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Nighttime Sleep Aid Doxylamine succinate 25 mg Tablet, 48-count — NDC 37835-831-48 (Billing 37835-0831-48)

by Bi-Mart · 48 TABLET in 1 BOTTLE

This is a package of 48 tablets of Nighttime Sleep Aid Doxylamine succinate 25 mg Tablet from Bi-Mart, marketed since Jun 2025 and currently FDA-listed. It is this product's only package size.

NDC 37835-0831-48
🏷️ FDA NDC (as labeled) 37835-831-48 billing pads the product segment with a zero
OTC Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Oct 8, 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

NDC database record

One package, one record: these facts belong to NDC 37835-831-48 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
37835 labeler · 831 product · 48 package
Package marketed since
Jun 1, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 3783583148 7
FDA record last changed
Oct 8, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 37835-831-48
Product NDC 37835-831
11-digit billing NDC 37835083148
Application # ANDA040564
SPL Set ID 5cebc512-d757-197b-e063-6394a90ae9fe
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 2025-06-01
Route ORAL
Dosage form TABLET
Substance DOXYLAMINE SUCCINATE
Why two NDCs? The FDA registers this code as 37835-831-48 — 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 → 37835-0831-48. 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.

Clinical

📗 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...
📖 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.

Pricing

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

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
37835-0831-48 You're viewing this Main listing 48 TABLET in 1 BOTTLE 2025-06-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice 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 mg 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 —
Nighttime Sleep Aid 25 mgthis 37835-0831-48 Bi-Mart 48 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

🏛️
2025
On the market since
Jun 2025
📍
2026
Currently FDA-listed
1 year 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.

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.

🧪 Avoiding an ingredient? See Doxylamine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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.

Manufacturer & labeler

LabelerBi-Mart
Application holderLNK INTERNATIONAL INC
FDA applicationANDA040564 (ANDA)
Labeler code37835
First marketedJun 2025
Product typeHuman Otc Drug
Portfolio60 products on file

More NDCs from Bi-Mart labeler code 37835

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 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.
📄 FDA label
📄 FDA label 19 words ▾

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

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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) — 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

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 Bi-Mart. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Bi-Mart 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.
← 37835-0812-36 · Bi-Mart 37835-0852-50 · Bi-Mart →
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.