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Allergy Relief Diphenhydramine Hydrochloride 25 mg Capsule, 24-count — NDC 70000-0771-02 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Allergy Relief Diphenhydramine Hydrochloride 25 mg Capsule, 24-count — NDC 70000-0771-2 (Billing 70000-0771-02)

by CARDINAL HEALTH 110, LLC. DBA LEADER · 24 BLISTER PACK in 1 CARTON / 1 CAPSULE in 1 BLISTER PACK

This is a package of 24 capsules of Allergy Relief Diphenhydramine Hydrochloride 25 mg Capsule from CARDINAL HEALTH 110, LLC. DBA LEADER, marketed since Aug 2026 and currently FDA-listed.

NDC 70000-0771-02
🏷️ FDA NDC (as labeled) 70000-0771-2 billing pads the package segment with a zero
This package
Contains24-count Pack sizes2 compare ↓
Product page 70000-0771-01 Also comes in: 100 capsules 70000-0771-1
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Oct 8, 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 70000-0771-2 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
70000 labeler · 0771 product · 2 package
Package marketed since
Aug 14, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 7000007712 9
FDA record last changed
Oct 8, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70000-0771-2
Product NDC 70000-0771
11-digit billing NDC 70000077102
Application # M012
SPL Set ID 519c86dd-fa86-5de2-e063-6394a90a462b
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 2026-08-14
Route ORAL
Dosage form CAPSULE
Substance DIPHENHYDRAMINE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 70000-0771-2 — 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 → 70000-0771-02. 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.

Clinical

📗 Our plain-language guide HelloPharmacist
  • Oral products temporarily relieve hay fever and other upper respiratory allergy symptoms like runny nose, sneezing and itchy, watery eyes. They also ease runny nose and sneezing fr...
  • Oral forms are generally taken every 4 to 6 hours, with no more than 6 doses in 24 hours. The amount depends on age and the product, so check the package chart or ask me or your do...
  • It can. Drowsiness is common, so be careful driving or using machinery. Alcohol, sedatives and tranquilizers make it worse, so avoid them.
  • Oral products are not for children under 2 years, and some are not for children under 6. Children can become excitable, and overdose can be very dangerous. Always follow the age di...
📖 Read our full Diphenhydramine 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: 100 capsules
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
70000-0771-01 70000-0771-1 Main listing 100 CAPSULE in 1 BOTTLE 2026-08-14 — Active
70000-0771-02 You're viewing this 24 BLISTER PACK in 1 CARTON / 1 CAPSULE in 1 BLISTER PACK 2026-08-14 — Active

Pack size FAQ

What quantity is in this package?
This is a 24-count package — 24 blister pack in 1 carton / 1 capsule in 1 blister pack.
How does this package differ from NDC 70000-0771-01?
Both are Allergy Relief Diphenhydramine Hydrochloride 25 mg Capsule — the drug itself is identical. This page's package is the 24-count one, while NDC 70000-0771-01 is the 100 capsules package.
What NDC number is used to bill for this package of Allergy Relief Diphenhydramine Hydrochloride 25 mg Capsule?
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
Diphenhydramine Hydrochloride 25 mg 42806-0648-10 Epic 1000 capsules $0.034 — FDA listed —
Allergy Relief 25 mg 63868-0087-01 Chain 100 capsules $0.034 — FDA listed —
Allergy Relief Diphenhydramine HCl 25 mg 70000-0585-01 Cardinal 12 capsules $0.053 — Availability likely —
Quality Choice Allergy Relief 25 mg 83324-0118-24 Chain 12 capsules $0.053 — Availability likely —
Good Neighbor Allergy Relief 25 mg 46122-0699-62 AmerisourceBergen 12 capsules $0.053 — Availability likely —
Diphenhydramine Hydrochloride 25 mg 00904-7237-24 Major 24 capsules $0.053 — Availability likely —
Allergy Relief 25 mg 83324-0087-01 CHAIN 100 capsules $0.053 — Availability likely —
Dimetane 25 mg 57237-0367-01 Rising 100 capsules $0.053 — Availability likely —
Diphenhydramine Hydrochloride 25 mg 70000-0598-01 LEADER/ 24 capsules $0.053 — Availability likely —
Sleep-Aid Diphenhydramine HCl 25 mg 70000-0584-01 Cardinal 12 capsules $0.215 — Availability likely —
Diphenhydramine Hydrochloride 25 mg 17714-0020-01 Advance 100 capsules — — FDA listed —
Dormin 25 mg 52412-0100-02 Randob 2 capsules — — Discontinued —
Diphenhydramine Hydrochloride 25 mg 60760-0697-30 St. 30 capsules — — Discontinued —
AXIV - VroZzz 25 mg 82706-0014-01 Vivunt 12 capsules — — FDA listed —
Allergy Relief Diphenhydramine HCl 25mg SoftGel 25 mg 84324-0029-01 NUVICARE 60 capsules — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 35916-0436-02 SOFTGEL 1000 capsules — — FDA listed —
Allergy Relief 25 mg 41163-0613-03 United 100 capsules — — FDA listed —
Allergy Relief 25 mg 41520-0996-04 FOODHOLD 12 capsules — — FDA listed —
Allergy 25 mg 53943-0113-01 DISCOUNT 24 capsules — — FDA listed —
Allergy Relief 25 mg 68998-0113-01 Marc 24 capsules — — FDA listed —
GOOD REMEDIES Allergy Relief SOFTGEL 25 mg 70692-0078-22 Strive 12 capsules — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 35916-0435-01 SOFTGEL 3 capsules — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 35916-0471-01 SOFTGEL 1000 capsules — — FDA listed —
ZzzQuil Nighttime Sleep-Aid 25 mg 37000-0501-08 The 2 capsules — — FDA listed —
Allergy Relief 25 mg 42507-0313-01 HYVEE 24 capsules — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 51316-0835-01 CVS 100 capsules — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 54738-0115-13 Richmond 100 capsules — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 55154-2344-00 Cardinal 10 capsules — — FDA listed —
Allergy Relief 25 mg 72476-0113-01 RETAIL 24 capsules — — FDA listed —
Kroger Allergy Relief 25 mg 30142-0554-24 THE 12 capsules — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 53345-0027-01 Humanwell 20000 capsules — — FDA listed —
Diphenhydramine HYDROCHLORIDE 25 mg 51662-1628-01 HF 2 capsules — — FDA listed —
Nighttime Sleep Aid 25 mg 68391-0613-92 BJWC 12 capsules — — FDA listed —
Sleep Aid 25 mg 83059-0115-08 Shield 8 capsules — — Discontinued —
Allergy Relief 25 mg 36800-0910-01 TopCo 24 capsules — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 51316-0347-05 CVS 120 capsules — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 53345-0002-02 Humanwell 20000 capsules — — FDA listed —
RIGHT REMEDIES Allergy Relief 25 mg 70692-0832-11 Strive 1000 capsules — — FDA listed —
Allergy Relief 25 mg 79903-0310-24 Walmart 12 capsules — — FDA listed —
Allergy Antihistamine 25 mg 30142-0832-48 KROGER 48 capsules — — FDA listed —
Discount Drugmart Allergy Relief 25 mg 53943-0821-24 Discount 12 capsules — — FDA listed —
Sleep Aid 25 mg 00363-6130-24 WALGREENS 24 capsules — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 00363-8350-02 Walgreen 600 capsules — — FDA listed —
Nighttime Sleep Aid 25 mg 00363-8989-12 WALGREEN 12 capsules — — FDA listed —
Allergy Relief Diphenhydramine HCl 25mg SoftGel 25 mg 72090-0052-01 Pioneer 100 capsules — — FDA listed —
Sleep Aid 25 mg 83059-0022-01 Shield 12 capsules — — Discontinued —
Benadryl Allergy Liqui-Gels 25 mg 50580-0228-24 Kenvue 12 capsules — — FDA listed —
Nighttime Sleep-Aid Softgel 25 mg 51316-0779-24 CVS 12 capsules — — FDA listed —
Allergy Relief Dye-Free Softgel 25 mg 51316-0998-22 CVS 12 capsules — — FDA listed —
Allergy Relief 25 mg 59640-0090-12 HEB 12 capsules — — FDA listed —
Quality Choice Nighttime Sleep-Aid 25 mg 63868-0970-24 Chain 12 capsules — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 69842-0825-00 CVS 24 capsules — — FDA listed —
Allergy Relief 25 mg 72036-0113-01 Harris 24 capsules — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 50090-7014-00 A-S 100 capsules — — FDA listed —
Nighttime Sleep Aid 25 mg 00363-1174-24 WALGREEN 12 capsules — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 00363-9835-01 Walgreen 100 capsules — — Discontinued —
Harris Teeter Allergy Relief 25 mg 72036-0521-24 Harris 12 capsules — — FDA listed —
Sleep Aid 25 mg 76162-0911-12 Company 12 capsules — — FDA listed —
meijer NIGHTTIME Sleep Aid SOFTGEL 25 mg 79481-0779-04 Meijer, 12 capsules — — FDA listed —
AXIV Allergy 25 mg 82706-0019-01 VIVUNT 12 capsules — — FDA listed —
Allergy Relief 25 mg 63941-0413-01 VALU 24 capsules — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 68788-8855-00 Preferred 10 capsules — — FDA listed —
Nighttime Sleep Aid 25 mg 79903-0083-01 Wal-Mart 12 capsules — — FDA listed —
equate NIGHTTIME Sleep-Aid 25 mg 79903-0400-12 WALMART 12 capsules — — FDA listed —
TopCare Allergy Relief 25 mg 36800-0367-24 TOPCO 12 capsules — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 53345-0007-01 Humanwell 20000 capsules — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 71335-2257-00 Bryant 100 capsules — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 72789-0317-10 PD-Rx 10 capsules — — FDA listed —
Sleep Aid 25 mg 83059-0075-08 Shield 8 capsules — — FDA listed —
Allergy Relief 25 mgthis 70000-0771-02 CARDINAL 24 capsules — — 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

🏛️
2026
On the market since
Aug 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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 pink / white
Shapecapsule
ImprintS832
Size14 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.

🧪 Avoiding an ingredient? See Diphenhydramine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 3QPI1U3FV8
    A preservative derived from benzoic acid that prevents bacterial and fungal growth in medicines. It helps extend shelf life and maintain product safety during storage and use.
  • UNII 767IP0Y5NH
    A synthetic red colorant used to give medicines their color. It helps patients identify their medication and makes the product visually appealing.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • 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 A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • 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.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

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

The official label also statesbutylparaben, D&C red no. 28, edible ink, FD&C blue no. 1, FD&C red no. 40, gelatin, lactose monohydrate, magnesium stearate, methylparaben, polysorbate-80, propylparaben, purified water, sodium lauryl sulphate, starch

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 applicationM012 (OTC MONOGRAPH DRUG)
Labeler code70000
First marketedAug 2026
Product typeHuman Otc Drug
Portfolio163 products on file

More NDCs from CARDINAL HEALTH 110, LLC. DBA LEADER labeler code 70000

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 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 45 words ▾

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

⏱️ Dosage and Administration 53 words ▾

Directions • take every 4 to 6 hours, or as directed by a doctor • do not take more than 6 times in 24 hours adults and children 12 years and older 1 to 2 capsules children 6 to under 12 years old 1 capsule children under 6 years old do not use

⚠️ Warnings 158 words ▾

Warnings Do not use • to make a child sleepy • with other products containing diphenhydramine, even one used on skin Ask a doctor before use if you have • a breathing problem such as emphysema or chronic bronchitis • glaucoma • trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product • marked drowsiness may occur • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery • excitability may occur, especially in children If pregnant or breast-feeding, ask a health professional before use.

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

📦 Storage and Handling 16 words ▾

Other information • store at 20 – 25°C (68–77°F) • protect from light, heat and moisture

🧪 Active Ingredient 9 words ▾

Active Ingredient (in each capsule) Diphenhydramine HCl 25 mg

🧪 Inactive Ingredients 31 words ▾

Inactive ingredients butylparaben, D&C red no. 28, edible ink, FD&C blue no. 1, FD&C red no. 40, gelatin, lactose monohydrate, magnesium stearate, methylparaben, polysorbate-80, propylparaben, purified water, sodium lauryl sulphate, starch

🎯 Purpose 2 words ▾

Purpose Antihistamine

📄 Keep Out of Reach of Children 45 words ▾

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

📄 Questions or Comments 7 words ▾

Questions or comments? 1-888-577-8033 Monday-Friday 8am-4pm EST

📄 Package Label / Principal Display Panel 3 words ▾

Packaging LeaderAllergy Relief

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 CARDINAL HEALTH 110, LLC. DBA LEADER. 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 100 capsules (70000-0771-01). 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.
← 70000-0766-01 · CARDINAL 70000-0772-01 · 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.