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ATTITUDE Sunly Mineral Sunscreen Stick Orange Blossom SPF 30 Zinc oxide 20 g/100g Stick, 60 g — NDC 61649-0092-60 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

ATTITUDE Sunly Mineral Sunscreen Stick Orange Blossom SPF 30 Zinc oxide 20 g/100g Stick, 60 g — NDC 61649-092-60 (Billing 61649-0092-60)

by 9055-7588 Quebec Inc. DBA Attitude · 60 g in 1 CARTON

This is a package of 60 g of ATTITUDE Sunly Mineral Sunscreen Stick Orange Blossom SPF 30 Zinc oxide 20 g/100g Stick from 9055-7588 Quebec Inc. DBA Attitude, marketed since Feb 2024 and currently FDA-listed. It is this product's only package size.

NDC 61649-0092-60
🏷️ FDA NDC (as labeled) 61649-092-60 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

NDC database record

One package, one record: these facts belong to NDC 61649-092-60 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
61649 labeler · 092 product · 60 package
Package marketed since
Feb 15, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 6164909260 4
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) 61649-092-60
Product NDC 61649-092
11-digit billing NDC 61649009260
UNII SOI2LOH54Z
Application # M020
SPL Set ID 0d840001-a648-df1b-e063-6294a90ab299
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-02-15
Route TOPICAL
Dosage form STICK
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 61649-092-60 — 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 → 61649-0092-60. 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 mineral sunscreen stick containing zinc oxide, a physical UV filter commonly used to protect skin from sun damage by reflecting and scattering ultraviolet rays. The product is applied topically to exposed skin and is marketed as an over-the-counter sunscreen under FDA's monograph rules for sunscreen products. The stick form makes it convenient for targeted application to areas like the face and nose.

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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
61649-0092-60 You're viewing this Main listing 60 g in 1 CARTON 2024-02-15 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
restorsea Rejuvenating Day SPF 30 Broad Spectrum UVA UVB with Vibransea Complex 20 g/100g 57670-0000-00 RESTORSEA 1 tube — — FDA listed —
SPF 50 Mineral Sunscreen 20 g/100g 72667-0101-01 Inspec 50 g — — FDA listed —
Radically Rejuvenating SPF Day Cream 20 g/100g 54136-0152-52 Better 52 g — — FDA listed —
Seriously Soothing SPF Day Cream 20 g/100g 54136-0179-52 Better 52 g — — FDA listed —
ATTITUDE Oatmeal Sensitive Natural Mineral Sunscreen Stick Unscented SPF 30 20 g/100g 61649-0100-60 9055-7588 60 g — — FDA listed —
Attitude Kids Oatmeal sensitive mineral sunscreen unscented SPF 30 20 g/100g 61649-0162-75 9055-7588 75 g — — FDA listed —
Attitude Oatmeal sensitive mineral sunscreen unscented SPF 30 20 g/100g 61649-0165-15 9055-7588 150 g — — FDA listed —
Zinc Oxide 20 g/100g 69771-0109-38 Geri-Gentle 1 tube — — FDA listed —
Aloe UP SPF 33 Mineral 20 g/100g 61477-0231-01 Aloe 30 g — — FDA listed —
Attitude mineral sunscreen orange blossom SPF 30 20 g/100g 61649-0022-15 9055-7588 150 g — — FDA listed —
Attitude mineral sunscreen unscented SPF 30 20 g/100g 61649-0030-85 Attitude 85 g — — Discontinued —
Attitude mineral sunscreen tropical SPF 30 20 g/100g 61649-0031-85 Attitude 85 g — — Discontinued —
ATTITUDE Sunly Kids Mineral Sunscreen Stick Unscented SPF 30 20 g/100g 61649-0098-60 9055-7588 60 g — — FDA listed —
ATTITUDE Sunly Tinted Mineral Sunscreen Face Stick Unscented SPF 30 20 g/100g 61649-0097-20 9055-7588 20 g — — FDA listed —
All Good Mineral Sport Sunscreen Sunstick SPF 30 20 g/100g 75786-0220-01 Elemental 17 g — — FDA listed —
Mackenzies SPF 40 Ocean Safe Sunscreen 20 g/100g 80325-0040-02 Naturally 80 g — — FDA listed —
Zinctral 20 g/100g 59088-0627-05 PureTek 57 g — — FDA listed —
Aloe Up SPF 50 Mineral 20 g/100g 61477-0234-01 Aloe 89 g — — FDA listed —
Aloe Up SPF 50 Kids Mineral 20 g/100g 61477-0236-01 Aloe 89 g — — FDA listed —
Attitude mineral sunscreen tropical SPF 30 20 g/100g 61649-0021-15 9055-7588 150 g — — FDA listed —
ATTITUDE Oceanly Phyto-sun lip balm SPF 30 Terracotta 20 g/100g 61649-0046-08 9055-7588 8.5 g — — FDA listed —
ATTITUDE Sunly Mineral Sunscreen Stick Unscented SPF 30 20 g/100g 61649-0090-60 9055-7588 60 g — — FDA listed —
ATTITUDE Sunly Mineral Sunscreen Stick Orange Blossom SPF 30 20 g/100gthis 61649-0092-60 9055-7588 60 g — — FDA listed —
Attitude Kids mineral sunscreen unscented SPF 30 20 g/100g 61649-0160-15 9055-7588 150 g — — FDA listed —
Mineral Defense Sport Ceramide Spf-30 20 g/100g 73054-0108-11 SOLARA 1 applicator — — FDA listed —
ProCure Zinc Oxide 20 g/100g 55681-0017-01 Twin 28.3 g — — FDA listed —
Attitude Kids mineral sunscreen unscented SPF 30 20 g/100g 61649-0038-85 Attitude 85 g — — Discontinued —
Attitude tinted mineral sunscreen face unscented SPF 30 20 g/100g 61649-0041-30 Attitude 30 g — — Discontinued —
ATTITUDE Oatmeal Sensitive Natural Mineral Sunscreen Face Stick Unscented SPF 30 20 g/100g 61649-0101-20 9055-7588 20 g — — FDA listed —
All Good Coconut Mineral Sunscreen Sunstick SPF 30 20 g/100g 75786-0221-01 Elemental 17 g — — FDA listed —
ATTITUDE Sunly Mineral Sunscreen Face Stick Unscented SPF 30 20 g/100g 61649-0094-20 9055-7588 20 g — — FDA listed —
Medpride 20 g/100g 52410-3040-03 Shield 28 g — — FDA listed —
Medline 20 g/100g 53329-0220-07 Medline 14 g — — FDA listed —
ATTITUDE Sunly Mineral Sunscreen Stick Tropical SPF 30 20 g/100g 61649-0091-60 9055-7588 60 g — — FDA listed —
Bio Spectra Attitude 20 g/100g 61649-0120-01 9055-7588 75 g — — FDA listed —
BLDG Active Skin Repair Sun Stick Performance Sunscreen 20 g/100g 70489-1423-01 Innovacyn, 15 g — — FDA listed —
Stream2Sea SPF 50 20 g/100g 69555-0050-01 Stream2Sea 1 jar — — FDA listed —
Stream2Sea Sport Lip Balm SPF 50 20 g/100g 69555-0500-01 Stream2Sea, 4 g — — FDA listed —
ATTITUDE Sunly Kids Mineral Sunscreen Face Stick Unscented SPF 30 20 g/100g 61649-0099-20 9055-7588 20 g — — FDA listed —
Bio Spectra Attitude 20 g/100g 61649-0110-15 9055-7588 150 g — — FDA listed —
dabur 20 g/100g 68747-3040-03 Dabur 28 g — — FDA listed —
New Kid on the Block 20 g/100g 84568-0552-12 Dimples 106.8 g — — FDA listed —
Lasso Tallow Sunscreen Spf 50 20 g/100g 87761-0004-01 Moes 140 g — — FDA listed —
Procure 20 g/100g 55681-0304-03 TWIN 28.3 g — — FDA listed —
ATTITUDE Oceanly Phyto-sun lip balm SPF 30 Baby Rose 20 g/100g 61649-0045-08 9055-7588 8.5 g — — FDA listed —
ATTITUDE Oceanly Phyto-sun lip balm SPF 30 Peachy Shell 20 g/100g 61649-0047-08 9055-7588 8.5 g — — FDA listed —
Endit Zinc Oxide Skin Protectant 20 g/100g 64068-0402-01 Endit 454 g — — FDA listed —
Stream2Sea Reef Safer Mineral Sunscreen SPF40 20 g/100g 69555-0400-10 Stream2Sea, 1 jar — — FDA listed —
365 Whole Foods Market Sport Mineral Spf 30 20 g/100g 42681-0062-01 Whole 44 g — — FDA listed —
Stream2Sea Ecostock SPF 40 Sunscreen 20 g/100g 69555-0401-01 Stream2Sea, 14 g — — FDA listed —
Utu Broad Spectrum SPF 30 Moisturizing Body Sunscreen 20 g/100g 87952-0004-02 Utu 1 bottle — — 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
Feb 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.

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

  • UNII K8NU647RJ0
    Behenyl behenate is a waxy ester derived from behenic acid. It acts as a lubricant and glidant in tablets and capsules to reduce friction during manufacturing and improve powder flow.
  • UNII WL0328HX19
    A natural plant-based wax derived from candelilla shrub leaves. It acts as a coating agent, hardener, and texture modifier to control how quickly the medicine releases and to improve the tablet or capsule's appearance and stability.
  • UNII N7YC58165T
    A synthetic polymer made from glycerin and sebacic acid, used as a film-former and binder in medications. It helps hold tablet or capsule ingredients together and may coat the product for controlled release.
  • UNII D5340Y2I9G
    Castor oil is a natural plant-based oil used in medicines as a lubricant, laxative agent, and solvent. It helps medicine ingredients dissolve or flow smoothly and can aid bowel movement in formulations designed for that purpose.
  • UNII 8D9H4QU99H
    A synthetic fatty acid ester derived from coconut oil, used as an emulsifier and solubilizer to help mix oil and water-based ingredients and improve how the body absorbs certain drugs.
  • UNII Q9L0O73W7L
    Coconut oil is a natural fat extracted from coconut fruit. It's used in medicines as a lubricant, emollient, or carrier to help dissolve or deliver active ingredients smoothly through the formulation.
  • UNII A626UU0W2A
    Glyceryl monobehenate is a waxy substance made from glycerin and behenic acid. It's used as a binder and lubricant to help hold tablet ingredients together and improve how smoothly the medicine flows during manufacturing.
  • UNII 930MLC8XGG
    A plant oil extracted from grape seeds, used as an emollient and solvent in medicines. It helps dissolve active ingredients and improve the texture and absorption of topical or liquid formulations.
  • UNII 42DG15CHXV
    A natural plant wax derived from sunflower seeds. It serves as a lubricant and glidant to help powders flow smoothly during manufacturing and tablet formation.
  • UNII C9H2L21V7U
    A fat derived from coconut or palm oil containing shorter fatty acid chains. It serves as a solvent and carrier to help dissolve or suspend active ingredients, improving absorption and stability in liquid formulations.
  • UNII 3GW44CIE3Y
    A synthetic fragrance compound used to add pleasant scent to medicines. It helps mask unpleasant tastes or odors in oral products and may improve patient acceptance of the medication.
  • UNII V8A1AW0880
    Mica is a naturally occurring mineral that's ground into fine powder. It's used in medicines as a colorant and anti-caking agent to improve appearance and prevent clumping in tablets or powders.
  • UNII OK17S3S98K
    A waxy, fatty substance derived from plant or animal sources. It acts as a lubricant and glidant to help the medicine flow smoothly during manufacturing and tablet compression.
  • UNII 67733846OW
    Phenethyl acetate is a synthetic fragrance compound used as a flavoring agent in medicines. It adds a pleasant fruit or floral aroma to help mask unpleasant tastes or odors in the formulation.
  • UNII YXH47AOU0F
    A synthetic fatty acid used as a thickener and stabilizer in medicines. It helps create the right texture and prevents separation of ingredients in liquid or semi-solid formulations.
  • UNII K49155WL9Y
    Shea butter is a fat extracted from shea tree nuts. It's used in medicines as an emollient and lubricant to soften the product, improve texture, and help ingredients blend smoothly together.
  • 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 3W1JG795YI
    Sunflower oil is a natural vegetable oil derived from sunflower seeds. It serves as a solvent, lubricant, and carrier in medicines, helping dissolve active ingredients and improve how the medication flows and absorbs in the body.
  • UNII 8Z96QXD6UM
    Triethyl citrate is a clear liquid derived from citric acid. It acts as a plasticizer and solvent in tablet coatings and film formulations, helping the coating remain flexible and adhere properly to the medicine.
  • UNII CHI530446X
    Vanillin is a natural or synthetic aromatic compound that gives vanilla flavor. It's used in medicines as a flavoring agent to mask bitter tastes and improve how the medicine tastes.

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

The official label also statesVitis Vinifera (Grape) Seed Oil, Caprylic/Capric Triglyceride, Cocos Nucifera (Coconut) Oil, Helianthus Annuus (Sunflower) Seed Oil, Polyhydroxystearic Acid, Helianthus Annuus (Sunflower) Seed Wax, Behenyl Behenate, Ricinus Communis (Castor) Seed Oil, Mica, Coco-Caprylate/Caprate, Butyrospermum Parkii (Shea) Butter, Glyceryl Behenate, Euphorbia Cerifera (Candelilla) Wax, Capryloyl Glycerin/Sebacic Acid Copolymer, Silica, Methyldihydrojasmonate*, Pentadecalactone*, Phenethyl Acetate*, Triethyl Citrate*, Vanillin*, *fragrance (Parfum).

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

Labeler9055-7588 Quebec Inc. DBA Attitude
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code61649
First marketedFeb 2024
Product typeHuman Otc Drug
Portfolio33 products on file

More NDCs from 9055-7588 Quebec Inc. DBA Attitude labeler code 61649

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 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 3 words ▾

Helps prevent sunburn.

⏱️ Dosage and Administration 95 words ▾

Adults and children older than 6 months. Apply generously 15 minutes before sun exposure. Reapply at least every 2 hours.

Sun Protection Measures : Spending time in the sun increases your risk of skin cancer and early aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPFvalue of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10am-2pm; and wear long-sleeved shirts, pants, hats and sunglasses. Use a water resistant sunscreen if swimming or sweating.

Children under 6 months of age: Ask a doctor.

⚠️ Warnings 53 words ▾

For external use only. Do not use on broken skin. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water. Stop use and consult a doctor if rash occurs.

📦 Storage and Handling 16 words ▾

Store at temperatures < 90F and protect from direct sun. Avoid contact of packaging with water.

🧪 Active Ingredient 4 words ▾

Zinc oxide (20 %)

🧪 Inactive Ingredients 56 words ▾

Vitis Vinifera (Grape) Seed Oil, Caprylic/Capric Triglyceride, Cocos Nucifera (Coconut) Oil, Helianthus Annuus (Sunflower) Seed Oil, Polyhydroxystearic Acid, Helianthus Annuus (Sunflower) Seed Wax, Behenyl Behenate, Ricinus Communis (Castor) Seed Oil, Mica, Coco-Caprylate/Caprate, Butyrospermum Parkii (Shea) Butter, Glyceryl Behenate, Euphorbia Cerifera (Candelilla) Wax, Capryloyl Glycerin/Sebacic Acid Copolymer, Silica, Methyldihydrojasmonate*, Pentadecalactone*, Phenethyl Acetate*, Triethyl Citrate*, Vanillin*, *fragrance (Parfum).

🎯 Purpose 1 words ▾

Sunscreen

📄 Do Not Use 6 words ▾

Do not use on broken skin.

📄 When Using This Product 15 words ▾

When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

📄 Stop Use and Ask a Doctor If 9 words ▾

Stop use and consult a doctor if rash occurs.

📄 Keep Out of Reach of Children 19 words ▾

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

📄 Questions or Comments 3 words ▾

Questions ? 1-855-509-7225

📄 Package Label / Principal Display Panel 38 words ▾

ATTITUDE SPF 30 orange blossom mineral sunscreen stick BROAD SPECTRUM SPF 30 UVA UVB + NON NANO SUNLY Plastic Free Suncare 60 g / 2.1 oz. NPN 80073697 Vegan EWG Verified Ocean Lovers Plastic Free Dermatologically tested 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 ✓ 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 9055-7588 Quebec Inc. DBA Attitude. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
9055-7588 Quebec Inc. DBA Attitude 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.
← 61649-0091-60 · 9055-7588 61649-0093-02 · 9055-7588 →
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.