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Dimenhydrinate 50 mg Tablet, 12-count — NDC 70000-0404-1 (Billing 70000-0404-01)

by LEADER/ Cardinal Health 110, Inc. · 1 BLISTER PACK in 1 CARTON / 12 TABLET in 1 BLISTER PACK

This is a package of 12 tablets of Dimenhydrinate 50 mg Tablet from LEADER/ Cardinal Health 110, Inc., marketed since Jan 2019 and currently FDA-listed, this package's marketing is listed to end Feb 2029; retail pharmacies pay about $0.0539 per tablet (NADAC). It is this product's only package size.

NDC 70000-0404-01
🏷️ FDA NDC (as labeled) 70000-0404-1 billing pads the package segment with a zero
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 70000-0404-1 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
70000 labeler · 0404 product · 1 package
Package marketed since
Jan 4, 2019
Package marketing ended
Feb 28, 2029
Sample package
No — commercial package
Billing quantity
12 EA per package
Barcode (UPC)
0096295135183
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70000-0404-1
Product NDC 70000-0404
11-digit billing NDC 70000040401
NCPDP billing unit EA — each (per item)
RxCUI 198603
UNII JB937PER5C
UPC 0096295135183
Application # M009
SPL Set ID 7c4adbdb-9bce-0c9c-e053-2a91aa0a8107
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-01-04
Marketing end 2029-02-28
Route ORAL
Dosage form TABLET
Substance DIMENHYDRINATE

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

GPI-14 50200030000310
GPI class Motion Sickness Relief
GCN Seq No 004720
GCN 18231
HICL code 004603
Ingredient (HICL) Dimenhydrinate
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 04:04.00.00
AHFS class First Generation Antihistamines
FDB label name MOTION SICKNESS 50 MG TABLET
FDB brand name Motion Sickness Relief
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 004720
  • GCN: 18231
  • GPI-14 (Medi-Span): 50200030000310
  • HICL (First Databank): 004603
  • AHFS class code: 04:04.00.00
  • RxCUI (RxNorm): 198603
Why two NDCs? The FDA registers this code as 70000-0404-1 — a 5-4-1 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 package segment → 70000-0404-01. 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.

RxNorm drug class

This medicine belongs to the Aminoalkyl ethers class.

Drug family (ATC) Aminoalkyl ethers
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 MOTION SICKNESS 50 MG TABLET Ingredient Dimenhydrinate
📗 Our plain-language guide HelloPharmacist
  • It prevents and treats the nausea, vomiting and dizziness of motion sickness. You'll see it in products like Dramamine and Gravol, and as an injection used in medical settings.
  • To prevent motion sickness, take your first dose about 30 to 60 minutes before you start traveling. After that, follow the repeat timing and daily limit on your product's label. Ch...
  • Quite possibly. Drowsiness is the most common side effect. Be careful driving or using machinery, and skip alcohol.
  • Tell me what else you take. Sedatives, tranquilizers and other sedating drugs can add to drowsiness. It can also hide warning signs of ear damage from certain antibiotics.
📖 Read our full Dimenhydrinate guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

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

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.054 $0.65 / 12 tablets
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.
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Jul 2022 Feb 2024 Jun 2026 $0.072 $0.036
▼ Down 7% over the last 21 months.
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
70000-0404-01 You're viewing this Main listing 1 BLISTER PACK in 1 CARTON / 12 TABLET in 1 BLISTER PACK 2019-01-04 Feb 28, 2029 Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Dimenhydrinate 50 mgthis 70000-0404-01 LEADER/ 12 tablets $0.054 — Availability likely —
Driminate 50 mg 00904-2051-59 Major 100 tablets $0.058 — Availability likely +7%
Dimenhydrinate 50 mg 00904-6772-12 Major 12 tablets $0.058 — Availability likely +7%
Motion Sickness Relief 50 mg 46122-0536-53 Amerisource 12 tablets $0.058 — Availability likely +7%
Motion Sickness Relief 50 mg 70000-0749-01 Cardinal 12 tablets $0.058 — Availability likely +7%
Motion Sickness 50 mg 70677-1087-01 Strategic 12 tablets $0.058 — Availability likely +7%
Motion Sickness Relief 50 mg 83324-0032-12 Chain 12 tablets $0.058 — Availability likely +7%
Motion Sickness Relief 50 mg 00363-1980-08 Walgreen 24 tablets — — FDA listed —
Gravol 50 mg 10237-0941-10 Church 10 tablets — — FDA listed —
Motion Sickness 50 mg 11673-0198-02 Target 12 tablets — — FDA listed —
Motion Sickness Relief 50 mg 11673-0354-24 TARGET 24 tablets — — FDA listed —
Motion Sickness Relief 50 mg 11822-0198-02 Rite 12 tablets — — FDA listed —
Motion Sickness Relief 50 mg 36800-0930-12 Topco 12 tablets — — FDA listed —
Motion Sickness Relief 50 mg 49035-0981-12 Wal-Mart 100 tablets — — FDA listed —
Motion Sickness 50 mg 50804-0198-02 Geiss, 12 tablets — — FDA listed —
Motion Sickness Relief 50 mg 50844-0199-02 L.N.K. 12 tablets — — FDA listed —
Motion Sickness 50 mg 59779-0198-02 CVS 12 tablets — — FDA listed —
Dramamine Original Formula 50 mg 63029-0901-01 Medtech 36 tablets — — FDA listed —
Motion Sickness Relief 50 mg 63941-0198-02 Valu 12 tablets — — FDA listed —
Motion Sickness Relief 50 mg 67091-0118-12 WinCo 12 tablets — — FDA listed —
Motion Sickness Relief 50 mg 69168-0408-86 Allegiant 12 tablets — — FDA listed —
Dimenhydrinate 50 mg 69842-0206-12 CVS 12 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

🏛️
2019
On the market since
Jan 2019
📍
2026
Currently FDA-listed
7 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.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

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

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerLEADER/ Cardinal Health 110, Inc.
FDA applicationM009 (OTC MONOGRAPH DRUG)
Labeler code70000
First marketedJan 2019
Product typeHuman Otc Drug
Portfolio38 products on file

More NDCs from LEADER/ Cardinal Health 110, Inc. labeler code 70000

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 🆘 Overdosage 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 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 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 15 words ▾

Uses for the prevention and treatment of nausea, vomiting, or dizziness associated with motion sickness

⏱️ Dosage and Administration 109 words ▾

Directions ■ to prevent motion sickness, the first dose should be taken one-half to one hour before starting activity ■ adults and children 12 years of age and over: 1 to 2 tablets every 4-6 hours; not to exceed 8 tablets in 24 hours, or as directed by a doctor ■ children 6 to under 12 years of age: 1/2 to 1 tablet every 6-8 hours; not to exceed 3 tablets in 24 hours, or as directed by a doctor ■ children 2 to under 6 years of age: 1/2 tablet every 6-8 hours; not to exceed 1 1/2 tablets in 24 hours, or as directed by a doctor

⚠️ Warnings 122 words ▾

Do not give to children under 2 years of age unless directed by a doctor Ask a doctor before use if you have ■ glaucoma ■ a breathing problem such as emphysema or chronic bronchitis ■ trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product ■ marked drowsiness may occur ■ avoid alcoholic drinks ■ alcohol, sedatives, and tranquilizers may increase drowsiness ■ 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 (1-800-222-1222) right away.

🆘 Overdosage 16 words ▾

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

🧪 Active Ingredient 10 words ▾

Drug Facts Active ingredient (in each tablet) Dimenhydrinate 50 mg

🧪 Inactive Ingredients 8 words ▾

croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose

🎯 Purpose 2 words ▾

Purpose Antiemetic

📄 Ask a Doctor Before Use If 29 words ▾

Ask a doctor before use if you have ■ glaucoma ■ a breathing problem such as emphysema or chronic bronchitis ■ trouble urinating due to an enlarged prostate gland

📄 Ask a Doctor or Pharmacist Before Use If 14 words ▾

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

📄 When Using This Product 32 words ▾

When using this product ■ marked drowsiness may occur ■ avoid alcoholic drinks ■ alcohol, sedatives, and tranquilizers may increase drowsiness ■ use caution 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 6 words ▾

Keep out of reach of children.

📄 Other Information 54 words ▾

Other information ■ each tablet contains : calcium 30 mg ■ store in a dry place at 15° – 30°C (59° – 86°F) ■ protect from moisture ■ see end flap for expiration date and lot number ■ TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN

📄 Questions or Comments 4 words ▾

Questions or comments? 1-800-231-4670

📄 Package Label / Principal Display Panel 32 words ▾

LEADER NDC 7000-0404-1 Original Formula Motion Sickness Relief Dimenhydrinate, 50 mg/ Antiemetic COMPARE TO DRAMAMINE® ORIGINAL FORMULA active ingredient* Fast Acting Motion Sickness Relief for Children & Adults 12 Tablets Cardinal Label

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

Medicare Part D spend CMS · PART D · 2025 (Q1-Q4)

Medicare Part D (outpatient prescription) spending for Dimenhydrinate — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Dimenhydrinate. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Total Part D spend
$4K
Claims incl. refills
15
Beneficiaries
—
Spend / beneficiary
—
Spend / claim
$269.22
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) ✓ Available
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.
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 LEADER/ Cardinal Health 110, Inc. has reported a marketing end date of 2029-02-28, after which this package is expected to stop being marketed. The directory data on this page refreshes weekly.
Who lists this product with the FDA?
LEADER/ Cardinal Health 110, 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.
← 70000-0401-01 · Cardinal 70000-0407-01 · Cardinal →
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.