ATTITUDE Sunly Lip Balm SPF 15 Watermelon ZINC OXIDE 10 g/100g Stick, 2 tubes — NDC 61649-557-02 (Billing 61649-0557-02)
by 9055-7588 Qubec Inc.DBA ATTITUDE · 2 TUBE in 1 BOX / 4.25 g in 1 TUBE
This is a package of 2 tubes of ATTITUDE Sunly Lip Balm SPF 15 Watermelon ZINC OXIDE 10 g/100g Stick from 9055-7588 Qubec Inc.DBA ATTITUDE, marketed since Dec 2025 and currently FDA-listed. It is this product's only package size.
NDC 61649-0557-02
🏷️ FDA NDC (as labeled)
61649-557-02
billing pads the product segment with a zero
🗂️ 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 →
NDC database record
One package, one record: these facts belong to NDC 61649-557-02 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 61649 labeler · 557 product · 02 package
- Package marketed since
- Dec 15, 2025
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 6164955702 8
- 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)
61649-557-02
Product NDC
61649-557
11-digit billing NDC
61649055702
UNII
SOI2LOH54Z
Application #
M020
SPL Set ID
450d038b-3f99-add8-e063-6294a90aee9a
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2025-12-15
Route
TOPICAL
Dosage form
STICK
Substance
ZINC OXIDE
Why two NDCs?
The FDA registers this code as 61649-557-02 — 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 → 61649-0557-02. 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
Clinical
🧪 What is this product?
This is a topical lip balm stick containing zinc oxide, marketed as an over-the-counter sunscreen product under FDA monograph rules. Zinc oxide is a mineral ingredient commonly used in sunscreen products to help protect skin from ultraviolet (UV) radiation. The product is formulated with a watermelon flavor and provides SPF 15 protection when applied to the lips.
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Zinc oxide (OTC drug) — tap one for details:
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.
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
💬 Questions about ZINC OXIDE?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per each | Per 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.
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 6, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 61649-0557-02 You're viewing this Main listing | 2 TUBE in 1 BOX / 4.25 g in 1 TUBE | 2025-12-15 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| ATTITUDE Super leaves Lip Balm SPF 15 Watermelon 10 g/100g 61649-0927-02 | 9055-7588 | 2 tubes | — | — | FDA listed | — |
| Skinsuit Lip Spf 30 10 g/100g 46007-0205-11 | Skin | 3.2 g | — | — | FDA listed | — |
| Sun and Honey 10 g/100g 85432-0001-01 | Amara | 1 tube | — | — | FDA listed | — |
| ATTITUDE Sunly Lip Balm SPF 15 Unscented 10 g/100g 61649-0550-02 | 9055-7588 | 2 tubes | — | — | FDA listed | — |
| Attitude Oceanly Phyto-Sun Tinted - SPF 15 - Broad Spectrum Sunscreen 10 g/100g 61649-0068-01 | Attitude | 30 g | — | — | FDA listed | — |
| ATTITUDE Sunly Lip Balm SPF 15 Watermelon 10 g/100gthis 61649-0557-02 | 9055-7588 | 2 tubes | — | — | FDA listed | — |
| ATTITUDE Sunly Lip balm Unscented SPF 15 10 g/100g 61649-0093-02 | 9055-7588 | 1 tube | — | — | FDA listed | — |
| ATTITUDE Super Leaves Lip Balm SPF15 Unscented 10 g/100g 61649-0920-02 | 9055-7588 | 2 tubes | — | — | FDA listed | — |
| Attitude - Leaves Bar - Lip Balm - SPF 15 - Mango 10 g/100g 61649-0983-01 | 9055-7588 | 8.5 g | — | — | FDA listed | — |
| DAILY FACE SUNSCREEN Broad Spectrum SPF 30 10 g/100g 81781-0101-50 | Lilyana | 1 tube | — | — | FDA listed | — |
| ATTITUDE Super leaves Lip Balm SPF 15 Coconut 10 g/100g 61649-0923-02 | 9055-7588 | 2 tubes | — | — | FDA listed | — |
| Zinc Oxide Perfecting Sunscreen 10 g/100g 84378-0100-74 | Epicuren | 74 g | — | — | FDA listed | — |
| ATTITUDE Sunly Lip Balm SPF 15 Coconut 10 g/100g 61649-0553-02 | 9055-7588 | 2 tubes | — | — | FDA listed | — |
| ATTITUDE Sunly Lip Balm SPF 15 Pineapple 10 g/100g 61649-0555-02 | 9055-7588 | 2 tubes | — | — | FDA listed | — |
| ATTITUDE Super leaves Lip Balm SPF 15 Exotic 10 g/100g 61649-0925-02 | 9055-7588 | 2 tubes | — | — | FDA listed | — |
| OLP diaper Rash cream A and D 10 g/100g 80489-0444-01 | OL | 1 tube | — | — | FDA listed | — |
| Attitude - Lip Balm - SPF 15 - Coconut 10 g/100g 61649-0985-01 | Attitude | 8.5 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
🏛️
2025
On the market since
Dec 2025
📍
2026
Currently FDA-listed
1 year 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.
- FDA Orange Book · refreshed Oct 3, 2026
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 4V59G5UW9X
Argan oil is a plant-derived oil from argan tree kernels. It's used in medicines as an emollient and skin-conditioning agent to help soften and moisturize the product's texture.
-
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 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 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 9TLV70SV6I
A natural essential oil extracted from bitter orange peel, used as a flavoring agent to mask unpleasant tastes and improve the palatability of medicines.
-
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 Z331YX9EL9
A synthetic fragrance compound used as a flavoring agent in medicines. It provides taste and aroma to make oral medications more palatable, particularly in liquid formulations or chewable products.
-
UNII L1T4AB29DS
A synthetic ester compound used as a flavoring agent in medicines. It provides a fruity, apple-like taste to help mask bitter or unpleasant flavors in oral medications.
-
UNII 76845O8NMZ
Ethyl acetate is a clear, colorless liquid solvent derived from acetic acid and ethanol. In medicines, it dissolves active ingredients, carries them into the product formulation, and helps control how quickly the drug releases and works in your body.
-
UNII UFD2LZ005D
Ethyl butyrate is a synthetic flavoring compound that smells fruity and buttery. It's added to medicines to improve taste and mask unpleasant flavors, making them easier to take.
-
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 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 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 9MC3I34447
A natural oil extracted from citrus peel, used as a flavoring agent and solvent to improve taste and help dissolve or distribute other ingredients in the medicine.
-
UNII C3M81465G5
Spearmint oil is a natural flavoring extract from spearmint plants. It's added to medicines to improve taste and mask bitter flavors, making medications easier to take.
-
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 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 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 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 statesCocos Nucifera (Coconut) Oil, Polyhydroxystearic Acid, Caprylic/Capric Triglyceride, Helianthus Annuus (Sunflower) Seed Oil, Behenyl Behenate, Butyrospermum Parkii (Shea) Butter, Helianthus Annuus (Sunflower) Seed Wax, Ricinus Communis (Castor) Seed Oil, Argania Spinosa (Argan) Kernel Oil, Citrus Aurantium Peel Oil*, Limonene*, Vanillin*, Mentha Viridis (Spearmint) Leaf Oil*, Caprylic/Capric Triglyceride*, Dimethyl Heptenal*, Ethyl 2-Methylbutyrate*, Ethyl Acetate*, Ethyl Butyrate*, *Flavour (Aroma), Euphorbia Cerifera (Candelilla) Wax, Coco-Caprylate/Caprate, Tocopherol.
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.- FDA label on DailyMed · label index refreshed Oct 6, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
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 Qubec Inc.DBA ATTITUDE
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code61649
First marketedDec 2025
Product typeHuman Otc Drug
Portfolio32 products on file
More NDCs from 9055-7588 Qubec Inc.DBA ATTITUDE labeler code 61649
- ATTITUDE Sensitive natural Mineral Sunscreen Stick SPF 50 Unscented ZINC OXIDE 24 g/100g Stick NDC 61649-544-01
- ATTITUDE Sunly Kids Mineral Sunscreen Stick SPF 50 Watermelon and Coco ZINC OXIDE 24 g/100g Stick NDC 61649-547-01
- ATTITUDE Sunly Mineral Sunscreen Stick SPF 50 Sun kissed vanilla ZINC OXIDE 24 g/100g Stick NDC 61649-548-01
- ATTITUDE Sunly Lip Balm SPF 15 Unscented ZINC OXIDE 10 g/100g Stick NDC 61649-550-02
- ATTITUDE Sunly Lip Balm SPF 15 Coconut ZINC OXIDE 10 g/100g Stick NDC 61649-553-02
- ATTITUDE Sunly Lip Balm SPF 15 Pineapple ZINC OXIDE 10 g/100g Stick NDC 61649-555-02
- ATTITUDE Sunly Mineral Sunscreen Face Stick SPF 50 Unscented ZINC OXIDE 24 g/100g Stick NDC 61649-560-02
- ATTITUDE Sunly Baby Mineral Sunscreen Face Stick SPF 50 Unscented ZINC OXIDE 24 g/100g Stick NDC 61649-561-02
- ATTITUDE Sunly Kids Mineral Sunscreen Face Stick SPF 50 Unscented ZINC OXIDE 24 g/100g Stick NDC 61649-562-02
- ATTITUDE Little Leaves Hand Sanitizer Watermelon and Coconut Ethyl alcohol 78.8 mL/100mL Solution NDC 61649-713-01
- ATTITUDE Baby Leaves Diaper cream - Unscented Zinc oxide 13 g/100g Cream NDC 61649-714-01
- BIO SPECTRA ATTITUDE Sodium fluoride .243 g/100g Gel, Dentifrice NDC 61649-723-01
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 openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
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
📄 Stop Use and Ask a Doctor If
📄 Keep Out of Reach of Children
📄 Questions or Comments
📄 Package Label / Principal Display Panel
🎯 Indications and Usage ▾
Helps prevent sunburn
⏱️ Dosage and Administration ▾
Adults and children older than 6 months • Apply generously 15 minutes before sun exposure • Reapply at least every 2 hours, after eating or drinking • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value ≥ 15 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.
⚠️ Warnings ▾
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. Stop use and consult a doctor if rash occurs.
📦 Storage and Handling ▾
Store at temperatures < 90°F and protect from direct sun. Avoid contact of the packaging with water
🧪 Active Ingredient ▾
Zinc oxide (10 %)
🧪 Inactive Ingredients ▾
Cocos Nucifera (Coconut) Oil, Polyhydroxystearic Acid, Caprylic/Capric Triglyceride, Helianthus Annuus (Sunflower) Seed Oil, Behenyl Behenate, Butyrospermum Parkii (Shea) Butter, Helianthus Annuus (Sunflower) Seed Wax, Ricinus Communis (Castor) Seed Oil, Argania Spinosa (Argan) Kernel Oil, Citrus Aurantium Peel Oil*, Limonene*, Vanillin*, Mentha Viridis (Spearmint) Leaf Oil*, Caprylic/Capric Triglyceride*, Dimethyl Heptenal*, Ethyl 2-Methylbutyrate*, Ethyl Acetate*, Ethyl Butyrate*, *Flavour (Aroma), Euphorbia Cerifera (Candelilla) Wax, Coco-Caprylate/Caprate, Tocopherol.
🎯 Purpose ▾
Sunscreen
📄 Do Not Use ▾
Do not use on broken skin.
📄 Stop Use and Ask a Doctor If ▾
Stop use and consult a doctor if rash occurs.
📄 Keep Out of Reach of Children ▾
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
📄 Questions or Comments ▾
Questions ? 1-855-509-7225
📄 Package Label / Principal Display Panel ▾
ATTITUDE EWG Verified VEGAN SPF 15 UVA ¦ UVB watermelon lip balm Broad spectrum sunscreen SPF 15 sunly 2 x 4.25 g / 0.14 oz. net wt. NPN 80109103 Made in Canada 16557T-01 16557BF-01< 16557BD-01
No label section mentions that — try another word, or open the full label on DailyMed below.
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) | ✓ 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 Qubec Inc.DBA ATTITUDE. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
9055-7588 Qubec 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.
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.