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Midol Complete Gelcaps 60 mg; 15 mg; 500 mg Tablet, Coated — NDC 00280-8015-24 package photo

Midol Complete Gelcaps 60 mg; 15 mg; 500 mg Tablet, Coated

by Bayer HealthCare LLC · 3 BLISTER PACK in 1 CARTON (0280-8015-24) / 24 TABLET, COATED in 1 BLISTER PACK
NDC 00280-8015-24
🏷️ FDA NDC (as labeled) 0280-8015-24 billing pads the labeler segment with a zero
OTC On market Non-controlled
🗂️ Data synced Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 0280-8015-24
Product NDC 0280-8015
11-digit billing NDC 00280801524
NCPDP billing unit EA — each (per item)
RxCUI 1597298
UNII 3G6A5W338E, R35D29L3ZA, 362O9ITL9D
UPC 0312843172531
Application # M027
SPL Set ID 0a4477ce-0a02-197d-e054-00144ff88e88
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 2014-12-15
Route ORAL
Dosage form TABLET, COATED
Substance CAFFEINE; PYRILAMINE MALEATE; ACETAMINOPHEN
GPI-14 64990003050320
GPI class Midol Complete
Why two NDCs? The FDA registers this code as 0280-8015-24 — a 4-4-2 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 labeler segment → 00280-8015-24. 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 Anilides class.

Drug family (ATC) Anilides
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.

🏭 Manufacturer & labeler

LabelerBayer HealthCare LLC
FDA applicationM027 (OTC MONOGRAPH DRUG)
Labeler code00280
First marketedDec 2014
Product typeHuman Otc Drug
Portfolio27 products on file
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

🧪 What is this product?

Midol Complete is an over-the-counter coated tablet taken by mouth. It contains three active ingredients: acetaminophen (a pain reliever and fever reducer), pyrilamine maleate (an antihistamine used to reduce drowsiness and swelling), and caffeine (a stimulant). This combination is typically used to temporarily relieve menstrual symptoms such as cramps, body aches, headache, and bloating.

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.

💊 What it looks like

Color turquoise
ShapeOval
ImprintMIDOL
Size1 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.

🧪 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 LMI26O6933
    Alumina is a white powder form of aluminum oxide. It's used as a filler to add bulk to tablets and capsules, and sometimes as a thickening or anti-caking agent in powdered formulations.
  • UNII R12CBM0EIZ
    A natural wax derived from a Brazilian palm tree, used as a coating and polish on tablets and capsules. It creates a smooth, shiny finish that protects the medicine and improves appearance.
  • UNII M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII 9DBA0SBB0L
    A synthetic red dye derived from coal tar used as a colorant in medicines and cosmetics. It gives tablets, capsules, and liquids their red or pink appearance for identification and visual appeal.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken 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.

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

The official label also statesInactive ingredients black iron oxide, carnauba wax, croscarmellose sodium, D&C red #33 aluminum lake, edetate disodium, FD&C blue #1 aluminum lake, gelatin, glycerin, hypromellose, lecithin, magnesium stearate, microcrystalline cellulose, pregelatinized starch, propylene glycol, shellac, simethicone, stearic acid, titanium dioxide, triacetin

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.
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
Midol Complete 500 mg/1; 60 mg/1; 15 mg 00280-8005-16 Bayer 16 tablets — — FDA listed —
Midol Complete Gelcaps 60 mg/1; 15 mg/1; 500 mgthis 00280-8015-24 Bayer 24 tablets — — FDA listed —
Menstrual Relief Maximum Strength 500 mg/1; 60 mg/1; 15 mg 00363-0252-21 Walgreen 8 tablets — — FDA listed —
Acetaminophen 500mg Caffeine 60mg Pyrilamine maleate 15mg 500 mg/1; 60 mg/1; 15 mg 00363-2310-24 WALGREENS 24 tablets — — FDA listed —
Menstrual Pain Relief 500 mg/1; 60 mg/1; 15 mg 00363-3900-10 Walgreen 40 tablets — — Discontinued —
Menstrual Relief 500 mg/1; 60 mg/1; 15 mg 00363-3909-21 Walgreen 8 tablets — — FDA listed —
Menstrual Complete Pain Relief 500 mg/1; 60 mg/1; 15 mg 00363-9390-10 Walgreen 40 tablets — — FDA listed —
Midol Complete 500 mg/1; 60 mg/1; 15 mg 00924-6010-02 Acme 100 tablets — — FDA listed —
Multi-Symptom Menstrual Relief 500 mg/1; 60 mg/1; 15 mg 11673-0363-64 TARGET 40 tablets — — FDA listed —
Menstrual Relief 500 mg/1; 60 mg/1; 15 mg 11673-0390-10 Target 40 tablets — — FDA listed —
Menstrual Complete Maximum Strength 500 mg/1; 60 mg/1; 15 mg 11822-0390-01 Rite 40 tablets — — FDA listed —
Menstrual Complete 500 mg/1; 60 mg/1; 15 mg 11822-3900-01 Rite 40 tablets — — FDA listed —
Menstrual Relief 500 mg/1; 60 mg/1; 15 mg 21130-0930-10 Better 40 tablets — — FDA listed —
Midol Complete 500 mg/1; 60 mg/1; 15 mg 29485-7964-02 Lil' 50 tablets — — FDA listed —
Menstrual Complete 500 mg/1; 60 mg/1; 15 mg 30142-0390-10 Kroger 40 tablets — — FDA listed —
Menstrual Complete 500 mg/1; 60 mg/1; 15 mg 36800-0391-08 Topco 24 tablets — — FDA listed —
Menstrual Complete 500 mg/1; 60 mg/1; 15 mg 37808-0389-10 H 40 tablets — — FDA listed —
Menstrual Relief Maximum Strength 500 mg/1; 60 mg/1; 15 mg 41163-0390-10 United 40 tablets — — FDA listed —
Menstrual Relief 500 mg/1; 60 mg/1; 15 mg 41163-0391-10 United 40 tablets — — FDA listed —
Comfort-Time 500 mg/1; 60 mg/1; 15 mg 49483-0347-24 Time 24 tablets — — FDA listed —
Midol Complete 500 mg/1; 60 mg/1; 15 mg 50269-0007-06 JC 12 tablets — — FDA listed —
Midol Complete 500 mg/1; 60 mg/1; 15 mg 50269-0009-06 JC 24 tablets — — FDA listed —
Menstrual Relief 500 mg/1; 60 mg/1; 15 mg 50804-0990-08 Geiss, 24 tablets — — FDA listed —
Menstrual Complete Maximum Strength 500 mg/1; 60 mg/1; 15 mg 50844-0390-19 L.N.K. 8 tablets — — FDA listed —
Menstrual Complete 500 mg/1; 60 mg/1; 15 mg 50844-0399-08 L.N.K. 24 tablets — — FDA listed —
Menstrual Relief 500 mg/1; 60 mg/1; 15 mg 51316-0390-10 CVS 40 tablets — — FDA listed —
Menstrual Complete 500 mg/1; 60 mg/1; 15 mg 53943-0390-10 Discount 40 tablets — — FDA listed —
Menstrual Complete 500 mg/1; 60 mg/1; 15 mg 55319-0301-21 Family 8 tablets — — FDA listed —
Dolex Fem 500 mg/1; 60 mg/1; 15 mg 55758-0326-25 Pharmadel 24 tablets — — FDA listed —
Menstrual Relief 500 mg/1; 60 mg/1; 15 mg 55910-0123-10 DOLGENCORP, 40 tablets — — FDA listed —
Menstrual Relief 500 mg/1; 60 mg/1; 15 mg 59779-0930-08 CVS 8 tablets — — FDA listed —
Menstrual Complete Maximum Strength 500 mg/1; 60 mg/1; 15 mg 63868-0032-24 CHAIN 24 tablets — — FDA listed —
Midol Complete, Travel BASIX 500 mg/1; 60 mg/1; 15 mg 66715-6445-02 Lil' 4 tablets — — FDA listed —
Midol Complete 500 mg/1; 60 mg/1; 15 mg 66715-9745-02 Lil' 4 tablets — — FDA listed —
Menstrual Complete 500 mg/1; 60 mg/1; 15 mg 67091-0334-40 WinCo 40 tablets — — FDA listed —
Midol 500 mg/1; 60 mg/1; 15 mg 67751-0145-01 Navajo 4 tablets — — FDA listed —
Menstrual Complete 500 mg/1; 60 mg/1; 15 mg 69168-0470-06 Allegiant 120 tablets — — FDA listed —
Menstrual Complete 500 mg/1; 60 mg/1; 15 mg 69517-0130-20 Healthlife 20 tablets — — FDA listed —
Buscapina 500 mg/1; 60 mg/1; 15 mg 69729-0130-24 OPMX 24 tablets — — FDA listed —
Buscapina 500 mg/1; 60 mg/1; 15 mg 69729-0131-72 OPMX 2 tablets — — FDA listed —
Buscapina 15 mg/1; 500 mg/1; 60 mg 69729-0132-06 OPMX 2 tablets — — FDA listed —
Buscapina 15 mg/1; 500 mg/1; 60 mg 69729-0818-50 OPMX 2 tablets — — FDA listed —
Midol Complete 15 mg/1; 500 mg/1; 60 mg 70264-0012-01 R 100 tablets — — FDA listed —
Menstrual Complete 500 mg/1; 60 mg/1; 15 mg 70692-0131-24 Strive 24 tablets — — FDA listed —
Menstrual Complete 60 mg/1; 15 mg/1; 500 mg 72090-0026-02 Pioneer 40 tablets — — FDA listed —
Menstrual Complete 500 mg/1; 60 mg/1; 15 mg 79481-0390-01 Meijer 40 tablets — — FDA listed —
Menstrual Complete 500 mg/1; 60 mg/1; 15 mg 79903-0266-40 WALMART 40 tablets — — FDA listed —
FLO PMS Complete 500 mg/1; 60 mg/1; 15 mg 83049-0489-08 O 24 tablets — — FDA listed —
Menstrual Pain Relief Complete 500 mg/1; 60 mg/1; 15 mg 83059-0006-01 Shield 15 tablets — — Discontinued —
Menstrual Pain Relief Complete 500 mg/1; 60 mg/1; 15 mg 83059-0105-01 Shield 15 tablets — — FDA listed —
Menstrual Pain Relief Complete 500 mg/1; 60 mg/1; 15 mg 83059-0119-08 Shield 80 tablets — — FDA listed —
Menstrual Complete 500 mg/1; 60 mg/1; 15 mg 83324-0017-24 Chain 24 tablets — — FDA listed —
Syncol Max 500 mg/1; 60 mg/1; 15 mg 83393-0390-02 Laboratorios 12 tablets — — FDA listed —
Midol Complete 500 mg/1; 60 mg/1; 15 mg 85237-1841-01 Select 2 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

🏛️
2014
On the market since
Dec 2014
📍
2026
Currently FDA-listed
12 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00280-8015-24 You're viewing this 3 BLISTER PACK in 1 CARTON (0280-8015-24) / 24 TABLET, COATED in 1 BLISTER PACK 2014-12-15 Active

🧭 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) ✓ 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 FDA registers it as 0280-8015-24, 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: 00280-8015-24, written without dashes as 00280801524. 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 00280-8015-24, the first segment (00280) is the labeler code FDA assigned to Bayer HealthCare LLC; the middle segment (8015) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (24) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Bayer HealthCare LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Bayer HealthCare 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 21 words ▾

Uses for the temporary relief of these symptoms associated with menstrual periods: cramps bloating water-weight gain headache backache muscle ache fatigue

⏱️ Dosage and Administration 47 words ▾

Directions · do not take more than the recommended dose · adults and children 12 years and older: · take 2 gelcaps with water · repeat every 6 hours, as needed · do not exceed 6 gelcaps per day · children under 12 years: consult a doctor

⚠️ Warnings 97 words ▾

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take · more than 6 gelcaps in 24 hours, which is the maximum daily amount for this product · with other drugs containing acetaminophen · 3 or more alcoholic drinks every day while using this product Allergy Alert: acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include: · skin reddening · blisters · rash · hives · facial swelling · asthma (wheezing) · shock If a skin or general allergic reaction occurs, stop use and seek medical help right away.

🧪 Active Ingredient 17 words ▾

Active ingredients (in each gelcap) Purpose Acetaminophen 500 mg..............................………………….Pain reliever Caffeine 60 mg……….…………………………………….……..….Diuretic Pyrilamine maleate 15 mg……………………………………Antihistamine

🧪 Inactive Ingredients 40 words ▾

Inactive ingredients black iron oxide, carnauba wax, croscarmellose sodium, D&C red #33 aluminum lake, edetate disodium, FD&C blue #1 aluminum lake, gelatin, glycerin, hypromellose, lecithin, magnesium stearate, microcrystalline cellulose, pregelatinized starch, propylene glycol, shellac, simethicone, stearic acid, titanium dioxide, triacetin

🎯 Purpose 1 words ▾

Purpose

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