITANIUM DIOXIDE
Why two NDCs? The FDA registers this code as 85395-203-15 — 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 → 85395-0203-15. 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?

This is a tinted mineral cream applied to the skin that contains titanium dioxide and zinc oxide as active ingredients. Both minerals function as physical sunscreen agents that work by reflecting and scattering ultraviolet light away from the skin. Tinted mineral sunscreens like this one are commonly used to help protect skin from sun exposure while providing light coverage. This product is an OTC monograph drug, meaning it is marketed under the FDA's established rules for sunscreen products rather than as an individually reviewed application.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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: 53 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
85395-0203-50 85395-203-50 53 g in 1 BOTTLE, PUMP 2019-04-01 — Active
85395-0203-15 You're viewing this Main listing 1.5 g in 1 PACKET Sample 2021-04-19 — 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 85395-0203-50?
Both are Tinted Minerals 1point8 oz Titanium Dioxide, Zinc Oxide 38 mg/g; 80 mg/g Cream — the drug itself is identical. This page's package is the 1.5 g one, while NDC 85395-0203-50 is the 53 g package.
What NDC number is used to bill for this package of Tinted Minerals 1point8 oz Titanium Dioxide, Zinc Oxide 38 mg/g; 80 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
non-tinted mineral sunscreen 38 mg/g; 80 mg/g 82746-0202-50 Clove 53 g — — FDA listed —
Mineral SPF 40, Tinted 38 mg/g; 80 mg/g 85292-0203-15 Acne 1.5 g — — FDA listed —
Tinted Mineral Sunscreen 38 mg/g; 80 mg/g 85318-0201-85 Maloney 85 g — — FDA listed —
Tinted Mattifying Face Mineral Sunscreen 38 mg/g; 80 mg/g 85370-0203-50 Lisa 53 g — — FDA listed —
AcneFix Tinted Mineral Sunscreen 38 mg/g; 80 mg/g 85396-0203-50 ACNEFIX 53 g — — FDA listed —
tinted mineral sunscreen 38 mg/g; 80 mg/g 85425-0203-50 Skin 53 g — — FDA listed —
Protector Solar Non-Tinted Spf Sunscreen 38 mg/g; 80 mg/g 85438-0202-50 The 53 g — — FDA listed —
Ultamatte Protection Sunscreen 38 mg/g; 80 mg/g 85564-0203-50 SKINFINITY 53 g — — FDA listed —
Non Tinted Mineral Sunscreen 38 mg/g; 80 mg/g 85585-0202-50 JEFFREY 53 g — — FDA listed —
Sunshade Tinted Mineral Sunscreen 38 mg/g; 80 mg/g 85730-0203-50 BELLAGENA 53 g — — FDA listed —
Daily Shield Facial Primer 38 mg/g; 80 mg/g 85738-0203-50 Skintique 53 g — — FDA listed —
Non Tinted Facial Mineral Protectant 38 mg/g; 80 mg/g 85746-0202-50 EUROPEAN 53 g — — FDA listed —
Tinted Mineral Sunscreen 38 mg/g; 80 mg/g 85886-0203-50 FRANCISCO 53 g — — FDA listed —
Tinted Mineral Sunscreen 38 mg/g; 80 mg/g 87049-0203-50 THE 53 g — — FDA listed —
Non-tinted Physical Block Sunscreen 38 mg/g; 80 mg/g 85301-0202-50 Tucson 53 g — — FDA listed —
Tinted Mineral Sunscreen 38 mg/g; 80 mg/g 85327-0203-50 Rhonda 53 g — — FDA listed —
Non-Tinted Mineral Sunscreen 38 mg/g; 80 mg/g 85329-0202-50 Lily 53 g — — FDA listed —
Florida Babe Sport Tinted Mineral Sunscreen 38 mg/g; 80 mg/g 85337-0203-15 Tichy 1.5 g — — FDA listed —
Dr B Clinical Skin Care Tinted Sunscreen 38 mg/g; 80 mg/g 85365-0203-50 NAIRA 53 g — — FDA listed —
Tinted Mineral Sunscreen 38 mg/g; 80 mg/g 85414-0203-15 Hirschman, 15 g — — FDA listed —
Tinted Mineral Sunscreen 38 mg/g; 80 mg/g 85493-0203-50 CLEARLY 53 g — — FDA listed —
Velvet Tinted Moisturizing Mineral Sunscreen 38 mg/g; 80 mg/g 85503-0203-50 SKIN 53 g — — FDA listed —
Mineral Sunscreen Tinted 38 mg/g; 80 mg/g 85558-0203-50 LOTUS 53 g — — FDA listed —
Matte Finish 38 mg/g; 80 mg/g 85599-0203-15 CLEAN 1.5 g — — FDA listed —
Mineral Tinted Sunscreen 38 mg/g; 80 mg/g 85620-0203-50 JADEIA 53 g — — FDA listed —
Clear Path Tinted Facial Sunscreen 38 mg/g; 80 mg/g 85735-0203-50 LULUS 53 g — — FDA listed —
Original Tint 38 mg/g; 80 mg/g 85768-0201-85 L 85 g — — FDA listed —
Flawless Finish 38 mg/g; 80 mg/g 85971-0203-50 ENSO 53 g — — FDA listed —
Mineral SPF 40, protect 38 mg/g; 80 mg/g 85292-0202-50 Acne 50 g — — FDA listed —
Sheer Mineral Sunscreen 38 mg/g; 80 mg/g 85327-0202-50 Rhonda 53 g — — FDA listed —
Mineral Primer tinted SPF40 38 mg/g; 80 mg/g 85356-0201-85 Oracle 85 g — — FDA listed —
Proper Protection Plus Primer Tinted 38 mg/g; 80 mg/g 85358-0203-50 Skin 53 g — — FDA listed —
True Tone Tinted 38 mg/g; 80 mg/g 85393-0203-50 That 53 g — — FDA listed —
Complexion Correction Tinted Primer Sunscreen 38 mg/g; 80 mg/g 85449-0203-15 MCRAE 1.5 g — — FDA listed —
Untinted Sheer Defense 38 mg/g; 80 mg/g 85516-0202-50 Kristina 53 g — — FDA listed —
Tinted Matte Defense Sunscreen Primer 38 mg/g; 80 mg/g 85533-0201-85 Mint 85 g — — FDA listed —
Tinted Matte Defense Sunscreen Primer 38 mg/g; 80 mg/g 85533-0203-15 Mint 1.5 g — — FDA listed —
Advanced Formula Tinted 38 mg/g; 80 mg/g 85883-0203-50 CR 53 g — — FDA listed —
Mineral Sunscreen SPF 40 Non-Tinted 38 mg/g; 80 mg/g 85296-0202-50 Skin 50 g — — FDA listed —
Tinted Physical Block Sunscreen 38 mg/g; 80 mg/g 85301-0203-15 Tucson 1.5 g — — FDA listed —
SPF 40 Broad Spectrum 38 mg/g; 80 mg/g 85339-0203-50 Teton 53 g — — FDA listed —
Matte Defense Mineral Sunscreen non tinted 38 mg/g; 80 mg/g 85367-0202-50 PURE 53 g — — FDA listed —
SANCTUARY Tinted Mineral Sunscreen 38 mg/g; 80 mg/g 85559-0203-50 CHAMPAGNE 53 g — — FDA listed —
Non-Tinted Mineral Sunscreen 38 mg/g; 80 mg/g 85597-0202-50 ESTHETIC 53 g — — FDA listed —
Defend Tinted Mineral SPF 40 38 mg/g; 80 mg/g 85603-0203-50 SMOOTH 53 g — — FDA listed —
Facial Mineral Sunscreen Mineral Protection 38 mg/g; 80 mg/g 85627-0201-85 CAPE 85 g — — FDA listed —
Solar Knight SPF 40 Broad Spectrum 38 mg/g; 80 mg/g 85697-0203-50 MASCARENAS 53 g — — FDA listed —
Daily Shade Matte Tinted 38 mg/g; 80 mg/g 85712-0203-50 BLISS 53 g — — FDA listed —
Tinted Facial Mineral Protectant 38 mg/g; 80 mg/g 85746-0203-50 EUROPEAN 53 g — — FDA listed —
Original Tint 38 mg/g; 80 mg/g 85768-0203-15 L.S. 1.5 g — — FDA listed —
Tinted Facial Mineral Sunscreen 38 mg/g; 80 mg/g 85939-0203-50 ORAIOS 53 g — — FDA listed —
Tinted Mineral Sunscreen 38 mg/g; 80 mg/g 85970-0203-50 MILL 53 g — — FDA listed —
Mineral Sunscreen Tinted 38 mg/g; 80 mg/g 85987-0203-50 ESTHETICS 53 g — — FDA listed —
Sunscreen 38 mg/g; 80 mg/g 85331-0202-50 Scottsdale 53 g — — FDA listed —
Tinted Mineral Sunscreen 38 mg/g; 80 mg/g 85467-0203-50 Tory 53 g — — FDA listed —
Virgo SOL Primer Sunscreen 38 mg/g; 80 mg/g 85491-0203-50 ULTRAVIOLET 53 g — — FDA listed —
Velvet NT Moisturizing Mineral Sunscreen 38 mg/g; 80 mg/g 85503-0202-50 SKIN 53 g — — FDA listed —
Tinted Facial Mineral Sunscreen SPF 40 38 mg/g; 80 mg/g 85508-0203-15 RSL89 1.5 g — — FDA listed —
Tinted Mineral Sunscreen 38 mg/g; 80 mg/g 85585-0203-50 JEFFREY 53 g — — FDA listed —
Facial Mineral Sunscreen Non Tinted 38 mg/g; 80 mg/g 85634-0202-50 DR. 53 g — — FDA listed —
Facial Mineral Sunscreen 38 mg/g; 80 mg/g 85691-0203-50 LEDUC, 53 g — — FDA listed —
Daily Shade Matte Tinted 38 mg/g; 80 mg/g 85712-0201-85 BLISS 85 g — — FDA listed —
Tinted Mineral Sunscreen 38 mg/g; 80 mg/g 85714-0203-50 KATHY 53 g — — FDA listed —
Mineral Sunscreen Non-Tinted 38 mg/g; 80 mg/g 87003-0202-50 YUMA 53 g — — FDA listed —
Sheer Facial Mineral Sunscreen 38 mg/g; 80 mg/g 85343-0203-50 BB 53 g — — FDA listed —
Tinted Sunscreen 38 mg/g; 80 mg/g 85381-0203-15 VIDA 1.5 g — — FDA listed —
Tinted Mineral Sunscreen Plus Primer Matte 38 mg/g; 80 mg/g 85400-0203-15 Simply 1.5 g — — FDA listed —
Prevention 2 Acne Safe Facial Mineral Sunscreen Non Tinted 38 mg/g; 80 mg/g 85404-0202-50 NY 53 g — — FDA listed —
Replenishing Non Tinted Sunscreen 38 mg/g; 80 mg/g 85418-0202-50 Beauty 53 g — — FDA listed —
Complexion Correction Primer Sunscreen clear 38 mg/g; 80 mg/g 85449-0202-15 MCRAE 1.5 g — — FDA listed —
Ultra Protection Sunscreen 38 mg/g; 80 mg/g 85563-0202-50 CLEAR 53 g — — FDA listed —
Matte Tint 38 mg/g; 80 mg/g 85649-0203-50 PATRICIA 53 g — — FDA listed —
Tinted Mineral Sunscreen Broad Spectrum SPF 40 38 mg/g; 80 mg/g 85747-0203-50 WECARE 53 g — — FDA listed —
Advanced Formula Non-Tinted 38 mg/g; 80 mg/g 85883-0202-15 CR 1.5 g — — FDA listed —
Anti-Aging Non-Tinted Sunscreen 38 mg/g; 80 mg/g 87444-0202-50 LASER 53 g — — FDA listed —
Anti-Aging Tinted Sunscreen 38 mg/g; 80 mg/g 87444-0203-50 LASER 53 g — — FDA listed —
PROCEUTICALS PRIVATE LABEL by TiZO non-tinted mineral sunscreen 38 mg/g; 80 mg/g 58892-0202-50 Fallien 53 g — — FDA listed —
Tinted Mineral Sunscreen 38 mg/g; 80 mg/g 85314-0201-85 Melinda 85 g — — FDA listed —
Tinted Mineral Sunscreen 38 mg/g; 80 mg/g 85376-0203-50 HSC 53 g — — FDA listed —
UV Defense Mineral Sunscreen Tinted 38 mg/g; 80 mg/g 85495-0203-50 CCLEAR 53 g — — FDA listed —
Tined Mineral Sunscreen Whipped Mousse 38 mg/g; 80 mg/g 85554-0203-50 ESTILO 53 g — — FDA listed —
Tinted Mineral Sunscreen 38 mg/g; 80 mg/g 85597-0203-50 ESTHETIC 53 g — — FDA listed —
Prime Protection Sunscreen non tinted 38 mg/g; 80 mg/g 85641-0202-50 KRISTI 53 g — — FDA listed —
Non Tinted Mineral Sunscreen 38 mg/g; 80 mg/g 85888-0202-50 MILESTHETICS 53 g — — FDA listed —
Tinted Physical Block Sunscreen 38 mg/g; 80 mg/g 85301-0201-85 Tucson 85 g — — FDA listed —
Florida Babe Sport Non-Tinted Mineral Sunscreen 38 mg/g; 80 mg/g 85337-0202-50 Tichy 53 g — — FDA listed —
Tinted Minerals 1point8 oz 38 mg/g; 80 mg/gthis 85395-0203-15 SPECKTRA6 1.5 g — — FDA listed —
Tinted Mineral Sunscreen 38 mg/g; 80 mg/g 85493-0201-85 CLEARLY 85 g — — FDA listed —
Matte Defense Sunscreen Primer 38 mg/g; 80 mg/g 85533-0202-50 Mint 53 g — — FDA listed —
Ultra Tinted Protection 38 mg/g; 80 mg/g 85563-0203-50 CLEAR 53 g — — FDA listed —
Tinted Mineral Sunscreen 38 mg/g; 80 mg/g 85604-0203-15 ESTHETICS 15 g — — FDA listed —
Tinted Facial Primer 38 mg/g; 80 mg/g 85707-0203-50 BEE 53 g — — FDA listed —
Mineral Sunscreen SPF 40 Tinted 38 mg/g; 80 mg/g 85296-0203-50 Skin 50 g — — FDA listed —
Tinted Mineral Sunscreen 38 mg/g; 80 mg/g 85318-0203-50 Maloney 53 g — — FDA listed —
Prevention Acne Safe Facial Mineral Sunscreen Tinted 38 mg/g; 80 mg/g 85404-0203-50 NY 53 g — — FDA listed —
Skin Filter Matte SPF 38 mg/g; 80 mg/g 85496-0203-50 MALORIE 53 g — — FDA listed —
Daily Defense Facial Sunscreen Plus Primer 38 mg/g; 80 mg/g 85596-0203-50 LAURA 53 g — — FDA listed —
Tinted Mineral Sunscreen 38 mg/g; 80 mg/g 85888-0203-50 MILESTHETICS 53 g — — FDA listed —
Solar Shield Tinted 38 mg/g; 80 mg/g 85890-0203-50 DENISE 53 g — — FDA listed —
Tinted Mineral Sunscreen 38 mg/g; 80 mg/g 85314-0203-50 Melinda 53 g — — FDA listed —
Non-Tinted Mineral Sunscreen 38 mg/g; 80 mg/g 85376-0202-15 HSC 15 g — — FDA listed —
non-tinted mineral sunscreen 38 mg/g; 80 mg/g 85425-0202-50 Skin 53 g — — FDA listed —
Tinted Mineral Sun Defense 38 mg/g; 80 mg/g 85581-0203-50 Helen's 53 g — — FDA listed —
Solar Shield non-tinted matte mineral SPF 40 38 mg/g; 80 mg/g 85632-0202-50 Joyce 53 g — — FDA listed —
Matte Tinted Mineral Sunscreen 38 mg/g; 80 mg/g 85642-0203-50 EDIT 53 g — — FDA listed —
Non-Tinted Mineral Sunscreen 38 mg/g; 80 mg/g 85886-0202-50 FRANCISCO 53 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

🏛️
2021
On the market since
Apr 2021
📍
2026
Currently FDA-listed
5 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

LabelerSPECKTRA6 LLC
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code85395
First marketedApr 2021
Product typeHuman Otc Drug
Portfolio2 products on file

More NDCs from SPECKTRA6 LLC labeler code 85395

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 ↗

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 SPECKTRA6 LLC. 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 53 g (85395-0203-50). 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?
SPECKTRA6 LLC 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.
← 85394-0220-30 · The 85395-0205-15 · SPECKTRA6 →
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.