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Head and Shoulders Tea Tree 2in1 Pyrithione Zinc 1 g/100mL Lotion/Shampoo — NDC 84126-0913-01 package photo

Head and Shoulders Tea Tree 2in1 Pyrithione Zinc 1 g/100mL Lotion/Shampoo

by The Procter & Gamble Manufacturing Company · 2 BOTTLE, PUMP in 1 CELLO PACK (84126-913-01) / 950 mL in 1 BOTTLE, PUMP
NDC 84126-0913-01
🏷️ FDA NDC (as labeled) 84126-913-01 billing pads the product segment with a zero
This package
Contains950 mL in 1 bottle, pump Pack sizes5 compare ↓
Also comes in: 370 ml 84126-0913-37 610 ml 84126-0913-61 835 ml 84126-0913-83 950 ml 84126-0913-95
OTC On market Non-controlled
🗂️ Data synced Sep 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

🆔 Identity & classification

FDA NDC (as labeled) 84126-913-01
Product NDC 84126-913
11-digit billing NDC 84126091301
Application # M032
SPL Set ID 5b9b2ad5-3015-2311-e063-6394a90aed0c
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-08-31
Route TOPICAL
Dosage form LOTION/SHAMPOO
Substance PYRITHIONE ZINC
Why two NDCs? The FDA registers this code as 84126-913-01 — 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 → 84126-0913-01. 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.

🏭 Manufacturer & labeler

LabelerThe Procter & Gamble Manufacturing Company
FDA applicationM032 (OTC MONOGRAPH DRUG)
Labeler code84126
First marketedAug 2026
Product typeHuman Otc Drug
Portfolio849 products on file
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.

🩺 Clinical

🧪 What is this product?

Head and Shoulders Tea Tree 2in1 is a shampoo and lotion product applied to the scalp and hair. Its active ingredient, pyrithione zinc, is commonly used in antidandruff and anti-itch scalp products to help reduce flaking and irritation. This is an over-the-counter monograph drug, meaning it is marketed under FDA's established rules for this category of hair and scalp care products rather than through an individual drug application.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 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 H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • 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 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 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • 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 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 YQO029V1L4
    A mineral compound that acts as a filler and acid buffer in medicines. It helps give the tablet its size and shape while neutralizing stomach acid to protect the active ingredient.
  • UNII 1AEY1M553N
    A natural oil extracted from spearmint or field mint leaves, used as a flavoring agent to give medicines a minty taste and aroma. It may also provide a cooling sensation in topical products.
  • UNII AV092KU4JH
    A natural oil extracted from peppermint plants. It's used as a flavoring agent to mask bitter tastes and add a refreshing mint flavor to medicines, making them easier to take.
  • UNII L7T10EIP3A
    A cooling compound from mint plants used as a flavoring agent and to create a fresh sensation in medicines. It helps mask bitter tastes and improve how the product feels in the mouth.
  • 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 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 A4V5C6R9FB
    Piroctone olamine is a antimicrobial compound used in medicines as a preservative or antifungal agent. It helps prevent bacterial and fungal growth in topical formulations like shampoos and skin products.
  • UNII AAJ238UT03
    A synthetic polymer used as a film-former and conditioning agent in topical formulations. It helps create a protective layer on skin or hair and improves product texture and spreadability.
  • 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 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII BPV390UAP0
    Sodium laureth sulfate is a mild detergent and surfactant derived from coconut oil or petroleum. It helps mix oil and water in formulations and is often used as a cleaning or foaming agent in topical products like shampoos and cleansers.
  • UNII 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • UNII G4LZF950UR
    Sodium xylenesulfonate is a synthetic organic salt used as a solubilizer and buffering agent in liquid medications. It helps dissolve active ingredients that don't mix well with water, improving how the medicine can be formulated and absorbed.
  • UNII VIF565UC2G
    Tea tree oil is an essential oil extracted from the leaves of the Australian tea tree plant. In medicines, it typically serves as a flavoring agent, fragrance, or antimicrobial component in topical formulations.
  • UNII 06YD7896S3
    A waxy, fatty substance derived from stearic acid. It acts as a thickener and texture modifier in medicines, helping control how quickly the drug dissolves and improving the product's firmness and consistency.
  • 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 I753WB2F1M
    FD&C Yellow No. 5 is a synthetic yellow colorant approved by the FDA. It is added to medicines to make pills, tablets, or liquids visually distinct and easier to identify.
  • UNII EQR32Y7H0M
    Zinc carbonate is an inorganic mineral compound. It's used in medicines as a buffer and absorbent to help maintain pH balance and control moisture in solid dosage forms.

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

The official label also stateswater, sodium lauryl sulfate, sodium laureth sulfate, cocamidopropyl betaine, sodium xylenesulfonate, zinc carbonate, fragrance, dimethicone, sodium chloride, menthol, sodium benzoate, guar hydroxypropyltrimonium chloride, piroctone olamine, glycerin, trihydroxystearin, butylene glycol, magnesium carbonate hydroxide, polyquaternium-76, pentylene glycol, mentha arvensis leaf/stem oil, mentha piperita (peppermint) flower/leaf/stem oil, neosetophoma cerealis extract, niacinamide, melaleuca alternifolia (tea tree) leaf oil, yellow 5, blue 1

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.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer gPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 370 ml 610 ml 835 ml 950 ml
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Pert Plus 2 in 1 Anti-Dandruff 1 g/100mL 81277-0801-13 TCP 400 ml — — FDA listed —
Head and Shoulders 2in1 Advanced Scalp Care 2in1 1 g/100mL 84126-0022-11 The 1180 ml — — FDA listed —
Head and Shoulders 2in1 Men Coastal Tide 1 g/100mL 84126-0024-37 The 370 ml — — FDA listed —
Head and Shoulders Moisturizing Avocado Oil 2in1 1 g/100mL 84126-0055-37 The 370 ml — — FDA listed —
Head and Shoulders Bare Minimal Ingredients Pure Clean 2in1 1 g/100mL 84126-0073-01 The 2 bottles — — FDA listed —
Head and Shoulders Coconut Daily 1 g/100mL 69423-0315-25 The 250 ml — — FDA listed —
Head and Shoulders 2in1 Men Advanced Series Full and Thick 1 g/100mL 69423-0329-38 The 380 ml — — Discontinued —
Head and Shoulders Aloe Vera Soothing Relief Daily 1 g/100mL 84126-0053-37 The 370 ml — — FDA listed —
Head and Shoulders Hydrating Coconut 2in1 1 g/100mL 84126-0219-37 The 370 ml — — FDA listed —
Head and Shoulders Smooth and Silky 2in1 1 g/100mL 37000-0095-12 The 1280 ml — — Discontinued —
Head and Shoulders MEN Old Spice Pure Sport 1 g/100mL 69423-0294-38 The 380 ml — — Discontinued —
Head and Shoulders Men Advanced Series Refreshing 2in1 Menthol 1 g/100mL 69423-0312-37 The 370 ml — — FDA listed —
Head and Shoulders Classic Clean with Vitamin E 1 g/100mL 69423-0647-11 The 1150 ml — — FDA listed —
Head and Shoulders Bare Minimal Ingredients 1 g/100mL 69423-0721-40 The 350 ml — — FDA listed —
Head and Shoulders Bare Minimal Ingredients Total Scalp Care 1 g/100mL 84126-0259-83 The 835 ml — — FDA listed —
Head and Shoulders Itchy Scalp 1 g/100mL 37000-0079-01 The 2 bottles — — FDA listed —
Head and Shoulders Dry Scalp Care 2in1 1 g/100mL 37000-0093-01 The 2 bottles — — Discontinued —
Head and Shoulders Coconut 2in1 1 g/100mL 69423-0316-01 The 2 bottles — — Discontinued —
Head and Shoulders Supreme Color Protect 1 g/100mL 69423-0346-35 The 350 ml — — FDA listed —
Head and Shoulders Tea Tree Oil Daily 1 g/100mL 69423-0416-01 The 2 bottles — — Discontinued —
Head and Shoulders Moisturizing Avocado Oil 1 g/100mL 69423-0589-38 The 380 ml — — FDA listed —
Head and Shoulders MEN Advanced Series Lavender Mint 2in1 1 g/100mL 69423-0619-38 The 380 ml — — Discontinued —
Head and Shoulders 2in1 Dry Scalp Care with Almond and Coconut Oil 1 g/100mL 69423-0648-11 The 1150 ml — — FDA listed —
Head and Shoulders 2in1 Classic Clean 1 g/100mL 37000-0070-12 The 1280 ml — — Discontinued —
Head and Shoulders Green Apple 2in1 1 g/100mL 37000-0078-02 The 2 bottles — — FDA listed —
Suave Professionals Men 2 in 1 Classic Clean AntiDandruff 1 g/100mL 64942-1353-01 Conopco 828 ml — — FDA listed —
Head and Shoulders Supreme Nourish and Smooth 1 g/100mL 69423-0344-35 The 350 ml — — FDA listed —
Head and Shoulders Supreme Soothe and Strengthen 1 g/100mL 69423-0345-35 The 350 ml — — FDA listed —
Head and Shoulders Scalp Restore 1 g/100mL 69423-0646-11 The 1150 ml — — FDA listed —
Head and Shoulders Ginger 2in1 1 g/100mL 69423-0670-37 The 370 ml — — FDA listed —
Mielle Lavender and Lychee Scalp Moisturizing 1 g/100mL 84126-0256-35 The 355 ml — — FDA listed —
Head and Shoulders Itchy Scalp 2in1 1 g/100mL 37000-0081-25 The 250 ml — — FDA listed —
Head and Shoulders Smooth and Silky 1 g/100mL 37000-0094-10 The 10 ml — — FDA listed —
Head and Shoulders Charcoal Daily 1 g/100mL 69423-0278-37 The 370 ml — — FDA listed —
Head and Shoulders Men Advanced Series Swagger Old Spice 1 g/100mL 69423-0326-37 The 370 ml — — FDA listed —
Head and Shoulders MEN Advanced Series Sandalwood 2in1 1 g/100mL 69423-0415-38 The 380 ml — — Discontinued —
Head and Shoulders Apple Cider Vinegar 1 g/100mL 69423-0521-37 The 370 ml — — FDA listed —
Head and Shoulders 2in1 MEN Citrus and Cedar 1 g/100mL 84126-0023-37 The 370 ml — — FDA listed —
Head and Shoulders Aloe Vera Soothing Relief 2in1 1 g/100mL 84126-0054-37 The 370 ml — — FDA listed —
Head and Shoulders 2in1 Men Vanilla and Amber 1 g/100mL 84126-0082-37 The 370 ml — — FDA listed —
Head and Shoulders Dry Scalp Complete Hydration 2in1 1 g/100mL 84126-0180-11 The 1150 ml — — FDA listed —
Head and Shoulders Green Apple 1 g/100mL 37000-0077-02 The 2 bottles — — FDA listed —
Head and Shoulders 2in1 Men Advanced Series Pure Sport Old Spice 1 g/100mL 69423-0293-01 The 2 bottles — — Discontinued —
Head and Shoulders Men Advanced Series Refreshing Menthol 1 g/100mL 69423-0311-37 The 370 ml — — FDA listed —
Head and Shoulders Deep Scalp Hydration 2in1 1 g/100mL 69423-0696-37 The 370 ml — — FDA listed —
First Aid Beauty Anti-Dandruff 1 g/100mL 69423-0591-23 The 236.5 ml — — FDA listed —
Head and Shoulders Shea Butter 1 g/100mL 69423-0671-37 The 370 ml — — FDA listed —
Nioxin PRO CLINICAL SCALP RECOVERY purifying 1 g/100mL 82157-0011-10 Wella 1000 ml — — FDA listed —
Head and Shoulders Bare Minimal Ingredients Itchy Scalp Relief 1 g/100mL 84126-0074-40 The 400 ml — — FDA listed —
Head and Shoulders Bare Minimal Ingredients Sensitive Scalp Care 1 g/100mL 84126-0154-01 The 2 bottles — — FDA listed —
Head and Shoulders Hydrating Coconut 1 g/100mL 84126-0218-25 The 250 ml — — FDA listed —
Head and Shoulders Dry Scalp Care 1 g/100mL 37000-0092-01 The 2 bottles — — FDA listed —
MOISTURIZING DANDRUFF 1% Pyrithione Zinc 1 g/100mL 54111-0169-50 Bentley 236 ml — — FDA listed —
Head and Shoulders MEN Advanced Series Bourbon 2in1 1 g/100mL 69423-0412-38 The 380 ml — — Discontinued —
Head and Shoulders Apple Cider Vinegar 2in1 1 g/100mL 69423-0522-12 The 1280 ml — — Discontinued —
Royal Oils by Head and Shoulders Sulfate Free Scalp Care 1 g/100mL 69423-0608-38 The 380 ml — — FDA listed —
Head and Shoulders Lemon Oil 2in1 1 g/100mL 69423-0620-40 The 400 ml — — Discontinued —
Head and Shoulders Deep Scalp Cleanse Daily 1 g/100mL 69423-0697-37 The 370 ml — — FDA listed —
Head and Shoulders Deep Scalp Cleanse 2in1 1 g/100mL 69423-0698-37 The 370 ml — — FDA listed —
Head and Shoulders Classic Clean 1 g/100mL 37000-0071-01 The 10 ml — — Discontinued —
Head and Shoulders Classic Clean Dandruff 1 g/100mL 67751-0053-01 Navajo 1 bottle — — FDA listed —
Head and Shoulders Deep Scalp Hydration Daily 1 g/100mL 69423-0672-37 The 370 ml — — FDA listed —
Head and Shoulders 2in1 MenTimber Old Spice 1 g/100mL 84126-0089-37 The 370 ml — — FDA listed —
Head and Shoulders Deep Moisture 1 g/100mL 69423-0247-38 The 380 ml — — Discontinued —
Head and Shoulders 2in1 Men Advanced Series Swagger Old Spice 1 g/100mL 69423-0327-01 The 2 bottles — — FDA listed —
Head and Shoulders Supreme Detox and Hydrate 1 g/100mL 69423-0343-35 The 350 ml — — FDA listed —
Head and Shoulders Tea Tree Oil 2in1 1 g/100mL 69423-0417-12 The 1280 ml — — Discontinued —
Head and Shoulders Bare Minimal Ingredients Soothing Hydration 1 g/100mL 69423-0722-40 The 400 ml — — FDA listed —
Balancing 1 g/100mL 73528-0110-01 Zero 280 ml — — FDA listed —
Head and Shoulders Hutchs Cooling Rush 1 g/100mL 84126-0263-37 The 370 ml — — FDA listed —
Head and Shoulders Polamalu s Hall of Fame Hair 1 g/100mL 84126-0265-37 The 370 ml — — FDA listed —
Head and Shoulders Double Coverage 2in1 1 g/100mL 84126-0264-37 The 370 ml — — FDA listed —
Rida Hair Research Institute RHRI Neoketramin Antifungal Yeast Relief 1 g/100mL 83004-0034-01 Rida 1 bottle — — FDA listed —
Head and Shoulders Scalp Restore Nourishing 1 g/100mL 84126-0909-40 The 400 ml — — FDA listed —
Head and Shoulders Tea Tree 2in1 1 g/100mLthis 84126-0913-01 The 2 bottles — — FDA listed —
Head and Shoulders Tea Tree Oil Daily 1 g/100mL 84126-0914-37 The 370 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

🏛️
2026
On the market since
Aug 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
84126-0913-01 You're viewing this 2 BOTTLE, PUMP in 1 CELLO PACK (84126-913-01) / 950 mL in 1 BOTTLE, PUMP 2026-08-31 Active
84126-0913-37 370 mL in 1 BOTTLE, PLASTIC (84126-913-37) 2026-08-31 Active
84126-0913-61 610 mL in 1 BOTTLE, PUMP (84126-913-61) 2026-08-31 Active
84126-0913-83 835 mL in 1 BOTTLE, PUMP (84126-913-83) 2026-08-31 Active
84126-0913-95 950 mL in 1 BOTTLE, PUMP (84126-913-95) 2026-08-31 Active

Pack size FAQ

What quantity is in NDC 84126-0913-01?
NDC 84126-0913-01 is listed by the FDA — 2 bottle, pump in 1 cello pack / 950 ml in 1 bottle, pump.
What NDC number is used to bill for this package of Head and Shoulders Tea Tree 2in1 Pyrithione Zinc 1 g/100mL Lotion/Shampoo?
Bill NDC 84126-0913-01 — the 11-digit billing format is 84126091301. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 FDA registers it as 84126-913-01, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 84126-0913-01, written without dashes as 84126091301. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 84126-0913-01, the first segment (84126) is the labeler code FDA assigned to The Procter & Gamble Manufacturing Company; the middle segment (0913) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
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 The Procter & Gamble Manufacturing Company. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 4 other package presentations of this same product, including 370 ml (84126-0913-37), 610 ml (84126-0913-61), 835 ml (84126-0913-83). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
The Procter & Gamble Manufacturing Company 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.

📄 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.
📄 FDA label
📄 FDA label 19 words ▾

No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 84126-0912-01 · The 84126-0914-37 · The →
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.