Diphenhydramine Hydrochloride 50 mg Capsule, 1,000-count — NDC 42806-0649-10 package photo

Diphenhydramine Hydrochloride 50 mg Capsule, 1,000-count

by Epic Pharma, LLC · 1000 CAPSULE in 1 BOTTLE (42806-649-10)
NDC 42806-0649-10
🏷️ FDA NDC (as labeled) 42806-649-10 billing pads the product 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 →

🆔 Identity & classification

FDA NDC (as labeled) 42806-649-10
Product NDC 42806-649
11-digit billing NDC 42806064910
NCPDP billing unit EA — each (per item)
RxCUI 1020477
UNII TC2D6JAD40
Application # part341
SPL Set ID 15437a72-24e5-4ef2-b1ea-8d8c0acbcd4c
Established class (EPC) Histamine-1 Receptor Antagonist
Mechanism of action Histamine H1 Receptor Antagonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH FINAL
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-11-22
Route ORAL
Dosage form CAPSULE
Substance DIPHENHYDRAMINE HYDROCHLORIDE
GPI-14 41200030100110
GPI class diphenhydrAMINE HCl
GCN Seq No 011583
GCN 45972
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 50 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 42806-649-10 — 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 → 42806-0649-10. 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

LabelerEpic Pharma, LLC
FDA applicationpart341 (OTC MONOGRAPH FINAL)
Labeler code42806
First marketedNov 2016
Product typeHuman Otc Drug
Portfolio171 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 50 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 →
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
ImprintAP;021
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 LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • 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 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 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.

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

The official label also statesbenzyl alcohol, butylparaben, D&C red #28, edible black ink, FD&C blue #1, FD&C red #40, gelatin, lactose, magnesium stearate, methylparaben, polysorbate 80, propylparaben, sodium lauryl sulfate

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMedingredient 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 eaPer package
Retail pharmacies payNADAC · weekly $0.020 $20.20 / 1000 capsules
Medicaid paysCMS SDUD · 12 mo $0.2426 $242.60 / 1000 capsules
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Mar 2022 Jul 2022 Nov 2022 $0.026 $0.019
▼ Down 4% over the last 12 months.
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 mgthis 42806-0649-10 Epic 1000 capsules $0.020 FDA listed
Diphenhydramine Hydrochloride 50 mg 00904-2056-61 Major 100 capsules $0.031 Availability likely +55%
Banophen 50 mg 00904-5307-60 Major 100 capsules $0.031 Discontinued +55%
Dimetane 50 mg 57237-0368-01 Rising 100 capsules $0.031 Availability likely +55%
Diphenhydramine HCl 50 mg 82568-0005-01 AARNA 100 capsules $0.031 Availability likely +55%
Nighttime Sleep Aid Maximum Strength 50 mg 62011-0416-01 Strategic 32 capsules $0.095 Discontinued +372%
Nighttime Sleep Aid maximum strength 50 mg 70000-0527-01 Cardinal 32 capsules $0.104 Availability likely +417%
Nighttime Sleep-Aid 50 mg 46122-0775-64 AMERISOURCE 60 capsules $0.117 Availability likely +480%
Nighttime Sleep Aid 50 mg 70000-0616-01 Cardinal 100 capsules $0.117 Availability likely +480%
Sleep Aid 50 mg 70677-1151-01 Strategic 32 capsules $0.117 Availability likely +480%
Sleep Aid 50 mg 83324-0151-32 QUALITY 32 capsules $0.117 Availability likely +480%
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 mg 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
Sleep Aid Nighttime 50 mg 36800-0784-96 TOPCO 96 capsules FDA listed
Nighttime Sleep Aid 50 mg 83059-0073-08 Shield 8 capsules FDA listed
HyVee Maximum Strength Nighttime Sleep-Aid SOFTGEL 50 mg 42507-0834-32 HyVee 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

🏛️
2016
On the market since
Nov 2016
📍
2026
Currently FDA-listed
10 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 42806-0649-10, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
1.6K
Units reimbursed last 4 qtrs
58.1K
Gross reimbursed last 4 qtrs
$14.1K
Avg / prescription
$8.94
Avg / unit
$0.2426
Latest quarter Q4 2025
393Rx
Medicaid pays / ea
$0.2426
gross reimbursed
vs
NADAC / ea
$0.0202
acquisition cost
=
Spread
+$0.2224
+1101% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
95% FFS
Fee-for-service · 1,493 Rx Managed care · 85 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: 4,450 units · 44.3 per 100k residents MI New York: 53,681 units · 274 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
44.3274
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New York 274 /100k
2 Michigan 44.3 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

🔬 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
42806-0649-10 You're viewing this 1000 CAPSULE in 1 BOTTLE (42806-649-10) 2016-11-22 Active

📄 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 23 words

USES temporarily relieves these symptoms of hay fever or other upper respiratory allergies: runny nose sneezing itchy nose or throat itchy, watery eyes

⏱️ Dosage and Administration 29 words

DIRECTIONS adults & children 12 years and over: take 1 capsule every 4-6 hours; not more than 6 does in 24 hours ​children under 12 years: ask a doctor

⚠️ Warnings 105 words

WARNINGS ​Do not use ​ with any other product containing diphenhydramine, even one used on skin ​Ask a doctor before use if you have ​ glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis ​Ask a doctor or pharmacist before use if you are ​ taking sedatives or tranqulizers ​When using this product ​you may get very drowsy 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. ​

🧪 Active Ingredient 9 words

ACTIVE INGREDIENT (IN EACH CAPSULE) Diphenhydramine HCl 50 mg

🧪 Inactive Ingredients 28 words

INACTIVE INGREDIENTS benzyl alcohol, butylparaben, D&C red #28, edible black ink, FD&C blue #1, FD&C red #40, gelatin, lactose, magnesium stearate, methylparaben, polysorbate 80, propylparaben, 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 ↗
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.