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NAUS-EASE MECLIZINE HYDROCHLORIDE 25 mg Film, Soluble — NDC 49467-0104-01 package photo

NAUS-EASE MECLIZINE HYDROCHLORIDE 25 mg Film, Soluble

by Sunascen Therapeutics LLC · 8 POUCH in 1 CARTON (49467-104-01) / 1 FILM, SOLUBLE in 1 POUCH
NDC 49467-0104-01
🏷️ FDA NDC (as labeled) 49467-104-01 billing pads the product segment with a zero
This package
Contains1 film, soluble in 1 pouch Pack sizes2 compare ↓
Also comes in: 1 film 49467-0104-16
OTC Discontinued Non-controlled ⚠ Inactivated by FDA
🗂️ Data synced Jul 14, 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

⚠️
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 ↗
⚠️
Excluded from the active FDA NDC Directory. FDA inactivated this product’s listing record, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2024. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 49467-104-01
Product NDC 49467-104
11-digit billing NDC 49467010401
Application # part336
SPL Set ID 45ed34ea-457f-4d7e-8d2f-2c3ff5054a87
Physiologic effect Antiemetic [EPC], Emesis Suppression
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH FINAL
Marketing status Discontinued
FDA listing status Inactivated by FDA (certified through Dec 2024)
Route ORAL
Dosage form FILM, SOLUBLE
Substance MECLIZINE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 49467-104-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 49467-0104-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerSunascen Therapeutics LLC
FDA applicationpart336 (OTC MONOGRAPH FINAL)
Labeler code49467
Product typeHuman Otc Drug
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.

🩺 Clinical

📗 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.

🧪 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 XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • UNII RS7A450LGA
    A sodium salt derived from citric acid that helps regulate acidity and maintain pH balance in the medicine. It also works as a binding agent to hold tablet ingredients together.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII D65DG142WK
    Maltitol is a sugar alcohol made by hydrogenating maltose. It's used as a sweetener and filler in medicines to improve taste and add bulk to tablets and capsules.
  • UNII 11628IH70O
    Polyethylene oxide is a synthetic polymer derived from ethylene. In medicines, it acts as a binder to hold ingredients together, a thickener to adjust texture, and a disintegrant to help the tablet or capsule break apart for absorption.

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

The official label also statesPolyethylene oxide, Hydroxypropyl methylcellulose, Maltitol, Citric acid, Sodium citrate, and FD&C green #3.

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.

💲 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: 1 film
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Naus-Ease 25 mgthis 49467-0104-01 Sunascen 1 film — — Discontinued —
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

📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
49467-0104-01 You're viewing this 8 POUCH in 1 CARTON (49467-104-01) / 1 FILM, SOLUBLE in 1 POUCH 2012-04-16 Inactivated by FDA
49467-0104-16 16 POUCH in 1 CARTON (49467-104-16) / 1 FILM, SOLUBLE in 1 POUCH 2012-04-16 Inactivated by FDA

Pack size FAQ

What quantity is in NDC 49467-0104-01?
NDC 49467-0104-01 is listed by the FDA — 8 pouch in 1 carton / 1 film, soluble in 1 pouch.
What NDC number is used to bill for this package of NAUS-EASE MECLIZINE HYDROCHLORIDE 25 mg Film, Soluble?
Bill NDC 49467-0104-01 — the 11-digit billing format is 49467010401. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product No longer marketed (per FDA listing data)
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 Final". 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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 FDA registers it as 49467-104-01, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 49467-0104-01, written without dashes as 49467010401. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 49467-0104-01, the first segment (49467) is the labeler code FDA assigned to Sunascen Therapeutics LLC; the middle segment (0104) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 film (49467-0104-16). 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?
Sunascen Therapeutics LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 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 ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🤰 Pregnancy 🧒 Pediatric Use 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📋 Description
🎯 Indications and Usage 89 words ▾

INDICATIONS AND USAGE For Consumers (the general public): Naus-Ease® (Meclizine Hydrochloride), USP Film Strips are used for the prevention and treatment of nausea and vomiting, or dizziness associated with motion sickness. For Health Professionals: Based on a review of Meclizine Hydrochloride, USP drug by the National Academy of Sciences – National Research Council and/or other information, FDA has classified the indications of Meclizine Hydrochloride, USP as follows: 1. The prevention and treatment (management) of nausea and vomiting, and dizziness associated with motion sickness.

2. For the treatment of vertigo.

⏱️ Dosage and Administration 100 words ▾

DOSAGE AND ADMINISTRATION (DIRECTIONS) Adults and children 12 years of age and over: Take 1 to 2 Naus-Ease® (Meclizine Hydrochloride), USP Film Strips (25 mg to 50 mg) once daily, or as directed by a physician. Place a film strip on the tongue. Allow each film strip to completely dissolve, and then swallow.

The initial dose of 25 mg to 50 mg of Naus-Ease® (Meclizine Hydrochloride), USP Film Strips should be taken one hour prior to travel for the prevention and treatment of motion sickness. Thereafter, the dose may be repeated every 24 hours for the duration of the journey.

⛔ Contraindications 16 words ▾

CONTRAINDICATIONS Meclizine Hydrochloride, USP is contraindicated in individuals who have shown a previous hypersensitivity to it.

⚠️ Warnings 194 words ▾

WARNINGS Clinical studies establishing safety and effectiveness in children under 12 years of age have not been done; therefore, usage is not recommended in children under 12 years of age unless directed by a doctor. Due to its potential anticholinergic action, do not take unless directed by a doctor if you have a breathing problem such as asthma, emphysema, or chronic bronchitis, glaucoma, or difficulty in urination due to enlargement of the prostate gland. Ask a doctor before use if you are taking sedatives or tranquilizers.

When using this product: 1. Do not exceed the recommended dosage. 2.

May cause drowsiness. 3. Patients should avoid alcoholic beverages while taking this drug.

4. Since drowsiness may, on occasion, occur with use of this drug, patients should be warned of this possibility and cautioned against driving a car or operating dangerous machinery. Therefore patients are reminded caution when driving or operating machinery.

5. Alcohol, sedatives and tranquilizers may increase drowsiness. If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, seek medical help or contact a Poison Control Center right away. Call Poison Control at 1-800-222-1222

🤒 Adverse Reactions 19 words ▾

ADVERSE REACTIONS Anaphylactoid reaction, drowsiness, dry mouth, headache, fatigue, vomiting and, on rare occasions, blurred vision have been reported.

🤰 Pregnancy 82 words ▾

Pregnancy Use Pregnancy Category B. Reproduction studies in rats have shown cleft palates at 25 to 50 times the human dose. Epidemiological studies in pregnant women, however, do not indicate that Meclizine Hydrochloride, USP increases the risk of abnormalities when administered during pregnancy.

Despite the animal findings, it would appear that the possibility of fetal harm is remote. Nevertheless, Meclizine Hydrochloride, USP or any other medication, should be used during pregnancy only if clearly necessary, and after speaking with a health professional.

🧒 Pediatric Use 36 words ▾

Pediatric Use Clinical studies establishing safety and effectiveness in children under 12 years of age have not been done; therefore, usage is not recommended in children under 12 years of age unless directed by a doctor.

🧬 Clinical Pharmacology 209 words ▾

CLINICAL PHARMACOLOGY Meclizine Hydrochloride, USP is an antihistamine that shows marked protective activity against nebulized histamine and lethal doses of intravenously injected histamine in guinea pigs. It has a marked effect in blocking the vasodepressor response to histamine, but only a slight blocking action against acetylcholine. Its activity is relatively weak in inhibiting the spasmogenic action of histamine on isolated guinea pig ileum.

Pharmacokinetics The available pharmacokinetic information for Meclizine Hydrochloride, USP following oral administration has been summarized from published literature. Absorption Meclizine Hydrochloride, USP is absorbed after oral administration with maximum plasma concentrations reaching at a median T max value of 3 hours post-dose (range: 1.5 to 6 hours) for the tablet dosage form. Distribution Drug distribution characteristics for Meclizine Hydrochloride, USP in humans remains unknown.

Metabolism The metabolic fate of Meclizine Hydrochloride, USP in humans is unknown. In an in vitro metabolic study using human hepatic microsome and recombinant CYP enzyme, CYP 2D6 was found to be the dominant enzyme for metabolism of Meclizine Hydrochloride, USP. The genetic polymorphism of CYP2D6 that results in extensive-, poor-, intermediate- and ultrarapid metabolizer phenotypes could contribute to large inter-individual variability in Meclizine Hydrochloride, USP exposure.

Elimination Meclizine Hydrochloride, USP has a plasma elimination half-life of about 5-6 hours in humans.

📦 How Supplied / Storage and Handling 71 words ▾

HOW SUPPLIED Naus-Ease® (Meclizine Hydrochloride), USP Film Strips are available in 25mg strengths. Each Film Strip is individualy wrapped in a pouch, and is available in 8 and 16 count package sizes. 25 mg (Green rectangular shaped, with "S1" printed on each film strip) Naus-Ease® (Meclizine Hydrochloride), USP; 8 Film Strips: NDC 49467-104-01 Naus-Ease® (Meclizine Hydrochloride), USP; 16 Film Strips: NDC 49467-104-16 Distributed by: Sunascen Therapeutics LLC Rockville, MD 20850 USA

🧪 Active Ingredient 7 words ▾

ACTIVE INGREDIENTS Meclizine Hydrochloride, USP 25 mg

🧪 Inactive Ingredients 15 words ▾

INACTIVE INGREDIENTS Polyethylene oxide, Hydroxypropyl methylcellulose, Maltitol, Citric acid, Sodium citrate, and FD&C green #3.

🎯 Purpose 2 words ▾

PURPOSE Antiemetic

📋 Description 66 words ▾

DESCRIPTION Chemically, Meclizine Hydrochloride, USP is 1-( p -Chloro-α-phenylbenzyl)-4-( m -methylbenzyl) piperazine dihydrochloride monohydrate. Meclizine Hydrochloride, USP is an oral antiemetic, which is a white to slightly yellowish crystalline powder having a slight odor and is tasteless. The molecular weight is 481.89 g/mol.

It has the following structural formula: C 25 H 27 CIN 2 ·2HCl·H 2 0 M.W. 481.88544 g/mol Meclizine Hydrochloride, USP Structural Formula

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 49464-0001-01 · Hubei 49471-0001-05 · ALK-ABELLO, →
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.