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Good Sense Sleep Time Diphenhydramine HCl 50 mg/30mL Solution, 177 mL — NDC 00113-0186-30 package photo

Good Sense Sleep Time Diphenhydramine HCl 50 mg/30mL Solution, 177 mL

by L. Perrigo Company · 177 mL in 1 BOTTLE (0113-0186-30)
NDC 00113-0186-30
🏷️ FDA NDC (as labeled) 0113-0186-30 billing pads the labeler segment with a zero
This package
Contains177 mL Cost per mL$0.0126 NADAC Per package$2.23 / 177 ml Pack sizes2 compare ↓
Also comes in: 355 ml 00113-0186-40
OTC Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ 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 →
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 0113-0186-30
Product NDC 0113-0186
11-digit billing NDC 00113018630
NCPDP billing unit ML — per mL (volume)
RxCUI 1248354
UNII TC2D6JAD40
Application # M010
SPL Set ID 164200a9-b1f8-44c9-8598-a7dff5020e9d
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 Discontinued
FDA listing status Discontinued by firm
Marketing start 2013-07-02
Route ORAL
Dosage form SOLUTION
Substance DIPHENHYDRAMINE HYDROCHLORIDE
GPI-14 60300020100940
GPI class GoodSense SleepTime
GCN Seq No 069285
GCN 32277
HICL code 004480
Ingredient (HICL) Diphenhydramine Hcl
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H2
Therapeutic class — intermediate (HIC2) Psychoactive Drugs
HIC3 code H2E
Therapeutic class — specific (HIC3) Sedative-Hypnotics,Non-Barbiturate
AHFS code 04:04.00.00
AHFS class First Generation Antihistamines
FDB label name GS SLEEP TIME 50 MG/30 ML LIQ
FDB brand name Sleep Time
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 0113-0186-30 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00113-0186-30. 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

LabelerL. Perrigo Company
FDA applicationM010 (OTC MONOGRAPH DRUG)
Labeler code00113
First marketedJul 2013
Product typeHuman Otc Drug
Portfolio228 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 GS SLEEP TIME 50 MG/30 ML LIQ Ingredient Diphenhydramine Hcl
📖 What it is MedlinePlus · NLM

Diphenhydramine is used to treat allergy and cold symptoms: sneezing runny nose red, itchy, watery eyes itching of the nose or throat Diphenhydramine is also used to treat insomnia (difficulty falling asleep or staying asleep) in adults, but should not be used to make a child sleepy. Diphenhydramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms. Diphenhydramine is also available in combination with other medications. This monograph only includes information about the use of diphenh...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Diphenhydramine is mainly used to temporarily ease the stuffy, sneezy, itchy symptoms of allergies — like hay fever — and the common cold. Think runny nose, sneezing, watery or itc...
  • What exactly does diphenhydramine treat?
  • Yes, and that's one of the most important things to know about this medicine. Drowsiness is one of its most common effects — it crosses into the brain and that's what causes the se...
  • It depends on your child's age and the product. Most oral diphenhydramine products are not recommended for children under 6, and liquid products labeled for children are generally...
📖 Read our full Diphenhydramine guide →
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 Purple
FlavorBerry
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 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • 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 XY6UN3QB6S
    A sweetener made from corn starch that contains fructose and glucose. It sweetens the medicine to improve taste and may help preserve the product.
  • UNII TUF2IVW3M2
    Poloxamer 407 is a synthetic polymer made from ethylene oxide and propylene oxide. In medicines, it acts as a thickener, emulsifier, and solubilizer to help mix ingredients and create the right texture.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII SB8ZUX40TY
    Saccharin sodium is an artificial sweetener made from saccharin salt. It's added to medicines to improve taste, especially in liquid formulations for children or bitter drugs.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

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

The official label also statesalcohol, anhydrous citric acid, FD&C blue #1, FD&C red #40, flavor, high fructose corn syrup, poloxamer 407, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

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

💲 Pricing

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

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly $0.013 $2.23 / 177 ml
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.
NADAC price history (per mL) — tap or hover for the price & month
Jun 2023 $0.013 $0.013
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
Sleep Aid 50 mg/30mL 46122-0754-29 Amerisource 355 ml $0.009 — Availability likely save 32%
Good Sense Sleep Time 50 mg/30mLthis 00113-0186-30 L. 177 ml $0.013 — Discontinued —
LEADER Nighttime Sleep-Aid 50 mg/30mL 70000-0174-02 CARDINAL 177 ml $0.014 — Availability likely +8%
Nighttime Sleep-Aid 50 mg/30mL 83324-0015-06 Chain 177 ml $0.014 — Availability likely +8%
Dye Free Wal Sleep Z 50 mg/30mL 00363-0753-12 WALGREEN 354 ml — — FDA listed —
Nighttime Sleep Aid 50 mg/30mL 00363-7300-12 WALGREEN 354 ml — — FDA listed —
Sleep Aid 50 mg/30mL 00363-8020-02 Walgreen 355 ml — — FDA listed —
Nighttime Sleep Aid 50 mg/30mL 11673-0285-02 TARGET 2 bottles — — FDA listed —
Sleep Aid 50 mg/30mL 11673-0750-12 TARGET 355 ml — — FDA listed —
Rite Aid Nighttime Sleep Aid Non Habit Forming 50 mg/30mL 11822-7530-01 RITE 354 ml — — FDA listed —
Nighttime Sleep-Aid 50 mg/30mL 11822-8002-01 Rite 177 ml — — FDA listed —
EZ Nite Sleep 50 mg/30mL 21130-0014-06 Safeway, 177 ml — — FDA listed —
Nightime Sleep Aid 50 mg/30mL 21130-0711-01 BETTER 354 ml — — FDA listed —
Nighttime Sleep Aid 50 mg/30mL 30142-0095-96 Kroger 2 bottles — — FDA listed —
Topcare ZZZ Sleep 50 mg/30mL 36800-0200-30 Topco 177 ml — — Discontinued —
ZzzQuil Nighttime Sleep-Aid 50 mg/30mL 37000-0500-04 The 118 ml — — FDA listed —
Nighttime Sleep Aid 50 mg/30mL 37808-0186-30 H 177 ml — — Discontinued —
Nighttime Sleep Aid 50 mg/30mL 37835-0319-30 Bi-Mart 355 ml — — FDA listed —
Diphenhydramine HCl 50 mg/30mL 37835-0519-12 BI-MART 355 ml — — FDA listed —
Equaline Night Time Sleep Aid 50 mg/30mL 41163-0186-30 United 177 ml — — Discontinued —
KROGER Nighttime Sleep-Aid 50 mg/30mL 41226-0730-12 KROGER 354 ml — — FDA listed —
nitetime sleep aid 50 mg/30mL 41250-0044-30 Meijer 177 ml — — Discontinued —
Meijer Nighttime Sleep-aid Berry Flavor 50 mg/30mL 41250-0738-12 MEIJER 354 ml — — FDA listed —
Meijer Nighttime Sleep Aid Non Habit Forming 50 mg/30mL 41250-0853-12 MEIJER 354 ml — — FDA listed —
Nighttime Sleep Aid 50 mg/30mL 41520-0034-06 Care 177 ml — — FDA listed —
Night Time Sleep Aid 50 mg/30mL 42507-0959-40 HyVee 355 ml — — FDA listed —
Nighttime Sleep Aid Alcohol Free 50 mg/30mL 49035-0330-02 Wal-Mart 355 ml — — FDA listed —
Sleep Aid 50 mg/30mL 49035-0704-02 Wal-Mart 355 ml — — FDA listed —
Sleep Aid NightTime 50 mg/30mL 49580-0314-02 P 355 ml — — FDA listed —
Nighttime Sleep Aid 50 mg/30mL 50844-0200-45 L.N.K. 177 ml — — Discontinued —
Nighttime Sleep Aid 50 mg/30mL 50844-0250-45 L.N.K. 177 ml — — FDA listed —
Nighttime Sleep-Aid 50 mg/30mL 53041-0633-58 Guardian 177 ml — — FDA listed —
Nighttime Sleep-Aid 50 mg/30mL 53942-0522-28 DeMoulas 354 ml — — FDA listed —
Night Time Sleep-Aid 50 mg/30mL 53943-0522-25 Discount 117 ml — — FDA listed —
Nighttime Sleep Aid 50 mg/30mL 55319-0802-02 Family 355 ml — — FDA listed —
Night Time Sleep Aid 50 mg/30mL 55910-0114-12 Dolgencorp, 355 ml — — FDA listed —
dg health sleep aid 50 mg/30mL 55910-0186-30 Dolgencorp, 177 ml — — Discontinued —
Sleep Aid NightTime 50 mg/30mL 55910-0899-12 Dolgencorp, 355 ml — — FDA listed —
Sleep Aid NightTime 50 mg/30mL 55910-0981-02 Dolgencorp, 355 ml — — FDA listed —
CVS Health Nighttime Sleep-Aid 50 mg/30mL 59779-0893-06 CVS 177 ml — — FDA listed —
Nighttime Sleep Aid, 24-7 Life BY 7-ELEVEN, 6oz 50 mg/30mL 66715-6543-04 Lil' 177 ml — — FDA listed —
Nighttime Sleep Aid Berry Flavor 50 mg/30mL 67091-0630-06 WINCO 177 ml — — FDA listed —
Premier Value Nighttime Sleep-Aid Liquid Sleep-Aid 50 mg/30mL 68016-0219-12 Chain 354 ml — — FDA listed —
Nighttime Sleep Aid Berry Flavor 50 mg/30mL 68163-0730-06 Raritan 177 ml — — FDA listed —
berkley and jensen sleep aid 50 mg/30mL 68391-0186-40 BJWC 3 bottles — — FDA listed —
Nighttime Sleep Aid 50 mg/30mL 68391-0793-09 BJWC 3 bottles — — FDA listed —
Nighttime Sleep Aid 50 mg/30mL 69168-0446-39 Allegiant 354 ml — — FDA listed —
Nighttime Sleep Aid 50 mg/30mL 69168-0486-39 Allegiant 355 ml — — FDA listed —
VICKS ZzzQuil NIGHTTIME SLEEP-AID Diphenhydramine HCl FREE OF 50 mg/30mL 69423-0795-12 The 354 ml — — FDA listed —
VICKS ZzzQuil NIGHTTIME SLEEP-AID 50 mg/30mL 69423-0812-12 The 354 ml — — FDA listed —
Vicks ZzzQuil Soothing Sleep Nighttime Sleep-Aid 50 mg/30mL 69423-0830-12 The 354 ml — — FDA listed —
Sleep-Aid 50 mg/30mL 69842-0470-02 CVS 355 ml — — FDA listed —
CVS Health Nighttime Sleep Aid 50 mg/30mL 69842-0753-12 CVS 354 ml — — FDA listed —
basic care nighttime sleep aid 50 mg/30mL 72288-0186-40 Amazon.com 355 ml — — FDA listed —
Nighttime Sleep Aid 50 mg/30mL 76162-0200-45 TOPCO 177 ml — — FDA listed —
Nighttime Sleep-Aid Non-Habit Forming 50 mg/30mL 76281-0522-24 AptaPharma 118 ml — — FDA listed —
Goodnow Sleep Aid 50 mg/30mL 82501-0186-00 Gobrands, 355 ml — — FDA listed —
Quality Choice Nighttime Sleep Aid 50 mg/30mL 83324-0336-06 QUALITY 177 ml — — FDA listed —
Vicks ZzzQuil Nighttime Sleep-Aid 84126-0306-03 The 1 kit — — FDA listed —
ZzzQuil Nighttime Sleep-Aid 50 mg/30mL 84126-0316-04 The 118 ml — — FDA listed —
VICKS ZzzQuil FREE and CLEAR NIGHTTIME SLEEP-AID 50 mg/30mL 84126-0370-12 The 354 ml — — FDA listed —
VICKS ZzzQuil FREE and CLEAR NIGHTTIME SLEEP-AID 50 mg/30mL 84126-0371-12 The 354 ml — — FDA listed —
Revasol Sleep Aid 50 mg/30mL 84379-0284-04 Rnv 118 ml — — FDA listed —
Nighttime Sleep Aid 50 mg/30mL 85828-0793-01 Grocery 354 ml — — FDA listed —
nighttime sleep aid 50 mg/30mL 72288-0765-40 Amazon.com 355 ml — — 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

🏛️
2013
On the market since
Jul 2013
📍
2026
Currently FDA-listed
13 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 Good Sense Sleep Time (this brand).

Top reported reactions

Completed Suicide760
Death530
Nausea456
Infusion Related Reaction450
Fatigue443
Dyspnoea408
Pain404

Age at onset

Neonate1
Infant1
Child9
Adolescent8
Adult130
Elderly43

Reporter sex

8,288 reports
Male · 41%
Female · 57%
Unknown · 1%

Serious outcomes

Death2,746
Hospitalization2,703
Life-threatening452
Disabling161
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 501 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 Per unit Per pack Marketing startStatus
00113-0186-30 You're viewing this 177 mL in 1 BOTTLE (0113-0186-30) $0.0126 / mL $2.23 2013-07-02 Discontinued by firm
00113-0186-40 355 mL in 1 BOTTLE (0113-0186-40) $0.0086 / mL $3.07 2013-07-02 Active

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

Per mL, this pack runs about 47% above the cheapest pack (355 mL, $0.0086 vs $0.0126 NADAC).

Pack size FAQ

What quantity is in NDC 00113-0186-30?
NDC 00113-0186-30 contains 177 mL — 177 ml in 1 bottle.
What is the difference between NDC 00113-0186-30 and NDC 00113-0186-40?
Both are Good Sense Sleep Time Diphenhydramine HCl 50 mg/30mL Solution — the drug itself is identical. NDC 00113-0186-30 is the 177 mL package, while NDC 00113-0186-40 is the 355 ml package. Per-mL NADAC also differs: $0.0126 here vs $0.0086 for the 355 ml pack.
What NDC number is used to bill for this package of Good Sense Sleep Time Diphenhydramine HCl 50 mg/30mL Solution?
Bill NDC 00113-0186-30 — the 11-digit billing format is 00113018630. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product No longer marketed (per FDA listing data)
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) ✓ Available
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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 0113-0186-30, 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: 00113-0186-30, written without dashes as 00113018630. 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 00113-0186-30, the first segment (00113) is the labeler code FDA assigned to L. Perrigo Company; the middle segment (0186) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (30) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 355 ml (00113-0186-40). 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?
L. Perrigo Company 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 20 words ▾

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

⏱️ Dosage and Administration 59 words ▾

Directions • take only one dose per day (24 hours) • only use the dose cup provided adults & children 12 yrs & over 30 mL at bed time if needed or as directed by a doctor children under 12 yrs do not use Other information • each 30 mL contains: sodium 20 mg • store at 20-25˚C (68-77˚F)

⚠️ Warnings 135 words ▾

Warnings Do not use • for children under 12 years of age • with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if you have • a breathing problem such as emphysema or chronic bronchitis • glaucoma • difficulty in urination due to an enlargement of the prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product • avoid alcoholic beverages Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks.

Insomnia may be a symptom of serious underlying medical illness. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

📦 Storage and Handling 15 words ▾

Other information • each 30 mL contains: sodium 20 mg • store at 20-25˚C (68-77˚F)

🧪 Active Ingredient 10 words ▾

Active ingredient (in each 30 mL) Diphenhydramine HCl 50 mg

🧪 Inactive Ingredients 29 words ▾

Inactive ingredients alcohol, anhydrous citric acid, FD&C blue #1, FD&C red #40, flavor, high fructose corn syrup, poloxamer 407, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate

🎯 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.