Home › NDC Lookup › Ingredients › Guaifenesin 400Mg And Phenylephrine Hcl... › 73057-0389-04
Pharbinex-PE GUAIFENESIN 400mg and PHENYLEPHRINE HCL 10MG 400 mg; 10 mg Tablet, Coated, 30-count — NDC 73057-0389-04 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Pharbinex-PE GUAIFENESIN 400mg and PHENYLEPHRINE HCL 10MG 400 mg; 10 mg Tablet, Coated, 30-count — NDC 73057-389-04 (Billing 73057-0389-04)

by Ulai Health LLC · 30 TABLET, COATED in 1 BOTTLE, PLASTIC

This is a package of 30 tablets of Pharbinex-PE GUAIFENESIN 400mg and PHENYLEPHRINE HCL 10MG 400 mg; 10 mg Tablet, Coated from Ulai Health LLC, marketed since Jul 2019 and currently FDA-listed. It is this product's only package size.

NDC 73057-0389-04
🏷️ FDA NDC (as labeled) 73057-389-04 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 73057-389-04 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
73057 labeler · 389 product · 04 package
Package marketed since
Jul 18, 2019
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0373057389047
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 73057-389-04
Product NDC 73057-389
11-digit billing NDC 73057038904
RxCUI 1304111
UNII 495W7451VQ, 04JA59TNSJ
UPC 0373057389047
Application # M012
SPL Set ID e459bb83-b1d6-42fc-aa46-99ad117e6144
Established class (EPC) Expectorant
Physiologic effect Decreased Respiratory Secretion Viscosity; Increased Respiratory Secretions
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-07-18
Route ORAL
Dosage form TABLET, COATED
Substance GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 1304111
Why two NDCs? The FDA registers this code as 73057-389-04 — 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 → 73057-0389-04. 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 Expectorant class.

Pharmacologic class Expectorant
Drug family (ATC) Expectorants
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

🧪 What is this product?

Pharbinex-PE is an over-the-counter coated tablet taken by mouth that contains guaifenesin and phenylephrine hydrochloride. Guaifenesin is an expectorant typically used to help thin and clear mucus and phlegm from the airways during colds and congestion. Phenylephrine hydrochloride is a decongestant that functions to narrow blood vessels in the nasal passages, which is commonly used to reduce swelling and relieve nasal congestion. This combination product is marketed as an OTC monograph drug, meaning it follows established FDA guidelines for this class of over-the-counter cold and congestion products.

Supplement & herbal interactions

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

Pricing

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

Price systemPer eachPer 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
73057-0389-04 You're viewing this Main listing 30 TABLET, COATED in 1 BOTTLE, PLASTIC 2019-07-18 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sunmark Chest Congestion Relief PE PE 400 mg/1; 10 mg 49348-0774-09 Strategic 50 tablets $0.075 — FDA listed —
Rugby Chest Congestion Relief PE 400 mg/1; 10 mg 00536-1309-07 Rugby 30 tablets $0.081 — FDA listed —
GNP Mucus Relief PE 400 mg/1; 10 mg 46122-0700-71 AmerisourceBergen 50 tablets $0.092 — Availability likely —
Mucus Relief PE Sinus Congestion 400 mg/1; 10 mg 70000-0141-01 Cardinal 50 tablets $0.092 — Availability likely —
Foster and Thrive Chest Congestion Relief PE PE 400 mg/1; 10 mg 70677-1056-01 Strategic 50 tablets $0.092 — Availability likely —
Mucus Relief PE 400 mg/1; 10 mg 00363-0542-01 Walgreen 30 tablets — — FDA listed —
Topcare Chest Congestion and Sinus Congestion Relief PE 400 mg/1; 10 mg 36800-0989-50 TOPCO 50 tablets — — FDA listed —
Always Save Mucus Relief PE 400 mg/1; 10 mg 63941-0986-50 Valu 50 tablets — — FDA listed —
CVS Health Chest Congestion Relief PE 400 mg/1; 10 mg 69842-0997-60 CVS 60 tablets — — FDA listed —
Pharbinex-PE 400 mg/1; 10 mgthis 73057-0389-04 Ulai 30 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.

Availability & generic status

🏛️
2019
On the market since
Jul 2019
📍
2026
Currently FDA-listed
7 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.

What it looks like

Color white
ShapeCapsule
ImprintPH043
Size19 mm
ScoringScored — splits in 2
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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 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 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 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • 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 7CVR7L4A2D
    A starch-derived carbohydrate produced by breaking down corn, potato, or tapioca starch. It functions as a filler and binder to give the medicine bulk and texture, and sometimes as a mild sweetener or texture enhancer in powders and tablets.
  • UNII T5L8T28FGP
    Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
  • UNII U725QWY32X
    Povidone K30 is a synthetic polymer made from petroleum. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the stomach so the medicine can be absorbed.
  • UNII RDH86HJV5Z
    Povidone K90 is a synthetic polymer made from a chemical called vinyl pyrrolidone. It acts as a binder to hold pill ingredients together and as a dispersant to help the medicine break down and dissolve properly in your body.
  • 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 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 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • UNII XHX3C3X673
    Triacetin is a clear, oily liquid made from glycerin and acetic acid. It works as a plasticizer and solvent in medicines, helping soften coatings and improve how liquids mix together in formulations.

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

The official label also statescroscarmellose sodium, hypromellose, lactose, magnesium stearate, maltodextrin, microcrystalline celluclose, mineral oil, povidone, silicon dioxide, sodium lauryl sulfate, stearic acid, titanium dioxide, triacetin

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

LabelerUlai Health LLC
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code73057
First marketedJul 2019
Product typeHuman Otc Drug
Portfolio18 products on file

More NDCs from Ulai Health LLC labeler code 73057

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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 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 50 words ▾

Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus helps to make cough more productive temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies promotes nasal and/or sinus drainage temporarily relieves sinus congestion and pressure

⏱️ Dosage and Administration 77 words ▾

Directions take with a full glass of water this product can be administered without regard for the timing of the meals do not exceed 6 doses in 24 hours or as directed by a doctor adults and children 12 years of age and over take 1 caplet every 4 hours as needed children 6 to under 12 years of age take ½ caplet every 4 hours as needed children under 6 years of age ask a doctor

📦 Storage and Handling 15 words ▾

Other information store at 20 0 - 25 0 C (68 0 -77 0 F)

🧪 Active Ingredient 10 words ▾

Active ingredients (in each caplet) Guaifenesin 400mg Phenylephrine HCl 10mg

🧪 Inactive Ingredients 24 words ▾

Inactive ingredients croscarmellose sodium, hypromellose, lactose, magnesium stearate, maltodextrin, microcrystalline celluclose, mineral oil, povidone, silicon dioxide, sodium lauryl sulfate, stearic acid, titanium dioxide, triacetin

🎯 Purpose 4 words ▾

Purpose Expectorant Nasal decongestant

📄 Do Not Use ~1 min read ▾

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes difficulty in urination due to an enlarged prostate gland cough accompanied by too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema When using this product do not exceed recommended dosage.

Stop use and ask a doctor if nervousness, dizziness or sleeplessness occurs symptoms do not improve within 7 days, or are accompanied by a fever cough persists more than 7 days, tends to recur, or is accompanied by a fever, rash, persistent headache These could be sings of a serious illness. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Directions take with a full glass of water this product can be administered without regard for the timing of the meals do not exceed 6 doses in 24 hours or as directed by a doctor adults and children 12 years of age and over take 1 caplet every 4 hours as needed children 6 to under 12 years of age take ½ caplet every 4 hours as needed children under 6 years of age ask a doctor

📄 Ask a Doctor Before Use If 46 words ▾

Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes difficulty in urination due to an enlarged prostate gland cough accompanied by too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

📄 When Using This Product 9 words ▾

When using this product do not exceed recommended dosage.

📄 Stop Use and Ask a Doctor If 51 words ▾

Stop use and ask a doctor if nervousness, dizziness or sleeplessness occurs symptoms do not improve within 7 days, or are accompanied by a fever cough persists more than 7 days, tends to recur, or is accompanied by a fever, rash, persistent headache These could be sings of a serious illness.

🤰 If Pregnant or Breast-Feeding 10 words ▾

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

📄 Keep Out of Reach of Children 22 words ▾

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

📄 Questions or Comments 34 words ▾

Questions or comments? (866) 562-2756 (Mon-Fri 8 AM to 4 PM EST) TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Distributed by: ULAI HEALTH LLC. Alexandria, VA 22312

📄 Package Label / Principal Display Panel 27 words ▾

PHARBEST NDC 73057-389-04 Manufactured in the USA Immediate Release PHARBINEX-PE Guaifenesin 400mg Phenylephrine HCl 10mg Expectorant & Nasal Decongestant 30 CAPLETS Pharbinex PE Caplet Product Label Image

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 Ulai Health LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Ulai Health 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.
← 73057-0386-08 · Ulai 73057-0510-11 · Ulai →
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.