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Diphenhydramine Hydrochloride 25 mg Capsule, Gelatin Coated, 20,000-count

by Catalent Ontario Limited · 20000 CAPSULE, GELATIN COATED in 1 BOX (61474-4241-2)
NDC 61474-4241-02
🏷️ FDA NDC (as labeled) 61474-4241-2 billing pads the package segment with a zero
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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 61474-4241-2
Product NDC 61474-4241
11-digit billing NDC 61474424102
SPL Set ID dc67ec20-1948-7421-e053-2a95a90a0895
DEA schedule Non-controlled
Marketing category DRUG FOR FURTHER PROCESSING
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2012-03-23
Dosage form CAPSULE, GELATIN COATED
Substance DIPHENHYDRAMINE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 61474-4241-2 — 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 → 61474-4241-02. 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.

🏭 Manufacturer & labeler

LabelerCatalent Ontario Limited
Labeler code61474
First marketedMar 2012
Product typeDrug For Further Processing
Portfolio41 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📗 Our plain-language guide HelloPharmacist
  • Diphenhydramine is mainly used to temporarily ease the stuffy, sneezy, itchy symptoms of allergies — like hay fever — and the common cold. Think runny nose, sneezing, watery or itc...
  • What exactly does diphenhydramine treat?
  • Yes, and that's one of the most important things to know about this medicine. Drowsiness is one of its most common effects — it crosses into the brain and that's what causes the se...
  • It depends on your child's age and the product. Most oral diphenhydramine products are not recommended for children under 6, and liquid products labeled for children are generally...
📖 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.

🧪 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
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 $0.054 — Availability likely —
Quality Choice Allergy Relief 25 mg 83324-0118-24 Chain 12 capsules $0.054 — Availability likely —
Good Neighbor Allergy Relief 25 mg 46122-0699-62 AmerisourceBergen 12 capsules $0.054 — Availability likely —
Diphenhydramine Hydrochloride 25 mg 00904-7237-24 Major 24 capsules $0.054 — Availability likely —
Allergy Relief 25 mg 83324-0087-01 CHAIN 100 capsules $0.054 — Availability likely —
Dimetane 25 mg 57237-0367-01 Rising 100 capsules $0.054 — Availability likely —
Diphenhydramine Hydrochloride 25 mg 70000-0598-01 LEADER/ 24 capsules $0.054 — Availability likely —
Sleep-Aid Diphenhydramine HCl 25 mg 70000-0584-01 Cardinal 12 capsules $0.221 — 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 — — FDA listed —
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 11014-0055-01 Catalent 20000 capsules — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 61474-4394-01 Catalent 20000 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 10888-8148-01 Patheon 20000 capsules — — FDA listed —
diphenhydramine hydrochloride 25 mg 11014-0019-01 Catalent 20000 capsules — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 61474-4033-01 Catalent 20000 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 —
Diphenhydramine Hydrochloride 25 mg 10267-4690-00 Contract 49780 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 —
Diphenhydramine Hydrochloride 25 mg 68210-5046-01 Prodose, 3000 capsules — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 73056-0018-21 Bioventure 21000 capsules — — FDA listed —
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 —
Diphenhydramine Hydrochloride 25 mgthis 61474-4241-02 Catalent 20000 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 —
Diphenhydramine Hydrochloride 25 mg 73056-0016-21 Bioventure 21000 capsules — — FDA listed —
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 — — FDA listed —
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 —
Diphenhydramine Hydrochloride 25 mg 63189-0020-10 AMOL 50000 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 mg 70000-0771-01 CARDINAL 100 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

🏛️
2012
On the market since
Mar 2012
📍
2026
Currently FDA-listed
14 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for DIPHENHYDRAMINE HYDROCHLORIDE — the ingredient across all brands.

Top reported reactions

Fatigue16,399
Nausea14,606
Headache14,003
Pain11,969
Dyspnoea11,085
Pruritus10,525
Infusion Related Reaction9,947

Age at onset

Neonate106
Infant195
Child1,828
Adolescent1,476
Adult20,867
Elderly9,044

Reporter sex

171,992 reports
Male · 33%
Female · 66%
Unknown · 0%

Serious outcomes

Hospitalization49,087
Life-threatening7,190
Disabling3,673
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 13,771 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
61474-4241-02 You're viewing this 20000 CAPSULE, GELATIN COATED in 1 BOX (61474-4241-2) — Active

🧭 About this NDC listing & data coverage

Listed for further processing / repackaging

What "drug for further processing" means

FDA lists this package under the "drug for further processing" marketing category: Catalent Ontario Limited supplies it to other companies for further processing or repackaging (blister cards that are later repackaged or co-packaged are a common example). The units themselves are a finished dosage form — which is why pricing or Medicaid data can still appear — but this exact package code may not be the presentation a retail pharmacy dispenses.

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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 "Drug For Further Processing". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 61474-4241-2, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 61474-4241-02, written without dashes as 61474424102. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 61474-4241-02, the first segment (61474) is the labeler code FDA assigned to Catalent Ontario Limited; the middle segment (4241) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Catalent Ontario Limited. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Catalent Ontario Limited 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.
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.

📄 Full FDA label FDA SPL

The complete FDA label for this product, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
📄 FDA label
📄 FDA label 19 words ▾

No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 61474-4203-01 · Catalent 61474-4252-01 · Catalent →
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.