meijer NIGHTTIME Sleep Aid SOFTGEL Diphenhydramine hydrochloride 25 mg Capsule, Liquid Filled — NDC 79481-0779-04 package photo

meijer NIGHTTIME Sleep Aid SOFTGEL Diphenhydramine hydrochloride 25 mg Capsule, Liquid Filled

by Meijer, Inc. · 2 BLISTER PACK in 1 CARTON (79481-0779-4) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
NDC 79481-0779-04
🏷️ FDA NDC (as labeled) 79481-0779-4 billing pads the package segment with a zero
This package
Contains12 capsule, liquid filled in 1 blister pack Pack sizes2 compare ↓
Also comes in: 12 capsules 79481-0779-08
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) 79481-0779-4
Product NDC 79481-0779
11-digit billing NDC 79481077904
RxCUI 1049909
UNII TC2D6JAD40
Application # M010
SPL Set ID 1bede4cd-bf55-8b84-e063-6394a90aa5c9
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 2024-06-27
Route ORAL
Dosage form CAPSULE, LIQUID FILLED
Substance DIPHENHYDRAMINE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 79481-0779-4 — a 5-4-1 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 package segment → 79481-0779-04. 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

LabelerMeijer, Inc.
FDA applicationM010 (OTC MONOGRAPH DRUG)
Labeler code79481
First marketedJun 2024
Product typeHuman Otc Drug
Portfolio200 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 →
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.

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 mLPer 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: 12 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 mg 73057-0348-03 Ulai 24 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 mgthis 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
Nighttime Sleep Aid 25 mg 00363-1174-24 WALGREEN 12 capsules FDA listed
Sleep Aid 25 mg 83059-0075-08 Shield 8 capsules FDA listed
Allergy Relief 25 mg 70000-0771-01 CARDINAL 100 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

🏛️
2024
On the market since
Jun 2024
📍
2026
Currently FDA-listed
2 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 meijer NIGHTTIME Sleep Aid SOFTGEL (this brand).

Top reported reactions

Fatigue3,537
Headache3,168
Pain3,157
Infusion Related Reaction2,800
Nausea2,742
Arthralgia2,738
Nasopharyngitis2,435

Age at onset

Neonate40
Infant16
Child154
Adolescent239
Adult3,235
Elderly1,301

Reporter sex

21,242 reports
Male · 29%
Female · 71%
Unknown · 0%

Serious outcomes

Hospitalization7,634
Death3,664
Life-threatening1,232
Disabling828
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 3,442 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
79481-0779-04 You're viewing this 2 BLISTER PACK in 1 CARTON (79481-0779-4) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 2024-06-27 Active
79481-0779-08 4 BLISTER PACK in 1 CARTON (79481-0779-8) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 2025-03-10 Active

Pack size FAQ

What quantity is in NDC 79481-0779-04?
NDC 79481-0779-04 is listed by the FDA — 2 blister pack in 1 carton / 12 capsule, liquid filled in 1 blister pack.
What NDC number is used to bill for this package of meijer NIGHTTIME Sleep Aid SOFTGEL Diphenhydramine hydrochloride 25 mg Capsule, Liquid Filled?
Bill NDC 79481-0779-04 — the 11-digit billing format is 79481077904. 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 — 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 79481-0779-4, 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: 79481-0779-04, written without dashes as 79481077904. 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 79481-0779-04, the first segment (79481) is the labeler code FDA assigned to Meijer, Inc.; the middle segment (0779) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) 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 Meijer, 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 12 capsules (79481-0779-08). 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?
Meijer, 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 19 words

Uses • for relief of occasional sleeplessness • reduces time to fall asleep if you have difficulty falling asleep

⏱️ Dosage and Administration 39 words

Directions • take only one dose (2 softgels) per day (24 hours) adults and children 12 years and over take 2 softgels at bedtime if needed or as directed by a doctor children under 12 years do not use

⚠️ Warnings 195 words

Warnings Do not use • for children under 12 years of age • with any other product containing diphenhydramine, even one used on skin • with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products Ask a doctor before use if you have • glaucoma • heart diseases • a breathing problem such as emphysema, asthma, or chronic bronchitis • difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are taking sedatives, tranquilizers, or any other sleep aid When using this product • avoid alcoholic beverages and other drugs that cause drowsiness.

Be careful when driving a motor vehicle or operating machinery. Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.

If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away.

Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

📦 Storage and Handling 17 words

Other information • store at room temperature between 20°-25°C (68°-77°F) • protect from light, heat and moisture

🧪 Active Ingredient 9 words

Active ingredient (in each softgel) Diphenhydramine HCl 25 mg

🧪 Inactive Ingredients 28 words

Inactive ingredients edible white ink, FD&C blue no.1, FD&C red no.40, gelatin(bovine), glycerin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol 400, povidone K-30, purified water, sorbitol sorbitan solution

🎯 Purpose 3 words

Purpose Nighttime sleep-aid

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.