HomeNDC LookupIngredientsChlorpheniramine Maleate › 70677-1016-01
Allergy Relief Chlorpheniramine maleate 4 mg Tablet, 100-count — NDC 70677-1016-01 package photo

Allergy Relief Chlorpheniramine maleate 4 mg Tablet, 100-count

by Strategic Sourcing Services LLC · 1 BOTTLE, PLASTIC in 1 CARTON (70677-1016-1) / 100 TABLET in 1 BOTTLE, PLASTIC
NDC 70677-1016-01
🏷️ FDA NDC (as labeled) 70677-1016-1 billing pads the package segment with a zero
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) 70677-1016-1
Product NDC 70677-1016
11-digit billing NDC 70677101601
NCPDP billing unit EA — each (per item)
RxCUI 1363309
UNII V1Q0O9OJ9Z
UPC 0010939955319
Application # M012
SPL Set ID c9fa8d93-d9d6-4206-a13d-32b9e7555e7f
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 2023-04-22
Route ORAL
Dosage form TABLET
Substance CHLORPHENIRAMINE MALEATE
GPI-14 41100020150310
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 FT ALLERGY (CHLORPHEN) 4 MG TB
FDB brand name Allergy Relief
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 70677-1016-1 — 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 → 70677-1016-01. 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

LabelerStrategic Sourcing Services LLC
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code70677
First marketedApr 2023
Product typeHuman Otc Drug
Portfolio316 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

Label name FT ALLERGY (CHLORPHEN) 4 MG TB 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'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
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 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 eaPer package
Retail pharmacies payNADAC · weekly $0.018 $1.81 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $0.2689 $26.89 / 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
Dec 2023 Dec 2025 Apr 2026 Aug 2026 $0.019 $0.016
▲ Up 10% over the last 12 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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Allergy Relief 4 Hour 4 mg 70000-0160-01 Cardinal 24 tablets $0.018 Discontinued save 3%
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 mgthis 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 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

🏛️
2023
On the market since
Apr 2023
📍
2026
Currently FDA-listed
3 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 70677-1016-01, 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
163
Units reimbursed last 4 qtrs
7.6K
Gross reimbursed last 4 qtrs
$2K
Avg / prescription
$12.54
Avg / unit
$0.2689
Latest quarter Q4 2025
68Rx
Medicaid pays / ea
$0.2689
gross reimbursed
vs
NADAC / ea
$0.0181
acquisition cost
=
Spread
+$0.2508
+1386% 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
100% FFS
Fee-for-service · 163 Rx Managed care · 0 Rx
State Medicaid map
Alaska: no data reported AK Maine: 693 units · 49.7 per 100k residents ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 6,911 units · 17.7 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
17.749.7
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 Maine 49.7 /100k
2 California 17.7 /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.

🔬 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 ALLERGY RELIEF (this brand).

Top reported reactions

Fatigue19,798
Pain16,932
Headache14,344
Nausea13,604
Rash13,091
Dyspnoea12,903
Diarrhoea11,506

Reporter sex

181,432 reports

Serious outcomes

Death18,453
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 18,323 9,030
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
70677-1016-01 You're viewing this 1 BOTTLE, PLASTIC in 1 CARTON (70677-1016-1) / 100 TABLET in 1 BOTTLE, PLASTIC 2023-04-22 Active

📄 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 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 115 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 use caution when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness excitability may occur, especially in children 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.

📦 Storage and Handling 24 words

Other information store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) protect from excessive moisture see end flap for expiration date and lot number

🧪 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 ↗
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.