Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
Neo-Synephrine Maximum PHENYLEPHRINE HYDROCHLORIDE 1 g/100mL Spray, 15 mL — NDC 0225-0810-47 (Billing 00225-0810-47)
by BF ASCHER AND CO INC · 15 mL in 1 BOTTLE, SPRAY
This is a package of 15 mL of Neo-Synephrine Maximum PHENYLEPHRINE HYDROCHLORIDE 1 g/100mL Spray from BF ASCHER AND CO INC, marketed since Jul 2020 and currently FDA-listed. It is this product's only package size.
NDC 00225-0810-47
🏷️ FDA NDC (as labeled)
0225-0810-47
billing pads the labeler segment with a zero
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
0225-0810-47
Product NDC
0225-0810
11-digit billing NDC
00225081047
NCPDP billing unit
ML — per mL (volume)
UNII
04JA59TNSJ
Application #
M012
SPL Set ID
ab8682a4-1f66-6709-e053-2995a90a8b4a
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
2020-07-01
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
Neo-Synephrine Cold/Allrgy Ext
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
NEO-SYNEPHRINE 1% SPRAY
FDB brand name
Neo-Synephrine
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 0225-0810-47 — 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 → 00225-0810-47. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
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.
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Label name NEO-SYNEPHRINE 1% SPRAY Ingredient Phenylephrine Hcl
📖 What it is MedlinePlus · NLM
Phenylephrine nasal spray is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine nasal spray will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.
Read the full MedlinePlus article ↗📗 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...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Phenylephrine Hydrochloride — tap one for details:
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
💬 Questions about PHENYLEPHRINE HYDROCHLORIDE?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 3, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 00225-0810-47 You're viewing this Main listing | 15 mL in 1 BOTTLE, SPRAY | 2020-07-01 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price 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/mL 00067-2086-01 | Haleon | 1 bottle | — | — | FDA listed | — |
| Neo-Synephrine Maximum 1 g/100mLthis 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 | — |
| Ephrine Nose Drops 1 g/100mL 00363-2023-10 | Walgreens | 1 bottle | — | — | FDA listed | — |
| Nasal 1 g/100mL 72288-0742-10 | Amazon.com | 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file
Availability & generic status
🏛️
2020
On the market since
Jul 2020
📍
2026
Currently FDA-listed
6 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.
- FDA Orange Book · refreshed Sep 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII XF417D3PSL
Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
-
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 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 1Q73Q2JULR
Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
-
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 statesanhydrous citric acid, benazalkonium chloride, purified water, sodium chloride, sodium citrate
Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.
Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed —
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.
Manufacturer & labeler
LabelerBF ASCHER AND CO INC
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code00225
First marketedJul 2020
Product typeHuman Otc Drug
Portfolio7 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 openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
FDA label — Drug Facts FDA SPL
The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage
⏱️ Dosage and Administration
⚠️ Warnings
📦 Storage and Handling
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
📄 Do Not Use
📄 Ask a Doctor Before Use If
📄 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 ▾
Temporarily relieves nasal congestion due to: common cold hay fever upper respiratory allergies Temporarily relieves sinus congestion and pressure Shrinks swollen membranes so you can breathe more freely Temporarily restores freer breathing through the nose.
⏱️ Dosage and Administration ▾
to spray, squeeze bottle quickly and firmly adults and children 12 years of age and older: 2 or 3 sprays in each nostril not more often then every 4 hours Children under 12 years of age: ask a doctor
⚠️ Warnings ▾
When using this product: 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. use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.
📦 Storage and Handling ▾
Store at room temperature, 59º - 86º F (15º -30º C) Retain carton for future reference on full labeling
🧪 Active Ingredient ▾
Phenylephrine hydrochloride 1.0%
🧪 Inactive Ingredients ▾
anhydrous citric acid, benazalkonium chloride, purified water, sodium chloride, sodium citrate
🎯 Purpose ▾
Nasal decongestant
📄 Do Not Use ▾
Do not use if you have ever had an allergic reaction to this product or any of its ingredients. Do not use more than directed. Do not use for more than 3 days.
📄 Ask a Doctor Before Use If ▾
Ask a doctor before use if you have: heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland Stop use and as a doctor if symptoms persist.
📄 Stop Use and Ask a Doctor If ▾
Stop use and ask a doctor if symptoms persist.
🤰 If Pregnant or Breast-Feeding ▾
If pregnant or breast-feeding, ask a health professional before use.
📄 Keep Out of Reach of Children ▾
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
📄 Questions or Comments ▾
Call 1-800-324-1880, 7:30 - 4:00 Central, Monday - Friday, or visit www.bfascher.com
📄 Package Label / Principal Display Panel ▾
Neo-Synephrine Extra Strength
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
About this NDC listing & data coverage
Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ 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 BF ASCHER AND CO INC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
BF ASCHER AND CO INC 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.