HomeNDC LookupIngredientsChlorpheniramine Maleate › 71335-0963-03
Chlorpheniramine Maleate 4 mg 4 mg Tablet, 100-count — NDC 71335-0963-03 package photo

Chlorpheniramine Maleate 4 mg 4 mg Tablet, 100-count

by Bryant Ranch Prepack · 100 TABLET in 1 BOTTLE (71335-0963-3)
NDC 71335-0963-03
🏷️ FDA NDC (as labeled) 71335-0963-3 billing pads the package segment with a zero
This package
Contains100-count Pack sizes6 compare ↓
OTC On market Non-controlled
🗂️ Data synced 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

FDA NDC (as labeled) 71335-0963-3
Product NDC 71335-0963
11-digit billing NDC 71335096303
RxCUI 1363309
UNII V1Q0O9OJ9Z
Application # M012
SPL Set ID 54681242-c861-4415-b5c0-d3ab55b62be1
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 2015-11-01
Route ORAL
Dosage form TABLET
Substance CHLORPHENIRAMINE MALEATE
Why two NDCs? The FDA registers this code as 71335-0963-3 — a 5-4-1 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 package segment → 71335-0963-03. 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

LabelerBryant Ranch Prepack
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code71335
First marketedNov 2015
Product typeHuman Otc Drug
Portfolio4,428 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.

🩺 Clinical

📗 Our plain-language guide HelloPharmacist
  • It's an antihistamine used to temporarily relieve classic hay fever and allergy symptoms — things like a runny nose, sneezing, itchy or watery eyes, and an itchy throat. It works o...
  • What is chlorpheniramine actually used for?
  • Yes — drowsiness is one of the most common effects of chlorpheniramine, and it can be significant. Don't plan on driving or operating heavy machinery until you know how your body r...
  • It's best to skip the alcohol while you're taking chlorpheniramine. Alcohol makes the drowsiness much stronger, which can be unsafe — especially if you need to drive or stay alert....
📖 Read our full Chlorpheniramine guide →
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 yellow
ShapeRound
ImprintAP;016
Size8 mm
ScoringNot scored
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 L11K75P92J
    A mineral salt made from calcium and phosphate. It acts as a filler and binder in tablets to add bulk and help hold the medicine together in solid form.
  • 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 35SW5USQ3G
    A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
  • 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 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 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.

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

The official label also statescroscarmellose sodium, D&C yellow# 10 (Al-lake), dicalcium phosphate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, silicon dioxide

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 DailyMedingredient 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 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.

🔁 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 mg 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 mgthis 71335-0963-03 Bryant 100 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

🏛️
2015
On the market since
Nov 2015
📍
2026
Currently FDA-listed
11 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.

🔬 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 Chlorpheniramine Maleate — the ingredient across all brands.

Top reported reactions

Fatigue4,312
Nausea4,024
Headache3,848
Dyspnoea3,781
Diarrhoea3,314
Pain2,929
Dizziness2,782

Reporter sex

64,382 reports
Male · 33%
Female · 66%
Unknown · 0%

Serious outcomes

Death3,944
Life-threatening1,982
Disabling1,877
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 4,348 0
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
71335-0963-01 30 TABLET in 1 BOTTLE (71335-0963-1) 2018-10-05 Active
71335-0963-02 60 TABLET in 1 BOTTLE (71335-0963-2) 2022-02-14 Active
71335-0963-03 You're viewing this 100 TABLET in 1 BOTTLE (71335-0963-3) 2022-02-14 Active
71335-0963-04 120 TABLET in 1 BOTTLE (71335-0963-4) 2022-02-14 Active
71335-0963-05 40 TABLET in 1 BOTTLE (71335-0963-5) 2022-02-14 Active
71335-0963-06 24 TABLET in 1 BOTTLE (71335-0963-6) 2024-05-17 Active

You're viewing one of 6 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 71335-0963-03?
NDC 71335-0963-03 is a 100-count package — 100 tablet in 1 bottle.
What is the difference between NDC 71335-0963-03 and NDC 71335-0963-06?
Both are Chlorpheniramine Maleate 4 mg 4 mg Tablet — the drug itself is identical. NDC 71335-0963-03 is the 100-count package, while NDC 71335-0963-06 is the 24 tablets package.
What NDC number is used to bill for this package of Chlorpheniramine Maleate 4 mg 4 mg Tablet?
Bill NDC 71335-0963-03 — the 11-digit billing format is 71335096303. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 FDA registers it as 71335-0963-3, 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: 71335-0963-03, written without dashes as 71335096303. 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 71335-0963-03, the first segment (71335) is the labeler code FDA assigned to Bryant Ranch Prepack; the middle segment (0963) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) 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 Bryant Ranch Prepack. 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 5 other package presentations of this same product, including 24 tablets (71335-0963-06), 30 tablets (71335-0963-01), 40 tablets (71335-0963-05). 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?
Bryant Ranch Prepack 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 23 words

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

⏱️ Dosage and Administration 54 words

Directions adults and children 12 years and over take 1 tablet every 4 to 6 hours, not more than 6 tablets in 24 hours children 6 years to under 12 years take 1/2 tablet every 4 to 6 hours, not more than 3 tablets in 24 hours children under 6 years do not use

⚠️ Warnings 26 words

Warnings Ask a doctor before use if you have glaucoma trouble urinating due to enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis

📦 How Supplied / Storage and Handling 53 words

HOW SUPPLIED NDC: 71335-0963-1: 30 Tablets in a BOTTLE NDC: 71335-0963-2: 60 Tablets in a BOTTLE NDC: 71335-0963-3: 100 Tablets in a BOTTLE NDC: 71335-0963-4: 120 Tablets in a BOTTLE NDC: 71335-0963-5: 40 Tablets in a BOTTLE NDC: 71335-0963-6: 24 Tablets in a BOTTLE Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

🧪 Active Ingredient 9 words

Active ingredient (in each tablet) Chlorpheniramine maleate 4 mg

🧪 Inactive Ingredients 18 words

Inactive ingredients croscarmellose sodium, D&C yellow# 10 (Al-lake), dicalcium phosphate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, silicon dioxide

🎯 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 ↗
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.