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Children Pain Relief 160 mg Tablet, Chewable, 60-count — NDC 69168-0440-60 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Children Pain Relief 160 mg Tablet, Chewable, 60-count — NDC 69168-440-60 (Billing 69168-0440-60)

by Allegiant Health · 60 TABLET, CHEWABLE in 1 BOTTLE

This is a package of 60 tablets of Children Pain Relief 160 mg Tablet, Chewable from Allegiant Health, marketed since Jul 2023 and currently FDA-listed.

NDC 69168-0440-60
🏷️ FDA NDC (as labeled) 69168-440-60 billing pads the product segment with a zero
This package
Contains60-count Pack sizes2 compare ↓
Product page 69168-0440-02 Also comes in: 150 tablets 69168-440-02
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 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 69168-440-60 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
69168 labeler · 440 product · 60 package
Package marketed since
Jul 18, 2023
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 6916844060 9
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 69168-440-60
Product NDC 69168-440
11-digit billing NDC 69168044060
RxCUI 313820
UNII 362O9ITL9D
Application # M013
SPL Set ID 44c90cbe-8ece-4dd8-9ea5-7f8d6f4c0096
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-07-18
Route ORAL
Dosage form TABLET, CHEWABLE
Substance ACETAMINOPHEN
Quick answers
  • RxCUI (RxNorm): 313820
Why two NDCs? The FDA registers this code as 69168-440-60 — 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 → 69168-0440-60. 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 Anilides class.

Drug family (ATC) Anilides
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 it is MedlinePlus · NLM

Acetaminophen is used to relieve mild to moderate pain and to reduce fever. Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It temporarily relieves minor aches and pains, like headache, backache, toothache, muscle aches, cold aches, minor arthritis pain and menstrual cramps. It also reduces fever.
  • Follow your product label or prescriber exactly and never exceed the maximum daily amount. Remember that the limit counts every product with acetaminophen. Too much can seriously d...
  • Check the label first. Many combination products also contain acetaminophen, and you shouldn't use two together. If you aren't sure, ask me or your pharmacist.
  • Having 3 or more alcoholic drinks every day while using it raises the risk of liver damage. If you take warfarin, talk with your doctor or pharmacist first, since regular high dail...
📖 Read our full Acetaminophen 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: 150 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
69168-0440-60 You're viewing this 60 TABLET, CHEWABLE in 1 BOTTLE 2023-07-18 — Active
69168-0440-02 69168-440-02 Main listing 150 TABLET, CHEWABLE in 1 BOTTLE 2024-08-22 — Active

You're viewing the smallest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 60-count package — 60 tablet, chewable in 1 bottle.
How does this package differ from NDC 69168-0440-02?
Both are Children Pain Relief 160 mg Tablet, Chewable — the drug itself is identical. This page's package is the 60-count one, while NDC 69168-0440-02 is the 150 tablets package.
What NDC number is used to bill for this package of Children Pain Relief 160 mg Tablet, Chewable?
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
childrens mapap 160 mg 00904-6645-24 Major 6 tablets $0.116 — Availability likely —
Pain Relief Childrens 160 mg 46122-0424-62 Amerisource 6 tablets $0.116 — Availability likely —
Chewable Acetaminophen Childrens 160 mg 70000-0309-01 Cardinal 24 tablets $0.116 — Availability likely —
Chewable Acetaminophen Childrens 160 mg 70000-0310-01 Cardinal 24 tablets $0.116 — Availability likely —
Childrens Chewables 160 mg 70677-1127-01 Strategic 6 tablets $0.116 — Availability likely —
Childrens Pain and Fever Relief 160 mg 83324-0071-24 Chain 24 tablets $0.116 — Availability likely —
Pain and Fever Childrens 160 mg 00363-9440-08 Walgreen 6 tablets — — FDA listed —
Acetaminophen 160 mg 00363-9605-07 WALGREEN 24 tablets — — FDA listed —
Children Pain and Fever Reliver 160 mg 11673-0240-24 Target 6 tablets — — FDA listed —
Children Pain and Fever Reliever 160 mg 11673-0241-24 Target 6 tablets — — FDA listed —
pain relief childrens 160 mg 11822-4450-08 Rite 24 tablets — — FDA listed —
pain relief childrens 160 mg 11822-9440-08 Rite 24 tablets — — FDA listed —
Childrens Pain Relief 160 mg 21130-0223-76 Better 6 tablets — — FDA listed —
childrens Pain and Fever 160 mg 36800-0449-08 Topco 24 tablets — — FDA listed —
Childrens Pain and Fever 160 mg 36800-0450-08 Topco 24 tablets — — FDA listed —
Childrens Pain Reliever 160 mg 37808-0499-08 H 6 tablets — — FDA listed —
Pain Reliever Childrens 160 mg 37808-0945-08 H 6 tablets — — FDA listed —
childrens acetaminophen 160 mg 41163-0045-08 United 6 tablets — — FDA listed —
childrens acetaminophen 160 mg 41163-0494-08 United 6 tablets — — FDA listed —
Kroger Children Pain plus Fever chewables 160 mg 41226-0061-24 KROGER 6 tablets — — FDA listed —
Children Pain and Fever Reliever 160 mg 41250-0244-24 MEIJER 6 tablets — — FDA listed —
Meijer Childrens Pain and Fever Reducer 160 mg 41250-0246-24 MEIJER 6 tablets — — FDA listed —
Pain and Fever Childrens 160 mg 49035-0455-08 Wal-Mart 6 tablets — — FDA listed —
Pain and Fever Childrens 160 mg 49035-0777-08 Wal-Mart 6 tablets — — FDA listed —
Childrens TYLENOL 160 mg 50580-0517-24 Kenvue 24 tablets — — FDA listed —
Childrens TYLENOL 160 mg 50580-0521-24 Kenvue 24 tablets — — FDA listed —
Childrens Tylenol 160 mg 50580-0522-24 Kenvue 24 tablets — — FDA listed —
Pain and Fever Childrens 160 mg 51316-0449-08 CVS 24 tablets — — FDA listed —
Pain and Fever Chewables Childrens 160 mg 51316-0450-08 CVS 24 tablets — — FDA listed —
Childrens Chewable Acetaminophen 160 mg 53943-0449-08 Discount 24 tablets — — FDA listed —
Childrens Pain Relief 160 mg 53943-0836-76 DISCOUNT 6 tablets — — FDA listed —
Childrens Pain Relief 160 mg 53943-0837-76 DISCOUNT 6 tablets — — FDA listed —
Childrens Acetaminophen 160 mg 55301-0450-08 ARMY 24 tablets — — FDA listed —
Pain and Fever Childrens 160 mg 55910-0948-08 DOLGENCORP, 6 tablets — — FDA listed —
Childrens Pain Relief 160 mg 58602-0765-76 Aurohealth 6 tablets — — FDA listed —
Childrens Pain Relief 160 mg 58602-0766-76 Aurohealth 6 tablets — — FDA listed —
Acetaminophen 160 mg 58602-0774-82 Aurohealth 48 tablets — — FDA listed —
Non-Aspirin childrens 160 mg 63868-0186-24 CHAIN 24 tablets — — Discontinued —
childrens pain reliever 160 mg 63941-0944-08 Valu 6 tablets — — Discontinued —
childrens acetaminophen 160 mg 67091-0311-24 WinCo 6 tablets — — FDA listed —
Children Pain Relief 160 mgthis 69168-0440-60 Allegiant 60 tablets — — FDA listed —
Mejoralito Children CHILDREN 160 mg 69729-0160-24 OPMX 12 tablets — — FDA listed —
Resfriol-ito Children 160 mg 69729-0161-24 OPMX 12 tablets — — FDA listed —
Childrens Pain Relief 160 mg 69842-0160-24 CVS 6 tablets — — FDA listed —
Pain Relief childrens 160 mg 69842-0449-95 CVS 24 tablets — — FDA listed —
Pain Relief childrens 160 mg 69842-0450-94 CVS 24 tablets — — FDA listed —
childrens mapap 160 mg 71205-0322-24 Proficient 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

🏛️
2023
On the market since
Jul 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.

What it looks like

Color purple
ShapeRound
Imprint44;449
Size16 mm
ScoringScored — splits in 2
FlavorGrape
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 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII 2S7830E561
    Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
  • UNII ZK64F7XSTX
    A red synthetic colorant made by combining D&C Red No. 27 dye with aluminum salts. It's used to give tablets, capsules, or other medicines their red or pink color.
  • UNII 2S42T2808B
    A synthetic red dye used as a colorant to give the medicine its red color. It helps make pills or liquids visually distinct and easier to identify.
  • UNII G263MI44RU
    Dextrates are a carbohydrate mixture made from corn or potato starch. They work as fillers and binders in tablets and capsules to add bulk and help hold the medicine together.
  • UNII 7Z8S9VYZ4B
    Ethylcellulose is a plant-derived thickener and film-former made by chemically modifying cellulose. It's used as a binder to hold tablet ingredients together, a coating to control how quickly medicine is released, or a thickener in liquid formulations.
  • UNII J9EQA3S2JM
    FD&C Blue No. 1 Aluminum Lake is a blue colorant made by combining FD&C Blue No. 1 dye with aluminum salts. It is used to color tablets, capsules, and other medicines for easy identification and appearance.
  • UNII UG00KM4WR7
    A plastic polymer used as a container material and film coating. It helps protect the medicine from moisture and air exposure during storage and shipping.
  • 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 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • 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 96K6UQ3ZD4
    Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.

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

The official label also statescitric acid, crospovidone, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, ethylcellulose, FD&C blue #1 aluminum lake, flavors, magnesium stearate, mannitol, polyethylene, stearic acid, sucralose

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

LabelerAllegiant Health
FDA applicationM013 (OTC MONOGRAPH DRUG)
Labeler code69168
First marketedJul 2023
Product typeHuman Otc Drug
Portfolio113 products on file

More NDCs from Allegiant Health labeler code 69168

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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 20 words ▾

Use(s) temporarily relieves minor aches and pains due to: headache sore throat flu toothache the common cold temporarily reduces fever

⏱️ Dosage and Administration 121 words ▾

Directions this product does not contain directions or complete warnings for adult use do not give more than directed find the right dose on chart below. If possible, use weight to dose; otherwise, use age. chew before swallowing; this product will soften in mouth for ease of chewing repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours do not give for more than 5 days unless directed by a doctor Weight (lb) Age (yr) Dose (chewable tablets)** Under 24 Under 2 Ask a doctor 24-35 2-3 1 tablet 36-47 4-5 1 1/2 tablets 48-59 6-8 2 tablets 60-71 9-10 2 1/2 tablets 72-95 11 3 tablets **or as directed by a doctor

⚠️ Warnings ~1 min read ▾

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes more than 5 doses in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if your child is allergic to acetaminophen or any of the inactive ingredients in this product Ask a doctor before use if your child has liver disease.

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin. When using this product do not exceed recommended dosage. Stop use and ask a doctor if pain gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present These could be signs of a serious condition.

Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

🧪 Active Ingredient 5 words ▾

Active ingredient(s) Acetaminophen 160 mg

🧪 Inactive Ingredients 31 words ▾

Inactive ingredients citric acid, crospovidone, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, ethylcellulose, FD&C blue #1 aluminum lake, flavors, magnesium stearate, mannitol, polyethylene, stearic acid, sucralose

🎯 Purpose 4 words ▾

Purpose Pain reliever/fever reducer

📄 Do Not Use 43 words ▾

Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if your child is allergic to acetaminophen or any of the inactive ingredients in this product

📄 Ask a Doctor Before Use If 11 words ▾

Ask a doctor before use if your child has liver disease.

📄 Ask a Doctor or Pharmacist Before Use If 17 words ▾

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin.

📄 When Using This Product 9 words ▾

When using this product do not exceed recommended dosage.

📄 Stop Use and Ask a Doctor If 41 words ▾

Stop use and ask a doctor if pain gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present These could be signs of a serious condition.

📄 Keep Out of Reach of Children 44 words ▾

Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

📄 Questions or Comments 10 words ▾

Questions/Comments Call 1-888-952-0050 Monday through Friday 9AM - 5PM EST

📄 Package Label / Principal Display Panel 9 words ▾

Principal Display Panel Children's Chewable Tablet Children's Chewable Tablet

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 Allegiant Health. 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 1 other package presentation of this same product, including 150 tablets (69168-0440-02). 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?
Allegiant Health 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.
← 69168-0439-06 · Allegiant 69168-0443-09 · Allegiant →
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.