Niacin

Single-ingredient niacin (vitamin B3) reference formula at 500 mg per serving, developed as a tablet, capsule or powder, with smaller-amount options.

Niacin is a reference formula for brands building a single-ingredient vitamin B3 product around the amounts seen on reference labels. The default amount is 500 mg per serving, and the development work centers on the choice between nicotinic acid and niacinamide, the amount tier for each sales market, and the tablet or capsule system that carries the active.

Tablet is the lead format because 500 mg of niacin fits one compressed unit, while capsule and powder versions carry the same active in their own excipient systems. Options of 100 and 250 mg sit beside the default, and the amount is a decision that the brand and its market review make together.

Ingredient Composition

IngredientPer ServingRaw Material FormAlternative Form (same amount of active)
Niacin500 mg (default amount)Nicotinic acid, USP or food grade, as a free-flowing powder; specification 500 mg niacin per servingNiacinamide (nicotinamide) at the same milligram amount of niacin; its input is recalculated from the supplier assay

Amounts are stated as mg of niacin. Nicotinic acid is C6H5NO2, 123.11 g/mol (PubChem CID 938); niacinamide is C6H6N2O, 122.12 g/mol (CID 936). Labels that state mg NE (niacin equivalents) are listed apart from mg of niacin; the FDA guidance defines 1 mg NE as 1 mg niacin or 60 mg tryptophan [2].

Intended Benefits & Formula Rationale

This formula is designed for products positioned around daily niacin intake. Niacin is included as the single active so that the form, the amount and the excipient system can be set without interaction with other actives.

Intended Benefit DirectionKey IngredientsFormulation Rationale
Daily niacin intakeNiacinIncluded as the water-soluble vitamin B3 [1]. Evidence: Referenced
Lipid nutrition at pharmacologic amountsNiacinA review describes niacin at pharmacologic doses as a lipid-altering agent, reports that the AIM-HIGH trial showed no benefit on cardiovascular endpoints, and names flushing and worsened hyperglycaemia as tolerability limits [1]. Evidence: Mixed

A single stated amount lets the brand set one specification per market. The amount and the active form are decisions for the brand and its market review, because the tolerable upper intake level for niacin from supplements is far below the 500 mg reference amount (see Formulation Considerations).

Available Formats

The niacin reference formula is built for tablet, capsule and powder versions; counts per serving are design choices that the brand can adjust.

FormatUnitPer ServingPack SizeOther Ingredients (typical)Suitability
Tablet1 tablet500 mg60 or 100 tabletsCellulose, stearic acid, magnesium stearate, silica, coatingLead format; one compressed unit
Capsule1 capsule500 mg60 or 90 capsulesFlow agent, lubricant, capsule shellSingle capsule fill
Powder1 stick pack500 mg30 stick packsDiluent, acidulant, sweetener, flavorDrink mix; taste work needed

Raw Material Input & Fill (Design Estimate)

Design estimates. The input is the labeled amount divided by the assumed assay of the raw material, taken at 100% nicotinic acid, so 500 mg needs 500 mg of raw material per serving.

FormatRaw Material Input per UnitDesign FillBalance for ExcipientsVerification Before Scale-Up
Tablet500 mg650 mg tablet weight150 mgHardness, disintegration, dissolution, content assay
Capsule500 mg600 mg per capsule100 mgFill weight variation, flow, content assay
Powder500 mg2000 mg per stick1500 mgDissolution, taste, content assay

Gummy and softgel versions are separate projects, because a niacin load of this size would take most of a gummy mass.

Formulation Considerations

Dose against the upper intake level. The NIH Office of Dietary Supplements lists a tolerable upper intake level of 35 mg per day of niacin for adults aged 19 and older, and states that 30 to 50 mg or more of nicotinic acid typically causes flushing [3]. The 500 mg reference amount is above that level, so the amount tier, the label statement and the market review are settled before any pilot work, and smaller amounts are carried as options.
Nicotinic acid or niacinamide. The ODS states that nicotinic acid and nicotinamide have different toxicity profiles [3]. The two are not interchangeable in a label statement, and the form is specified on the formula and on the label rather than left as the word niacin.
Tolerability and evidence. The review in [1] names flushing and worsened hyperglycaemia among diabetic patients as limits on niacin therapy and reports that outcome trials such as AIM-HIGH did not show cardiovascular benefit. These findings belong to the safety and claim review of the finished product.
High-load tablet. At 500 mg of active in a 650 mg design tablet, the binder and coating level decide hardness and release behavior, so dissolution is measured early in sampling.

Customization Options

Brands adjust the amount per serving, the niacin form, the format and the release system.

ParameterRangeNote
Amount per serving25, 100, 250 or 500 mgOptions for the brand; each tier is checked against the limit of the sales market
Niacin formNicotinic acid or niacinamideDifferent tolerability and label wording; input recalculated from assay
Label unitmg or mg NESet by the sales market; 1 mg NE equals 1 mg niacin under the FDA definition [2]
FormatTablet, capsule or powderGummy and softgel are separate projects
Add-onsChromium, B-vitamin complexA second active reshapes the tablet weight and the specification

The pilot run confirms dissolution of the high-load tablet, capsule fill weight and flow, taste in the powder version, and the content assay of the first units against the labeled amount of niacin.

Flavor Options

FormatSuggested FlavorsWhy
PowderOrange, lemon-limeCitrus profiles sit well with the acidic taste of nicotinic acid

Technical Status & Data Sources

ItemStatusDetails
Reference formulaNIH DSLDThe ingredient and amount come from a labeled product in the NIH DSLD (500 mg on the label of CF000875; example DSLD labels 6362, 14238, 19007). The label names the ingredient as niacin; nicotinic acid is set as the form.
SpecificationSet in formulationNicotinic acid, 500 mg niacin per serving; assay, impurity limits and method are fixed with the supplier. Unit size, fill weight and stability are set in formulation.
Data sourceNIH DSLDDSLD v9.4.0, downloaded 2026-01-10: 50,824 reference formulas merged from on-market labels with complete ingredient amounts. Counts show how labels are distributed.
Market reviewPer marketDose limits, labeling and claims are reviewed for each sales market before a finished product is developed.
ReferencesSources[1] Creider JC, Hegele RA, Joy TR. Niacin: another look at an underutilized lipid-lowering medication. Nat Rev Endocrinol. 2012;8(9):517-28. DOI · PubMed<br>[2] U.S. FDA. Converting Units of Measure for Folate, Niacin, and Vitamins A, D, and E on the Nutrition and Supplement Facts Labels: Guidance for Industry. August 2019. Source<br>[3] NIH Office of Dietary Supplements. Niacin: Fact Sheet for Health Professionals. Source

Related products

OEM/ODM Development Inquiry

Essencefield supports custom supplement formulation and OEM/ODM development, including ingredient selection, dosage adjustments, delivery formats, flavors, packaging, and commercial supply. Submit your project requirements below to explore customization options, sample development, and manufacturing solutions tailored to your brand and target market.