Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
Vivarin caffeine 200 mg Tablet, 16-count — NDC 71179-018-16 (Billing 71179-0018-16)
by Vespyr Brands LLC · 2 BLISTER PACK in 1 CARTON / 8 TABLET in 1 BLISTER PACK
This is a package of 16 tablets of Vivarin caffeine 200 mg Tablet from Vespyr Brands LLC, marketed since Jun 2023 and currently FDA-listed. It is the main listing for this product, which comes in 4 package sizes.
NDC 71179-0018-16
🏷️ FDA NDC (as labeled)
71179-018-16
billing pads the product segment with a zero
This package
Contains16-count
Pack sizes4 compare ↓
Main listing for product 71179-018 · Also comes in:
24 tablets 71179-018-24
40 tablets 71179-018-40
60 tablets 71179-018-60
🗂️ 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 →
NDC database record
One package, one record: these facts belong to NDC 71179-018-16 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 71179 labeler · 018 product · 16 package
- Package marketed since
- Jun 19, 2023
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Barcode (UPC-A, from the NDC)
- 3 7117901816 6
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
71179-018-16
Product NDC
71179-018
11-digit billing NDC
71179001816
UNII
3G6A5W338E
Application #
M011
SPL Set ID
4537a56b-e875-4961-9fff-3f778746f126
Established class (EPC)
Central Nervous System Stimulant; Methylxanthine
Physiologic effect
Central Nervous System Stimulation
Chemical class
Xanthines
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2023-06-19
Route
ORAL
Dosage form
TABLET
Substance
CAFFEINE
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
GCN Seq No
000033
GCN
00212
HICL code
000012
Ingredient (HICL)
Caffeine
HIC1 code
A
Therapeutic class — broad (HIC1)
Cardiovascular System
HIC2 code
A1
Therapeutic class — intermediate (HIC2)
Cardiac Stimulants
HIC3 code
A1B
Therapeutic class — specific (HIC3)
Xanthines
AHFS code
28:20.32.00
AHFS class
Respiratory And Cns Stimulants
FDB label name
VIVARIN 200 MG TABLET
FDB brand name
Vivarin
Legend status
O — Over-the-counter (OTC) drug or device
Quick answers
- GSN (GCN sequence number): 000033
- GCN: 00212
- HICL (First Databank): 000012
- AHFS class code: 28:20.32.00
- RxCUI (RxNorm): 198520
Why two NDCs?
The FDA registers this code as 71179-018-16 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 71179-0018-16. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 3, 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 Central Nervous System Stimulant class.
Pharmacologic class
Central Nervous System Stimulant, Methylxanthine
Drug family (ATC)
Tests for gastric secretion, Other dermatologicals, Xanthine 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 VIVARIN 200 MG TABLET Ingredient Caffeine
📗 Our plain-language guide HelloPharmacist
- It is used short term to treat apnea of prematurity, which means pauses in breathing in premature infants. It is given as an injection or an oral solution by the healthcare team.
- The baby usually gets a one-time loading dose into a vein, then a smaller maintenance dose about every 24 hours. The maintenance dose can be given into a vein or by mouth. The dose...
- Babies may be jittery or irritable, have a fast heart rate, have feeding problems, or have a rash. Blood sugar and urine output can also change. Tell the care team if you notice an...
- Yes. Necrotizing enterocolitis, a serious intestinal problem in premature infants, was seen in trials. A cause was not proven, and the team watches closely for it. Too much caffein...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Caffeine (OTC drug) — tap one for details:
1
Nutrient depletion considerations
Caffeine (OTC drug) may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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 3, 2026
💬 Questions about caffeine?
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 4, 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 |
|---|---|---|---|---|
| 71179-0018-16 You're viewing this Main listing | 2 BLISTER PACK in 1 CARTON / 8 TABLET in 1 BLISTER PACK | 2023-06-19 | — | Active |
| 71179-0018-40 71179-018-40 | 5 BLISTER PACK in 1 CARTON / 8 TABLET in 1 BLISTER PACK | 2023-06-19 | — | Active |
| 71179-0018-60 71179-018-60 | 1 BOTTLE in 1 CARTON / 60 TABLET in 1 BOTTLE | 2024-01-02 | — | Active |
| 71179-0018-24 71179-018-24 | 1 BOTTLE in 1 CARTON / 24 TABLET in 1 BOTTLE | 2025-09-25 | — | Active |
Pack size FAQ
What quantity is in this package?
This is a 16-count package — 2 blister pack in 1 carton / 8 tablet in 1 blister pack.
How does this package differ from NDC 71179-0018-24?
Both are Vivarin caffeine 200 mg Tablet — the drug itself is identical. This page's package is the 16-count one, while NDC 71179-0018-24 is the 24 tablets package.
What NDC number is used to bill for this package of Vivarin caffeine 200 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 |
|---|---|---|---|---|---|---|
| Alert Aid 200 mg 46122-0457-73 | Amerisource | 16 tablets | $0.083 | — | Availability likely | — |
| Caffeine 200 mg 70000-0409-01 | LEADER/ | 16 tablets | $0.083 | — | Availability likely | — |
| Stay Awake 200 mg 70677-1126-01 | Strategic | 16 tablets | $0.083 | — | Availability likely | — |
| Stay Awake 200 mg 83324-0074-16 | Chain | 16 tablets | $0.083 | — | Availability likely | — |
| Awake Maximum Strength 200 mg 00363-3440-11 | Walgreen | 60 tablets | — | — | FDA listed | — |
| Caffeine 200 mg 00363-5009-01 | Walgreen | 100 tablets | — | — | FDA listed | — |
| stay awake 200 mg 11822-2260-02 | Rite | 100 tablets | — | — | FDA listed | — |
| JET ALERT Double Strength 200 mg 15579-0200-16 | Bell | 90 tablets | — | — | FDA listed | — |
| Stay Awake Maximum Strength 200 mg 21130-0226-10 | Better | 40 tablets | — | — | FDA listed | — |
| Awake Maximum Strength 200 mg 21130-0944-11 | Better | 60 tablets | — | — | FDA listed | — |
| Stay Awake 200 mg 30142-0284-40 | KROGER | 40 tablets | — | — | FDA listed | — |
| Stay Awake 200 mg 30142-0726-10 | Kroger | 40 tablets | — | — | FDA listed | — |
| Awake Maximum Strength 200 mg 36800-0844-11 | Topco | 60 tablets | — | — | FDA listed | — |
| Stay Awake 200 mg 41163-0226-10 | United | 40 tablets | — | — | FDA listed | — |
| Stay Awake Maximum Strength 200 mg 41163-0434-11 | United | 60 tablets | — | — | FDA listed | — |
| Stay Awake 200 mg 49035-0226-31 | Wal-Mart | 80 tablets | — | — | FDA listed | — |
| Alert 200 mg 49483-0343-44 | Time | 40 tablets | — | — | FDA listed | — |
| Stay Awake 200 mg 50804-0262-10 | Geiss, | 40 tablets | — | — | FDA listed | — |
| Alert Alertness Aid 200 mg 50844-0226-12 | L.N.K. | 100 tablets | — | — | FDA listed | — |
| Stay Awake 200 mg 53943-0320-02 | DISCOUNT | 40 tablets | — | — | FDA listed | — |
| Stay Awake 200 mg 55301-0226-10 | ARMY | 40 tablets | — | — | FDA listed | — |
| Alert 200 mg 55910-0226-21 | DOLGENCORP, | 16 tablets | — | — | FDA listed | — |
| stay awake 200 mg 56062-0030-01 | PUBLIX | 16 tablets | — | — | FDA listed | — |
| Stay Awake 200 mg 57243-0226-21 | Salado | 16 tablets | — | — | FDA listed | — |
| Stay Awake 200 mg 57344-0220-02 | AAA | 40 tablets | — | — | FDA listed | — |
| caffeine 200 mg 58602-0747-47 | Aurohealth | 40 tablets | — | — | FDA listed | — |
| Stay Awake 200 mg 63868-0114-16 | CHAIN | 16 tablets | — | — | FDA listed | — |
| Stay Awake 200 mg 63941-0020-01 | VALU | 16 tablets | — | — | FDA listed | — |
| NoDoz Alertness Aid 200 mg 66715-9899-03 | Lil' | 2 tablets | — | — | FDA listed | — |
| Stay Awake 200 mg 67091-0117-16 | WinCo | 16 tablets | — | — | FDA listed | — |
| Vivarin 200 mg 67751-0226-04 | Navajo | 4 tablets | — | — | FDA listed | — |
| Alertness Aid 200 mg 68016-0680-16 | Chain | 16 tablets | — | — | Discontinued | — |
| Stay Awake 200 mg 68998-0076-84 | Marc | 8 tablets | — | — | FDA listed | — |
| Stay Awake 200 mg 69168-0076-40 | Allegiant | 40 tablets | — | — | FDA listed | — |
| Caffeine 200 mg 69842-0500-11 | CVS | 60 tablets | — | — | FDA listed | — |
| Caffeine 200 mg 69842-0509-10 | CVS | 40 tablets | — | — | FDA listed | — |
| Vivarin 200 mgthis 71179-0018-16 | Vespyr | 16 tablets | — | — | FDA listed | — |
| Stay Awake 200 mg 72036-0020-02 | Harris | 40 tablets | — | — | FDA listed | — |
| Stay Awake 200 mg 72476-0102-01 | RETAIL | 16 tablets | — | — | FDA listed | — |
| Topcare Stay Awake Maximum Strength 200 mg 76162-0002-58 | TopCo | 8 tablets | — | — | FDA listed | — |
| Stay Awake 200 mg 83059-0008-01 | Shield | 15 tablets | — | — | Discontinued | — |
| Stay Awake 200 mg 83059-0097-03 | Shield | 30 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 Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
🏛️
2023
On the market since
Jun 2023
📍
2026
Currently FDA-listed
3 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 Oct 3, 2026
What it looks like
Color
yellow
ShapeRound
ImprintV;V
Size11 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 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.
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.- FDA label on DailyMed · label index refreshed Oct 3, 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
LabelerVespyr Brands LLC
FDA applicationM011 (OTC MONOGRAPH DRUG)
Labeler code71179
First marketedJun 2023
Product typeHuman Otc Drug
Portfolio12 products on file
More NDCs from Vespyr Brands LLC labeler code 71179
- Guaifenesin 1200 mg Tablet, Extended Release NDC 71179-002-21
- CONTAC COLD AND FLU Acetaminophen, Dextromethorphan hydrobromide and Doxylamine Succinate 325 mg; 15 mg; 6.25 mg Capsule NDC 71179-003-08
- CONTAC Allergy Loratadine 10 mg Tablet NDC 71179-010-85
- Guaifenesin and Dextromethorphan HBr 1200 mg; 60 mg Tablet, Extended Release NDC 71179-011-21
- Cold-EEZE Cold Remedy Zinc Gluconate 13.3 mg Lozenge NDC 71179-320-25
- Cold-EEZE Cold Remedy Zinc Gluconate, Sambucus Nigra, Avena Sativa L., Rosa Canina, Echinacea Purpurea 6.2 mg; 50 mg; 2 mg; 4 mg; 13.3 mg Lozenge NDC 71179-323-12
- Cold-EEZE Cold Remedy Zinc Gluconate 13.3 mg Lozenge NDC 71179-324-02
- Cold-EEZE Cold Remedy honey lemon Zinc Gluconate 13.3 mg Lozenge NDC 71179-340-04
- Cold-EEZE Cold Remedy Zinc Gluconate, Sambucus Nigra, Avena Sativa L., Rosa Canina, Echinacea Purpurea 13.3 mg; 50 mg; 6.2 mg; 2 mg; 4 mg Lozenge NDC 71179-342-25
- Cold-EEZE Cold Remedy Zinc Gluconate, Sambucus Nigra, Glycyrrhiza Glabra 13.3 mg; 4.5 mg; 45 mg Lozenge NDC 71179-343-25
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
📄 Stop Use and Ask a Doctor If
🤰 If Pregnant or Breast-Feeding
📄 Keep Out of Reach of Children
📄 Questions or Comments
📄 Package Label / Principal Display Panel
🎯 Indications and Usage ▾
Use Helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness
⏱️ Dosage and Administration ▾
Directions Adults and children 12 years of age and over: take 1 tablet not more often than every 3 to 4 hours.
⚠️ Warnings ▾
Warnings Do not use as a substitute for sleep. This product is intended for occasional use only. in children under 12 years of age
📦 Storage and Handling ▾
Other information each tablet contains calcium 60 mg store in a dry place at 15° - 30°C (59° - 86°F) avoid excessive heat (greater than 100°F) or humidity
🧪 Active Ingredient ▾
Drug Facts Active ingredient (in each tablet) Caffeine 200mg
🧪 Inactive Ingredients ▾
Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 aluminum lake, dicalcium phosphate dihydrate, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, corn starch, titanium dioxide
🎯 Purpose ▾
Purpose Alertness aid
📄 When Using This Product ▾
When using this product limit the use of caffeine-containing medications, foods, or beverages because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally, rapid heartbeat. The recommended dose of this product contains about as much caffeine as a cup of coffee.
📄 Stop Use and Ask a Doctor If ▾
Stop use and ask a doctor if fatigue or drowsiness persists or continues to recur.
🤰 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? Call toll-free 1-855-874-0970 weekdays DISTRIBUTED BY: Vespyr Brands®, Inc. East Windsor, NJ 08520 Made in India Code: TS/DRUGS/16/2014
📄 Package Label / Principal Display Panel ▾
16 Tablets Container Carton NDC 71179-018-16 V VIVARIN® CAFFEINE ALERTNESS AID 16 Tablets | 200 mg Each PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 200 mg (16 Tablets Container Carton)
24 Tablets Container Carton VIVARIN CAFFEINE ALERTNESS AID SAFE & EFFECTIVE 24 Tablets | 200 mg Each NDC 71179-018-24 24 count label
60 Tablets Container Carton VIVARIN CAFFEINE ALERTNESS AID SAFE & EFFECTIVE 60 Tablets | 200 mg Each NDC 71179-018-24 60 count label 60 count bonus 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 Vivarin (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 35%
Female · 65%
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) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 Vespyr Brands LLC. 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 3 other package presentations of this same product, including 24 tablets (71179-0018-24), 40 tablets (71179-0018-40), 60 tablets (71179-0018-60). 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?
Vespyr Brands 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.
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.