🧴image loading
(from DailyMed)

Aavini Double Layer Brightening Spot Correcting Essence Oil .15 g/100mL; .4116 g/100mL; 25.8 g/100mL; 2.1 g/100mL Liquid, 30 mL — NDC 85004-001-01 (Billing 85004-0001-01)

by Qingyuan Moksha Biotechnology Co., Ltd. · 30 mL in 1 BOTTLE

This is a package of 30 mL of Aavini Double Layer Brightening Spot Correcting Essence Oil .15 g/100mL; .4116 g/100mL; 25.8 g/100mL; 2.1 g/100mL Liquid from Qingyuan Moksha Biotechnology Co., Ltd., marketed since Mar 2025 and currently FDA-listed. It is this product's only package size.

NDC 85004-0001-01
🏷️ FDA NDC (as labeled) 85004-001-01 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 Aug 27, 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 85004-001-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
85004 labeler · 001 product · 01 package
Package marketed since
Mar 10, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 8500400101 8
FDA record last changed
Aug 27, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 85004-001-01
Product NDC 85004-001
11-digit billing NDC 85004000101
UNII GW89575KF9, B8WCK70T7I, 7D1YQ9Y5EZ, 25X51I8RD4
Application # M016
SPL Set ID 2ff89a13-3969-2df1-e063-6394a90ac0d3
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-03-10
Route CUTANEOUS
Dosage form LIQUID
Substance SQUALANE; TREHALOSE; HYDROGENATED POLYBUTENE (1300 MW); NIACINAMIDE
Why two NDCs? The FDA registers this code as 85004-001-01 — 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 → 85004-0001-01. 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?

Aavini Double Layer Brightening Spot Correcting Essence Oil is a liquid skincare product applied to the skin. It contains niacinamide, which is commonly used in cosmetic products to help improve skin appearance and texture, along with squalane and hydrogenated polybutene, which function as emollients to soften and moisturize the skin. Trehalose is included as a humectant to help retain moisture. This is an over-the-counter monograph product marketed under established FDA guidelines for this product category.

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 mLPer 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
85004-0001-01 You're viewing this Main listing 30 mL in 1 BOTTLE 2025-03-10 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Aavini Double Layer Brightening Spot Correcting Essence Oil .15 g/100mL; .4116 g/100mL; 25.8 g/100mL; 2.1 g/100mLthis 85004-0001-01 Qingyuan 30 ml — — 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

🏛️
2025
On the market since
Mar 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.

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 TR046Y3K1G
    A liquid alcohol derived from petroleum or plant sources. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII 6MW60CB71P
    A stabilized form of vitamin C used as an antioxidant in medicines. It prevents other ingredients from breaking down or discoloring during storage.
  • UNII 86HT4R42SH
    A plant extract from the adenium obesum (desert rose) leaf. It may be used as a natural flavor, fragrance, or botanical ingredient to enhance the product's sensory appeal or provide plant-derived compounds.
  • UNII 344S277G0Z
    Allantoin is a naturally derived compound that helps soften and soothe skin. In medicines, it works as a skin-conditioning agent and may help support wound healing and reduce irritation in topical formulations.
  • UNII 9E8X80D2L0
    A synthetic form of vitamin E used as an antioxidant and preservative in medications. It helps prevent the active ingredients from degrading when exposed to oxygen or light.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
  • UNII 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 2V52R0NHXW
    Ascorbyl glucoside is a stable form of vitamin C derived from ascorbic acid and glucose. It functions as an antioxidant in medicines to protect other ingredients from breaking down when exposed to air or light.
  • UNII QN83US2B0N
    Ascorbyl palmitate is a fat-soluble form of vitamin C used as an antioxidant in medicines. It prevents oils and fats in the product from breaking down and becoming less stable over time.
  • UNII 47143LT58A
    A synthetic form of vitamin C that acts as an antioxidant. It prevents other ingredients in the medicine from breaking down or discoloring when exposed to air or light.
  • UNII 3XUS85K0RA
    Butylene glycol is a clear liquid derived from petroleum or plants that acts as a humectant, solvent, and preservative booster in medicines. It helps keep formulations stable, dissolve active ingredients, and maintain moisture in topical products.
  • UNII CI87N1IM01
    A mixture of liquid hydrocarbons derived from petroleum, used as a lubricant and glidant to help the medicine flow smoothly during manufacturing and ensure even tablet coating or capsule filling.
  • UNII KUB8101TNF
    A plant extract from Japanese camellia flowers used as a natural colorant and antioxidant in medications. It may help preserve the product and contribute to its appearance.
  • UNII F1X8L2B00J
    A naturally derived fatty substance that helps bind and condition the product's texture. It works as an emollient and skin-conditioning agent in topical formulations, helping maintain moisture and smoothness.
  • UNII 4370DF050B
    Ceramide NP is a waxy, lipid-based substance that mimics natural skin oils. It's used in topical formulations as an emollient and skin-conditioning agent to help soften, smooth, and protect the skin barrier.
  • UNII V7M2259XJM
    Ceramide NS is a lipid compound derived from natural sources or synthesized chemically. It works as an emollient and skin-conditioning agent that helps soften and smooth the product's texture while improving how it feels on the skin.
  • UNII 350KA7O6HK
    D&C Violet No. 2 is a synthetic purple dye approved by the FDA for use in medicines. It serves as a colorant to make tablets, capsules, or liquids visually distinct for identification purposes.
  • UNII 4QP5U84YF7
    A synthetic green colorant used to tint medicines and make them visually distinctive. It helps identify the medication and may improve appearance of tablets or capsules.
  • UNII 2S42T2808B
    A synthetic red dye used as a colorant to give the medicine its red color. It helps make pills or liquids visually distinct and easier to identify.
  • UNII CA2Y0FE3FX
    A salt derived from licorice root extract, used as a flavoring agent and sweetener. It may also help soothe and protect mucous membranes in throat lozenges and cough products.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • UNII A1A1I8X02B
    A clear liquid solvent derived from ethylene glycol. It helps dissolve active ingredients and improve how the medicine flows and mixes in liquid formulations.
  • UNII 2865993309
    Ethylhexyl palmitate is an oily chemical made from palm oil and alcohol. It acts as an emollient and skin-conditioning agent in topical medicines, helping the product spread smoothly and keeping skin soft.
  • UNII 147D247K3P
    Ethylhexylglycerin is a synthetic preservative used to prevent bacteria and mold from growing in medicines and personal care products. It helps keep the product safe and stable throughout its shelf life.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII H1109Z9J4N
    A natural emulsifier derived from soybean oil. It helps mix oil and water-based ingredients together, ensuring even distribution of active ingredients throughout the medicine.
  • UNII G1L3HT4CMH
    A synthetic compound used in medicines as a preservative and antimicrobial agent. It helps prevent bacterial and fungal growth, extending the product's shelf life.
  • UNII T4V6TWG28D
    A plant-derived thickening agent made from cellulose. It increases viscosity and helps form a gel or paste consistency in medications, and may serve as a binder or coating material in various formulations.
  • UNII 5307V7XW8I
    A beneficial bacterium added to certain medicines and supplements. It acts as a probiotic ingredient, helping maintain or restore healthy gut bacteria balance in formulations designed for digestive wellness.
  • UNII 412ZHA4T4Y
    A plant-derived oil extracted from meadowfoam seeds. It acts as an emollient and skin-conditioning agent, helping soften and smooth the product texture while improving how it spreads on skin.
  • UNII 9I70D8O47I
    A plant-derived ingredient from the root of Lithospermum erythrorhizon. It may be used as a natural colorant or preservative in formulations.
  • UNII DE08037SAB
    Magnesium sulfate is a mineral salt that acts as an osmotic agent in medications. It draws water into the intestines to soften stool or is used as a filler and processing aid in some solid dosage forms.
  • UNII J3QD0LD11P
    A synthetic compound made by combining glucose with methyl alcohol and polyethylene glycol. It acts as an emulsifier and solvent to help blend water and oil-based ingredients and improve how the medicine dissolves or spreads.
  • UNII WV9CM0O67Z
    Panthenol is a humectant and skin-conditioning agent derived from pantothenic acid. It's added to medicines to help retain moisture and soothe skin irritation.
  • UNII 788QAG3W8A
    A synthetic polymer that combines polyethylene glycol, glycidyl ether, and sodium hyaluronate. It acts as a thickener and film-former in topical products, helping maintain texture and improve how the medicine spreads on skin.
  • UNII 50C1307PZG
    Pentylene glycol is a humectant and preservative helper derived from petroleum or plant sources. It draws moisture into the product and helps prevent bacterial growth, keeping medicines stable during storage.
  • UNII 1T6N4D9YV6
    A natural fat-like substance derived from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and may improve how the body absorbs the active medicine.
  • UNII 724GKU717M
    Jojoba oil is a natural liquid wax extracted from jojoba plant seeds. It's used in medicines as an emollient and lubricant to soften and smooth the product, and sometimes as a carrier or penetration enhancer.
  • UNII WN66R7GL93
    A modified form of hyaluronic acid, a naturally occurring substance that holds water. Used as a thickener, lubricant, and moisture-retaining agent in formulations, especially in topical or injectable products.
  • UNII F63GOY24UQ
    A natural polysaccharide derived from hyaluronic acid, chemically modified with butyroyl and formoyl groups. Used in formulations as a thickener, humectant, and film-former to improve texture and help retain moisture in topical or injectable products.
  • UNII 2YGO1190AP
    A plant-derived carbohydrate from yeast or fungi, chemically modified to carry sodium and carboxyl groups. It acts as a thickener, stabilizer, and binder in medications to improve texture, consistency, and shelf life.
  • UNII YSE9PPT4TH
    Hyaluronate sodium is a natural carbohydrate that holds moisture. It's used in medicines as a lubricant, thickener, and moisture-retaining agent to improve texture and delivery of the active ingredient.
  • 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 TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

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

The official label also statesAQUA、C15-19 ALKANE、GLYCERIN BUTYLENE GLYCOL METHYL GLUCETH-20、MAGNESIUM SULFATE、 1,2- HEXANEDIOL、HYDROXYACETOPHENONE PANTHE-NOL、LIMNANTHES ALBA (MEADOWFOAM) SEED OIL、 SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL、ARGANIA SPINOSA KERNEL OIL、CAMELLIA JAPONICA FLOWER EXTRACT、SODIUM HYALURONATE、3-0- ETHYL ASCORBIC ACID、ALLANTOIN LITHOSPERMUM ERYTHRORHIZON ROOT EXTRACT、XANTHAN GUM、ASCORBYL TETRAISOPALMITATE、DIPOTASSIUM GLYCYRRHIZATE、 ASCORBYL GLUCOSIDE、PENTYLENE GLYCOL、TOCOPH-EROL、ADENIUM OBESUM LEAF CELL EXTRACT、HYDRO- LYZED SODIUM HYALURONATE、LACTOBACILLUS/SOYM-ILK FERMENT FILTRATE、ETHYLHEXYL PALMITATE、BETA-GLUCAN、 SODIUM ACETYLATED HYALURONATE、TOCOPHERYL ACETATE、SODIUM HYALURONATE CROSSPOLYMER、HYDROXYETHYLCELL-ULOSE、HYDROGENATED LECTTHIN、 ASCORBYL PALMIT-ATE CERAMIDE NS/CERAMIDE NG、CERAMIDENP、 CER-AMIDE AP、CI 73360、ETHYLHEXYLGLYCERIN、DISODIUM EDTA、PHOSPHATIDYLCHOLINE、 CI 61565、CI 60725、ETHOXYDIGLYCOL

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

LabelerQingyuan Moksha Biotechnology Co., Ltd.
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code85004
First marketedMar 2025
Product typeHuman Otc Drug
Portfolio2 products on file

More NDCs from Qingyuan Moksha Biotechnology Co., Ltd. labeler code 85004

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 24 words ▾

Use shake well before use, take an appropriate amount of the product and apply it evenly to the facial skin. Gently massage until absorbed.

⏱️ Dosage and Administration 22 words ▾

Directions Apply proper amount of whitening and spot lightening essence evenly on the face, which can be gently massaged to help absorb

⚠️ Warnings 30 words ▾

Warnings It is recommended to try it locally behind the ear before initial use; If you experience any discomfort during use, please stop using immediately.This product is for external use.

📦 Storage and Handling 16 words ▾

Other information Please keep in a cool and dry place, away from sunlight and high temperatures.

🧪 Active Ingredient 11 words ▾

Active Ingredient(s) NIACINAMIDE 2.1% SQUALANE 0.15% TREHALOSE 0.4116% HYDROGENATED POLYISOBUTENE 25.8%

🧪 Inactive Ingredients 70 words ▾

Inactive ingredients AQUA、C15-19 ALKANE、GLYCERIN BUTYLENE GLYCOL METHYL GLUCETH-20、MAGNESIUM SULFATE、 1,2- HEXANEDIOL、HYDROXYACETOPHENONE PANTHE-NOL、LIMNANTHES ALBA (MEADOWFOAM) SEED OIL、 SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL、ARGANIA SPINOSA KERNEL OIL、CAMELLIA JAPONICA FLOWER EXTRACT、SODIUM HYALURONATE、3-0- ETHYL ASCORBIC ACID、ALLANTOIN LITHOSPERMUM ERYTHRORHIZON ROOT EXTRACT、XANTHAN GUM、ASCORBYL TETRAISOPALMITATE、DIPOTASSIUM GLYCYRRHIZATE、 ASCORBYL GLUCOSIDE、PENTYLENE GLYCOL、TOCOPH-EROL、ADENIUM OBESUM LEAF CELL EXTRACT、HYDRO- LYZED SODIUM HYALURONATE、LACTOBACILLUS/SOYM-ILK FERMENT FILTRATE、ETHYLHEXYL PALMITATE、BETA-GLUCAN、 SODIUM ACETYLATED HYALURONATE、TOCOPHERYL ACETATE、SODIUM HYALURONATE CROSSPOLYMER、HYDROXYETHYLCELL-ULOSE、HYDROGENATED LECTTHIN、 ASCORBYL PALMIT-ATE CERAMIDE NS/CERAMIDE NG、CERAMIDENP、 CER-AMIDE AP、CI 73360、ETHYLHEXYLGLYCERIN、DISODIUM EDTA、PHOSPHATIDYLCHOLINE、 CI 61565、CI 60725、ETHOXYDIGLYCOL

🎯 Purpose 7 words ▾

Purpose Whitening Agent Repair Moisturizing agent Moisturizer

📄 Do Not Use 6 words ▾

Do not use OPEN SKIN WOUND

📄 When Using This Product 23 words ▾

When using this product, if it accidentally gets into the eyes, please rinse thoroughly with water and keep out of reach of children.

📄 Stop Use and Ask a Doctor If 19 words ▾

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

📄 Keep Out of Reach of Children 7 words ▾

If accidentally swallowed, please seek medical attention.

📄 Package Label / Principal Display Panel 7 words ▾

Package Label - Principal Display Panel undefined

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 Qingyuan Moksha Biotechnology Co., Ltd.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Qingyuan Moksha Biotechnology Co., Ltd. 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.