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Diphenhydramine HCL 25 mg Tablet, Coated, 50,000-count

by TCB USA Corporation · 50000 TABLET, COATED in 1 BOX (62485-047-05)
NDC 62485-0047-05
🏷️ FDA NDC (as labeled) 62485-047-05 billing pads the product segment with a zero
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) 62485-047-05
Product NDC 62485-047
11-digit billing NDC 62485004705
SPL Set ID a60db032-4e17-42db-b819-869edf0cb98b
DEA schedule Non-controlled
Marketing category DRUG FOR FURTHER PROCESSING
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-05-12
Dosage form TABLET, COATED
Substance DIPHENHYDRAMINE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 62485-047-05 — 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 → 62485-0047-05. 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.

🏭 Manufacturer & labeler

LabelerTCB USA Corporation
Labeler code62485
First marketedMay 2018
Product typeDrug For Further Processing
Portfolio29 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

📗 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.

🧪 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.

We could not link this NDC to a current FDA Structured Product Label. An inactive-ingredient list is therefore not available from this source.
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.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Allergy Relief 25 mg 70677-1014-01 Strategic 12 tablets $0.037 — Availability likely —
Banophen 25 mg 00904-5551-24 Major 12 tablets $0.037 — Availability likely —
Allergy Relief 25 mg 70000-0136-01 Cardinal 12 tablets $0.037 — Availability likely —
Diphenhydramine HCl 25 mg 00536-1214-29 Rugby 100 tablets $0.037 — Availability likely —
Allergy Relief 25 mg 46122-0441-62 Amerisource 12 tablets $0.037 — Availability likely —
Sleep Tabs 25 mg 00904-4274-51 Major 50 tablets $0.060 — Availability likely —
Nighttime Sleep Aid 25 mg 70677-1128-01 Strategic 12 tablets $0.060 — Availability likely —
Sleep Aid 25 mg 46122-0651-62 Amerisource 12 tablets $0.060 — Availability likely —
Sleep Aid 25 mg 70000-0244-01 Cardinal 12 tablets $0.066 — FDA listed —
Allergy 25 mg 69168-0048-01 Allegiant 100 tablets — — FDA listed —
Banophen 25 mg 71205-0611-20 Proficient 20 tablets — — FDA listed —
Geri-Dryl allergy relief 25 mg 83939-0683-01 VerityRx 1 tablet — — FDA listed —
Diphenhydramine HCL 25 mgthis 62485-0047-05 TCB 50000 tablets — — FDA listed —
Sleep Aid Nighttime 25 mg 51316-0367-12 CVS 100 tablets — — FDA listed —
Sleep Aid Nighttime 25 mg 55319-0367-08 Family 12 tablets — — FDA listed —
Allergy Relief Complete 25 mg 67091-0200-10 WinCo 100 tablets — — FDA listed —
Allergy Relief 25 mg 79903-0491-10 Walmart 100 tablets — — FDA listed —
Allergy Relief 25 mg 11822-0329-01 Rite 365 tablets — — FDA listed —
Allergy Relief 25 mg 21130-0329-06 Better 200 tablets — — Discontinued —
Sleep Aid 25 mg 36800-0672-06 Topco 200 tablets — — FDA listed —
Medique at Home Diphen 25 mg 47682-0166-50 Unifirst 1 tablet — — FDA listed —
Banophen 25 mg 50090-5546-00 A-S 12 tablets — — FDA listed —
Allergy Relief 25 mg 50844-0329-02 L.N.K. 12 tablets — — FDA listed —
Allergy Relief 25 mg 55910-0329-51 DOLGENCORP, 365 tablets — — FDA listed —
Geri-Dryl allergy relief 25 mg 57896-0683-01 Geri-Care 100 tablets — — FDA listed —
Allergy Relief Dye-Free 25 mg 59779-0614-06 CVS 200 tablets — — FDA listed —
Sleep Aid 25 mg 00363-6720-12 Walgreen 100 tablets — — FDA listed —
Allergy Relief 25 mg 69517-0003-01 HealthLife 100 tablets — — Discontinued —
Nighttime Sleep Aid 25 mg 69517-0004-03 HealthLife 300 tablets — — Discontinued —
Night Time Sleep-Aid 25 mg 80513-0383-22 Advanced 220 tablets — — FDA listed —
Geri-Dryl allergy relief 25 mg 85766-0092-01 Sportpharm 100 tablets — — FDA listed —
Allergy Relief 25 mg 87509-0001-06 Famora 650 tablets — — FDA listed —
Diphenhydramine HCL 25 mg 62485-0011-10 TCB 100000 tablets — — FDA listed —
Diphenhydramine HCL 25 mg 62485-0026-05 TCB 50000 tablets — — FDA listed —
Allergy Relief 25 mg 50844-0229-08 L.N.K. 12 tablets — — FDA listed —
Allergy Medicine 25 mg 63981-0329-78 COSTCO 600 tablets — — FDA listed —
Allergy Relief 25 mg 69452-0444-31 BIONPHARMA 600 tablets — — FDA listed —
Sleep Aid 25 mg 11822-3670-02 Rite 100 tablets — — FDA listed —
Sleep 25 mg 57243-0189-21 Salado 16 tablets — — FDA listed —
Nighttime Sleep-aid 25 mg 57896-0785-72 Geri-Care 72 tablets — — FDA listed —
Allergy Relief 25 mg 00363-3291-08 Walgreen 12 tablets — — FDA listed —
Sleep Aid Night Time 25 mg 55910-0687-08 DOLGENCORP, 12 tablets — — FDA listed —
Allergy 25 mg 56062-0923-08 Publix 12 tablets — — FDA listed —
Diphenhydramine HCL 25 mg 69618-0025-01 Reliable 100 tablets — — FDA listed —
Allergy Relief 25 mg 71141-0177-32 Lidl 100 tablets — — FDA listed —
Banophen 25 mg 83112-0555-59 Health 1 tablet — — FDA listed —
Allergy Relief 25 mg 11673-0494-01 TARGET 100 tablets — — FDA listed —
Allergy Relief 25 mg 21130-0596-01 BETTER 100 tablets — — FDA listed —
Sleep Aid Nighttime 25 mg 49035-0367-08 Wal-Mart 12 tablets — — FDA listed —
Nytol 25 mg 63029-0211-01 Medtech 32 tablets — — FDA listed —
Nighttime Sleep Aid 25 mg 67091-0115-10 WinCo 100 tablets — — FDA listed —
Sleep Aid Nighttime 25 mg 00363-0367-08 Walgreen 12 tablets — — FDA listed —
Diphenhydramine HCL 25 mg 62485-0025-05 TCB 50000 tablets — — FDA listed —
Sleep Aid Nighttime 25 mg 21130-0763-06 Better 200 tablets — — FDA listed —
Allergy Relief 25 mg 37808-0932-08 H 12 tablets — — FDA listed —
Allergy Relief 25 mg 41163-0329-08 United 12 tablets — — FDA listed —
Sleep Aid 25 mg 55910-0614-12 DOLGENCORP, 100 tablets — — FDA listed —
Nighttime Sleep-aid 25 mg 80136-0785-96 NORTHEAST 96 tablets — — FDA listed —
Nighttime Sleep Aid 25 mg 41163-0367-06 United 200 tablets — — FDA listed —
allergy relief 25 mg 41250-0614-12 Meijer 100 tablets — — FDA listed —
Sleep Aid NightTime 25 mg 49035-0672-51 Wal-Mart 365 tablets — — FDA listed —
Allergy Relief 25 mg 49035-0929-12 Wal-Mart 100 tablets — — FDA listed —
Allergy Relief 25 mg 55301-0329-12 ARMY 100 tablets — — FDA listed —
Allergy Relief 25 mg 55910-0293-08 DOLGENCORP, 12 tablets — — FDA listed —
Nighttime Sleep Aid 25 mg 59779-0367-08 CVS 12 tablets — — Discontinued —
Sleep II Nighttime Sleep Aid 25 mg 00363-0189-46 Walgreen 96 tablets — — FDA listed —
Sleep-Aid Nighttime 25 mg 69842-0672-51 CVS 365 tablets — — FDA listed —
Nighttime Sleep Aid 25 mg 37835-0812-36 Bi-Mart 36 tablets — — FDA listed —
Sleep-Aid 25 mg 55301-0189-23 ARMY 72 tablets — — FDA listed —
Allergy Relief 25 mg 55319-0329-02 Family 12 tablets — — FDA listed —
Aller-Ben 25 mg 68196-0829-78 Sam's 600 tablets — — Discontinued —
Geri-Dryl allergy relief 25 mg 68788-8104-00 Preferred 10 tablets — — FDA listed —
Allergy Relief 25 mg 80513-0722-06 Advanced 600 tablets — — FDA listed —
sleep aid 25 mg 11822-0672-06 Rite 200 tablets — — FDA listed —
Sleep Aid Night Time 25 mg 55910-0772-51 DOLGENCORP, 365 tablets — — FDA listed —
Allergy Relief 25 mg 59779-0923-03 CVS 10 tablets — — FDA listed —
Sleep Aid 25 mg 67091-0339-24 WinCo 12 tablets — — FDA listed —
Allergy Relief 25 mg 00363-6141-12 Walgreen 100 tablets — — 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

🏛️
2018
On the market since
May 2018
📍
2026
Currently FDA-listed
8 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

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

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

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Diphenhydramine HCl (matched by generic name) — the program that covers self-administered drugs. 8 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Diphenhydramine HCl. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$374.3K
Claims incl. refills
20.3K
Beneficiaries
11.2K
Spend / beneficiary
$33.36
Spend / claim
$18.44
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Diphenhydramine HCl — the ingredient across all brands.

Top reported reactions

Fatigue1,233
Nausea1,116
Pain989
Headache968
Dyspnoea918
Diarrhoea863
Completed Suicide800

Age at onset

Neonate7
Infant4
Child26
Adolescent25
Adult653
Elderly520

Reporter sex

19,270 reports
Male · 37%
Female · 63%
Unknown · 1%

Serious outcomes

Hospitalization5,416
Death3,648
Life-threatening970
Disabling602
Reports over time (by year) — tap or hover for the count & year
2024 2025 2026 650 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
62485-0047-05 You're viewing this 50000 TABLET, COATED in 1 BOX (62485-047-05) — Active

🧭 About this NDC listing & data coverage

Listed for further processing / repackaging

What "drug for further processing" means

FDA lists this package under the "drug for further processing" marketing category: TCB USA Corporation supplies it to other companies for further processing or repackaging (blister cards that are later repackaged or co-packaged are a common example). The units themselves are a finished dosage form — which is why pricing or Medicaid data can still appear — but this exact package code may not be the presentation a retail pharmacy dispenses.

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 — Not published for this NDC No photo available yet for this listing.
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 — 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 "Drug For Further Processing". 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 62485-047-05, 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: 62485-0047-05, written without dashes as 62485004705. 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 62485-0047-05, the first segment (62485) is the labeler code FDA assigned to TCB USA Corporation; the middle segment (0047) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (05) 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 TCB USA Corporation. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
TCB USA Corporation 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.
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.

📄 Full FDA label FDA SPL

The complete FDA label for this product, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
📄 FDA label
📄 FDA label 19 words ▾

No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 62485-0046-05 · TCB 62485-0048-05 · TCB →
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.