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Diphenhydramine Hydrochloride 50 mg Capsule, 100-count — NDC 00904-2056-61 package photo

Diphenhydramine Hydrochloride 50 mg Capsule, 100-count

by Major Pharmaceuticals · 10 BLISTER PACK in 1 BOX (0904-2056-61) / 10 CAPSULE in 1 BLISTER PACK
NDC 00904-2056-61
🏷️ FDA NDC (as labeled) 0904-2056-61 billing pads the labeler 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) 0904-2056-61
Product NDC 0904-2056
11-digit billing NDC 00904205661
NCPDP billing unit EA — each (per item)
RxCUI 1020477, 1049909, 1092422
UNII TC2D6JAD40
Application # M012
SPL Set ID 04e70311-6412-4a20-84e3-f6e26d5f19ab
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
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 0904-2056-61 — a 4-4-2 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 labeler segment → 00904-2056-61. 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

LabelerMajor Pharmaceuticals
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code00904
First marketedJan 2009
Product typeHuman Otc Drug
Portfolio629 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 →

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;835
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 EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 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 eaPer package
Retail pharmacies payNADAC · weekly $0.031 $3.13 / 100 capsules
Medicaid paysCMS SDUD · 12 mo $2.00 $199.50 / 100 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 Jul 2022 Feb 2024 Aug 2026 $0.032 $0.019
▲ Up 48% over the last 22 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 mg 42806-0649-10 Epic 1000 capsules $0.020 — FDA listed save 35%
Diphenhydramine Hydrochloride 50 mgthis 00904-2056-61 Major 100 capsules $0.031 — Availability likely —
Banophen 50 mg 00904-5307-60 Major 100 capsules $0.031 — Discontinued —
Dimetane 50 mg 57237-0368-01 Rising 100 capsules $0.031 — Availability likely —
Diphenhydramine HCl 50 mg 82568-0005-01 AARNA 100 capsules $0.031 — Availability likely —
Nighttime Sleep Aid Maximum Strength 50 mg 62011-0416-01 Strategic 32 capsules $0.095 — Discontinued +204%
Nighttime Sleep Aid maximum strength 50 mg 70000-0527-01 Cardinal 32 capsules $0.104 — Availability likely +234%
Nighttime Sleep-Aid 50 mg 46122-0775-64 AMERISOURCE 60 capsules $0.117 — Availability likely +274%
Nighttime Sleep Aid 50 mg 70000-0616-01 Cardinal 100 capsules $0.117 — Availability likely +274%
Sleep Aid 50 mg 70677-1151-01 Strategic 32 capsules $0.117 — Availability likely +274%
Sleep Aid 50 mg 83324-0151-32 QUALITY 32 capsules $0.117 — Availability likely +274%
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

🏛️
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.

🗺️ 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 00904-2056-61, 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
12.2K
Units reimbursed last 4 qtrs
345.2K
Gross reimbursed last 4 qtrs
$688.8K
Avg / prescription
$56.37
Avg / unit
$1.9950
Latest quarter Q4 2025
2.4KRx
Medicaid pays / ea
$1.9950
gross reimbursed
vs
NADAC / ea
$0.0313
acquisition cost
=
Spread
+$1.9637
+6274% 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 ⓘ
59% FFS 41% MCO
Fee-for-service · 7,247 Rx Managed care · 4,972 Rx
State Medicaid map
Alaska: no data reported AK Maine: 3,030 units · 217 per 100k residents ME Washington: 2,177 units · 27.9 per 100k residents WA Idaho: no data reported ID Montana: 13 units · 1.1 per 100k residents MT North Dakota: no data reported ND Minnesota: 1,262 units · 22.0 per 100k residents MN Wisconsin: 2,403 units · 40.7 per 100k residents WI Michigan: 17,210 units · 171 per 100k residents MI New York: 132,224 units · 676 per 100k residents NY Vermont: no data reported VT New Hampshire: 287 units · 20.5 per 100k residents NH Oregon: 454 units · 10.7 per 100k residents OR Nevada: 1,326 units · 41.5 per 100k residents NV Wyoming: no data reported WY South Dakota: 107 units · 11.6 per 100k residents SD Iowa: no data reported IA Illinois: 722 units · 5.8 per 100k residents IL Indiana: 754 units · 11.0 per 100k residents IN Ohio: 5,941 units · 50.4 per 100k residents OH Pennsylvania: 36,576 units · 282 per 100k residents PA New Jersey: 4,352 units · 46.8 per 100k residents NJ Massachusetts: 7,590 units · 108 per 100k residents MA California: 84,231 units · 216 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: 2,734 units · 138 per 100k residents NE Missouri: no data reported MO Kentucky: 3,650 units · 80.6 per 100k residents KY West Virginia: 1,090 units · 61.6 per 100k residents WV Virginia: 3,994 units · 45.8 per 100k residents VA Maryland: 4,161 units · 67.3 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: 5,363 units · 72.2 per 100k residents AZ New Mexico: no data reported NM Kansas: 379 units · 12.9 per 100k residents KS Arkansas: no data reported AR Tennessee: 16 units · 0.2 per 100k residents TN North Carolina: 103 units · 1.0 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 13,865 units · 303 per 100k residents LA Mississippi: 146 units · 5.0 per 100k residents MS Alabama: no data reported AL Georgia: 4,996 units · 45.3 per 100k residents GA D.C.: 2,156 units · 318 per 100k residents DC Hawaii: 1,651 units · 115 per 100k residents HI Texas: 20 units · 0.1 per 100k residents TX Florida: 263 units · 1.2 per 100k residents FL
Units reimbursed · per 100k residents
0.1676
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 676 /100k
2 D.C. 318 /100k
3 Louisiana 303 /100k
4 Pennsylvania 282 /100k
5 Maine 217 /100k
6 California 216 /100k
7 Michigan 171 /100k
8 Nebraska 138 /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
00904-2056-61 You're viewing this 10 BLISTER PACK in 1 BOX (0904-2056-61) / 10 CAPSULE in 1 BLISTER PACK 2009-01-02 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 ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 66 words ▾

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

⏱️ Dosage and Administration 121 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 39 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 ↗
← 00904-2051-59 · Major 00904-2500-91 · Major →
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.