Home › NDC Lookup › Ingredients › Doxylamine Succinate › 50844-0386-27
⚪image loading
(from DailyMed)

Nighttime Sleep Aid Doxylamine succinate 25 mg Tablet, 32-count

by L.N.K. International, Inc. · 2 BLISTER PACK in 1 CARTON (50844-386-27) / 16 TABLET in 1 BLISTER PACK
NDC 50844-0386-27
🏷️ FDA NDC (as labeled) 50844-386-27 billing pads the product segment with a zero
This package
Contains32-count Pack sizes5 compare ↓
Also comes in: 8 tablets 50844-0386-19 32 tablets 50844-0386-90 48 tablets 50844-0386-22 96 tablets 50844-0386-96
OTC Generic 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) 50844-386-27
Product NDC 50844-386
11-digit billing NDC 50844038627
RxCUI 1101446
UNII V9BI9B5YI2
UPC 0350844386199
Application # ANDA040564
SPL Set ID 918ad808-ccfd-429f-9052-19905a634606
Established class (EPC) Antihistamine
Mechanism of action Histamine Receptor Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2002-04-11
Route ORAL
Dosage form TABLET
Substance DOXYLAMINE SUCCINATE
Why two NDCs? The FDA registers this code as 50844-386-27 — 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 → 50844-0386-27. 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 Antihistamine class.

Pharmacologic class Antihistamine
Drug family (ATC) Aminoalkyl ethers
How it works Histamine 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.N.K. International, Inc.
Application holderLNK INTERNATIONAL INC
FDA applicationANDA040564 (ANDA)
Labeler code50844
First marketedApr 2002
Product typeHuman Otc Drug
Portfolio62 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📖 What it is MedlinePlus · NLM

Doxylamine is used to treat insomnia (difficulty falling asleep or staying asleep).   Doxylamine 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. Doxylamine is also used in combination with acetaminophen, dextromethorphan, decongestants and other medications to manage cold and flu symptoms. This monograph only includes information about the use of doxylamine alone. If you are taking the doxylamine combination products, read the information on the package label or ask your doctor or pharmacis...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It depends on the product you have. If you picked up a sleep-aid tablet — like Nighttime Sleep Aid or berkley and jensen sleep aid — it's meant to help you fall asleep more easily....
  • For sleep-aid tablets, the directions say to take one tablet about 30 minutes before you plan to go to bed, and only once per night. It's important that you have a full night's sle...
  • How do I take the sleep-aid tablet — can I take it earlier in the evening?
  • No — please avoid alcohol entirely while you're using doxylamine. Alcohol and doxylamine both cause drowsiness, and combining them can make the sedation much stronger than you expe...
📖 Read our full Doxylamine 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII O7TSZ97GEP
    A mineral compound that serves as a filler and binding agent in tablets and capsules. It adds bulk to the medicine and helps hold ingredients together during manufacturing.
  • UNII J9EQA3S2JM
    FD&C Blue No. 1 Aluminum Lake is a blue colorant made by combining FD&C Blue No. 1 dye with aluminum salts. It is used to color tablets, capsules, and other medicines for easy identification and appearance.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.

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

The official label also statesdibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 8 tablets 32 tablets 48 tablets 96 tablets
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
Good sense sleep aid 25 mg 00113-0441-64 L. 32 tablets $0.122 — Availability likely —
good sense sleep aid ultra 25 mg 00113-4032-62 L. 24 tablets $0.122 — Availability likely —
Nighttime Sleep Aid 25 mg 46122-0788-15 Amerisource 32 tablets $0.122 — Availability likely —
Sleep-Aid 25 mg 70000-0567-01 Cardinal 48 tablets $0.122 — Availability likely —
Sleep Aid 25 mg 70677-1129-01 Strategic 32 tablets $0.122 — Availability likely —
good sense sleep aid ultra 25 mg 00113-6044-67 L. 48 tablets — — FDA listed —
Sleep Aid 25 mg 00363-0386-12 Walgreen 100 tablets — — FDA listed —
sleep aid 25 mg 00363-3462-80 Walgreen 96 tablets — — FDA listed —
ultra sleep aid 25 mg 00363-8011-62 Walgreen 24 tablets — — FDA listed —
up and up nighttime sleep aid 25 mg 11673-0171-01 Target 96 tablets — — FDA listed —
sleep aid 25 mg 11822-0441-00 Rite 48 tablets — — FDA listed —
sleep aid 25 mg 11822-3000-00 Rite 24 tablets — — FDA listed —
Nighttime Sleep Aid 25 mg 21130-0986-27 Better 32 tablets — — FDA listed —
Nighttime Sleep-Aid 25 mg 30142-0366-27 Kroger 32 tablets — — FDA listed —
Sleep Aid 25 mg 30142-0386-27 Kroger 32 tablets — — FDA listed —
TopCare Sleep Aid 25 mg 36800-0441-64 Topco 32 tablets — — FDA listed —
Nighttime Sleep Aid 25 mg 37808-0886-27 H 32 tablets — — FDA listed —
Sleep Aid 25 mg 41163-0986-22 United 48 tablets — — FDA listed —
Unisom SleepTabs 25 mg 41167-0063-05 Chattem, 16 tablets — — FDA listed —
Unisom SleepTabs 25 mg 41167-0608-00 Chattem, 16 tablets — — FDA listed —
Sleep Aid 25 mg 41250-0441-01 Meijer 96 tablets — — FDA listed —
Sleep Aid 25 mg 41250-0986-22 Meijer 48 tablets — — FDA listed —
CareOne Nighttime Sleep Aid 25 mg 41520-0634-64 American 32 tablets — — FDA listed —
nighttime sleep aid 25 mg 42507-0033-64 HyVee 32 tablets — — FDA listed —
Sleep Aid 25 mg 49035-0968-27 Wal-Mart 32 tablets — — FDA listed —
Nighttime Sleep Aid 25 mg 50844-0260-21 L.N.K. 16 tablets — — FDA listed —
Nighttime Sleep Aid 25 mgthis 50844-0386-27 L.N.K. 32 tablets — — FDA listed —
Sleep Aid 25 mg 51316-0368-22 CVS 48 tablets — — FDA listed —
Sleep Aid 25 mg 55301-0986-27 ARMY 32 tablets — — FDA listed —
Nighttime Sleep Aid 25 mg 55319-0439-16 Family 16 tablets — — FDA listed —
dg health sleep aid 25 mg 55910-0909-53 Dolgencorp 12 tablets — — FDA listed —
sleep aid 25 mg 56062-0441-01 Publix 96 tablets — — FDA listed —
Nighttime Sleep Aid 25 mg 59779-0441-01 CVS 96 tablets — — FDA listed —
Sleep Aid 25 mg 63981-0986-96 COSTCO 96 tablets — — FDA listed —
Nighttime Sleep Aid, 24-7 Life by 7-Eleven 25 mg 66715-5642-04 Lil' 16 tablets — — FDA listed —
ZzzQuil ULTRA, Travel BASIX 25 mg 66715-6451-03 Lil' 3 tablets — — FDA listed —
ZzzQuil ULTRA, Lil Drug Store 25 mg 66715-9751-02 Lil' 2 tablets — — FDA listed —
berkley and jensen sleep aid 25 mg 68391-0441-02 BJWC 192 tablets — — FDA listed —
Nighttime Sleep Aid 25 mg 69168-0439-06 Allegiant 120 tablets — — FDA listed —
Vicks ZzzQuil Ultra 25 mg 69423-0902-12 The 12 tablets — — FDA listed —
Nighttime Sleep Aid 25 mg 69842-0386-22 CVS 48 tablets — — FDA listed —
Basic Care Sleep Aid 25 mg 72288-0441-01 Amazon.com 96 tablets — — FDA listed —
SLEEP AID 25mg 25 mg 73581-0205-02 YYBA 200 tablets — — FDA listed —
Topcare Sleep Aid 25 mg 76162-0159-62 Topco 24 tablets — — FDA listed —
topcare sleep aid 25 mg 76162-0603-67 Topco 48 tablets — — FDA listed —
sleep aid ultra 25 mg 79481-0096-00 Meijer, 24 tablets — — FDA listed —
Night Time Sleep Aid 25 mg 80513-0371-25 Advanced 225 tablets — — FDA listed —
Nighttime Sleep Aid 25 mg 85828-0439-38 Grocery 32 tablets — — FDA listed —
Nocto Sleep Aid 25 mg 27854-0375-01 Belmora 24 tablets — — FDA listed —
Sleep Aid 25 mg 72288-0432-01 Amazon.com 96 tablets — — FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2002
On the market since
Apr 2002
📍
2026
Currently FDA-listed
24 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
50844-0386-19 1 BLISTER PACK in 1 CARTON (50844-386-19) / 8 TABLET in 1 BLISTER PACK 2002-04-11 Active
50844-0386-22 3 BLISTER PACK in 1 CARTON (50844-386-22) / 16 TABLET in 1 BLISTER PACK 2002-04-11 Active
50844-0386-27 You're viewing this 2 BLISTER PACK in 1 CARTON (50844-386-27) / 16 TABLET in 1 BLISTER PACK 2002-04-11 Active
50844-0386-90 32 TABLET in 1 BOTTLE, PLASTIC (50844-386-90) 2002-04-11 Active
50844-0386-96 2 BOTTLE, PLASTIC in 1 CARTON (50844-386-96) / 96 TABLET in 1 BOTTLE, PLASTIC 2002-04-11 Active

Pack size FAQ

What quantity is in NDC 50844-0386-27?
NDC 50844-0386-27 is a 32-count package — 2 blister pack in 1 carton / 16 tablet in 1 blister pack.
What is the difference between NDC 50844-0386-27 and NDC 50844-0386-19?
Both are Nighttime Sleep Aid Doxylamine succinate 25 mg Tablet — the drug itself is identical. NDC 50844-0386-27 is the 32-count package, while NDC 50844-0386-19 is the 8 tablets package.
What NDC number is used to bill for this package of Nighttime Sleep Aid Doxylamine succinate 25 mg Tablet?
Bill NDC 50844-0386-27 — the 11-digit billing format is 50844038627. 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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

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 50844-386-27, 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: 50844-0386-27, written without dashes as 50844038627. 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 50844-0386-27, the first segment (50844) is the labeler code FDA assigned to L.N.K. International, Inc.; the middle segment (0386) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (27) 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 L.N.K. International, 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 4 other package presentations of this same product, including 8 tablets (50844-0386-19), 32 tablets (50844-0386-90), 48 tablets (50844-0386-22). 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.N.K. International, 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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 8 words ▾

Use helps to reduce difficulty in falling asleep

⏱️ Dosage and Administration 37 words ▾

Directions adults and children 12 years of age and over: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor children under 12 years of age: do not use

⚠️ Warnings 151 words ▾

Warnings Do not use in children under 12 years of age with any other product containing doxylamine unless you have time for a full night’s sleep Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or any other sleep-aid tranquilizers any other antihistamines any other drugs When using this product avoid alcoholic beverages do not drive a motor vehicle or operate machinery take only at bedtime Stop use and ask a doctor if sleeplessness persists continuously for more than two 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.

📦 Storage and Handling 34 words ▾

Other information TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at controlled room temperature 20°-25°C (68°-77°F) see end flap for expiration date and lot number

🧪 Active Ingredient 9 words ▾

Active ingredient (in each tablet) Doxylamine succinate 25 mg

🧪 Inactive Ingredients 18 words ▾

Inactive ingredients dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

🎯 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 ↗
← 50844-0375-02 · L.N.K. 50844-0390-19 · L.N.K. →
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.