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Back and Body Extra Strength Aspirin, Caffeine 500 mg; 32.5 mg Tablet, Film Coated, 50-count — NDC 70000-0127-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Back and Body Extra Strength Aspirin, Caffeine 500 mg; 32.5 mg Tablet, Film Coated, 50-count — NDC 70000-0127-1 (Billing 70000-0127-01)

by Cardinal Health 110, LLC. DBA Leader · 1 BOTTLE, PLASTIC in 1 CARTON / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

This is a package of 50 tablets of Back and Body Extra Strength Aspirin, Caffeine 500 mg; 32.5 mg Tablet, Film Coated from Cardinal Health 110, LLC. DBA Leader, no longer marketed (first marketed Apr 2004), no longer in the FDA NDC Directory.

NDC 70000-0127-01
🏷️ FDA NDC (as labeled) 70000-0127-1 billing pads the package segment with a zero
This package
Contains50-count Pack sizes2 compare ↓
Product page 70000-0127-02 Also comes in: 100 tablets 70000-0127-2
OTC Discontinued Non-controlled ⚠ Discontinued by firm ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 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

⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70000-0127-1
Product NDC 70000-0127
11-digit billing NDC 70000012701
NCPDP billing unit EA — each (per item)
RxCUI 702316
UNII R16CO5Y76E, 3G6A5W338E
UPC 0096295129625
Application # M013
SPL Set ID 519eb216-9fa6-4d60-a2a4-3310bdb5b4ab
Established class (EPC) Nonsteroidal Anti-inflammatory Drug; Platelet Aggregation Inhibitor; Central Nervous System Stimulant; Methylxanthine
Mechanism of action Cyclooxygenase Inhibitors
Physiologic effect Decreased Prostaglandin Production; Decreased Platelet Aggregation; Central Nervous System Stimulation
Chemical class Anti-Inflammatory Agents, Non-Steroidal; Xanthines
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status Discontinued
FDA listing status Discontinued by firm
Marketing start 2004-04-12
Route ORAL
Dosage form TABLET, FILM COATED
Substance ASPIRIN; CAFFEINE

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

GPI-14 64990002250321
GPI class Back & Body Extra Strength
GCN Seq No 068068
GCN 30760
HICL code 001794
Ingredient (HICL) Aspirin/Caffeine
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H3
Therapeutic class — intermediate (HIC2) Analgesics
HIC3 code H3D
Therapeutic class — specific (HIC3) Analgesic/Antipyretics, Salicylates
AHFS code 20:12.18.00
AHFS class Platelet-Aggregation Inhibitors
FDB label name BACK-BODY PAIN 500-32.5MG CPLT
FDB brand name Back-Body Pain Reliever
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 068068
  • GCN: 30760
  • GPI-14 (Medi-Span): 64990002250321
  • HICL (First Databank): 001794
  • AHFS class code: 20:12.18.00
  • RxCUI (RxNorm): 702316
Why two NDCs? The FDA registers this code as 70000-0127-1 — 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 → 70000-0127-01. 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 Platelet Aggregation Inhibitor class.

Pharmacologic class Platelet Aggregation Inhibitor, Nonsteroidal Anti-inflammatory Drug
Drug family (ATC) Other agents for local oral treatment, Platelet aggregation inhibitors excl. heparin, Salicylic acid and derivatives
How it works Cyclooxygenase Inhibitors
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 BACK-BODY PAIN 500-32.5MG CPLT Ingredient Aspirin/Caffeine
🧪 What is this product?

Back and Body Extra Strength Aspirin, Caffeine is an over-the-counter oral tablet containing aspirin and caffeine. Aspirin is typically used to reduce pain and fever and to help decrease inflammation, while caffeine is commonly added to pain relievers as a central nervous system stimulant. This product is marketed as an OTC monograph drug, meaning it follows FDA's established safety and use guidelines for this category rather than being individually reviewed by the agency. The tablet is film-coated for easier swallowing.

4
Nutrient depletion considerations

Aspirin, Caffeine may be associated with lower levels of 4 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Aspirin, Caffeine nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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: 100 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 Per unit Per pack Marketing startMarketing endStatus
70000-0127-01 You're viewing this 1 BOTTLE, PLASTIC in 1 CARTON / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC — — 2004-04-12 — Discontinued by firm
70000-0127-02 70000-0127-2 Main listing 1 BOTTLE, PLASTIC in 1 CARTON / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC $0.0422 / ea $4.22 2004-04-12 — Active

Pack size FAQ

What quantity is in this package?
This is a 50-count package — 1 bottle, plastic in 1 carton / 50 tablet, film coated in 1 bottle, plastic.
How does this package differ from NDC 70000-0127-02?
Both are Back and Body Extra Strength Aspirin, Caffeine 500 mg; 32.5 mg Tablet, Film Coated — the drug itself is identical. This page's package is the 50-count one, while NDC 70000-0127-02 is the 100 tablets package.
What NDC number is used to bill for this package of Back and Body Extra Strength Aspirin, Caffeine 500 mg; 32.5 mg Tablet, Film Coated?
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.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Bayer Headache 500 mg/1; 32.5 mg 00280-0064-01 Bayer 100 tablets — — FDA listed —
Aspirina Cafeina 32.5 mg/1; 500 mg 00280-0162-01 Bayer 24 tablets — — FDA listed —
Bayer Back and Body Extra Strength 35.5 mg/1; 500 mg 00280-2150-02 Bayer 200 tablets — — FDA listed —
pain relief back and body EXTRA STRENGTH 500 mg/1; 32.5 mg 11822-4130-02 Rite 100 tablets — — FDA listed —
Back and Body 500 mg/1; 32.5 mg 30142-0654-12 Kroger 100 tablets — — FDA listed —
Back and Body Extra Strength 500 mg/1; 32.5 mg 41250-0143-12 Meijer 100 tablets — — FDA listed —
Green Guard Extra Strength Pain Relief 500 mg/1; 32.5 mg 47682-0048-80 Unifirst 2 tablets — — FDA listed —
Medi First Pain Ache 500 mg/1; 32.5 mg 47682-0821-36 Unifirst 2 tablets — — FDA listed —
Medi First Plus Pain Ache 500 mg/1; 32.5 mg 47682-0921-36 Unifirst 2 tablets — — FDA listed —
Back and Body Extra Strength 500 mg/1; 32.5 mg 50844-0413-08 L.N.K. 24 tablets — — FDA listed —
AeroTab Pain Reliever 500 mg/1; 32.5 mg 55305-0135-01 Aero 2 tablets — — FDA listed —
Back and Body Extra Strength 500 mg/1; 32.5 mg 55910-0134-15 DOLGENCORP, 50 tablets — — FDA listed —
Back and Body Extra Strength 500 mg/1; 32.5 mg 59779-0143-12 CVS 100 tablets — — FDA listed —
Back and Body Pain Relief 500 mg/1; 32.5 mg 67091-0430-50 WinCo 50 tablets — — FDA listed —
Back and Body Extra Strength 500 mg/1; 32.5 mgthis 70000-0127-01 Cardinal 50 tablets — — Discontinued —
Thompson XS Pain Ache 32.5 mg/1; 500 mg 73408-0821-80 Thompson 2 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

🏛️
2004
On the market since
Apr 2004
📍
2026
Currently FDA-listed
22 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 white
ShapeOval
Imprint44;413
Size17 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 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII 7CVR7L4A2D
    A starch-derived carbohydrate produced by breaking down corn, potato, or tapioca starch. It functions as a filler and binder to give the medicine bulk and texture, and sometimes as a mild sweetener or texture enhancer in powders and tablets.
  • 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 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • 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.

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

The official label also statescorn starch, hypromellose, maltodextrin, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate

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

LabelerCardinal Health 110, LLC. DBA Leader
FDA applicationM013 (OTC MONOGRAPH DRUG)
Labeler code70000
First marketedApr 2004
Product typeHuman Otc Drug
Portfolio163 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 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist Before Use If 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 18 words ▾

Uses for the temporary relief of backache pain muscle aches and pains minor aches and pains of arthritis

⏱️ Dosage and Administration 49 words ▾

Directions do not take more than directed drink a full glass of water with each dose adults and children 12 years and over: take 2 caplets every 6 hours, not to exceed 8 caplets in 24 hours children under 12 years: do not use unless directed by a doctor

⚠️ Warnings ~2 min read ▾

Warnings Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy alert: Aspirin may cause a severe allergic reaction, which may include: hives shock facial swelling asthma (wheezing) Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding.

The chance is higher if you take more or for a longer time than directed take a blood thinning (anticoagulant) or steroid drug are age 60 or older have 3 or more alcoholic drinks every day while using this product have had stomach ulcers or bleeding problems take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] Do not use if you are allergic to aspirin or any other pain reliever/fever reducer if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have asthma you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic Ask a doctor or pharmacist before use if you are taking a prescription drug for gout diabetes arthritis Stop use and ask a doctor if an allergic reaction occurs.

Seek medical help right away. you experience any of the following signs of stomach bleeding: vomit blood have bloody or black stools feel faint have stomach pain that does not get better ringing in the ears or a loss of hearing occurs pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 20 words ▾

Other information store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number

🧪 Active Ingredient 15 words ▾

Active ingredients (in each caplet) Aspirin 500 mg (NSAID)* Caffeine 32.5 mg *nonsteroidal anti-inflammatory drug

🧪 Inactive Ingredients 13 words ▾

Inactive ingredients corn starch, hypromellose, maltodextrin, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate

🎯 Purpose 6 words ▾

Purpose Pain reliever Pain reliever aid

📄 Do Not Use 31 words ▾

Do not use if you are allergic to aspirin or any other pain reliever/fever reducer if you have ever had an allergic reaction to this product or any of its ingredients

📄 Ask a Doctor Before Use If 42 words ▾

Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have asthma you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic

📄 Ask a Doctor or Pharmacist Before Use If 18 words ▾

Ask a doctor or pharmacist before use if you are taking a prescription drug for gout diabetes arthritis

📄 Stop Use and Ask a Doctor If 87 words ▾

Stop use and ask a doctor if an allergic reaction occurs. Seek medical help right away. you experience any of the following signs of stomach bleeding: vomit blood have bloody or black stools feel faint have stomach pain that does not get better ringing in the ears or a loss of hearing occurs pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur These could be signs of a serious condition.

🤰 If Pregnant or Breast-Feeding 47 words ▾

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

📄 Keep Out of Reach of Children 21 words ▾

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

📄 Questions or Comments 4 words ▾

Questions or comments? 1-800-426-9391

📄 Package Label / Principal Display Panel 166 words ▾

Principal display panel LEADER ™ NDC 70000-0127-2 Extra Strength Back & Body Aspirin (NSAID), 500 mg | Caffeine, 32.5 mg Pain Reliever | Pain Reliever Aid Relieves Backaches and Muscle Aches & Pains COMPARE TO BAYER ® BACK & BODY active ingredients † 100% Money Back Guarantee 100 CAPLETS Actual Size TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING † This product is not manufactured or distributed by Bayer AG, owner of the registered trademark Bayer ® Back & Body. 50844 REV0222B41312 Cardinal Health™ DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017 www.myleader.com 1-800-200-6313 Essential to Care™ since 1979 √ All LEADER™ Brand Products Have A 100% Money Back Guarantee Return to place of purchase if not satisfied. ©2022 Cardinal Health.

All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, ESSENTIAL TO CARE, LEADER, and the Leader LOGO are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners.

Leader 44-413 Leader 44-413

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

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 Back and Body Extra Strength (this brand).

Top reported reactions

Rash3
Therapeutic Response Unexpected2
Amnesia1
Anaphylactoid Reaction1
Ataxia1
Atrial Fibrillation1
Balance Disorder1

Age at onset

Adult1
Elderly1

Reporter sex

8 reports
Male · 13%
Female · 88%

Serious outcomes

Hospitalization2
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.

About this NDC listing & data coverage

Over-the-counter (OTC) product No longer marketed (per FDA listing data)
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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 100 tablets (70000-0127-02). 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?
Cardinal Health 110, LLC. DBA Leader 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.
← 70000-0125-01 · Cardinal 70000-0132-01 · CARDINAL →
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.