NDC 00485-0254-01 — ED A-HIST CHLORPHENIRAMINE MALEATE and

🆔 Identity & classification

FDA NDC (as labeled) 0485-0254-01

Product NDC 0485-0254

11-digit billing NDC 00485025401

NCPDP billing unit EA — each (per item)

RxCUI 1090443

UNII V1Q0O9OJ9Z, 04JA59TNSJ

SPL Set ID 9147416d-9f3d-4ee4-a0c0-723e29830325

Established class (EPC) Histamine-1 Receptor Antagonist; alpha-1 Adrenergic Agonist

Mechanism of action Adrenergic alpha1-Agonists; Histamine H1 Receptor Antagonists

DEA schedule Non-controlled

Marketing category UNAPPROVED DRUG OTHER

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2011-10-08

Route ORAL

Dosage form TABLET, COATED

Substance CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE

GPI-14 43993002300315

GPI class Ed A-Hist

GCN Seq No 059701

GCN 25462

HICL code 000446

Ingredient (HICL) Chlorpheniramine/Phenylephrine

HIC1 code Z

Therapeutic class — broad (HIC1) Body As A Whole

HIC2 code Z2

Therapeutic class — intermediate (HIC2) Antihistamines, Antiserotonins, Immunosuppressants

HIC3 code Z2N

Therapeutic class — specific (HIC3) 1St Gen Antihistamine And Decongestant Combination

AHFS code 12:12.04.00

AHFS class Alpha-Adrenergic Agonists (12:12)

FDB label name ED-A-HIST 4 MG-10 MG TABLET

FDB brand name Ed A-Hist

Legend status O — Over-the-counter (OTC) drug or device

Why two NDCs? The FDA registers this code as 0485-0254-01 — 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 → 00485-0254-01. 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 Histamine-1 Receptor Antagonist class.

Pharmacologic class Histamine-1 Receptor Antagonist

Drug family (ATC) Substituted alkylamines

How it works Histamine H1 Receptor Antagonists

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.

🏭 Manufacturer & labeler

LabelerEDWARDS PHARMACEUTICALS, INC.

Labeler code00485

First marketedOct 2011

Product typeHuman Otc Drug

Portfolio11 products on file

🔎 All NDCs from EDWARDS PHARMACEUTICALS, INC.

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

Label name ED-A-HIST 4 MG-10 MG TABLET Ingredient Chlorpheniramine/Phenylephrine

📖 About the active ingredient MedlinePlus · NLM

General information about the ingredient itself — the description of this specific product follows below.

Chlorpheniramine is used to treat allergy symptoms: sneezing runny nose itchy nose or throat red, itchy, watery eyes Chlorpheniramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.

Read the full MedlinePlus article ↗

🧪 What is this product?

This is an unapproved over-the-counter oral tablet containing chlorpheniramine maleate, an antihistamine typically used to relieve allergy symptoms such as itching, sneezing, and runny nose, and phenylephrine hydrochloride, a decongestant commonly used to help relieve nasal congestion. The tablet is coated for ease of swallowing. Because this product is marketed without an approved FDA application, consumers should be aware of its unapproved status.

Patient education

📘 MedlinePlus patient leaflet ↗

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.

💊 What it looks like

Color brown

ShapeOval

ImprintE;1

Size13 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 L06K8R7DQK
A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
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 H77VEI93A8
A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
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 AG9B65PV6B
A starch derivative made from corn that helps tablets and capsules break apart quickly when swallowed. It acts as a disintegrant, allowing the medicine to dissolve and be absorbed in your stomach and intestines.

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

The official label also statesFD&C Blue #2, FD&C Yellow #5, FD&C Yellow #6, Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate. Contains FD&C Yellow No. 5 (tartrazine) as a color additive

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 system	Per ea	Per package
Retail pharmacies payNADAC · weekly	$0.223	$22.25 / 100 tablets
Medicaid paysCMS SDUD · 12 mo	$0.4068	$40.68 / 100 tablets
Medicare drug plans payPart D · quarterly	No Part D plan price is available for this NDC in our data.

NADAC price history (per ea) — tap or hover for the price & month

▲ Up 15% over the last 6 months.

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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Ed A-Hist 4 mg/1; 10 mgthis 00485-0254-01	EDWARDS	100 tablets	$0.222	—	Availability likely	—
Sinus PE plus Allergy 4 mg/1; 10 mg 00363-4621-08	Walgreen	24 tablets	—	—	FDA listed	—
Sinus and Allergy Relief PE 4 mg/1; 10 mg 11822-0462-08	Rite	24 tablets	—	—	FDA listed	—
Sinus and Allergy Relief PE 4 mg/1; 10 mg 36800-0642-08	Topco	24 tablets	—	—	FDA listed	—
sinus plus allergy PE maximum strength 4 mg/1; 10 mg 41163-0666-08	United	24 tablets	—	—	FDA listed	—
Suphedrine PE Sinus plus Allergy 4 mg/1; 10 mg 55301-0462-08	ARMY	24 tablets	—	—	FDA listed	—
Cold and Allergy 4 mg/1; 10 mg 55910-0962-22	DOLGENCORP,	48 tablets	—	—	FDA listed	—
Sinus PE plus Allergy Maximum Strength 4 mg/1; 10 mg 59779-0962-08	CVS	24 tablets	—	—	FDA listed	—
Cold and Allergy 10 mg/1; 4 mg 69168-0406-93	Allegiant	24 tablets	—	—	FDA listed	—
Sinus PE and Allergy 4 mg/1; 10 mg 79903-0075-08	WALMART	24 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

🏛️

2011

On the market since

Oct 2011

📍

2026

Currently FDA-listed

15 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 00485-0254-01, not the drug overall. Other pack sizes report separately.

💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.

📅 Q1 2025 – Q4 2025 · 4 quarters of data

ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.

Prescriptions last 4 qtrs

175

Units reimbursed last 4 qtrs

5.4K

Gross reimbursed last 4 qtrs

$2.2K

Avg / prescription

$12.46

Avg / unit

$0.4068

Latest quarter Q4 2025

36Rx

Medicaid pays / ea

$0.4068

gross reimbursed

vs

NADAC / ea

$0.2225

acquisition cost

=

Spread

+$0.1843

+83% vs cost

What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.

Fee-for-service vs managed care ⓘ

75% FFS 25% MCO

Fee-for-service · 132 Rx Managed care · 43 Rx

State Medicaid map

Units reimbursed · per 100k residents

7.47.9

gray = no data reported ⓘ

Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.

Tap or hover a state

…for its Medicaid breakdown

🏆 Top states by units · per 100k residents

1 California 7.9 /100k

2 Texas 7.4 /100k

National units — by quarter

💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
00485-0254-01 You're viewing this	100 TABLET, COATED in 1 BOTTLE, PLASTIC (0485-0254-01)	2011-10-08	Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product Marketed without an FDA application

Listed without an FDA application

This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.

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)	✓ Available
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)	✓ Available

“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 "Unapproved Drug Other". Products approved under an application carry an NDA, ANDA, or BLA number.

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 0485-0254-01, 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: 00485-0254-01, written without dashes as 00485025401. 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 00485-0254-01, the first segment (00485) is the labeler code FDA assigned to EDWARDS PHARMACEUTICALS, INC.; the middle segment (0254) 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 EDWARDS PHARMACEUTICALS, INC.. Listing status can change — the directory data on this page refreshes weekly.

Who lists this product with the FDA?

EDWARDS PHARMACEUTICALS, 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.

📄 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose

🎯 Indications and Usage 38 words ▾

Uses temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: runny nose sneezing itching of the nose or throat itchy, watery eyes nasal congestion reduces swelling of nasal passages

⏱️ Dosage and Administration 70 words ▾

Directions Do not exceed recommended dosage. Adults and children 12 years of age and over: 1 tablet every 4 hours, not to exceed 6 tablets in 24 hours, or as directed by a doctor Children 6 to under 12 years of age: 1/2 tablet every 4 hours, not to exceed 3 tablets is 24 hours, or as directed by a doctor Children under 6 years of age: Consult a doctor.

⚠️ Warnings 208 words ▾

Warnings Do not exceed recommended dosage. Do not use this product 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 a breathing problem such as emphysema or chronic bronchitis glaucoma heart disease high blood pressure thyroid disease diabetes mellitus difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product excitability may occur, especially in children may cause drowsiness alcohol, sedatives and tranquilizers may increase the drowsiness effect avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or are accompanied by a fever new symptoms occur If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

🧪 Active Ingredient 17 words ▾

Active Ingredients (in each tablet) Purpose Chlorpheniramine Maleate 4 mg Antihistamine Phenylephrine HCl 10 mg Nasal Decongestant

🧪 Inactive Ingredients 28 words ▾

Inactive ingredients FD&C Blue #2, FD&C Yellow #5, FD&C Yellow #6, Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate. Contains FD&C Yellow No. 5 (tartrazine) as a color additive

🎯 Purpose 17 words ▾

Active Ingredients (in each tablet) Purpose Chlorpheniramine Maleate 4 mg Antihistamine Phenylephrine HCl 10 mg Nasal Decongestant

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

🔗 Related NDC lookups

🧪 All Chlorpheniramine Maleate And Phenylephrine Hydrochloride NDCsSame ingredient 🏭 All EDWARDS labeler NDCsLabeler code 00485 📚 All Histamine-1 Receptor Antagonist NDCsDrug class

💊 Related drugs in this class

Other drugs that share this product’s specific therapeutic class — 1St Gen Antihistamine And Decongestant Combination.

Phenylephrine Hcl/Prometh Hcl 00121-0926-16 Pseudoephed/Diphenhydramine 00363-0192-08 Brompheniramine/Phenylephrine 00485-0202-16 Brompheniramin/Pseudoephedrine 00485-0206-16 Chlorpheniramine/Pseudoephed 00904-5351-24 Phenylephrine Hcl/Pheniramine 50991-0776-01

Where does this data come from?

Other drugs sharing this product’s First Databank therapeutic class (HIC3). Each links to that NDC’s page in our directory.

ED A-HIST CHLORPHENIRAMINE MALEATE and PHENYLEPHRINE HYDROCHLORIDE 4 mg; 10 mg Tablet, Coated, 100-count

🆔 Identity & classification

🏷️ RxNorm drug class

🏭 Manufacturer & labeler

🩺 Clinical

Patient education

Supplement & herbal interactions

💊 What it looks like

🧪 Inactive Ingredients / Excipients

Inactive ingredient FAQ

💲 Pricing

🔁 Therapeutic equivalents

⏳ Availability & generic status

🗺️ Medicaid utilization & spend

📦 Packaging — all sizes for this product

🧭 About this NDC listing & data coverage

Listed without an FDA application

Questions about this listing

📄 FDA label — Drug Facts FDA SPL

🔗 Related NDC lookups

💊 Related drugs in this class