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Midol Complete Caffeine Free ACETAMINOPHEN, CAFFEINE, and PYRILAMINE MALEATE 500 mg; 25 mg; 15 mg Tablet, 24-count — NDC 0280-0078-01 (Billing 00280-0078-01)

by Bayer HealthCare LLC. · 6 BLISTER PACK in 1 CARTON / 4 TABLET in 1 BLISTER PACK

This is a package of 24 tablets of Midol Complete Caffeine Free ACETAMINOPHEN, CAFFEINE, and PYRILAMINE MALEATE 500 mg; 25 mg; 15 mg Tablet from Bayer HealthCare LLC., marketed since Jan 2021 and currently FDA-listed. It is this product's only package size.

NDC 00280-0078-01
🏷️ FDA NDC (as labeled) 0280-0078-01 billing pads the labeler 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0280-0078-01
Product NDC 0280-0078
11-digit billing NDC 00280007801
RxCUI 1052637
UNII 362O9ITL9D, UA8U0KJM72, R35D29L3ZA
UPC 0312843591530
Application # M027
SPL Set ID 177d78c7-871c-cb39-e063-6394a90aab24
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-01-29
Route ORAL
Dosage form TABLET
Substance ACETAMINOPHEN; PAMABROM; PYRILAMINE MALEATE
Quick answers
  • RxCUI (RxNorm): 1052637
Why two NDCs? The FDA registers this code as 0280-0078-01 — 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 → 00280-0078-01. 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 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.

Clinical

🧪 What is this product?

Midol Complete Caffeine Free is an over-the-counter oral tablet marketed under FDA's OTC monograph rules. It contains acetaminophen, a pain reliever and fever reducer commonly used for general aches and discomfort. Pamabrom functions as a diuretic, and pyrilamine maleate is an antihistamine, both typically included in menstrual symptom products to address bloating and related discomfort. This combination is designed to address multiple symptoms associated with menstruation in a single tablet.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00280-0078-01 You're viewing this Main listing 6 BLISTER PACK in 1 CARTON / 4 TABLET in 1 BLISTER PACK 2021-01-29 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Menstrual Relief Maximum Strength Multi Symptom 500 mg/1; 25 mg/1; 15 mg 70000-0145-01 Cardinal 20 tablets $0.093 — Availability likely —
Menstrual Pain Relief 500 mg/1; 25 mg/1; 15 mg 83324-0057-20 Chain 20 tablets $0.093 — Availability likely —
Midol Complete Caffeine Free 500 mg/1; 25 mg/1; 15 mgthis 00280-0078-01 Bayer 24 tablets — — FDA listed —
menstrual pain relief maximum strength 500 mg/1; 25 mg/1; 15 mg 11822-6790-04 Rite 40 tablets — — FDA listed —
Menstrual Relief Maximum Strength 500 mg/1; 25 mg/1; 15 mg 36800-0979-10 Topco 40 tablets — — FDA listed —
Green Guard Cramp Relief 15 mg/1; 500 mg/1; 25 mg 47682-0049-80 Unifirst 2 tablets — — FDA listed —
Medi First Plus PMS Relief 25 mg/1; 15 mg/1; 500 mg 47682-0723-80 Unifirst 2 tablets — — FDA listed —
Medi First PMS Relief 25 mg/1; 15 mg/1; 500 mg 47682-0823-80 Unifirst 2 tablets — — FDA listed —
Menstrual Relief Maximum Strength 500 mg/1; 25 mg/1; 15 mg 50844-0679-27 L.N.K. 32 tablets — — FDA listed —
Multi-Symptom PMS Relief 500 mg/1; 25 mg/1; 15 mg 51316-0679-27 CVS 32 tablets — — FDA listed —
Menstrual Relief Maximum Strength 500 mg/1; 25 mg/1; 15 mg 55301-0679-27 ARMY 32 tablets — — FDA listed —
Menstrual Relief Maximum Strength 500 mg/1; 25 mg/1; 15 mg 55319-0979-27 Family 32 tablets — — FDA listed —
PMS Relief Maximum Strength 500 mg/1; 25 mg/1; 15 mg 59779-0879-08 CVS 24 tablets — — Discontinued —
Pamprin Multi-Symptom Maximum Strength 15 mg/1; 25 mg/1; 500 mg 71687-3003-01 Focus 20 tablets — — FDA listed —
Premsyn pms Premenstrual Pain Relief 500 mg/1; 25 mg/1; 15 mg 71687-3102-04 Focus 40 tablets — — FDA listed —
Thompson Cramp Relief 500 mg/1; 25 mg/1; 15 mg 73408-0923-80 Thompson 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

🏛️
2021
On the market since
Jan 2021
📍
2026
Currently FDA-listed
5 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.

What it looks like

Color white
ShapeOval
ImprintMCC
Size17 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 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 OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • 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 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 46N107B71O
    Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • UNII XHX3C3X673
    Triacetin is a clear, oily liquid made from glycerin and acetic acid. It works as a plasticizer and solvent in medicines, helping soften coatings and improve how liquids mix together in formulations.

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

The official label also statescarnauba wax, croscarmellose sodium, D&C red #30 aluminum lake, D&C yellow #10 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, propylene glycol, shellac, 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.

Manufacturer & labeler

LabelerBayer HealthCare LLC.
FDA applicationM027 (OTC MONOGRAPH DRUG)
Labeler code00280
First marketedJan 2021
Product typeHuman Otc Drug
Portfolio240 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.

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 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist Before Use If 📄 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 20 words ▾

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

⏱️ Dosage and Administration 41 words ▾

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

⚠️ Warnings ~1 min read ▾

Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 6 caplets 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 acetamonophen 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.

Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have liver disease glaucoma difficulty in urination due to enlargement of the prostate gland a breathing problem such as emphysema or chronic bronchitis Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product you may get drowsy avoid alcoholic drinks excitability may occur, especially in children alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if new symptoms occur redness or swelling is present pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days 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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

📦 Storage and Handling 15 words ▾

Other information Store at room temperature. Avoid temperatures above 25 o C (77 o F).

🧪 Active Ingredient 20 words ▾

Active ingredients (in each caplet) Purpose Acetaminophen 500 mg Pain reliever Pamabrom 25 mg Diuretic Pyrilamine maleate 15 mg Antihistamine

🧪 Inactive Ingredients 29 words ▾

Inactive ingredients carnauba wax, croscarmellose sodium, D&C red #30 aluminum lake, D&C yellow #10 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, propylene glycol, shellac, titanium dioxide, triacetin

🎯 Purpose 20 words ▾

Active ingredients (in each caplet) Purpose Acetaminophen 500 mg Pain reliever Pamabrom 25 mg Diuretic Pyrilamine maleate 15 mg Antihistamine

📄 Do Not Use 43 words ▾

Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you have ever had an allergic reaction to this product or any of its ingredients

📄 Ask a Doctor Before Use If 30 words ▾

Ask a doctor before use if you have liver disease glaucoma difficulty in urination due to enlargement of the prostate gland a breathing problem such as emphysema or chronic bronchitis

📄 Ask a Doctor or Pharmacist Before Use If 20 words ▾

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers

📄 When Using This Product 34 words ▾

When using this product you may get drowsy avoid alcoholic drinks excitability may occur, especially in children alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery

📄 Stop Use and Ask a Doctor If 33 words ▾

Stop use and ask a doctor if new symptoms occur redness or swelling is present pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days

🤰 If Pregnant or Breast-Feeding 10 words ▾

If pregnant or breast-feeding, ask a health professional before use.

📄 Keep Out of Reach of Children 43 words ▾

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

📄 Questions or Comments 9 words ▾

Questions or comments? 1-800-331-4536 (Mon-Fri 9AM - 5PM EST)

📄 Package Label / Principal Display Panel 28 words ▾

PRINCIPAL DISPLAY PANEL - 24 Caplet Blister Carton Midol ® Complete Caffeine Free Acetaminophen /Pamabrom/Pyrilamine Maleate Pain Reliever/Diuretic/Antihistamine MULTI-SYMPTOM RELIEF OF CRAMPS, BLOATING HEADCACHE, BACKACHE 24 CAPLETS PDP

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 ACETAMINOPHEN, CAFFEINE, and PYRILAMINE MALEATE — the ingredient across all brands.

Top reported reactions

Nausea32
Vomiting32
Diarrhoea26
Abdominal Pain24
Dizziness23
Abdominal Pain Upper21
Asthenia20

Age at onset

Infant1
Child3
Adolescent13
Adult52
Elderly10

Reporter sex

304 reports
Male · 21%
Female · 79%

Serious outcomes

Hospitalization105
Death42
Life-threatening18
Disabling6
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 30 4
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 — Not published for this NDC No photo available yet for this listing.
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 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 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.
← 00280-0071-01 · Bayer 00280-0079-01 · Bayer →
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.