Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
Phenylephrine Hydrochloride 10 mg Tablet, 30,000-count — NDC 57631-018-00 (Billing 57631-0018-00)
by InvaTech Pharma Solutions LLC · 30000 TABLET in 1 DRUM
This is a package of 30,000 tablets of Phenylephrine Hydrochloride 10 mg Tablet from InvaTech Pharma Solutions LLC, marketed since Jan 2021 and currently FDA-listed. It is this product's only package size.
NDC 57631-0018-00
🏷️ FDA NDC (as labeled)
57631-018-00
billing pads the product 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 →
NDC database record
One package, one record: these facts belong to NDC 57631-018-00 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 57631 labeler · 018 product · 00 package
- Package marketed since
- Jan 13, 2021
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 5763101800 4
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
57631-018-00
Product NDC
57631-018
11-digit billing NDC
57631001800
RxCUI
1049182
UNII
04JA59TNSJ
Application #
M012
SPL Set ID
b8d360fa-0d80-f6a8-e053-2a95a90a8bd4
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
2021-01-13
Route
ORAL
Dosage form
TABLET
Substance
PHENYLEPHRINE HYDROCHLORIDE
Quick answers
- RxCUI (RxNorm): 1049182
Why two NDCs?
The FDA registers this code as 57631-018-00 — 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 → 57631-0018-00. 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
📖 What it is MedlinePlus · NLM
Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine 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 each | 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 |
|---|---|---|---|---|
| 57631-0018-00 You're viewing this Main listing | 30000 TABLET in 1 DRUM | 2021-01-13 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Nasal Decongestant PE Maximum Strength 10 mg 70677-1152-01 | Strategic | 18 tablets | $0.050 | — | Availability likely | — |
| Nasal Decongestant PE 10 mg 00363-4531-07 | Walgreen | 18 tablets | — | — | FDA listed | — |
| PhysiciansCare Sinus Non-Drowsy 10 mg 00924-0133-01 | Acme | 1 tablet | — | — | FDA listed | — |
| Sinus Pressure and Congestion Relief PE Maximum Strength 10 mg 11822-4530-02 | Rite | 24 tablets | — | — | FDA listed | — |
| Nasal Decongestant PE 10 mg 21130-0453-07 | Better | 18 tablets | — | — | FDA listed | — |
| Sinus Decongestion PE 10 mg 30142-0534-07 | Kroger | 18 tablets | — | — | FDA listed | — |
| Sinus Congestion 10 mg 30142-0853-07 | Kroger | 18 tablets | — | — | FDA listed | — |
| PE Sinus Congestion 10 mg 36800-0704-07 | Topco | 18 tablets | — | — | FDA listed | — |
| Nasal Decongestant PE 10 mg 37808-0453-23 | H | 24 tablets | — | — | FDA listed | — |
| Nasal Decongestant PE 10 mg 37835-0651-01 | Bi-Mart | 100 tablets | — | — | FDA listed | — |
| Medi-First Sinus Decongestant 10 mg 47682-0809-13 | Unifirst | 1 tablet | — | — | FDA listed | — |
| Medi-First Plus Sinus Decongestant 10 mg 47682-0990-33 | Unifirst | 1 tablet | — | — | FDA listed | — |
| Unishield Sinus Decongestant 10 mg 49314-2083-03 | Unishield | 1 tablet | — | — | FDA listed | — |
| Pseudo Time Pe 10 mg 49483-0234-00 | TIME | 100000 tablets | — | — | FDA listed | — |
| Good Sense Nasal Decongestant PE 10 mg 50090-3659-00 | A-S | 36 tablets | — | — | FDA listed | — |
| Phenylephrine HCl Maximum Strength 10 mg 50090-5606-00 | A-S | 18 tablets | — | — | FDA listed | — |
| Nasal Decongestant Pe 10 mg 50090-7449-00 | A-S | 18 tablets | — | — | FDA listed | — |
| Sudafed PE Sinus Congestion 10 mg 50580-0437-01 | Kenvue | 18 tablets | — | — | FDA listed | — |
| Sinus Congestion 10 mg 50844-0493-08 | L.N.K. | 24 tablets | — | — | FDA listed | — |
| Suphedrine PE Sinus Congestion Non-Drowsy 10 mg 55301-0753-23 | ARMY | 24 tablets | — | — | FDA listed | — |
| SU PHEDRINE PE Non-Drowsy, Maximum Strength 10 mg 57243-0453-44 | Salado | 18 tablets | — | — | FDA listed | — |
| Su Phedrine Pe Sinus Congestion 10 mg 57243-0953-44 | Salado | 18 tablets | — | — | FDA listed | — |
| Phenylephrine Hydrochloride 10 mgthis 57631-0018-00 | InvaTech | 30000 tablets | — | — | FDA listed | — |
| Nasal Decongestant PE Non-Drowsy Maximum Strength 10 mg 63868-0144-19 | CHAIN | 18 tablets | — | — | FDA listed | — |
| Nasal Decongestant PE Maximum Strength 10 mg 67091-0207-18 | WinCo | 18 tablets | — | — | FDA listed | — |
| Nasal Decongestant PE Maximum Strength Non-Drowsy 10 mg 69168-0272-17 | Allegiant | 300 tablets | — | — | FDA listed | — |
| Redicare Nasal and Sinus Decongestant 10 mg 71105-0272-02 | Redicare | 100 tablets | — | — | FDA listed | — |
| Gencare-Nasal Decongestant PE 10 mg 72090-0025-01 | Pioneer | 300 tablets | — | — | FDA listed | — |
| Gencare-Nasal Decongestant PE 10 mg 72090-0039-01 | Pioneer | 300 tablets | — | — | FDA listed | — |
| Crane Safety Sinus Decongestant 10 mg 73408-0990-33 | Crane | 1 tablet | — | — | FDA listed | — |
| ValuMeds Nasal Decongestant Phenylephrine HCl 10 mg 82725-1111-01 | Cabinet | 300 tablets | — | — | FDA listed | — |
| Goodmeds Non-Drowsy Nasal Decongestant PE 10 mg 82725-4111-01 | Cabinet | 365 tablets | — | — | FDA listed | — |
| Sinus Congestion 10 mg 83324-0073-18 | Chain | 18 tablets | — | — | FDA listed | — |
| Phenylephrine Hydrochloride 10 mg 83586-0010-00 | HHH | 130000 tablets | — | — | FDA listed | — |
| Nasal Decongestant PE 10 mg 83586-0160-01 | HHH | 100 tablets | — | — | FDA listed | — |
| Nasal Decongestant PE 10 mg 84324-0010-01 | NUVICARE | 100 tablets | — | — | FDA listed | — |
| Nasal Decongestant PE Maximum Strength 10 mg 85766-0178-18 | Sportpharm | 18 tablets | — | — | FDA listed | — |
| Medi-First Plus Sinus Decongestant 10 mg 85766-0182-01 | Sportpharm | 1 tablet | — | — | FDA listed | — |
| GoodMeds Nasal Decongestant 10 mg 82725-4011-01 | Cabinet | 365 tablets | — | — | FDA listed | — |
| ValuMeds Nasal Decongestant PE Phenylephrine 10 mg 82725-1011-01 | Cabinet | 300 tablets | — | — | FDA listed | — |
| Nasal Decongestant PE 10 mg 80513-0789-01 | Advanced | 100 tablets | — | — | 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 Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
🏛️
2021
On the market since
Jan 2021
📍
2026
Currently FDA-listed
5 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 Oct 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 97Z1WI3NDX
A mineral compound of calcium and phosphorus that acts as a filler and binding agent in tablets and capsules. It helps give the medicine its solid shape and may improve how well ingredients blend together.
-
UNII M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
-
UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
-
UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
-
UNII B697894SGQ
Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
-
UNII 532B59J990
Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
-
UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
-
UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
-
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.
9 inactive ingredients listed in the exact product block matched to this NDC.
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
LabelerInvaTech Pharma Solutions LLC
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code57631
First marketedJan 2021
Product typeHuman Otc Drug
Portfolio9 products on file
More NDCs from InvaTech Pharma Solutions LLC labeler code 57631
- Acetaminophen 500 mg Tablet NDC 57631-004-00
- Acetaminophen and Diphenhydramine citrate 500 mg; 38 mg Tablet NDC 57631-010-00
- Guaifenesin 400 400 mg Tablet NDC 57631-012-00
- Guaifenesin and Dextromethorphan Hydrobromide 400 mg; 20 mg Tablet NDC 57631-013-10
- Sennosides 8.6 mg Tablet NDC 57631-016-00
- Senna with Docusate (Red) 50 mg; 8.6 mg Tablet NDC 57631-017-00
- Pyridostigmine Bromide Granules DC 16% 30 mg Granule NDC 57631-108-00
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.
📄 Package Label / Principal Display Panel ▾
phenyl-drum
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 ↗
Reported adverse events (FAERS)
Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for PHENYLEPHRINE HYDROCHLORIDE — the ingredient across all brands.
Top reported reactions
Age at onset
Reporter sex
Male · 31%
Female · 69%
Unknown · 0%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
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 InvaTech Pharma Solutions LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
InvaTech Pharma Solutions 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.
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.