Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
Nocto Sleep Aid Doxylamine succinate 25 mg Tablet, 24-count — NDC 27854-375-01 (Billing 27854-0375-01)
by Belmora LLC · 1 BOTTLE, PLASTIC in 1 CARTON / 24 TABLET in 1 BOTTLE, PLASTIC
This is a package of 24 tablets of Nocto Sleep Aid Doxylamine succinate 25 mg Tablet from Belmora LLC, marketed since Oct 2019 and currently FDA-listed. It is this product's only package size.
NDC 27854-0375-01
🏷️ FDA NDC (as labeled)
27854-375-01
billing pads the product segment with a zero
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
27854-375-01
Product NDC
27854-375
11-digit billing NDC
27854037501
RxCUI
1101446,
2257285
UNII
V9BI9B5YI2
Application #
ANDA040564
SPL Set ID
d255309b-0023-48fe-890f-6a4fe04dbb85
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
2019-10-31
Route
ORAL
Dosage form
TABLET
Substance
DOXYLAMINE SUCCINATE
Quick answers
- RxCUI (RxNorm): 1101446
Why two NDCs?
The FDA registers this code as 27854-375-01 — 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 → 27854-0375-01. 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
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.
- RxClass (NLM) · catalog refreshed Oct 1, 2026
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. Sleep-aid tablets help you fall asleep more easily. Some NyQuil and other liquid or syrup products relieve hay fever and upper respiratory allergy sympto...
- Adults and children 12 and over take one tablet about 30 minutes before bed, once daily or as your doctor directs. Take it only at bedtime. These tablets are not for children under...
- No. The label says to avoid alcohol while using doxylamine. Also don’t drive or run machinery.
- Yes, if you have emphysema or chronic bronchitis, glaucoma, or trouble urinating from an enlarged prostate. Also check if you take sedatives, other sleep aids, or other antihistami...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Doxylamine Succinate — tap one for details:
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.
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
💬 Questions about Doxylamine succinate?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per each | Per 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.
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 2, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 27854-0375-01 You're viewing this Main listing | 1 BOTTLE, PLASTIC in 1 CARTON / 24 TABLET in 1 BOTTLE, PLASTIC | 2019-10-31 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Sleep Aid 25 mg 70677-1129-01 | Strategic | 32 tablets | $0.116 | — | Availability likely | — |
| good sense sleep aid ultra 25 mg 00113-4032-62 | L. | 24 tablets | $0.116 | — | Availability likely | — |
| Good sense sleep aid 25 mg 00113-0441-64 | L. | 32 tablets | $0.116 | — | Availability likely | — |
| Nighttime Sleep Aid 25 mg 46122-0788-15 | Amerisource | 32 tablets | $0.116 | — | Availability likely | — |
| Sleep-Aid 25 mg 70000-0567-01 | Cardinal | 48 tablets | $0.116 | — | Availability likely | — |
| Topcare Sleep Aid 25 mg 76162-0159-62 | Topco | 24 tablets | — | — | FDA listed | — |
| sleep aid ultra 25 mg 79481-0096-00 | Meijer, | 24 tablets | — | — | FDA listed | — |
| TopCare Sleep Aid 25 mg 36800-0441-64 | Topco | 32 tablets | — | — | FDA listed | — |
| CareOne Nighttime Sleep Aid 25 mg 41520-0634-64 | American | 32 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 | — |
| berkley and jensen sleep aid 25 mg 68391-0441-02 | BJWC | 192 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 | — |
| Sleep Aid 25 mg 49035-0968-27 | Wal-Mart | 32 tablets | — | — | FDA listed | — |
| Nighttime Sleep Aid 25 mg 50844-0386-19 | L.N.K. | 8 tablets | — | — | FDA listed | — |
| Sleep Aid 25 mg 51316-0368-22 | CVS | 48 tablets | — | — | FDA listed | — |
| topcare sleep aid 25 mg 76162-0603-67 | Topco | 48 tablets | — | — | FDA listed | — |
| Night Time Sleep Aid 25 mg 80513-0371-25 | Advanced | 225 tablets | — | — | FDA listed | — |
| Nighttime Sleep Aid 25 mg 37808-0886-27 | H | 32 tablets | — | — | FDA listed | — |
| nighttime sleep aid 25 mg 42507-0033-64 | HyVee | 32 tablets | — | — | FDA listed | — |
| ZzzQuil ULTRA, Travel BASIX 25 mg 66715-6451-03 | Lil' | 3 tablets | — | — | FDA listed | — |
| Nighttime Sleep Aid 25 mg 69842-0386-22 | CVS | 48 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 | — |
| Unisom SleepTabs 25 mg 41167-0063-05 | Chattem, | 16 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 55301-0986-27 | ARMY | 32 tablets | — | — | FDA listed | — |
| Sleep Aid 25 mg 63981-0986-96 | COSTCO | 96 tablets | — | — | FDA listed | — |
| SLEEP AID 25mg 25 mg 73581-0205-02 | YYBA | 200 tablets | — | — | FDA listed | — |
| up and up nighttime sleep aid 25 mg 11673-0171-01 | Target | 96 tablets | — | — | FDA listed | — |
| Sleep Aid 25 mg 00363-0386-12 | Walgreen | 100 tablets | — | — | FDA listed | — |
| ultra sleep aid 25 mg 00363-8011-62 | Walgreen | 24 tablets | — | — | FDA listed | — |
| Vicks ZzzQuil Ultra 25 mg 69423-0902-12 | The | 12 tablets | — | — | FDA listed | — |
| Nocto Sleep Aid 25 mgthis 27854-0375-01 | Belmora | 24 tablets | — | — | FDA listed | — |
| Sleep Aid 25 mg 30142-0386-27 | Kroger | 32 tablets | — | — | FDA listed | — |
| ZzzQuil ULTRA, Lil Drug Store 25 mg 66715-9751-02 | Lil' | 2 tablets | — | — | FDA listed | — |
| Nighttime Sleep Aid 25 mg 85828-0439-38 | Grocery | 32 tablets | — | — | FDA listed | — |
| good sense sleep aid ultra 25 mg 00113-6044-67 | L. | 48 tablets | — | — | FDA listed | — |
| Sleep Aid 25 mg 41163-0986-22 | United | 48 tablets | — | — | FDA listed | — |
| Unisom SleepTabs 25 mg 41167-0608-00 | Chattem, | 16 tablets | — | — | FDA listed | — |
| Nighttime Sleep Aid 25 mg 50844-0260-21 | L.N.K. | 16 tablets | — | — | FDA listed | — |
| Nighttime Sleep Aid 25 mg 59779-0441-01 | CVS | 96 tablets | — | — | FDA listed | — |
| sleep aid 25 mg 00363-3462-80 | Walgreen | 96 tablets | — | — | FDA listed | — |
| Basic Care Sleep Aid 25 mg 72288-0441-01 | Amazon.com | 96 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file
Availability & generic status
🏛️
2019
On the market since
Oct 2019
📍
2026
Currently FDA-listed
7 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.
- FDA Orange Book · refreshed Sep 3, 2026
What it looks like
Color
blue
ShapeOval
Imprint44;386
Size1 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.
- FDA label on DailyMed · label index refreshed Oct 1, 2026
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.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
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.
Manufacturer & labeler
LabelerBelmora LLC
Application holderLNK INTERNATIONAL INC
FDA applicationANDA040564 (ANDA)
Labeler code27854
First marketedOct 2019
Product typeHuman Otc Drug
Portfolio24 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
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
📄 Do Not Use
📄 Ask a Doctor Before Use If
📄 Ask a Doctor or Pharmacist Before Use If
📄 When Using This Product
📄 Stop Use and Ask a Doctor If
🤰 If Pregnant or Breast-Feeding
📄 Keep Out of Reach of Children
📄 Questions or Comments
📄 Package Label / Principal Display Panel
🎯 Indications and Usage ▾
Use helps to reduce difficulty in falling asleep
⏱️ Dosage and Administration ▾
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 ▾
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 trouble urinating due to an enlarged prostate gland glaucoma 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 ▾
Other information store at controlled room temperature 20°-25°C (68°-77°F) see end flap for expiration date and lot number
🧪 Active Ingredient ▾
Active ingredient (in each tablet) Doxylamine succinate 25 mg
🧪 Inactive Ingredients ▾
Inactive ingredients dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate
🎯 Purpose ▾
Purpose Nighttime sleep-aid
📄 Do Not Use ▾
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 ▾
Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland glaucoma
📄 Ask a Doctor or Pharmacist Before Use If ▾
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 ▾
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 ▾
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 ▾
If pregnant or breast-feeding, ask a health professional before use.
📄 Keep Out of Reach of Children ▾
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
📄 Questions or Comments ▾
Questions or comments? Call 1-888-779-2877 M-F 9AM-5PM EST
📄 Package Label / Principal Display Panel ▾
Principal display panel Belmora LLC NDC 27854-375-01 NOCTO ® SLEEP AID Doxylamine Succinate Tablets 25 mg Nighttime Sleep-Aid Helps to reduce difficulty in falling asleep 24 Tablets Actual Size One Tablet Per Dose Nocto 44-386 Nocto 44-386
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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) | ✓ 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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Belmora LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Belmora LLC 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.
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.