Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
Bonine meclizine hydrochloride 25 mg Tablet, Chewable, 8-count — NDC 65197-297-08 (Billing 65197-0297-08)
by WellSpring Pharmaceutical Corporation · 1 BLISTER PACK in 1 BOX / 8 TABLET, CHEWABLE in 1 BLISTER PACK
This is a package of 8 tablets of Bonine meclizine hydrochloride 25 mg Tablet, Chewable from WellSpring Pharmaceutical Corporation, marketed since Apr 2025 and currently FDA-listed. It is the main listing for this product, which comes in 5 package sizes.
NDC 65197-0297-08
🏷️ FDA NDC (as labeled)
65197-297-08
billing pads the product segment with a zero
This package
Contains8-count
Pack sizes5 compare ↓
Main listing for product 65197-297 · Also comes in:
8 tablets 65197-297-16
8 tablets 65197-297-24
8 tablets 65197-297-48
12 tablets 65197-297-12
🗂️ 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 →
⚠️
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)
65197-297-08
Product NDC
65197-297
11-digit billing NDC
65197029708
UNII
HDP7W44CIO
UPC
0365197275120
Application #
M009
SPL Set ID
0b2ea6b8-b342-4940-8922-898758fbeb31
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
2025-04-01
Route
ORAL
Dosage form
TABLET, CHEWABLE
Substance
MECLIZINE HYDROCHLORIDE
Quick answers
- RxCUI (RxNorm): 995632
Why two NDCs?
The FDA registers this code as 65197-297-08 — 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 → 65197-0297-08. 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 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.
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
📖 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...
Patient education
Supplement & herbal interactions
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 meclizine hydrochloride?
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 3, 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 |
|---|---|---|---|---|
| 65197-0297-08 You're viewing this Main listing | 1 BLISTER PACK in 1 BOX / 8 TABLET, CHEWABLE in 1 BLISTER PACK | 2025-04-01 | — | Active |
| 65197-0297-12 65197-297-12 | 1 BOTTLE in 1 BOX / 12 TABLET, CHEWABLE in 1 BOTTLE | 2025-04-01 | — | Active |
| 65197-0297-16 65197-297-16 | 2 BLISTER PACK in 1 BOX / 8 TABLET, CHEWABLE in 1 BLISTER PACK | 2025-04-01 | — | Active |
| 65197-0297-24 65197-297-24 | 3 BLISTER PACK in 1 CARTON / 8 TABLET, CHEWABLE in 1 BLISTER PACK | 2025-04-01 | — | Active |
| 65197-0297-48 65197-297-48 | 2 CARTON in 1 CARTON / 3 BLISTER PACK in 1 CARTON / 8 TABLET, CHEWABLE in 1 BLISTER PACK | 2026-05-31 | — | Active |
Pack size FAQ
What quantity is in this package?
This is a 8-count package — 1 blister pack in 1 box / 8 tablet, chewable in 1 blister pack.
How does this package differ from NDC 65197-0297-12?
Both are Bonine meclizine hydrochloride 25 mg Tablet, Chewable — the drug itself is identical. This page's package is the 8-count one, while NDC 65197-0297-12 is the 12 tablets package.
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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price 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 mg 65197-0275-02 | WellSpring | 2 tablets | — | — | FDA listed | — |
| Bonine 25 mg 65197-0296-08 | WellSpring | 8 tablets | — | — | FDA listed | — |
| Bonine 25 mgthis 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file
Availability & generic status
🏛️
2025
On the market since
Apr 2025
📍
2026
Currently FDA-listed
1 year 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.
- FDA Orange Book · refreshed Sep 3, 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 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 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 O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
6 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statescolloidal silicon dioxide, dextrose, FD&C red #40 aluminum lake, flavor, lactose monohydrate, magnesium stearate, pregelatinized starch, propylene glycol, 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.- 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
LabelerWellSpring Pharmaceutical Corporation
FDA applicationM009 (OTC MONOGRAPH DRUG)
Labeler code65197
First marketedApr 2025
Product typeHuman Otc Drug
Portfolio30 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
🤰 If Pregnant or Breast-Feeding
📄 Keep Out of Reach of Children
📄 Questions or Comments
📄 Package Label / Principal Display Panel
🎯 Indications and Usage ▾
Uses prevents and treats nausea, vomiting or dizziness associated with motion sickness
⏱️ Dosage and Administration ▾
Directions 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 ▾
Warnings Do not use in children under 12 years of age unless directed by a doctor. Ask a doctor before use if you have difficulty in urination due to enlargement of the prostate gland glaucoma a breathing problem such as emphysema or chronic bronchitis Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product avoid alcoholic beverages alcohol, sedatives, and tranquilizers may increase drowsiness drowsiness may occur use caution 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 ▾
Other information store at 25˚C (77˚F); excursions permitted between 15˚-30˚C (59˚-86˚F) see end flap for expiration date and lot number protect from heat and humidity
🧪 Active Ingredient ▾
Active ingredient (in each tablet) Meclizine HCl 25 mg
🧪 Inactive Ingredients ▾
Inactive ingredients colloidal silicon dioxide, dextrose, FD&C red #40 aluminum lake, flavor, lactose monohydrate, magnesium stearate, pregelatinized starch, propylene glycol, saccharin sodium, silicon dioxide
🎯 Purpose ▾
Purpose Antiemetic
📄 Do Not Use ▾
Do not use in children under 12 years of age unless directed by a doctor.
📄 Ask a Doctor Before Use If ▾
Ask a doctor before use if you have difficulty in urination due to enlargement of the prostate gland glaucoma a breathing problem such as emphysema or chronic bronchitis
📄 Ask a Doctor or Pharmacist Before Use If ▾
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.
📄 When Using This Product ▾
When using this product avoid alcoholic beverages alcohol, sedatives, and tranquilizers may increase drowsiness drowsiness may occur use caution when driving a motor vehicle or operating machinery
🤰 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? 1 (844) 241-5454 or www.bonine.com
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 65197-297 TRAVEL SIZE Less drowsy vs. Dramamine® dimenhydrinate. Dramamine® is a registered trademark of Medtech Products Inc. 9X the Adventure** Meclizine HCl • Antiemetic 25 mg bonine 12ct bonine 12 ct Carton Back CT029512RF Carton 12 Front
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
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: this package is listed as actively marketed, with no marketing end date reported by WellSpring Pharmaceutical Corporation. 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 (65197-0297-16), 8 tablets (65197-0297-24), 8 tablets (65197-0297-48). 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.
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.