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Diphenhydramine HCL 25 mg Capsule, 15-count — NDC 66267-0080-15 package photo

Diphenhydramine HCL 25 mg Capsule, 15-count

by NuCare Pharmaceuticals, Inc. · 15 CAPSULE in 1 BOTTLE, PLASTIC (66267-080-15)
NDC 66267-0080-15
🏷️ FDA NDC (as labeled) 66267-080-15 billing pads the product segment with a zero
This package
Contains15-count Pack sizes6 compare ↓
Also comes in: 20 capsules 66267-0080-20 24 capsules 66267-0080-24 30 capsules 66267-0080-30 60 capsules 66267-0080-60 90 capsules 66267-0080-90
OTC Discontinued Non-controlled ⚠ Inactivated by FDA
🗂️ Data synced Jul 15, 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. FDA inactivated this product’s listing record, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2024. 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

FDA NDC (as labeled) 66267-080-15
Product NDC 66267-080
11-digit billing NDC 66267008015
NCPDP billing unit EA — each (per item)
Application # part341
SPL Set ID 3dbdf67f-766b-12ee-e054-00144ff8d46c
Established class (EPC) Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH FINAL
Marketing status Discontinued
FDA listing status Inactivated by FDA (certified through Dec 2024)
Route ORAL
Dosage form CAPSULE
Substance DIPHENHYDRAMINE HYDROCHLORIDE
GCN Seq No 011582
GCN 45971
HICL code 004480
Ingredient (HICL) Diphenhydramine Hcl
HIC1 code Z
Therapeutic class — broad (HIC1) Body As A Whole
HIC2 code Z2
Therapeutic class — intermediate (HIC2) Antihistamines, Antiserotonins, Immunosuppressants
HIC3 code Z2P
Therapeutic class — specific (HIC3) Antihistamines - 1St Generation
AHFS code 04:04.00.00
AHFS class First Generation Antihistamines
FDB label name DIPHENHYDRAMINE 25 MG CAPSULE
FDB brand name Diphenhydramine Hcl
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 66267-080-15 — 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 → 66267-0080-15. 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

LabelerNuCare Pharmaceuticals, Inc.
FDA applicationpart341 (OTC MONOGRAPH FINAL)
Labeler code66267
Product typeHuman Otc Drug
Portfolio362 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name DIPHENHYDRAMINE 25 MG CAPSULE Ingredient Diphenhydramine Hcl
📖 What it is MedlinePlus · NLM

Diphenhydramine is used to treat allergy and cold symptoms: sneezing runny nose red, itchy, watery eyes itching of the nose or throat Diphenhydramine is also used to treat insomnia (difficulty falling asleep or staying asleep) in adults, but should not be used to make a child sleepy. Diphenhydramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms. Diphenhydramine is also available in combination with other medications. This monograph only includes information about the use of diphenh...

Read the full MedlinePlus article ↗
📗 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.

💊 What it looks like

Color pink
ShapeCapsule
ImprintPH014
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.

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.
Medicare Part B allowsASP · Q0163 No ASP payment limit on file for Q0163 this quarter.
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: 20 capsules 24 capsules 30 capsules 60 capsules 90 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.

🧾 Billing & reimbursement

FDA NDC (as labeled)66267-080-15
11-digit billing NDC66267-0080-15
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeQ0163
DescriptorDIPHENHYDRAMINE HYDROCHLORIDE, 50 MG, ORAL, FDA APPROVED PRESCRIPTION ANTI-EMETIC, FOR USE AS A COMPLETE THERAPEUTIC SUBSTITUTE FOR AN IV ANTI-EMETIC AT TIME OF CHEMOTHERAPY TREATMENT NOT TO EXCEED A 48 HOUR DOSAGE REGIMEN
Billing units / pkg0.5 units
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

🔁 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 —
Diphenhydramine Hydrochloride 25 mg 00904-7237-24 Major 24 capsules $0.054 — Availability likely —
Allergy Relief 25 mg 46122-0440-62 Amerisource 24 capsules $0.054 — Availability likely —
Good Neighbor Allergy Relief 25 mg 46122-0699-62 AmerisourceBergen 12 capsules $0.054 — Availability likely —
Allergy Relief 25 mg 46122-0828-51 AMERISOURCE 12 capsules $0.054 — Availability likely —
Dimetane 25 mg 57237-0367-01 Rising 100 capsules $0.054 — Availability likely —
Allergy Relief Diphenhydramine HCl 25 mg 70000-0585-01 Cardinal 12 capsules $0.054 — Availability likely —
Diphenhydramine Hydrochloride 25 mg 70000-0598-01 LEADER/ 24 capsules $0.054 — Availability likely —
Allergy Relief 25 mg 70677-1015-01 Strategic 24 capsules $0.054 — Availability likely —
Diphenhydramine HCl 25 mg 82568-0004-01 AARNA 100 capsules $0.054 — Availability likely —
Allergy Relief 25 mg 83324-0087-01 CHAIN 100 capsules $0.054 — Availability likely —
Quality Choice Allergy Relief 25 mg 83324-0118-24 Chain 12 capsules $0.054 — Availability likely —
Allergy Relief 25 mg 83324-0280-24 CHAIN 12 capsules $0.054 — Availability likely —
Sleep-Aid Diphenhydramine HCl 25 mg 70000-0584-01 Cardinal 12 capsules $0.221 — Availability likely —
Free and Pure Allergy Relief Dye Free 25 mg 00363-1175-24 WALGREEN 12 capsules — — FDA listed —
Allergy Relief 25 mg 00363-1900-08 Walgreen 24 capsules — — FDA listed —
Sleep Aid 25 mg 00363-6130-24 WALGREENS 24 capsules — — FDA listed —
Allergy Relief Dye Free 25 mg 00363-6682-24 Walgreens 12 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 —
Diphenhydramine Hydrochloride 25 mg 00363-9835-01 Walgreen 100 capsules — — FDA listed —
Nighttime Sleep Aid 25 mg 11673-0703-24 TARGET 12 capsules — — FDA listed —
Allergy Relief 25 mg 11822-0190-01 Rite 100 capsules — — FDA listed —
Pharbedryl 25 mg 16103-0348-03 Pharbest 24 capsules — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 17714-0020-01 Advance 100 capsules — — FDA listed —
Kroger Allergy Relief 25 mg 30142-0554-24 THE 12 capsules — — FDA listed —
Allergy Antihistamine 25 mg 30142-0832-48 KROGER 48 capsules — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 35916-0435-01 SOFTGEL 3 capsules — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 35916-0436-02 SOFTGEL 1000 capsules — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 35916-0471-01 SOFTGEL 1000 capsules — — FDA listed —
TopCare Allergy Relief 25 mg 36800-0367-24 TOPCO 12 capsules — — FDA listed —
Allergy Relief 25 mg 36800-0910-01 TopCo 24 capsules — — FDA listed —
ZzzQuil Nighttime Sleep-Aid 25 mg 37000-0501-08 The 2 capsules — — FDA listed —
Allergy Medicine 25 mg 37835-0647-01 Bi-Mart 100 capsules — — FDA listed —
Allergy Relief 25 mg 41163-0613-03 United 100 capsules — — FDA listed —
Unisom SleepMinis Nighttime Sleep-Aid 25 mg 41167-0067-00 Chattem, 60 capsules — — FDA listed —
EZ Nite Sleep 25 mg 41226-0613-24 KROGER 12 capsules — — FDA listed —
Allergy Relief 25 mg 41520-0996-04 FOODHOLD 12 capsules — — FDA listed —
Allergy Relief 25 mg 42507-0313-01 HYVEE 24 capsules — — FDA listed —
Allergy Relief 25 mg 42681-0050-01 Whole 30 capsules — — FDA listed —
Nighttime sleep aid 25 mg 42829-0925-20 ASCENT 120 capsules — — Discontinued —
Allergy Relief 25 mg 49035-0901-08 Wal-Mart 24 capsules — — FDA listed —
Diphenhydramine HCL 25 mg 50090-5716-00 A-S 30 capsules — — FDA listed —
Diphenhydramine HCL 25 mg 50090-5744-01 A-S 28 capsules — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 50090-7014-00 A-S 100 capsules — — FDA listed —
Benadryl Allergy Liqui-Gels 25 mg 50580-0228-24 Kenvue 12 capsules — — FDA listed —
Allergy Relief 25 mg 50804-0091-08 Geiss, 24 capsules — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 51316-0347-05 CVS 120 capsules — — FDA listed —
Allergy Relief mini Softgels 25 mg 51316-0687-36 CVS 365 capsules — — FDA listed —
Nighttime Sleep-Aid Softgel 25 mg 51316-0779-24 CVS 12 capsules — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 51316-0835-01 CVS 100 capsules — — FDA listed —
Allergy Relief Dye-Free Softgel 25 mg 51316-0998-22 CVS 12 capsules — — FDA listed —
Diphenhydramine HYDROCHLORIDE 25 mg 51662-1628-01 HF 2 capsules — — FDA listed —
Dormin 25 mg 52412-0100-02 Randob 2 capsules — — Discontinued —
Diphenhydramine Hydrochloride 25 mg 53345-0002-02 Humanwell 20000 capsules — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 53345-0007-01 Humanwell 20000 capsules — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 53345-0027-01 Humanwell 20000 capsules — — FDA listed —
Allergy 25 mg 53943-0113-01 DISCOUNT 24 capsules — — FDA listed —
Discount Drugmart Allergy Relief 25 mg 53943-0821-24 Discount 12 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 —
Diphenhydramine HCl 25 mg 55289-0479-10 PD-Rx 10 capsules — — FDA listed —
Allergy Relief 25 mg 55301-0190-08 ARMY 24 capsules — — FDA listed —
Allergy Relief 25 mg 55910-0191-08 DOLGENCORP, 24 capsules — — FDA listed —
Allergy Relief 25 mg 55910-0752-09 DOLGENCORP 12 capsules — — FDA listed —
Complete Allergy Medicine 25 mg 57243-0190-08 Salado 24 capsules — — FDA listed —
Allergy Relief 25 mg 59640-0090-12 HEB 12 capsules — — FDA listed —
Allergy Relief 25 mg 59779-0019-22 CVS 48 capsules — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 60760-0697-30 St. 30 capsules — — FDA listed —
Pharbedryl 25 mg 60760-0699-30 St. 30 capsules — — FDA listed —
Quality Choice Nighttime Sleep-Aid 25 mg 63868-0970-24 Chain 12 capsules — — FDA listed —
Allergy Relief 25 mg 63941-0413-01 VALU 24 capsules — — FDA listed —
Diphenhydramine HCL 25 mg 66424-0020-01 SDA 100 capsules — — FDA listed —
ZzzQuil 50 mg/21 66715-9746-01 Lil' 2 capsules — — FDA listed —
Allergy Relief Complete 25 mg 67091-0201-24 WinCo 24 capsules — — FDA listed —
Diphenhydramine HCL 25 mg 68071-3352-04 NuCare 4 capsules — — FDA listed —
Diphenhydramine HCl 25 mg 68071-3877-03 NuCare 30 capsules — — FDA listed —
Nighttime Sleep Aid 25 mg 68391-0613-92 BJWC 12 capsules — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 68788-8855-00 Preferred 10 capsules — — FDA listed —
Diphenhydramine HCL 25 mg 68788-9687-00 Preferred 10 capsules — — FDA listed —
Allergy Relief 25 mg 68998-0113-01 Marc 24 capsules — — FDA listed —
Allergy DyeFree 25 mg 69168-0409-86 Allegiant 12 capsules — — FDA listed —
Sleep Aid 25 mg 69168-0431-86 Allegiant 12 capsules — — FDA listed —
Allergy Relief 25 mg 69452-0453-09 BIONPHARMA 12 capsules — — FDA listed —
Diphenhydramine HCl 25 mg 69618-0024-01 Reliable 100 capsules — — FDA listed —
Diphenhydramine HCl 25 mg 69842-0537-11 CVS 60 capsules — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 69842-0825-00 CVS 24 capsules — — FDA listed —
GOOD REMEDIES Allergy Relief SOFTGEL 25 mg 70692-0078-22 Strive 12 capsules — — FDA listed —
RIGHT REMEDIES Allergy Relief 25 mg 70692-0832-11 Strive 1000 capsules — — FDA listed —
Diphenhydramine HCL 25 mg 71205-0615-30 Proficient 30 capsules — — FDA listed —
Diphenhydramine HCL 25 mg 71335-0352-00 Bryant 100 capsules — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 71335-2257-00 Bryant 100 capsules — — FDA listed —
Diphenhydramine HCl 25 mg 71399-1027-01 Akron 100 capsules — — FDA listed —
Allergy Relief 25 mg 72036-0113-01 Harris 24 capsules — — FDA listed —
Harris Teeter Allergy Relief 25 mg 72036-0521-24 Harris 12 capsules — — FDA listed —
Allergy Relief Diphenhydramine HCl 25mg SoftGel 25 mg 72090-0052-01 Pioneer 100 capsules — — FDA listed —
Allergy Relief 25 mg 72476-0113-01 RETAIL 24 capsules — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 72789-0317-10 PD-Rx 10 capsules — — FDA listed —
Allergy Relief 25 mg 73057-0348-03 Ulai 24 capsules — — FDA listed —
Diphenhydramine Hydrochloride 25 mg 73629-0007-22 AMZ789 220 capsules — — FDA listed —
Sleep Aid 25 mg 76162-0911-12 Company 12 capsules — — FDA listed —
Dye Free Allergy Relief 25 mg 76162-0914-24 Topco 12 capsules — — FDA listed —
Antihistamine 25 mg 77333-0227-10 Gendose 100 capsules — — FDA listed —
meijer NIGHTTIME Sleep Aid SOFTGEL 25 mg 79481-0779-04 Meijer, 12 capsules — — FDA listed —
Allergy Relief 25 mg 79481-0880-01 Meijer 12 capsules — — FDA listed —
Allergy Relief Dye Free 25 mg 79903-0057-24 Wal-Mart 12 capsules — — FDA listed —
Nighttime Sleep Aid 25 mg 79903-0083-01 Wal-Mart 12 capsules — — FDA listed —
Allergy Relief Dye Free 25 mg 79903-0193-48 Wal-Mart 12 capsules — — FDA listed —
Allergy Relief 25 mg 79903-0310-24 Walmart 12 capsules — — FDA listed —
equate NIGHTTIME Sleep-Aid 25 mg 79903-0400-12 WALMART 12 capsules — — FDA listed —
AXIV - VroZzz 25 mg 82706-0014-01 Vivunt 12 capsules — — FDA listed —
AXIV Allergy 25 mg 82706-0019-01 VIVUNT 12 capsules — — FDA listed —
Sleep Aid 25 mg 83059-0022-01 Shield 12 capsules — — Discontinued —
ValuRx Dye Free Allergy Relief 25 mg 83059-0080-01 Shield 12 capsules — — Discontinued —
ValuRx Dye Free Allergy Relief 25 mg 83059-0081-01 Shield 12 capsules — — Discontinued —
Sleep Aid 25 mg 83059-0115-08 Shield 8 capsules — — Discontinued —
Allergy Relief Diphenhydramine HCl 25mg SoftGel 25 mg 84324-0029-01 NUVICARE 60 capsules — — FDA listed —
Diphenhydramine HCL 25 mgthis 66267-0080-15 NuCare 15 capsules — — Discontinued —
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
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.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Diphenhydramine HCl — the program that covers self-administered drugs. 8 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Diphenhydramine HCl. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$374.3K
Claims incl. refills
20.3K
Beneficiaries
11.2K
Spend / beneficiary
$33.36
Spend / claim
$18.44
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 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 HCl — the ingredient across all brands.

Top reported reactions

Fatigue1,233
Nausea1,116
Pain989
Headache968
Dyspnoea918
Diarrhoea863
Completed Suicide800

Age at onset

Neonate7
Infant4
Child26
Adolescent25
Adult653
Elderly520

Reporter sex

19,270 reports
Male · 37%
Female · 63%
Unknown · 1%

Serious outcomes

Hospitalization5,416
Death3,648
Life-threatening970
Disabling602
Reports over time (by year) — tap or hover for the count & year
2024 2025 2026 650 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
66267-0080-15 You're viewing this 15 CAPSULE in 1 BOTTLE, PLASTIC (66267-080-15) 2016-09-30 Inactivated by FDA
66267-0080-20 20 CAPSULE in 1 BOTTLE, PLASTIC (66267-080-20) 2016-09-30 Inactivated by FDA
66267-0080-24 24 CAPSULE in 1 BOTTLE, PLASTIC (66267-080-24) 2016-09-30 Inactivated by FDA
66267-0080-30 30 CAPSULE in 1 BOTTLE, PLASTIC (66267-080-30) 2016-09-30 Inactivated by FDA
66267-0080-60 60 CAPSULE in 1 BOTTLE, PLASTIC (66267-080-60) 2016-09-30 Inactivated by FDA
66267-0080-90 90 CAPSULE in 1 BOTTLE, PLASTIC (66267-080-90) 2016-09-30 Inactivated by FDA

You're viewing the smallest of 6 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 66267-0080-15?
NDC 66267-0080-15 is a 15-count package — 15 capsule in 1 bottle, plastic.
What is the difference between NDC 66267-0080-15 and NDC 66267-0080-20?
Both are Diphenhydramine HCL 25 mg Capsule — the drug itself is identical. NDC 66267-0080-15 is the 15-count package, while NDC 66267-0080-20 is the 20 capsules package.
What NDC number is used to bill for this package of Diphenhydramine HCL 25 mg Capsule?
Bill NDC 66267-0080-15 — the 11-digit billing format is 66267008015. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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) — 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 ✓ Available
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 Final". 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 FDA registers it as 66267-080-15, 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: 66267-0080-15, written without dashes as 66267008015. 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 66267-0080-15, the first segment (66267) is the labeler code FDA assigned to NuCare Pharmaceuticals, Inc.; the middle segment (0080) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (15) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 5 other package presentations of this same product, including 20 capsules (66267-0080-20), 24 capsules (66267-0080-24), 30 capsules (66267-0080-30). 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?
NuCare Pharmaceuticals, Inc. 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.

📄 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
🎯 Indications and Usage 24 words ▾

Uses: Temporarily relieves these symptoms associated with the common cold, hay fever, or other respiratory allergies. Sneezing. Nasal congestion. Runny nose. Itchy, watery eyes.

⏱️ Dosage and Administration 41 words ▾

Directions: Take every 4-6 hours Do not take more than 6 doses in 24 hours. Adults and children 12 years or over 1 to 2 capsule Children 6 to under 12 years 1 capsule Children under 6 years ask a doctor

⚠️ Warnings 1 words ▾

Warnings:

📦 Storage and Handling 16 words ▾

Other information: Store at room temperature 15-30 degrees C (59-86 degrees F) Protect from excessive moisture

🧪 Active Ingredient 10 words ▾

Active ingredient(in each capsule) Diphenhydramine HCL 25 mg Purpose Antihistamine

🧪 Inactive Ingredients 30 words ▾

Inactive ingredients: Black Iron Oxide, D & C Red #28, FD & C Blue #1, FD & C Red #40, Gelatin, Lactose Monohydrate, Magnesium Stearate, Silicon Dioxide, Sodium Lauryl Sulfate

🎯 Purpose 2 words ▾

Purpose Antihistamine

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 66267-0071-14 · NuCare 66267-0081-30 · NuCare →
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.