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Diphenhydramine HCl 50 mg Capsule, 10-count — NDC 55154-0661-00 package photo

Diphenhydramine HCl 50 mg Capsule, 10-count

by Cardinal Health 107, LLC · 10 BLISTER PACK in 1 BAG (55154-0661-0) / 1 CAPSULE in 1 BLISTER PACK
NDC 55154-0661-00
🏷️ FDA NDC (as labeled) 55154-0661-0 billing pads the package segment with a zero
OTC 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) 55154-0661-0
Product NDC 55154-0661
11-digit billing NDC 55154066100
RxCUI 1020477
UNII TC2D6JAD40
UPC 0055154066105
Application # M012
SPL Set ID abc0e348-8532-4658-bd8c-d7dbe5a28c7d
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 2009-01-02
Marketing end 2027-12-31
Route ORAL
Dosage form CAPSULE
Substance DIPHENHYDRAMINE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 55154-0661-0 — 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 → 55154-0661-00. 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 Histamine-1 Receptor Antagonist class.

Pharmacologic class Histamine-1 Receptor Antagonist
Drug family (ATC) Propionic acid derivatives, Antihistamines for topical use, Aminoalkyl ethers
How it works Histamine H1 Receptor Antagonists
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.

🏭 Manufacturer & labeler

LabelerCardinal Health 107, LLC
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code55154
First marketedJan 2009
Product typeHuman Otc Drug
Portfolio477 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

📖 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
ImprintCPC;836
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.

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

  • 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 J2B2A4N98G
    Lactose is a natural sugar derived from milk. In medications, it serves as a filler and binder to add bulk and help hold tablet or capsule ingredients together during manufacturing.
  • 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 statesD&C Red #28, FD&C Blue #1, FD&C Red #40, Gelatin, Lactose and 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.

💲 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 50 mg 42806-0649-10 Epic 1000 capsules $0.020 — FDA listed —
Diphenhydramine Hydrochloride 50 mg 00904-2056-61 Major 100 capsules $0.030 — Availability likely —
Banophen 50 mg 00904-5307-60 Major 100 capsules $0.030 — Discontinued —
Dimetane 50 mg 57237-0368-01 Rising 100 capsules $0.030 — Availability likely —
Diphenhydramine HCl 50 mg 82568-0005-01 AARNA 100 capsules $0.030 — Availability likely —
Nighttime Sleep Aid Maximum Strength 50 mg 62011-0416-01 Strategic 32 capsules $0.095 — Discontinued —
Nighttime Sleep Aid maximum strength 50 mg 70000-0527-01 Cardinal 32 capsules $0.104 — Availability likely —
Nighttime Sleep-Aid 50 mg 46122-0775-64 AMERISOURCE 60 capsules $0.111 — Availability likely —
Nighttime Sleep Aid 50 mg 70000-0616-01 Cardinal 100 capsules $0.111 — Availability likely —
Sleep Aid 50 mg 70677-1151-01 Strategic 32 capsules $0.111 — Availability likely —
Sleep Aid 50 mg 83324-0151-32 QUALITY 32 capsules $0.111 — Availability likely —
Nighttime Sleep-Aid 50 mg 46122-0695-72 AMERISOURCE 60 capsules $0.111 — Discontinued —
Wal Som Nighttime Sleep Aid 50 mg 00363-0816-16 Walgreens 160 capsules — — FDA listed —
Wal Som Nighttime Sleep Aid Nighttime 50 mg 00363-0860-16 Walgreens 160 capsules — — FDA listed —
Allergy Relief 50 mg 00363-6123-20 WALGREEN 100 capsules — — FDA listed —
Sleep Aid 50 mg 11673-0360-32 TARGET 32 capsules — — FDA listed —
Pharbedryl 50 mg 16103-0347-08 Pharbest 100 capsules — — FDA listed —
Diphenhydramine Hydrochloride 50 mg 17714-0021-01 Advance 100 capsules — — FDA listed —
Sleep Aid 50 mg 21130-0052-32 Better 32 capsules — — FDA listed —
Sleep Aid 50 mg 21130-0816-32 Safeway, 32 capsules — — FDA listed —
Sleep Aid 50 mg 21130-0860-32 Safeway, 32 capsules — — FDA listed —
SleepAid (Diphenhydramine HCL) 50 mg 24689-0154-01 APNAR 100 capsules — — FDA listed —
Kroger Nighttime Sleep-Aid 50 mg 30142-0558-64 THE 64 capsules — — FDA listed —
Nighttime Sleep-Aid 50 mg 30142-0681-18 KROGER 64 capsules — — FDA listed —
Sleep Aid 50 mg 30142-0715-32 The 32 capsules — — FDA listed —
Diphenhydramine Hydrochloride 50 mg 35916-0438-01 SOFTGEL 100 capsules — — FDA listed —
Diphenhydramine Hydrochloride 50 mg 35916-0470-01 Softgel 1000 capsules — — FDA listed —
Diphenhydramine hydrochloride 50 mg 35916-0472-01 Softgel 1000 capsules — — FDA listed —
Nighttime Sleep Aid 50 mg 36800-0116-32 TOP 32 capsules — — FDA listed —
Sleep Aid Maximum Strength 50 mg 37808-0860-12 H 120 capsules — — FDA listed —
Sleep Aid Nighttime 50 mg 41163-0860-32 United 32 capsules — — FDA listed —
Unisom SleepGels Nighttime Sleep-Aid 50 mg 41167-0061-00 Chattem, 8 capsules — — Discontinued —
Nighttime Sleep-Aid 50 mg 42681-0051-01 Whole 32 capsules — — FDA listed —
Nighttime sleep aid 50 mg 42829-0950-20 ASCENT 120 capsules — — Discontinued —
Sleep Aid 50 mg 49035-0736-10 EQUATE 100 capsules — — FDA listed —
Benadryl Allergy Extra Strength Liqui-Gels 50 mg 50580-0322-20 Kenvue 10 capsules — — FDA listed —
Sleep Aid 50 mg 50804-0410-38 Good 32 capsules — — FDA listed —
Nighttime Sleep Aid 50 mg 50804-0860-32 Good 32 capsules — — FDA listed —
Nighttime SLEEP AID 50 mg 51013-0817-01 PuraCap 100 capsules — — FDA listed —
Diphenhydramine Hydrochloride 50 mg 53345-0005-01 Humanwell 12000 capsules — — FDA listed —
Diphenhydramine Hydrochloride 50 mg 53345-0022-01 Humanwell 12000 capsules — — FDA listed —
Nighttime Sleep-Aid 50 mg 53943-0485-18 DISCOUNT 64 capsules — — FDA listed —
Discount Drugmart Nighttime Sleep-Aid 50 mg 53943-0822-64 Discount 64 capsules — — FDA listed —
Diphenhydramine Hydrochloride 50 mg 54738-0116-01 Richmond 100 capsules — — FDA listed —
Diphenhydramine HCl 50 mgthis 55154-0661-00 Cardinal 10 capsules — — FDA listed —
Sleep Aid 50 mg 55319-0564-32 Family 32 capsules — — FDA listed —
Sleep Aid 50 mg 55910-0798-16 Dolgencorp, 16 capsules — — FDA listed —
Sleep Aid 50 mg 55910-0894-16 Dolgencorp, 16 capsules — — FDA listed —
Sleep Aid Nighttime 50 mg 55910-0916-16 Dolgencorp, 16 capsules — — FDA listed —
Sleep Aid Maximum Strength 50 mg 59726-0760-64 P 64 capsules — — FDA listed —
Sleep Aid Maximum Strength 50 mg 59726-0816-64 P 64 capsules — — FDA listed —
Nighttime Sleep Aid 50 mg 59726-0916-32 P 32 capsules — — FDA listed —
Diphenhydramine HCL 50 mg 63187-0866-10 Proficient 10 capsules — — FDA listed —
Banophen 50 mg 63629-9451-01 Bryant 30 capsules — — FDA listed —
Sleep Aid Maximum Strength 50 mg 63868-0415-32 QUALITY 32 capsules — — FDA listed —
Sleep Aid Maximum Strength 50 mg 63868-0900-32 QUALITY 32 capsules — — FDA listed —
Nighttime Sleep-Aid 50 mg 63941-0604-17 VALU 60 capsules — — FDA listed —
Nighttime Sleep-Aid 50 mg 63941-0683-17 VALU 60 capsules — — FDA listed —
Nighttime sleep aid Maximum Strength 50 mg 63941-0860-16 Best 1 capsule — — FDA listed —
Nighttime sleep aid Maximum Strength 50 mg 63941-0916-16 Best 1 capsule — — FDA listed —
Diphenhydramine HCL 50 mg 66267-0081-30 NuCare 30 capsules — — FDA listed —
Diphenhydramine HCL 50 mg 66267-0779-06 NuCare 6 capsules — — FDA listed —
Diphenhydramine HCL 50 mg 66424-0021-01 SDA 100 capsules — — FDA listed —
Sleep Aid Maximum Strength 50 mg 67091-0413-32 WinCo 32 capsules — — FDA listed —
Nighttime Sleep Aid 50 mg 68210-4160-08 Prodose, 8 capsules — — FDA listed —
Diphenhydramine Hydrochloride 50 mg 68210-5057-01 Prodose, 3000 capsules — — FDA listed —
Banophen 50 mg 68788-7830-01 Preferred 15 capsules — — FDA listed —
Diphenhydramine HCL 50 mg 68788-9688-01 Preferred 15 capsules — — FDA listed —
Sleep Aid 50 mg 69168-0410-03 Allegiant 250 capsules — — FDA listed —
Sleep Aid 50 mg 69168-0917-40 Allegiant 32 capsules — — FDA listed —
Sleep Aid Maximum Strength 50 mg 69256-0860-32 Harris 32 capsules — — FDA listed —
Nighttime Sleep Aid Maximum Strength 50 mg 69256-0916-32 Harris 32 capsules — — FDA listed —
nighttime sleep-aid 50 mg 69452-0322-79 Bionpharma 160 capsules — — FDA listed —
Nighttime Sleep-Aid 50 mg 69452-0427-10 BIONPHARMA 32 capsules — — FDA listed —
Nighttime Sleep-Aid 50 mg 69452-0451-22 BIONPHARMA 120 capsules — — FDA listed —
Allergy Relief 50 mg 69452-0452-20 BIONPHARMA 100 capsules — — FDA listed —
Nighttime Sleep Aid 50 mg 69607-0916-06 WR 96 capsules — — FDA listed —
Sleep Aid Nighttime 50 mg 69842-0860-32 CVS 32 capsules — — FDA listed —
Sleep Aid Nighttime 50 mg 69842-0916-32 CVS 32 capsules — — FDA listed —
Diphenhydramine Hydrochloride 50 mg 70692-0785-61 Strive 16 capsules — — FDA listed —
RIGHT REMEDIES Maximum Strength Nighttime Sleep-Aid Softgel 50 mg 70692-0834-71 Strive 275 capsules — — FDA listed —
Banophen 50 mg 71335-0081-00 Bryant 12 capsules — — FDA listed —
Diphenhydramine HCl 50 mg 71399-1028-01 Akron 100 capsules — — FDA listed —
SleepAid Softgels 50 mg 72090-0023-01 PIONEER 180 capsules — — FDA listed —
Nighttime Sleep Aid 50 mg 72476-0860-32 Care 32 capsules — — FDA listed —
Nighttime Sleep Aid Maximum Strength 50 mg 72476-0916-32 Care 32 capsules — — FDA listed —
Diphenhydramine HCL 50 mg 72789-0532-20 PD-Rx 20 capsules — — FDA listed —
Pharbedryl 50 mg 73057-0347-08 Ulai 100 capsules — — FDA listed —
Allergy Relief Diphenhydramine HCL 50 MG 73581-0020-10 YYBA 1000 capsules — — FDA listed —
DIPHENHYDRAMINE HYDROCHLORIDE 50mg 50 mg 73629-0001-22 AMZ789 220 capsules — — FDA listed —
TopCare health NIGHTTIME MAXIMUM STRENGTH Sleep Aid 50 mg 76162-0438-96 Topco 96 capsules — — FDA listed —
Nightime Sleep Aid 50 mg 76168-0065-37 Velocity 1 capsule — — FDA listed —
Antihistamine 50 mg 77333-0231-10 Gendose 100 capsules — — FDA listed —
Sleep Aid 50 mg 81522-0916-32 FSA 32 capsules — — FDA listed —
Sleep Aid 50 mg 82442-0530-32 TARGET 32 capsules — — FDA listed —
Nighttime Sleep Aid 50 mg 83059-0028-08 Shield 8 capsules — — Discontinued —
Nighttime Sleep Aid 50 mg 83059-0109-08 Shield 8 capsules — — Discontinued —
SleepAid Softgels 50 mg 84324-0011-01 NUVICARE 100 capsules — — FDA listed —
Nighttime Sleep Aid 50 mg 85828-0410-38 Grocery 32 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

🏛️
2009
On the market since
Jan 2009
📍
2026
Currently FDA-listed
17 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.

📊 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
55154-0661-00 You're viewing this 10 BLISTER PACK in 1 BAG (55154-0661-0) / 1 CAPSULE in 1 BLISTER PACK 2009-01-02 Active

🧭 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 FDA registers it as 55154-0661-0, 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: 55154-0661-00, written without dashes as 55154066100. 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 55154-0661-00, the first segment (55154) is the labeler code FDA assigned to Cardinal Health 107, LLC; the middle segment (0661) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (00) 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 it is currently marketed — but Cardinal Health 107, LLC has reported a marketing end date of 2027-12-31, after which this package is expected to stop being marketed. The directory data on this page refreshes weekly.
Who lists this product with the FDA?
Cardinal Health 107, LLC 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 79 words ▾

Use 25 MG • Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: o runny nose o sneezing o itchy, watery eyes o itchy throat and nose • Temporarily relieves these symptoms due to the common cold: o runny nose o sneezing 50 MG • Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies and common cold o sneezing o runny nose o itchy, watery eyes o itchy throat and nose

⏱️ Dosage and Administration 123 words ▾

Directions • Take every 4-6 hours • Do not take more than 6 doses in 24 hours 25 MG adults and children 12 years of age and over 1 to 2 capsules children 6 years to under 12 years of age 1 capsule children under 6 years of age do not use this product in children under 6 years of age 50 MG adults and children 12 years of age and over 1 capsule children 6 years to under 12 years of age Ask a doctor, the proper dosage strength is not available in this package** **Do not attempt to break capsules. The proper dosage strength and dosing information for children under 12 years of age is available on the 25 mg package.

⚠️ Warnings 43 words ▾

WARNINGS Do not use 25 MG • to make a child sleepy • with any other product containing diphenhydramine, even one used on skin 50 MG • to make a child sleepy • with any other product containing diphenhydramine, including one applied topically

🧪 Active Ingredient 14 words ▾

Active Ingredient (in each banded capsule) Diphenhydramine HCl… 25 mg Diphenhydramine HCl… 50 mg

🧪 Inactive Ingredients 15 words ▾

Inactive Ingredients D&C Red #28, FD&C Blue #1, FD&C Red #40, Gelatin, Lactose and Starch.

🎯 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 ↗
← 55154-0613-00 · Cardinal 55154-0669-00 · 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.