Home
› NDC Lookup
› 68016-0807-04
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
Premier Value Nausea Control Cherry Flavor dextrose(glucose),Levulose(fructose),Phosphoric acid 1.87 g/5mL; 1.87 g/5mL; 21.5 mg/5mL Solution — NDC 68016-807-04 (Billing 68016-0807-04)
by PHARMACY VALUE ALLIANCE, LLC · 1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE
This is a package of Premier Value Nausea Control Cherry Flavor dextrose(glucose),Levulose(fructose),Phosphoric acid 1.87 g/5mL; 1.87 g/5mL; 21.5 mg/5mL Solution from PHARMACY VALUE ALLIANCE, LLC, marketed since Apr 2019 and currently FDA-listed. It is this product's only package size.
NDC 68016-0807-04
🏷️ FDA NDC (as labeled)
68016-807-04
billing pads the product segment with a zero
🗂️ FDA directory synced Oct 8, 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 68016-807-04 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 68016 labeler · 807 product · 04 package
- Package marketed since
- Apr 16, 2019
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC)
- 0840986015069
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
68016-807-04
Product NDC
68016-807
11-digit billing NDC
68016080704
RxCUI
318146
UNII
IY9XDZ35W2, 6YSS42VSEV, E4GA8884NN
UPC
0840986015069
SPL Set ID
8f000438-a9c3-45ca-8cb5-79151b2b3ead
DEA schedule
Non-controlled
Marketing category
UNAPPROVED DRUG OTHER
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2019-04-16
Route
ORAL
Dosage form
SOLUTION
Substance
DEXTROSE, UNSPECIFIED FORM; FRUCTOSE; PHOSPHORIC ACID
Quick answers
- RxCUI (RxNorm): 318146
Why two NDCs?
The FDA registers this code as 68016-807-04 — 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 → 68016-0807-04. 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 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 8, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
RxNorm drug class
This medicine belongs to the Carbohydrates class.
Drug family (ATC)
Carbohydrates
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 8, 2026
Clinical
🧪 What is this product?
Premier Value Nausea Control is an unapproved oral solution containing dextrose (glucose), fructose, and phosphoric acid. The simple sugars dextrose and fructose are typically used in nausea relief products to provide quick energy and settle the stomach, while phosphoric acid is commonly included in such formulations for its traditional use in managing nausea symptoms. This product is marketed without an FDA-approved application.
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 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
💬 Questions about dextrose(glucose),Levulose(fructose),Phosphoric acid?
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 mL | 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 9, 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 |
|---|---|---|---|---|
| 68016-0807-04 You're viewing this Main listing | 1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE | 2019-04-16 | — | Active |
Therapeutic equivalents
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 8, 2026
- FDA Orange Book · refreshed Oct 9, 2026
- CMS NADAC weekly file
Availability & generic status
🏛️
2019
On the market since
Apr 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.
- FDA Orange Book · refreshed Oct 9, 2026
What it looks like
Color
Red
FlavorCherry
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 8, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII WZB9127XOA
A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
-
UNII PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
-
UNII A2I8C7HI9T
Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
-
UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
4 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesFD&C red no. 40, flavors, glycerin, methylparaben, purified water.
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 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 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
LabelerPHARMACY VALUE ALLIANCE, LLC
Labeler code68016
First marketedApr 2019
Product typeHuman Otc Drug
Portfolio26 products on file
More NDCs from PHARMACY VALUE ALLIANCE, LLC labeler code 68016
- Cold and Flu Relief Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl 325 mg; 10 mg; 5 mg Capsule, Liquid Filled NDC 68016-797-16
- Nighttime Cold and Flu Relief Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate 325 mg; 15 mg; 6.25 mg Capsule, Liquid Filled NDC 68016-798-16
- Daytime Nighttime Cold Flu Relief Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCL Kit NDC 68016-799-48
- Famotidine 10 mg Tablet NDC 68016-800-30
- Famotidine 20 mg Tablet NDC 68016-801-25
- Isopropyl Alcohol 91 mL/100mL Liquid NDC 68016-804-43
- Premier Value Isopropyl Alcohol 70 mL/100mL Swab NDC 68016-809-30
- 70% Isopropyl alcohol 70 mL/100mL Liquid NDC 68016-810-43
- Premier Value Extra Strength Simethicone 125 mg Tablet, Chewable NDC 68016-811-18
- Ibuprofen 200 mg Capsule, Liquid Filled NDC 68016-813-40
- Premiere Value Ear Drops for Swimmers Isopropyl Alcohol 950 mg/mL Liquid NDC 68016-820-91
- Premier Value Instant Antiseptic Pain Relief Camphor 10.8% and Phenol 4.7% 108 mg/mL; 47 mg/mL Liquid NDC 68016-821-45
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 8, 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
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
📄 Do Not Use
📄 Ask a Doctor Before Use If
📄 Stop Use and Ask a Doctor If
🤰 If Pregnant or Breast-Feeding
📄 Keep Out of Reach of Children
📄 Package Label / Principal Display Panel
🎯 Indications and Usage ▾
Uses ▪ For relief of upset stomach associated with nausea
⏱️ Dosage and Administration ▾
Directions ▪ for maximum effectiveness never dilute or drink fluids of any kind immediately before or after taking this product ▪ repeat dose every 15 minutes or until distress subsides ▪ do not take more than 5 doses in 1 hour without consulting a doctor ▪ measure only with dosing cup provided. Dosing cup to be used with this product only. Do not use with other products. ▪ mL= milliliter age dose adults and children 12 years of age and over 15 mL or 30 mL children 2 to under 12 years of age 5 ml or 10 mL
⚠️ Warnings ▾
Warnings ▪ This product contains fructose and should not be taken by persons with hereditary fructose intolerance (HFI). Do not use if you have ▪ allergic reactions to any of the ingredients in this product Ask a doctor before use if you have ▪ diabetes Stop use and ask a doctor if ▪ symptoms persist, return or get worse 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. (1-800-222-1222)
🧪 Active Ingredient ▾
Active ingredients (per 5 mL) Dextrose (glucose) 1.87 g Levulose (fructose) 1.87 g Phosphoric acid 21.5 mg
🧪 Inactive Ingredients ▾
Inactive ingredients FD&C red no. 40, flavors, glycerin, methylparaben, purified water.
🎯 Purpose ▾
Purpose Upset Stomach Reliever
📄 Do Not Use ▾
Do not use if you have ▪ allergic reactions to any of the ingredients in this product
📄 Ask a Doctor Before Use If ▾
Ask a doctor before use if you have ▪ diabetes
📄 Stop Use and Ask a Doctor If ▾
Stop use and ask a doctor if ▪ symptoms persist, return or get worse
🤰 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. (1-800-222-1222)
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL Nausea Control Cherry Flavor
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 Dextrose(glucose),Levulose(fructose),Phosphoric acid — the ingredient across all brands.
Top reported reactions
Reporter sex
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
Marketed without an FDA application
Listed without an FDA application
This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.
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 "Unapproved Drug Other". 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 PHARMACY VALUE ALLIANCE, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
PHARMACY VALUE ALLIANCE, 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.