Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
Meclizine 12.5 mg Tablet, 100-count — NDC 16103-386-08 (Billing 16103-0386-08)
by Pharbest Pharmaceuticals, Inc. · 100 TABLET in 1 BOTTLE, PLASTIC
This is a package of 100 tablets of Meclizine 12.5 mg Tablet from Pharbest Pharmaceuticals, Inc., marketed since Feb 2018 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.
NDC 16103-0386-08
🏷️ FDA NDC (as labeled)
16103-386-08
billing pads the product segment with a zero
This package
Contains100-count
Pack sizes2 compare ↓
Also priced by: Part D plans $0.1825/unit — full pricing hub ↓
Main listing for product 16103-386 · Also comes in:
1000 tablets 16103-386-11
🗂️ 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)
16103-386-08
Product NDC
16103-386
11-digit billing NDC
16103038608
NCPDP billing unit
EA — each (per item)
RxCUI
995624
UNII
HDP7W44CIO
Application #
M009
SPL Set ID
8b3c9283-b618-4d57-9f15-7cf73e8737f5
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
2018-02-01
Route
ORAL
Dosage form
TABLET
Substance
MECLIZINE HYDROCHLORIDE
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
GPI-14
50200050000305
GPI class
Meclizine HCl
GCN Seq No
004731
GCN
18301
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
MECLIZINE 12.5 MG CAPLET
FDB brand name
Meclizine Hcl
Legend status
O — Over-the-counter (OTC) drug or device
Quick answers
- GSN (GCN sequence number): 004731
- GCN: 18301
- GPI-14 (Medi-Span): 50200050000305
- HICL (First Databank): 001975
- AHFS class code: 04:04.16.00
- RxCUI (RxNorm): 995624
Why two NDCs?
The FDA registers this code as 16103-386-08 — 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 → 16103-0386-08. 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
Label name MECLIZINE 12.5 MG CAPLET 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...
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 HCl 12.5 mg?
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 · Q2 2026 | $0.1825 | $18.25 / 100 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.
- 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 |
|---|---|---|---|---|
| 16103-0386-08 You're viewing this Main listing | 100 TABLET in 1 BOTTLE, PLASTIC | 2018-02-01 | — | Active |
| 16103-0386-11 16103-386-11 | 1000 TABLET in 1 BOTTLE, PLASTIC | 2018-02-01 | — | Active |
You're viewing the smallest of 2 pack sizes for this product.
Pack size FAQ
What quantity is in this package?
This is a 100-count package — 100 tablet in 1 bottle, plastic.
How does this package differ from NDC 16103-0386-11?
Both are Meclizine 12.5 mg Tablet — the drug itself is identical. This page's package is the 100-count one, while NDC 16103-0386-11 is the 1000 tablets package.
What NDC number is used to bill for this package of Meclizine 12.5 mg Tablet?
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 12.5 mg 00536-1297-01 | RUGBY | 100 tablets | $0.031 | — | Availability likely | — |
| Meclizine Hydrochloride 12.5 mg 24689-0138-01 | APNAR | 100 tablets | $0.031 | — | Availability likely | — |
| Meclizine HCl 12.5 mg 57237-0333-01 | Rising | 100 tablets | $0.031 | — | Availability likely | — |
| Meclizine HCl 12.5 mg 68001-0528-00 | BluePoint | 100 tablets | $0.031 | — | Availability likely | — |
| Meclizine Hydrochloride 12.5 mg 00904-7375-61 | Major | 100 tablets | $0.044 | AA | Availability likely | — |
| Meclizine Hydrochloride 12.5 mg 16571-0660-01 | Rising | 100 tablets | $0.044 | AA | Availability likely | — |
| Meclizine Hydrochloride 12.5 mg 50268-0522-15 | AvPAK | 50 tablets | $0.044 | AA | Availability likely | — |
| Meclizine Hydrochloride 12.5 mg 53746-0441-01 | Amneal | 100 tablets | $0.044 | AA | Availability likely | — |
| Meclizine Hydrochloride 12.5 mg 59651-0807-01 | Aurobindo | 100 tablets | $0.044 | AA | Availability likely | — |
| Meclizine Hydrochloride 12.5 mg 59746-0122-06 | Jubilant | 100 tablets | $0.044 | AA | Availability likely | — |
| Meclizine Hydrochloride 12.5 mg 60687-0775-01 | American | 100 tablets | $0.044 | AA | Availability likely | — |
| Meclizine Hydrochloride 12.5 mg 62135-0952-90 | Chartwell | 90 tablets | $0.044 | AA | Availability likely | — |
| Meclizine Hydrochloride 12.5 mg 70710-1161-00 | Zydus | 1000 tablets | $0.044 | AA | Availability likely | — |
| Meclizine Hydrochloride 12.5 mg 42806-0012-01 | Epic | 100 tablets | $0.046 | AA | Availability likely | — |
| Meclizine Hydrochloride 12.5 mg 00615-8514-39 | NCS | 30 tablets | — | AA | FDA listed | — |
| Meclizine 12.5 mgthis 16103-0386-08 | Pharbest | 100 tablets | — | — | FDA listed | — |
| Meclizine HCL 12.5 mg 17714-0117-01 | Advance | 100 tablets | — | — | FDA listed | — |
| Meclizine Hydrochloride 12.5 mg 63629-2432-01 | Bryant | 1000 tablets | — | AA | FDA listed | — |
| Meclizine Hydrochloride 12.5 mg 65162-0441-03 | Amneal | 30 tablets | — | AA | FDA listed | — |
| Meclizine Hydrochloride 12.5 mg 67296-2250-03 | Redpharm | 30 tablets | — | AA | FDA listed | — |
| Meclizine Hydrochloride 12.5 mg 68788-8633-01 | Preferred | 10 tablets | — | AA | FDA listed | — |
| Meclizine HCL 12.5 mg 69618-0027-01 | Reliable | 100 tablets | — | — | FDA listed | — |
| Meclizine Hydrochloride 12.5 mg 70518-3768-00 | REMEDYREPACK | 30 tablets | — | AA | FDA listed | — |
| Meclizine Hydrochloride 12.5 mg 70771-1539-00 | Zydus | 1000 tablets | — | AA | FDA listed | — |
| Meclizine Hydrochloride 12.5 mg 71205-0416-10 | Proficient | 10 tablets | — | AA | FDA listed | — |
| Meclizine Hydrochloride 12.5 mg 71205-0647-10 | Proficient | 10 tablets | — | AA | FDA listed | — |
| Meclizine HCL 12.5 mg 71205-0762-30 | Proficient | 30 tablets | — | — | FDA listed | — |
| Meclizine Hydrochloride 12.5 mg 71335-0153-01 | Bryant | 30 tablets | — | AA | FDA listed | — |
| Meclizine Hydrochloride 12.5 mg 71335-1563-01 | Bryant | 30 tablets | — | AA | FDA listed | — |
| Meclizine Hydrochloride 12.5 mg 71335-1872-01 | Bryant | 30 tablets | — | AA | FDA listed | — |
| Meclizine Hydrochloride 12.5 mg 71335-3139-01 | Bryant | 1000 tablets | — | AA | FDA listed | — |
| Meclizine Hydrochloride 12.5 mg 71335-3141-01 | Bryant | 30 tablets | — | AA | FDA listed | — |
| Meclizine Hydrochloride 12.5 mg 72162-1690-00 | Bryant | 1000 tablets | — | AA | FDA listed | — |
| Meclizine Hydrochloride 12.5 mg 72189-0302-30 | DirectRx | 30 tablets | — | AA | FDA listed | — |
| Meclizine 12.5 mg 73057-0386-08 | Ulai | 100 tablets | — | — | FDA listed | — |
| Meclizine Hydrochloride 12.5 mg 76420-0797-01 | Asclemed | 100 tablets | — | AA | FDA listed | — |
| Meclizine 12.5 mg 80513-0427-02 | Advanced | 200 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
🏛️
2018
On the market since
Feb 2018
📍
2026
Currently FDA-listed
8 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.
- FDA Orange Book · refreshed Sep 3, 2026
What it looks like
Color
white
ShapeCapsule
ImprintPH049
Size13 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 L11K75P92J
A mineral salt made from calcium and phosphate. It acts as a filler and binder in tablets to add bulk and help hold the medicine together in solid form.
-
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 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 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 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.
6 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesCroscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid
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
LabelerPharbest Pharmaceuticals, Inc.
FDA applicationM009 (OTC MONOGRAPH DRUG)
Labeler code16103
First marketedFeb 2018
Product typeHuman Otc Drug
Portfolio15 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
📄 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 1 hour before travel starts Adults and children 12 years and over take 2 or 4 caplets once daily or as directed by doctor
⚠️ Warnings ▾
Warnings Do not use for 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 may cause drowsiness alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks 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 (800-222-1222).
📦 Storage and Handling ▾
Other information Tamper Evident: do not use if safety seal under cap is broken or missing each caplet contains: calcium 28 mg store at 20°-25°C (68°-77°F), excursions permitted between 15-30°C(59-86°F)
🧪 Active Ingredient ▾
Active ingredient (in each caplet) Meclizine HCl 12.5mg
🧪 Inactive Ingredients ▾
Inactive ingredients Croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid
🎯 Purpose ▾
Purpose Antiemetic
📄 When Using This Product ▾
When using this product do not exceed recommended dosage may cause drowsiness alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks 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 (800-222-1222).
📄 Questions or Comments ▾
Questions or comments? (866) 562-2756 (Mon-Fri, 8 AM to 4 PM EST).
📄 Package Label / Principal Display Panel ▾
PHARBEST NDC 16103-386-08 Manufactured in the USA Motion Sickness Relief MECLIZINE Meclizine HCl 12.5 mg Anti-Emetic • Motion Sickness • Nausea • Vomiting 100 CAPLETS Meclizine 12.5 mg caplet Product Label
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 ↗
Reported adverse events (FAERS)
Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for MECLIZINE (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 26%
Female · 74%
Unknown · 0%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
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 Pharbest Pharmaceuticals, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1000 tablets (16103-0386-11). 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?
Pharbest Pharmaceuticals, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
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.