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Chlorpheniramine Maleate 4 mg Tablet, 100-count — NDC 55289-0560-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Chlorpheniramine Maleate 4 mg Tablet, 100-count — NDC 55289-560-01 (Billing 55289-0560-01)

by PD-Rx Pharmaceuticals, Inc. · 100 TABLET in 1 BOTTLE, PLASTIC

This is a package of 100 tablets of Chlorpheniramine Maleate 4 mg Tablet from PD-Rx Pharmaceuticals, Inc., marketed since Dec 1992 and currently FDA-listed. It is the main listing for this product, which comes in 3 package sizes.

NDC 55289-0560-01
🏷️ FDA NDC (as labeled) 55289-560-01 billing pads the product segment with a zero
This package
Contains100-count Pack sizes3 compare ↓
Main listing for product 55289-560 · Also comes in: 24 tablets 55289-560-24 30 tablets 55289-560-30
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 20, 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) 55289-560-01
Product NDC 55289-560
11-digit billing NDC 55289056001
NCPDP billing unit EA — each (per item)
RxCUI 1363309
UNII V1Q0O9OJ9Z
UPC 0355289560241
Application # M012
SPL Set ID 7a3452a2-930f-48b1-8c59-dbceb10b9c78
Established class (EPC) Histamine-1 Receptor Antagonist
Mechanism of action Histamine H1 Receptor Antagonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1992-12-19
Route ORAL
Dosage form TABLET
Substance CHLORPHENIRAMINE MALEATE

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

GCN Seq No 011640
GCN 46512
HICL code 004505
Ingredient (HICL) Chlorpheniramine Maleate
HIC1 code Z
Therapeutic class — broad (HIC1) Body As A Whole
HIC2 code Z2
Therapeutic class — intermediate (HIC2) Antihistamines, Antiserotonins, Immunosuppressants
HIC3 code Z2P
Therapeutic class — specific (HIC3) Antihistamines - 1St Generation
AHFS code 04:04.00.00
AHFS class First Generation Antihistamines
FDB label name CHLORPHENIRAMINE 4 MG TABLET
FDB brand name Chlorpheniramine Maleate
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 011640
  • GCN: 46512
  • HICL (First Databank): 004505
  • AHFS class code: 04:04.00.00
  • RxCUI (RxNorm): 1363309
Why two NDCs? The FDA registers this code as 55289-560-01 — 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 → 55289-0560-01. 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.

Clinical

Label name CHLORPHENIRAMINE 4 MG TABLET Ingredient Chlorpheniramine Maleate
📖 What it is MedlinePlus · NLM

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 ↗
📗 Our plain-language guide HelloPharmacist
  • It temporarily relieves allergy symptoms from hay fever and other upper respiratory allergies. That means sneezing, runny nose, itchy, watery eyes, and an itchy nose or throat. It...
  • It depends on the product. Regular tablets and the liquid are generally taken every 4 to 6 hours. The extended-release tablets are taken about every 12 hours. Check your package fo...
  • It can, and the drowsiness may be marked. Be careful driving or using machinery. Some people, especially children, can get excitable instead.
  • It's best to avoid alcohol, since it adds to drowsiness. Sedatives and tranquilizers can also increase drowsiness, so talk to me or your doctor before taking them together.
📖 Read our full Chlorpheniramine guide →

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.
Try another pack size: 24 tablets 30 tablets
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
55289-0560-01 You're viewing this Main listing 100 TABLET in 1 BOTTLE, PLASTIC 2011-03-26 — Active
55289-0560-24 55289-560-24 24 TABLET in 1 BOTTLE, PLASTIC 2011-03-26 — Active
55289-0560-30 55289-560-30 30 TABLET in 1 BOTTLE, PLASTIC 2011-03-26 — Active

You're viewing the largest of 3 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 100-count package — 100 tablet in 1 bottle, plastic.
How does this package differ from NDC 55289-0560-24?
Both are Chlorpheniramine Maleate 4 mg Tablet — the drug itself is identical. This page's package is the 100-count one, while NDC 55289-0560-24 is the 24 tablets package.
What NDC number is used to bill for this package of Chlorpheniramine Maleate 4 mg Tablet?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Allergy Relief 4 Hour 4 mg 70000-0160-01 Cardinal 24 tablets $0.018 — Discontinued —
Allergy 4 mg 00904-0012-24 Major 24 tablets $0.018 — Availability likely —
Allergy Relief 4 mg 46122-0618-62 Amerisource 24 tablets $0.018 — Availability likely —
Allergy Relief 4 mg 70677-1016-01 Strategic 100 tablets $0.018 — Availability likely —
Allergy Relief 4 mg 83324-0068-24 Chain 24 tablets $0.018 — Availability likely —
Aller-chlor 4 mg 00536-1006-01 Rugby 100 tablets $0.018 — Availability likely —
Allergy Relief 4 mg 00363-1941-15 Walgreen 50 tablets — — FDA listed —
allergy relief 4 mg 11822-0662-01 Rite 100 tablets — — FDA listed —
Anti Allergy 4 mg 17714-0016-01 Advance 100 tablets — — FDA listed —
Allergy Relief 4 mg 36800-0694-08 Topco 24 tablets — — FDA listed —
Allergy 4 mg 37835-0633-01 Bi-Mart 100 tablets — — FDA listed —
Allergy 4 mg 41163-0194-08 United 24 tablets — — FDA listed —
Medique Chlorphen 4 mg 47682-0169-46 Unifirst 1 tablet — — FDA listed —
Allergy Time 4 mg 49483-0242-00 Time 100000 tablets — — FDA listed —
Allergy 4 mg 50090-0049-00 A-S 100 tablets — — FDA listed —
Allergy Relief 4 mg 50804-0277-93 Good 24 tablets — — FDA listed —
Sprinsol 4 mg 51467-0101-01 FORTUNE 24 tablets — — FDA listed —
Chlorpheniramine maleate 4mg 4 mg 53185-0277-24 Athlete's 24 tablets — — FDA listed —
Anti Allergy 4 mg 54738-0103-01 Richmond 100 tablets — — FDA listed —
Chlorpheniramine Maleate 4 mgthis 55289-0560-01 PD-Rx 100 tablets — — FDA listed —
Allergy Relief 4 Hour 4 mg 57896-0974-01 Geri-Care 100 tablets — — FDA listed —
Allergy Relief 4 mg 63868-0333-24 CHAIN 24 tablets — — FDA listed —
Allergy Relief 4 Hour 4 mg 67091-0203-24 WinCo 24 tablets — — FDA listed —
Allergy Relief 4 mg 68016-0683-81 Chain 100 tablets — — FDA listed —
Allergy 4 mg 68998-0277-93 Marc 24 tablets — — FDA listed —
Allergy 4 mg 69168-0277-93 Allegiant 24 tablets — — FDA listed —
Allergy Relief 4 mg 69842-0194-12 CVS 100 tablets — — FDA listed —
Chlorpheniramine Maleate 4 mg 71335-0963-01 Bryant 30 tablets — — FDA listed —
Allergy 4 mg 71335-2056-01 Bryant 30 tablets — — FDA listed —
Allergy Relief 4 mg 71335-2812-01 Bryant 100 tablets — — FDA listed —
Allergy Relief 4 Hour 4 mg 71335-3093-01 Bryant 30 tablets — — FDA listed —
Pharbechlor 4 mg 73057-0346-11 Ulai 1000 tablets — — FDA listed —
Allergy Relief 4 mg 79903-0074-12 WALMART 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.

Availability & generic status

🏛️
1992
On the market since
Dec 1992
📍
2026
Currently FDA-listed
34 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 yellow
ShapeRound
Imprint44;194
Size8 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 3SY5LH9PMK
    Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
  • UNII CQ3XH3DET6
    D&C Yellow No. 10 Aluminum Lake is a yellow colorant made by combining a dye with aluminum salts. It's used in medicines to add color for product identification and visual appeal.
  • 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 O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.

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

The official label also statescorn starch, D&C yellow #10 aluminum lake, lactose anhydrous, magnesium stearate, microcrystalline cellulose

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

LabelerPD-Rx Pharmaceuticals, Inc.
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code55289
First marketedDec 1992
Product typeHuman Otc Drug
Portfolio832 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
🎯 Indications and Usage 26 words ▾

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: sneezing runny nose itchy, watery eyes itching of the nose or throat

⏱️ Dosage and Administration 58 words ▾

Directions take every 4 to 6 hours, or as directed by a doctor adults and children 12 years and over 1 tablet. Do not exceed 6 tablets in 24 hours. children 6 to under 12 years 1/2 tablet (break tablet in half). Do not exceed 3 whole tablets in 24 hours. children under 6 years do not use

⚠️ Warnings 116 words ▾

Warnings Do not use to make a child sleepy. Ask a doctor before use if you have glaucoma a breathing problem such as emphysema or chronic bronchitis 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 drowsiness may occur avoid alcoholic beverages excitability may occur, especially in children use caution when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness 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 (800-222-1222).

📦 Storage and Handling 35 words ▾

Other information store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) protect from excessive moisture use by expiration date on package TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING FROM BOTTLE

🧪 Active Ingredient 9 words ▾

Active ingredient (in each tablet) Chlorpheniramine maleate 4 mg

🧪 Inactive Ingredients 15 words ▾

Inactive ingredients corn starch, D&C yellow #10 aluminum lake, lactose anhydrous, magnesium stearate, microcrystalline cellulose

🎯 Purpose 2 words ▾

Purpose Antihistamine

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 PD-Rx Pharmaceuticals, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 24 tablets (55289-0560-24), 30 tablets (55289-0560-30). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
PD-Rx 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.
← 55289-0536-60 · PD-Rx 55289-0563-01 · PD-Rx →
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.