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Diphenhydramine Hydrochloride 50 mg Capsule, 1,000-count — NDC 17714-0021-10 package photo

Diphenhydramine Hydrochloride 50 mg Capsule, 1,000-count

by Advance Pharmaceutical Inc. · 1000 CAPSULE in 1 BOTTLE (17714-021-10)
NDC 17714-0021-10
🏷️ FDA NDC (as labeled) 17714-021-10 billing pads the product segment with a zero
This package
Contains1,000-count Pack sizes2 compare ↓
Also comes in: 100 capsules 17714-0021-01
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) 17714-021-10
Product NDC 17714-021
11-digit billing NDC 17714002110
RxCUI 1020477
UNII TC2D6JAD40
UPC 0017714021108, 0017714021016
Application # part341
SPL Set ID e1275cf5-94a7-4a15-be5c-81af95f8dd24
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 1989-10-05
Route ORAL
Dosage form CAPSULE
Substance DIPHENHYDRAMINE HYDROCHLORIDE
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 CAP
FDB brand name Diphenhydramine Hcl
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 17714-021-10 — 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 → 17714-0021-10. 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

LabelerAdvance Pharmaceutical Inc.
FDA applicationpart341 (OTC MONOGRAPH FINAL)
Labeler code17714
First marketedOct 1989
Product typeHuman Otc Drug
Portfolio24 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 CAP Ingredient Diphenhydramine Hcl
📗 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
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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · Q0163 No ASP payment limit on file for Q0163 this quarter.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 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.

🧾 Billing & reimbursement

FDA NDC (as labeled)17714-021-10
11-digit billing NDC17714-0021-10
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeQ0163
DescriptorDIPHENHYDRAMINE HYDROCHLORIDE, 50 MG, ORAL, FDA APPROVED PRESCRIPTION ANTI-EMETIC, FOR USE AS A COMPLETE THERAPEUTIC SUBSTITUTE FOR AN IV ANTI-EMETIC AT TIME OF CHEMOTHERAPY TREATMENT NOT TO EXCEED A 48 HOUR DOSAGE REGIMEN
Billing units / pkg1 units
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Diphenhydramine Hydrochloride 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 —
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 mgthis 17714-0021-10 Advance 1000 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

🏛️
1989
On the market since
Oct 1989
📍
2026
Currently FDA-listed
37 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 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
17714-0021-01 100 CAPSULE in 1 BOTTLE (17714-021-01) 1989-10-05 Active
17714-0021-10 You're viewing this 1000 CAPSULE in 1 BOTTLE (17714-021-10) 1989-10-05 Active

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 17714-0021-10?
NDC 17714-0021-10 is a 1,000-count package — 1000 capsule in 1 bottle.
What is the difference between NDC 17714-0021-10 and NDC 17714-0021-01?
Both are Diphenhydramine Hydrochloride 50 mg Capsule — the drug itself is identical. NDC 17714-0021-10 is the 1,000-count package, while NDC 17714-0021-01 is the 100 capsules package.
What NDC number is used to bill for this package of Diphenhydramine Hydrochloride 50 mg Capsule?
Bill NDC 17714-0021-10 — the 11-digit billing format is 17714002110. 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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Final". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
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 17714-021-10, 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: 17714-0021-10, written without dashes as 17714002110. 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 17714-0021-10, the first segment (17714) is the labeler code FDA assigned to Advance Pharmaceutical Inc.; the middle segment (0021) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (10) 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 Advance Pharmaceutical Inc.. 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 1 other package presentation of this same product, including 100 capsules (17714-0021-01). 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?
Advance Pharmaceutical Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 23 words ▾

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

⏱️ Dosage and Administration 29 words ▾

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

⚠️ Warnings 100 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 tranquilizers When using this product you may get very drowsy avoid alcoholic drinks alcohol, sedatives & 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 bule #1, FD&C red# 40, gelatin, lactose, magnesium stearate, methylparaben, polysorbate 80, propylparaben, sodium laurel 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 ↗
← 17714-0020-01 · Advance 17714-0023-50 · Advance →
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.