Home › NDC Lookup › Ingredients › Phenylephrine Hydrochloride › 00067-2086-01
👃image loading
(from DailyMed)

4 Way Fast Acting Phenylephrine hydrochloride 10 mg/mL Spray, 1 bottle — NDC 0067-2086-01 (Billing 00067-2086-01)

by Haleon US Holdings LLC · 1 BOTTLE, SPRAY in 1 CARTON / 29.6 mL in 1 BOTTLE, SPRAY

This is a package of 1 bottle of 4 Way Fast Acting Phenylephrine hydrochloride 10 mg/mL Spray from Haleon US Holdings LLC, marketed since Jan 2010 and currently FDA-listed. It is this product's only package size.

NDC 00067-2086-01
🏷️ FDA NDC (as labeled) 0067-2086-01 billing pads the labeler 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0067-2086-01
Product NDC 0067-2086
11-digit billing NDC 00067208601
NCPDP billing unit ML — per mL (volume)
RxCUI 1087043
UNII 04JA59TNSJ
Application # M012
SPL Set ID a8fc41c7-4425-41b8-b1c6-eb22ac054734
Established class (EPC) alpha-1 Adrenergic Agonist
Mechanism of action Adrenergic alpha1-Agonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2010-01-01
Route NASAL
Dosage form SPRAY
Substance PHENYLEPHRINE HYDROCHLORIDE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 42102050102015
GPI class 4-Way Fast Acting
GCN Seq No 008062
GCN 34124
HICL code 002087
Ingredient (HICL) Phenylephrine Hcl
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q7
Therapeutic class — intermediate (HIC2) Nasal Preparations
HIC3 code Q7D
Therapeutic class — specific (HIC3) Nose Preparations, Vasoconstrictors(Otc)
AHFS code 12:12.04.00
AHFS class Alpha-Adrenergic Agonists (12:12)
FDB label name 4 WAY 1% NASAL SPRAY
FDB brand name 4 Way
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 008062
  • GCN: 34124
  • GPI-14 (Medi-Span): 42102050102015
  • HICL (First Databank): 002087
  • AHFS class code: 12:12.04.00
  • RxCUI (RxNorm): 1087043
Why two NDCs? The FDA registers this code as 0067-2086-01 — a 4-4-2 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 labeler segment → 00067-2086-01. 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.

RxNorm drug class

This medicine belongs to the alpha-1 Adrenergic Agonist class.

Pharmacologic class alpha-1 Adrenergic Agonist
Drug family (ATC) Sympathomimetics excl. antiglaucoma preparations, Adrenergic and dopaminergic agents, Other agents for treatment of hemorrhoids and anal fissures for topical use
How it works Adrenergic alpha1-Agonists
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

Label name 4 WAY 1% NASAL SPRAY Ingredient Phenylephrine Hcl
📗 Our plain-language guide HelloPharmacist
  • It depends on the product. The injection raises low blood pressure during anesthesia and, for some products, septic shock. Eye drops dilate the pupil, nasal products relieve conges...
  • Be careful. Over-the-counter phenylephrine should not be used with a prescription MAOI or within 2 weeks of stopping one. If you aren't sure whether your medicine is an MAOI, ask m...
  • With the injection, the most common are nausea, vomiting and headache. Call for help right away if you have chest pain, a very slow heartbeat, or pain or skin changes around the IV...
  • Stop and talk to a doctor if you get nervousness, dizziness or sleeplessness. Also stop if symptoms last more than 7 days or come with a fever. Don't use more than the label recomm...
📖 Read our full Phenylephrine guide →

Supplement & herbal interactions

Some supplements/herbs that may interact with Phenylephrine Hydrochloride — tap one for details:

Butcher's BroomModerate
🌿 Every supplement checked against Phenylephrine Hydrochloride (1 interactions) — ranked by severity →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

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

Price systemPer 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
00067-2086-01 You're viewing this Main listing 1 BOTTLE, SPRAY in 1 CARTON / 29.6 mL in 1 BOTTLE, SPRAY 2010-01-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Good Sense Nasal Four 1 g/100mL 00113-0648-10 L. 1 bottle $0.067 — Availability likely —
Extra Strength Sinus Relief Nasal Decongestant 1 g/100mL 70000-0132-01 CARDINAL 1 bottle $0.070 — Availability likely —
Quality Choice 1 g/100mL 83324-0215-01 CHAIN 1 bottle $0.070 — Availability likely —
good neighbor pharmacy nasal four 1 g/100mL 46122-0689-03 Amerisource 1 bottle $0.084 — Availability likely —
4 Way Fast Acting 10 mg/mLthis 00067-2086-01 Haleon 1 bottle — — FDA listed —
Neo-Synephrine Maximum 1 g/100mL 00225-0810-47 BF 15 ml — — FDA listed —
Neo-Synephrine Severe 1 g/100mL 00225-0811-47 BF 15 ml — — FDA listed —
nasal 1 g/100mL 00363-0717-10 Walgreen 1 bottle — — FDA listed —
Better Living 1 g/100mL 21130-0728-30 BETTER 1 bottle — — FDA listed —
nasal 1 g/100mL 30142-0539-10 Kroger 1 bottle — — FDA listed —
Topcare Nasal Four 1 g/100mL 36800-0648-10 Topco 1 bottle — — FDA listed —
heb nasal 1 g/100mL 37808-0728-30 H 1 bottle — — FDA listed —
equaline nasal 1 g/100mL 41163-0648-10 United 1 bottle — — FDA listed —
Publix 1 g/100mL 41415-0728-30 PUBLIX 1 bottle — — FDA listed —
CareOne Fast Acting Nasal 1 g/100mL 41520-0729-10 American 1 bottle — — FDA listed —
Nasal Four 1 g/100mL 42507-0648-10 HyVee 1 bottle — — FDA listed —
Equate Nasal 1 g/100mL 49035-0648-10 Wal-Mart 1 bottle — — FDA listed —
No Drip Nasal 10 mg/mL 51316-0648-10 CVS 1 bottle — — FDA listed —
dg health nasal four 1 g/100mL 55910-0802-10 Dolgencorp, 1 bottle — — FDA listed —
Dollar General 1 g/100mL 55910-0827-30 DOLGENCORP, 1 bottle — — FDA listed —
CVS Health Four Actions Nasal Decongestant 10 mg/mL 59779-0838-30 CVS 1 bottle — — FDA listed —
Quality Choice 1 g/100mL 63868-0697-30 CHAIN 1 bottle — — FDA listed —
Extra Strength Nasal 1 g/100mL 69842-0443-30 CVS 1 bottle — — FDA listed —
Nasal 1 g/100mL 69842-0648-10 CVS 1 bottle — — FDA listed —
basic care nasal 1 g/100mL 72288-0648-10 Amazon.com 1 bottle — — FDA listed —
Nasal 1 g/100mL 79481-0101-00 Meijer, 1 bottle — — FDA listed —
Equate Nasal 10 mg/mL 79903-0276-01 WALMART 1 bottle — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2010
On the market since
Jan 2010
📍
2026
Currently FDA-listed
16 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

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

  • UNII F5UM2KM3W7
    Benzalkonium chloride is a chemical compound that works as a preservative and antimicrobial agent in medications. It prevents bacterial and fungal growth in liquid formulations to keep the product safe during storage and use.
  • UNII LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • UNII R57ZHV85D4
    Boric acid is a weak acid derived from boron. In medicines, it typically serves as a buffer to help maintain the product's pH level and may act as a preservative in certain formulations.
  • UNII 91MBZ8H3QO
    Sodium borate is an inorganic salt compound used in medicines as a buffer to help maintain a stable pH level, and sometimes as a mild preservative or cleansing agent in topical formulations.
  • 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.

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

The official label also statesbenzalkonium chloride solution, benzyl alcohol, boric acid, purified water, sodium borate

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

LabelerHaleon US Holdings LLC
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code00067
First marketedJan 2010
Product typeHuman Otc Drug
Portfolio405 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.

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 📄 Ask a Doctor Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 14 words ▾

Uses temporarily relieves nasal congestion due to: common cold hay fever upper respiratory allergies

⏱️ Dosage and Administration 57 words ▾

Directions adults and children 12 years and over: 2 or 3 sprays in each nostril not more often than every 4 hours children under 12 years: ask a doctor Use instructions: with head in a normal, upright position, put atomizer tip into nostril. Squeeze bottle with firm, quick pressure while inhaling. Wipe nozzle clean after each use.

⚠️ Warnings 128 words ▾

Warnings Ask a doctor before use if you have heart disease diabetes thyroid disease high blood pressure trouble urinating due to an enlarged prostate gland When using this product do not use more than directed do not use for more than 3 days. Frequent or prolonged use may cause nasal congestion to come back or get worse. use only as directed temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge may occur use of this container by more than one person may spread infection Stop use and ask a doctor if symptoms persist If pregnant or breast-feeding , ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

📦 Storage and Handling 6 words ▾

Other information store at 20°-25°C (68°-77°F)

🧪 Active Ingredient 5 words ▾

Active ingredient Phenylephrine hydrochloride 1%

🧪 Inactive Ingredients 13 words ▾

Inactive ingredients benzalkonium chloride solution, benzyl alcohol, boric acid, purified water, sodium borate

🎯 Purpose 3 words ▾

Purpose Nasal Decongestant

📄 Ask a Doctor Before Use If 24 words ▾

Ask a doctor before use if you have heart disease diabetes thyroid disease high blood pressure trouble urinating due to an enlarged prostate gland

📄 When Using This Product 63 words ▾

When using this product do not use more than directed do not use for more than 3 days. Frequent or prolonged use may cause nasal congestion to come back or get worse. use only as directed temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge may occur use of this container by more than one person may spread infection

📄 Stop Use and Ask a Doctor If 9 words ▾

Stop use and ask a doctor if symptoms persist

🤰 If Pregnant or Breast-Feeding 11 words ▾

If pregnant or breast-feeding , ask a health professional before use.

📄 Keep Out of Reach of Children 20 words ▾

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

📄 Questions or Comments 4 words ▾

Questions or comments? 1-855-297-3031

📄 Package Label / Principal Display Panel 36 words ▾

Principal Display 4 way Phenylephrine Hydrochloride 1% Nasal Decongestant Fast Acting Fast Relief of : Nasal Congestion Swollen Nasal Membranes Sinus Congestion Sinus Pressure Nasal Spray 1 fl oz (29.6 mL) 00213365_4 Way Fast Acting_1 oz.jpg

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 Haleon US Holdings LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Haleon US Holdings 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.
← 00067-2056-24 · Haleon 00067-2200-20 · Haleon →
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.