Home › NDC Lookup › Ingredients › Meclizine Hydrochloride › 65197-0275-16
⚪image loading
(from DailyMed)

Bonine meclizine hydrochloride 25 mg Tablet, Chewable — NDC 65197-275-16 (Billing 65197-0275-16)

by WellSpring Pharmaceutical Corporation · 2 BLISTER PACK in 1 BOX / 8 TABLET, CHEWABLE in 1 BLISTER PACK

This is a package of Bonine meclizine hydrochloride 25 mg Tablet, Chewable from WellSpring Pharmaceutical Corporation, marketed since Dec 2014 and currently FDA-listed, this package's marketing is listed to end Dec 2026.

NDC 65197-0275-16
🏷️ FDA NDC (as labeled) 65197-275-16 billing pads the product segment with a zero
This package
Contains8 tablet, chewable in 1 blister pack Pack sizes4 compare ↓
Product page 65197-0275-02 Also comes in: 2 tablets 65197-275-02 8 tablets 65197-275-08 12 tablets 65197-275-12
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ 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 →

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 65197-275-16 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
65197 labeler · 275 product · 16 package
Package marketed since
Dec 15, 2014
Package marketing ended
Dec 31, 2026
Sample package
No — commercial package
Barcode (UPC)
0365197275120, 0365197275083
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Meclizine Hydrochloride (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Mar 16, 2026 — Failed tablet specifications. (Amerisource Health Services LLC) · FDA recall D-0418-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 65197-275-16
Product NDC 65197-275
11-digit billing NDC 65197027516
NCPDP billing unit EA — each (per item)
RxCUI 995632, 995634
UNII HDP7W44CIO
UPC 0365197275120, 0365197275083
Application # M009
SPL Set ID ad3d66ca-a52c-43ba-b9e2-6269b8a413a9
Established class (EPC) Antiemetic
Physiologic effect Emesis Suppression
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2014-12-15
Marketing end 2026-12-31
Route ORAL
Dosage form TABLET, CHEWABLE
Substance MECLIZINE HYDROCHLORIDE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 50200050000510
GPI class Bonine
GCN Seq No 004736
GCN 18312
HICL code 001975
Ingredient (HICL) Meclizine Hcl
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H6
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Midbrain
HIC3 code H6J
Therapeutic class — specific (HIC3) Antiemetic/Antivertigo Agents
AHFS code 04:04.16.00
AHFS class Piperazine Derivatives
FDB label name BONINE 25 MG CHEWABLE TABLET
FDB brand name Bonine
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 004736
  • GCN: 18312
  • GPI-14 (Medi-Span): 50200050000510
  • HICL (First Databank): 001975
  • AHFS class code: 04:04.16.00
  • RxCUI (RxNorm): 995632
Why two NDCs? The FDA registers this code as 65197-275-16 — 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 → 65197-0275-16. 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 Antiemetic class.

Pharmacologic class Antiemetic
Drug family (ATC) Piperazine derivatives
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.

Clinical

Label name BONINE 25 MG CHEWABLE TABLET Ingredient Meclizine Hcl
📖 What it is MedlinePlus · NLM

Meclizine is used to prevent and treat nausea, vomiting, and dizziness caused by motion sickness. It is most effective if taken before symptoms appear.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Meclizine is mainly used to prevent and treat the nausea, vomiting, and dizziness that comes with motion sickness — whether you're on a boat, in a car, or on a plane. It's also use...
  • For the best chance of preventing motion sickness, take meclizine about one hour before you start traveling. After that first dose, you can take it once every 24 hours as needed fo...
  • Yes, drowsiness is the most common side effect — it's actually worth planning around. Avoid driving or operating heavy machinery until you know how it affects you. And definitely s...
  • This one requires a conversation with your doctor. Human studies haven't clearly linked meclizine to birth defects, but animal studies did show fetal harm at doses similar to what...
📖 Read our full Meclizine guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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.
Try another pack size: 2 tablets 8 tablets 12 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
65197-0275-02 65197-275-02 Main listing 2 TABLET, CHEWABLE in 1 POUCH 2014-12-15 Dec 31, 2026 Active
65197-0275-08 65197-275-08 1 BLISTER PACK in 1 BOX / 8 TABLET, CHEWABLE in 1 BLISTER PACK 2014-12-15 Dec 31, 2026 Active
65197-0275-12 65197-275-12 1 BOTTLE in 1 BOX / 12 TABLET, CHEWABLE in 1 BOTTLE 2014-12-15 Dec 31, 2026 Active
65197-0275-16 You're viewing this 2 BLISTER PACK in 1 BOX / 8 TABLET, CHEWABLE in 1 BLISTER PACK 2014-12-15 Dec 31, 2026 Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 2 blister pack in 1 box / 8 tablet, chewable in 1 blister pack.
What NDC number is used to bill for this package of Bonine meclizine hydrochloride 25 mg Tablet, Chewable?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Meclizine Hydrochloride 25 mg 00536-1299-01 Rugby 100 tablets $0.033 — Availability likely —
Meclizine HCl 25 mg 16571-0824-01 Rising 100 tablets $0.033 — Availability likely —
Motion Sickness Relief 25 mg 46122-0774-51 Amerisource 8 tablets $0.033 — Availability likely —
Motion-Time Chewable 25 mg/251 49483-0333-01 Time-Cap 100 tablets $0.033 — Availability likely —
Meclizine HCl 25 mg 68001-0529-00 BluePoint 100 tablets $0.033 — Availability likely —
Motion Sickness 25 mg 70677-1290-01 Strategic 100 tablets $0.033 — Availability likely —
Travel ease 25 mg 83324-0027-16 Chain 8 tablets $0.033 — Availability likely —
Motion Sickness Relief 25 mg 00363-4040-21 Walgreen 8 tablets — — FDA listed —
Meclizine Hydrochloride 25 mg 00363-5172-07 Walgreen 12 tablets — — FDA listed —
Motion Sickness Relief 25 mg 11822-4040-01 Rite 8 tablets — — FDA listed —
Meclizine 25 mg 16103-0387-08 Pharbest 100 tablets — — FDA listed —
Meclizine Hydrochloride 25 mg 16571-0663-01 Rising 100 tablets — — FDA listed —
Meclizine HCL 25 mg 17714-0115-01 Advance 100 tablets — — FDA listed —
Meclizine 25 mg 37835-0202-01 Bi-Mart 100 tablets — — FDA listed —
Meclizine 25 mg 43063-0804-01 PD-Rx 100 tablets — — FDA listed —
Meclizine Hydrochloride 25 mg 50090-5496-00 A-S 30 tablets — — FDA listed —
Meclizine Hydrochloride 25 mg 50090-5952-00 A-S 30 tablets — — FDA listed —
Motion Sickness Relief 25 mg 51013-0322-54 PuraCap 2 tablets — — FDA listed —
Motion Sickness Relief 25 mg 51316-0404-21 CVS 8 tablets — — FDA listed —
Motion Sickness 25 mg 51316-0441-21 CVS 8 tablets — — FDA listed —
Meclizine HCL 25 mg 54738-0025-01 Richmond 100 tablets — — FDA listed —
Dramamine 25 mg 63029-0906-12 Medtech 12 tablets — — FDA listed —
Dramamine 25 mg 63029-0913-12 Medtech 12 tablets — — FDA listed —
Dramamine 25 mg 63029-0914-12 Medtech 12 tablets — — FDA listed —
Bonine 25 mgthis 65197-0275-16 WellSpring 8 tablets — — FDA listed —
Bonine 25 mg 65197-0296-08 WellSpring 8 tablets — — FDA listed —
Bonine 25 mg 65197-0297-08 WellSpring 8 tablets — — FDA listed —
Meclizine Hydrochloride 25 mg 68071-2574-02 NuCare 20 tablets — — FDA listed —
Meclizine HCL 25 mg 68788-7982-01 Preferred 10 tablets — — FDA listed —
Meclizine HCl 25 mg 68788-8529-01 Preferred 10 tablets — — FDA listed —
Meclizine HCL 25 mg 69618-0028-01 Reliable 100 tablets — — FDA listed —
Motion Sickness Relief 25 mg 69842-0395-54 CVS 2 tablets — — FDA listed —
Meclizine HCL 25 mg 71205-0606-30 Proficient 30 tablets — — FDA listed —
Meclizine 25 mg 71335-1215-00 Bryant 120 tablets — — FDA listed —
Meclizine HCL 25 mg 71335-1607-00 Bryant 120 tablets — — FDA listed —
Meclizine Hydrochloride 25 mg 71335-2177-00 Bryant 120 tablets — — FDA listed —
Meclizine HCl 25 mg 71335-9751-00 Bryant 120 tablets — — FDA listed —
Meclizine HCL 25 mg 71610-0528-30 Aphena 30 tablets — — FDA listed —
Meclizine Hydrochloride 25 mg 71610-0836-30 Aphena 30 tablets — — FDA listed —
Meclizine Hydrochloride 25 mg 72789-0250-12 PD-Rx 12 tablets — — FDA listed —
Meclizine 25 mg 80513-0421-02 Advanced 200 tablets — — FDA listed —
Dramamine Chewable Orange 25 mg 63029-0915-08 Medtech 4 tablets — — 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

🏛️
2014
On the market since
Dec 2014
📍
2026
Currently FDA-listed
12 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.

What it looks like

Color pink
ShapeRound
ImprintBonine;201
Size9 mm
ScoringScored — splits in 2
FlavorRaspberry
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 M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII 2S7830E561
    Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
  • 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 EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • 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 4N14V5R27W
    A natural flavoring derived from raspberry fruit that gives medicines a pleasant taste. It helps mask bitter or unpleasant flavors to make medications easier to swallow.
  • 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 ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • UNII Q74T35078H
    Vanilla is a flavoring ingredient extracted from vanilla orchid beans. It's added to medicines to improve taste and make them more pleasant to take, especially for children or patients who need liquid formulations.

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

The official label also statescroscarmellose sodium, crospovidone, FD&C red #40 lake, lactose, magnesium stearate, raspberry flavor, silica, sodium saccharin, stearic acid, vanilla flavor. corn starch, FD&C red #40 aluminum lake, flavor, lactose anhydrous, magnesium stearate, saccharin sodium, silicon dioxide

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.

Manufacturer & labeler

LabelerWellSpring Pharmaceutical Corporation
FDA applicationM009 (OTC MONOGRAPH DRUG)
Labeler code65197
First marketedDec 2014
Product typeHuman Otc Drug
Portfolio30 products on file

More NDCs from WellSpring Pharmaceutical Corporation labeler code 65197

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.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 When Using This Product 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 12 words ▾

Uses prevents and treats nausea, vomiting or dizziness associated with motion sickness

⏱️ Dosage and Administration 77 words ▾

Directions (65197-275) dosage should be taken one hour before travel starts adults and children 12 years of age and over: take 1 to 2 tablets once daily or as directed by a doctor

Directions (65197-296) dosage should be taken one hour before travel starts chew or crush tablets completely before swallowing; do not swallow tablets whole adults and children 12 years and over: take 1 to 2 chewable tablets once daily or as directed by a doctor

⚠️ Warnings 128 words ▾

Warnings Do not use in children under 12 years of age unless directed by a doctor. Do not take this product, unless directed by a doctor, if you have glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. When using this product do not exceed recommended dosage you may get drowsy alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery 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 27 words ▾

Other information TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

🧪 Active Ingredient 9 words ▾

Active ingredient (in each tablet) Meclizine HCl 25 mg

🧪 Inactive Ingredients 41 words ▾

Inactive ingredients (65197-275) croscarmellose sodium, crospovidone, FD&C red #40 lake, lactose, magnesium stearate, raspberry flavor, silica, sodium saccharin, stearic acid, vanilla flavor.

Inactive Ingredients (65197-296) corn starch, FD&C red #40 aluminum lake, flavor, lactose anhydrous, magnesium stearate, saccharin sodium, silicon dioxide

🎯 Purpose 2 words ▾

Purpose Antiemetic

📄 Do Not Use 32 words ▾

Do not use in children under 12 years of age unless directed by a doctor.

Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor.

📄 Ask a Doctor Before Use If 31 words ▾

Do not take this product, unless directed by a doctor, if you have glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis

📄 When Using This Product 33 words ▾

When using this product do not exceed recommended dosage you may get drowsy alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery

🤰 If Pregnant or Breast-Feeding 10 words ▾

If pregnant or breast-feeding, ask a health professional before use.

📄 Keep Out of Reach of Children 21 words ▾

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

📄 Questions or Comments 6 words ▾

Questions? 1 (844) 241-5454 or www.bonine.com

📄 Package Label / Principal Display Panel 90 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 65197-275 UP TO 24 HOUR PROTECTION BONINE ® MECLIZINE HYDROCHLORIDE • ANTIEMETIC Nausea - Dizziness - Vomiting *Less drowsy than Dramamine Bonine 12 ct Bonine 12 ct

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 65197-296 NEW LOOK! Same great formula 9X the Adventure** **Results may vary. Meclizine HCL • Antiemetic 25mg *Less drowsy than Dramamine ® BONINE ® MECLIZINE HCL Prevents & Treats: Motion Sickness / Nausea & Vomiting / Dizziness / Cyber Sickness Up to 24 Hours Relief Bonine 8ct Blue new Design Bonine 8ct Blue new Design

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) ✓ 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 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 it is currently marketed — but WellSpring Pharmaceutical Corporation has reported a marketing end date of 2026-12-31, after which this package is expected to stop being marketed. The directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 2 tablets (65197-0275-02), 8 tablets (65197-0275-08), 12 tablets (65197-0275-12). 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?
WellSpring Pharmaceutical Corporation 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.
← 65197-0230-24 · WellSpring 65197-0296-08 · WellSpring →
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.