HomeNDC LookupIngredientsDiphenhydramine Hcl 25Mg › 73057-0348-11
Allergy Relief 25 mg Diphenhydramine HCl 25mg 25 mg Capsule, 1,000-count — NDC 73057-0348-11 package photo

Allergy Relief 25 mg Diphenhydramine HCl 25mg 25 mg Capsule, 1,000-count

by Ulai Health LLC · 1000 CAPSULE in 1 BOTTLE, PLASTIC (73057-348-11)
NDC 73057-0348-11
🏷️ FDA NDC (as labeled) 73057-348-11 billing pads the product segment with a zero
This package
Contains1,000-count Pack sizes3 compare ↓
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) 73057-348-11
Product NDC 73057-348
11-digit billing NDC 73057034811
RxCUI 1049909
UNII TC2D6JAD40
UPC 0373057348082
Application # M010
SPL Set ID 751f13d4-c4d6-47a5-b40d-1563de08c048
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 2019-07-01
Route ORAL
Dosage form CAPSULE
Substance DIPHENHYDRAMINE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 73057-348-11 — 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 → 73057-0348-11. 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

LabelerUlai Health LLC
FDA applicationM010 (OTC MONOGRAPH DRUG)
Labeler code73057
First marketedJul 2019
Product typeHuman Otc Drug
Portfolio18 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 →
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.

💡 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 XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • 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 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 ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and 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.

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

The official label also statesblack iron oxide, D&C red #28, FD&C blue #1, FD&C red #40, gelatin, lactose monohydrate, magnesium stearate, silicon dioxide, 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 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.
Try another pack size: 24 capsules 100 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.

🔁 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 mgthis 73057-0348-11 Ulai 1000 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
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

🏛️
2019
On the market since
Jul 2019
📍
2026
Currently FDA-listed
7 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

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

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

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Allergy Relief 25 mg (this brand).

Top reported reactions

Rash1
Skin Fissures1
Urticaria1

Reporter sex

2 reports
Female · 100%
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 1 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
73057-0348-03 24 CAPSULE in 1 BOTTLE, PLASTIC (73057-348-03) 2019-07-01 Active
73057-0348-08 100 CAPSULE in 1 BOTTLE, PLASTIC (73057-348-08) 2019-07-01 Active
73057-0348-11 You're viewing this 1000 CAPSULE in 1 BOTTLE, PLASTIC (73057-348-11) 2019-07-01 Active

You're viewing the largest of 3 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 73057-0348-11?
NDC 73057-0348-11 is a 1,000-count package — 1000 capsule in 1 bottle, plastic.
What is the difference between NDC 73057-0348-11 and NDC 73057-0348-03?
Both are Allergy Relief 25 mg Diphenhydramine HCl 25mg 25 mg Capsule — the drug itself is identical. NDC 73057-0348-11 is the 1,000-count package, while NDC 73057-0348-03 is the 24 capsules package.
What NDC number is used to bill for this package of Allergy Relief 25 mg Diphenhydramine HCl 25mg 25 mg Capsule?
Bill NDC 73057-0348-11 — the 11-digit billing format is 73057034811. 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
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 73057-348-11, 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: 73057-0348-11, written without dashes as 73057034811. 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 73057-0348-11, the first segment (73057) is the labeler code FDA assigned to Ulai Health LLC; the middle segment (0348) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (11) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Ulai Health LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 24 capsules (73057-0348-03), 100 capsules (73057-0348-08). 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?
Ulai Health 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 38 words

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat temporarily relieves these symptoms due to the common cold: runny nose sneezing

⏱️ Dosage and Administration 47 words

Directions take every 4 to 6 hours, or as directed by a doctor do not exceed 6 doses in 24 hours adults and children 12 years and over 1 to 2 capsules children 6 to under 12 years 1 capsule children under 6 years ask a doctor

⚠️ Warnings 1 words

Warnings

📦 Storage and Handling 10 words

Other information store at 20-25 o C (68-77 o F)

🧪 Active Ingredient 10 words

Active ingredient (in each banded capsule) Diphenhydramine HCl 25 mg

🧪 Inactive Ingredients 24 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 ↗
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.