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Oribe Serene Scalp Anti Dandruff 2 g/100g Lotion — NDC 71438-0020-12 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Oribe Serene Scalp Anti Dandruff 2 g/100g Lotion — NDC 71438-020-12 (Billing 71438-0020-12)

by Oribe Hair Care LLC · 1 TUBE in 1 CARTON / 100 g in 1 TUBE

This is a package of Oribe Serene Scalp Anti Dandruff 2 g/100g Lotion from Oribe Hair Care LLC, marketed since Nov 2017 and currently FDA-listed. It is this product's only package size.

NDC 71438-0020-12
🏷️ FDA NDC (as labeled) 71438-020-12 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 71438-020-12 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
71438 labeler · 020 product · 12 package
Package marketed since
Nov 20, 2017
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 7143802012 1
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 71438-020-12
Product NDC 71438-020
11-digit billing NDC 71438002012
RxCUI 205104
UNII O414PZ4LPZ
Application # M032
SPL Set ID 34c4abb5-6f96-4866-a37f-4f9be6c43f2b
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2017-11-20
Route TOPICAL
Dosage form LOTION
Substance SALICYLIC ACID
Quick answers
  • RxCUI (RxNorm): 205104
Why two NDCs? The FDA registers this code as 71438-020-12 — 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 → 71438-0020-12. 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.

RxNorm drug class

This medicine belongs to the Salicylic acid and derivatives class.

Drug family (ATC) Salicylic acid and derivatives, Other antifungals for topical use, Antiinflammatory agents, non-steroids
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

📖 What it is MedlinePlus · NLM

Topical salicylic acid is used to help clear and prevent pimples and skin blemishes in people who have acne. Topical salicylic acid is also used to treat skin conditions that involve scaling or overgrowth of skin cells such as psoriasis (a skin disease in which red, scaly patches form on some areas of the body), ichthyoses (inborn conditions that cause skin dryness and scaling), dandruff, corns, calluses, and warts on the hands or feet. Topical salicylic acid should not be used to treat genital warts, warts on the face, warts with hair growing from them, warts in the nose or mouth, moles, or b...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It is used in a facial routine for acne-prone and oil-prone skin. The routine includes a cleanser, serum, toner and emulsion. Salicylic acid helps loosen and shed dead skin cells.
  • Use the cleanser morning and evening, and the serum in the morning after cleansing. Use the toner in the evening on dry skin, and the emulsion at night after cleansing. Avoid your...
  • Mild stinging, burning, itching, dryness and extra peeling can happen. If dryness or peeling bothers you, try using the serum or toner every other day. If it gets excessive, stop a...
  • It is best not to. Using another topical acne medication at the same time makes irritation and dryness more likely. If you get irritated, use only one at a time.
📖 Read our full Salicylic Acid Topical guide →

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.
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
71438-0020-12 You're viewing this Main listing 1 TUBE in 1 CARTON / 100 g in 1 TUBE 2017-11-20 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Satinique Anti Dandruff Scalp and Hair 20 mg/mL 10056-0536-00 Access 280 ml — — FDA listed —
Sulfur 8 Medicated Dandruff with Salicylic Acid 20 mg/mL 12022-0039-00 J. 222 ml — — FDA listed —
Glovers Therapeutic Care 20 mg/mL 12022-0040-00 J. 118 ml — — FDA listed —
Texture ID Anti Dandruff Peppermint Oil and Aloe .02 g/g 60717-0410-12 RNA 1 g — — FDA listed —
Texture ID Anti Dandruff Peppermint Oil and Aloe Conditioner .02 g/g 60717-0411-12 RNA 1 g — — FDA listed —
RE-fresh Scalp Care 2 g/100mL 64942-1928-01 Conopco, 400 ml — — FDA listed —
RE-fresh Scalp Care 2 g/100mL 64942-1929-01 Conopco, 400 ml — — FDA listed —
bhs beautiful hair and scalp 2 g/100mL 64942-1964-01 Conopco, 400 ml — — FDA listed —
bhs beautiful hair and scalp 2 g/100mL 64942-1966-01 Conopco, 400 ml — — FDA listed —
bhs beautiful hair and scalp 2 g/100mL 64942-1968-01 Conopco, 400 ml — — FDA listed —
bhs beautiful hair and scalp 2 g/100mL 64942-1970-01 Conopco, 400 ml — — FDA listed —
bhs beautiful hair and scalp 2 g/100mL 64942-1972-01 Conopco, 400 ml — — FDA listed —
bhs beautiful hair and scalp 2 g/100mL 64942-2058-01 Conopco, 400 ml — — FDA listed —
bhs beautiful hair and scalp 2 g/100mL 64942-2059-01 Conopco, 400 ml — — FDA listed —
bhs beautiful hair and scalp 2 g/100mL 64942-2060-01 Conopco, 400 ml — — FDA listed —
bhs beautiful hair and scalp 2 g/100mL 64942-2061-01 Conopco, 400 ml — — FDA listed —
bhs beautiful hair and scalp 2 g/100mL 64942-2062-01 Conopco, 400 ml — — FDA listed —
Mens Rogaine 2% Salicylic Acid Anti-Dandruff Plus Conditioner 20 mg/mL 69968-0954-02 Kenvue 248 ml — — FDA listed —
Oribe Serene Scalp Anti Dandruff 2 g/100g 71438-0010-07 Oribe 1 packet — — FDA listed —
Oribe Serene Scalp Anti Dandruff 2 g/100gthis 71438-0020-12 Oribe 1 tube — — FDA listed —
Pert 2 in 1 Advanced plus 2 g/100mL 81277-0802-13 Sodalis 400 ml — — FDA listed —
Hermon Folliculitis Shampoo. 8 g/400mL 85398-0009-01 Beautivity 400 ml — — FDA listed —
ProBliva Anti Fungal Shampoo. 4.72 g/236g 85464-0003-01 CAVTECH 236 g — — FDA listed —
Swiftalyn Antifungal Scalp Shampoo. 20 mg/g 87013-0004-01 GENUINE 280 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

🏛️
2017
On the market since
Nov 2017
📍
2026
Currently FDA-listed
9 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.

🧪 Avoiding an ingredient? See Salicylic Acid Topical inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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

  • UNII QP4QYZ033C
    A natural gum obtained from the acacia tree, used as a binder to hold ingredients together and as a thickener to create the proper texture in liquid or semi-solid medicines.
  • UNII OF5P57N2ZX
    Alanine is a naturally occurring amino acid used in medicines as a buffering agent and pH stabilizer. It helps maintain the proper acidity level in liquid formulations to improve stability and taste.
  • UNII 94ZLA3W45F
    Arginine is an amino acid used in medicines as a buffer and pH adjuster. It helps maintain the proper acidity level and stability of liquid formulations.
  • UNII PQ6CK8PD0R
    Ascorbic acid, also known as vitamin C, is a white crystalline powder. It serves as an antioxidant to prevent degradation of other ingredients and may also function as a preservative in the formulation.
  • UNII 30KYC7MIAI
    Aspartic acid is an amino acid used in pharmaceutical formulations as a pH buffer and to help stabilize active ingredients. It works to maintain the proper acidity level in the medicine.
  • UNII 6SO6U10H04
    Biotin is a B-vitamin used as a nutritional supplement in some medications. It may also serve as a colorant or marker in formulations.
  • UNII DSO12WL7AU
    A salt derived from citric acid, this ingredient acts as a buffer and pH regulator in medicines. It helps maintain stable acidity levels and may improve taste or aid preservation.
  • UNII 3J5I6254YO
    A plant-derived ingredient from watermelon fruit. Used in formulations as a natural filler and texturizer to add bulk and consistency to the medicine.
  • UNII 5OCF3O11KX
    A plant-derived surfactant made from coconut oil. It helps mix oil and water ingredients together in the formulation and can improve how the medicine spreads or feels on the skin.
  • UNII D6DH1DTN7E
    Disodium laureth sulfosuccinate is a synthetic surfactant and emulsifier derived from lauryl alcohol. It helps mix oil and water-based ingredients together and is commonly used in topical formulations to improve product texture and spreadability.
  • UNII TE7660XO1C
    Glycine is an amino acid used in medicines as a buffer to help stabilize pH and improve taste. It may also serve as a filler or binder to give the product proper form and consistency.
  • UNII B16G315W7A
    A plant-derived thickener made from guar gum that has been chemically modified to carry a positive charge. It's used in medicines as a thickening agent and to help keep ingredients evenly mixed throughout the product.
  • UNII 4QD397987E
    An amino acid used as a buffer and stabilizer in medications. It helps maintain the pH balance and protects the active drug from breaking down during storage and use.
  • UNII 6HQ855798J
    Laureth-4 is a synthetic detergent made from lauryl alcohol and ethylene oxide. It acts as an emulsifier and solubilizer, helping blend oil and water-based ingredients and improve how the body absorbs the active drug.
  • UNII MWN6IZU3XM
    A plant extract from edelweiss flowers. It's used in medicines as a natural ingredient to help preserve the product and may contribute to texture or appearance.
  • UNII 47EV26G96N
    A natural extract from litchi fruit used as a flavoring agent and colorant in medicines. It adds taste and may provide a reddish hue to the product.
  • UNII 25X51I8RD4
    Niacinamide is a form of vitamin B3, a water-soluble nutrient. In medicines, it may be added as a nutritional supplement or to support skin health, though its primary role here is as an active ingredient rather than a traditional inactive filler.
  • 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 762O8IWA10
    PEG-8 laurate is a synthetic compound made by combining polyethylene glycol with lauric acid. It acts as an emulsifier and solubilizer in medicines, helping to blend water and oil-based ingredients together and improve how well some drugs dissolve.
  • UNII HIE492ZZ3T
    Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
  • UNII J21YE3W98E
    Pisum sativum is a plant-derived ingredient commonly known as garden pea. It's used in medicines as a binder and filler to help hold the tablet together and add bulk to the formulation.
  • UNII 7T1F30V5YH
    A synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in liquid formulations.
  • UNII WZH3C48M4T
    Potassium hydroxide is a strong alkaline chemical used in medicines to adjust and maintain the pH level of liquid formulations, helping keep the product stable and the active ingredients effective.
  • UNII 1VPU26JZZ4
    Potassium sorbate is a salt derived from sorbic acid, a naturally occurring preservative. It prevents growth of mold, yeast, and some bacteria, extending the medicine's shelf life.
  • UNII 00J8H295NB
    A synthetic polymer used as a film-forming agent and conditioner. It coats tablet or capsule surfaces to improve appearance, protect contents, and sometimes enhance how the medicine releases in your body.
  • UNII 3Z20C92XNB
    A natural sweetener derived from sugarcane that makes the medicine taste better and helps mask bitter flavors. It also acts as a filler to give the product proper texture and consistency.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII O9W3D3YF5U
    A synthetic surfactant derived from petroleum-based olefins. It helps dissolve or suspend active ingredients and other substances in liquid formulations, improving how the medicine mixes and flows.
  • UNII 632GS99618
    Sodium lauroyl sarcosinate is a mild, plant-derived cleaning agent used in medicines as a surfactant and emulsifier. It helps mix oil and water-based ingredients and may aid tablet disintegration.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • 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 EE76EZ4QNZ
    A plant extract from bilberry fruit used as a natural colorant and flavoring agent in medicines. It provides blue to purple color and contributes subtle fruit taste to tablets, capsules, or liquids.
  • UNII HG18B9YRS7
    Valine is an amino acid, one of the building blocks of proteins. In medicines, it acts as a filler and bulking agent to give the product proper volume and texture.
  • 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.

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

The official label also statesAqua/Water/Eau, Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, Glycerin, Acrylates Copolymer, Disodium Laureth Sulfosuccinate, Sodium Lauroyl Sarcosinate, Citrullus Lanatus (Watermelon) Fruit Extract, Litchi Chinensis Fruit Extract, Leontopodium Alpinum Extract, Biotin, Niacinamide, Panthenol, Tocopheryl Acetate, Vaccinium Myrtillus Fruit Extract, Saccharum Officinarum (Sugarcane) Extract, Citrus Aurantium Dulcis (Orange) Fruit Extract, Citrus Limon (Lemon) Fruit Extract, Acer Saccharum (Sugar Maple) Extract, Acacia Seyal Gum Extract, Pisum Sativum (Pea) Sprout Extract, Hydrolyzed Quinoa, Hydrolyzed Vegetable Protein PG-Propyl Silanetriol, Ascorbic Acid, Aspartic Acid, Alanine, Arginine, Glycine, Histidine, Isoleucine, Phenylalanine, Proline, Serine, Threonine, Valine, Sodium PCA, PCA, Capryloyl/Caproyl Methyl Glucamide, Polysorbate 20, PEG-8 Laurate, Potassium Hydroxide, Guar Hydroxypropyltrimonium Chloride, Bis-Cetearyl Amodimethicone, Linoleamidopropyl PG-Dimonium Chloride Phosphate, Silicone Quaternium-22, Cetyl Triethylmonium Dimethicone PEG-8 Succinate, Laureth-4, Polyglyceryl-3 Caprate, Quaternium-95, PEG/PPG-18/18 Dimethicone, Ceteareth-25, Ceteareth-7, Sodium Lactate, Dipropylene Glycol, Propanediol, Tetrasodium EDTA, Synthetic Fluorphlogopite, Tin Oxide, Citric Acid, Potassium Sorbate, Sodium Benzoate, Chlorphenesin, Phenoxyethanol, Parfum/Fragrance, Hexyl Cinnamal, Limonene, Linalool, CI 77891 (Titanium Dioxide)

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

LabelerOribe Hair Care LLC
FDA applicationM032 (OTC MONOGRAPH DRUG)
Labeler code71438
First marketedNov 2017
Product typeHuman Otc Drug
Portfolio2 products on file

More NDCs from Oribe Hair Care LLC labeler code 71438

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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 9 words ▾

Uses For the relief of the symptoms of dandruff

⏱️ Dosage and Administration 16 words ▾

Directions For best resulls use ot least twice a week or as directed by a doctor

⚠️ Warnings 23 words ▾

Warnings For external use only When using this product • Avoid contact wilh lhe eyes. • lf conlacl occurs, rinse thoroughly wlth water

🧪 Active Ingredient 5 words ▾

Active Ingredients Salicylic Acid 2.0%

🧪 Inactive Ingredients 153 words ▾

Inactive Ingredients Aqua/Water/Eau, Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, Glycerin, Acrylates Copolymer, Disodium Laureth Sulfosuccinate, Sodium Lauroyl Sarcosinate, Citrullus Lanatus (Watermelon) Fruit Extract, Litchi Chinensis Fruit Extract, Leontopodium Alpinum Extract, Biotin, Niacinamide, Panthenol, Tocopheryl Acetate, Vaccinium Myrtillus Fruit Extract, Saccharum Officinarum (Sugarcane) Extract, Citrus Aurantium Dulcis (Orange) Fruit Extract, Citrus Limon (Lemon) Fruit Extract, Acer Saccharum (Sugar Maple) Extract, Acacia Seyal Gum Extract, Pisum Sativum (Pea) Sprout Extract, Hydrolyzed Quinoa, Hydrolyzed Vegetable Protein PG-Propyl Silanetriol, Ascorbic Acid, Aspartic Acid, Alanine, Arginine, Glycine, Histidine, Isoleucine, Phenylalanine, Proline, Serine, Threonine, Valine, Sodium PCA, PCA, Capryloyl/Caproyl Methyl Glucamide, Polysorbate 20, PEG-8 Laurate, Potassium Hydroxide, Guar Hydroxypropyltrimonium Chloride, Bis-Cetearyl Amodimethicone, Linoleamidopropyl PG-Dimonium Chloride Phosphate, Silicone Quaternium-22, Cetyl Triethylmonium Dimethicone PEG-8 Succinate, Laureth-4, Polyglyceryl-3 Caprate, Quaternium-95, PEG/PPG-18/18 Dimethicone, Ceteareth-25, Ceteareth-7, Sodium Lactate, Dipropylene Glycol, Propanediol, Tetrasodium EDTA, Synthetic Fluorphlogopite, Tin Oxide, Citric Acid, Potassium Sorbate, Sodium Benzoate, Chlorphenesin, Phenoxyethanol, Parfum/Fragrance, Hexyl Cinnamal, Limonene, Linalool, CI 77891 (Titanium Dioxide)

🎯 Purpose 3 words ▾

Purpose Dandruff Shampoo

📄 Keep Out of Reach of Children 30 words ▾

Keep out of reach of children. Keep out of reach of children. lf condition worsens or does nol improve alter regular use of this product as directed, consult a doctor.

📄 Other Information 11 words ▾

Other Information Protect lhis product from excessive heat and direct sun.

📄 Questions or Comments 6 words ▾

Questions or Comments? 1-888-0RIBE-99 / [email protected]

📄 Package Label / Principal Display Panel 5 words ▾

Principal Display Panel 71438

1000

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 Oribe Hair Care LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Oribe Hair Care 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.
← 71438-0010-07 · Oribe 71441-0180-10 · ONID →
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.