Home › NDC Lookup › Ingredients › Ibuprofen › 81522-0700-04
Ibuprofen Childrens 100 mg/5mL Suspension — NDC 81522-0700-04 package photo

Ibuprofen Childrens 100 mg/5mL Suspension

by FSA Store Inc. (Caring Mills) · 1 BOTTLE in 1 CARTON (81522-700-04) / 118 mL in 1 BOTTLE
NDC 81522-0700-04
🏷️ FDA NDC (as labeled) 81522-700-04 billing pads the product segment with a zero
OTC Generic On market Non-controlled
🗂️ Data synced 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

⚠️
Other active recalls for Ibuprofen (different manufacturers) — 5 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Mar 2, 2026 — Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product. (STRIDES PHARMA INC) · FDA recall D-0390-2026
Class III · Oct 29, 2024 — Failed Tablet/Capsule Specifications (Dr. Reddy's Laboratories, Inc.) · FDA recall D-0047-2025
Class II · Aug 6, 2024 — Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit. (Dr. Reddy's Laboratories, Inc.) · FDA recall D-0644-2024
Class II · Aug 6, 2024 — Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit. (Dr. Reddy's Laboratories, Inc.) · FDA recall D-0646-2024
Class II · Aug 6, 2024 — Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit. (Dr. Reddy's Laboratories, Inc.) · FDA recall D-0645-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 81522-700-04
Product NDC 81522-700
11-digit billing NDC 81522070004
RxCUI 197803
UNII WK2XYI10QM
UPC 0349580479043
Application # ANDA074916
SPL Set ID 6505b0f6-1045-46c5-9ece-4bb38bdb0855
Established class (EPC) Nonsteroidal Anti-inflammatory Drug
Mechanism of action Cyclooxygenase Inhibitors
Chemical class Anti-Inflammatory Agents, Non-Steroidal
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-04-21
Route ORAL
Dosage form SUSPENSION
Substance IBUPROFEN
Why two NDCs? The FDA registers this code as 81522-700-04 — 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 → 81522-0700-04. 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.

🏷️ RxNorm drug class

This medicine belongs to the Nonsteroidal Anti-inflammatory Drug class.

Pharmacologic class Nonsteroidal Anti-inflammatory Drug
Drug family (ATC) Other cardiac preparations, Antiinflammatory products for vaginal administration, Propionic acid derivatives
How it works Cyclooxygenase Inhibitors
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

LabelerFSA Store Inc. (Caring Mills)
Application holderP AND L DEVELOPMENT LLC
FDA applicationANDA074916 (ANDA)
Labeler code81522
First marketedApr 2022
Product typeHuman Otc Drug
Portfolio16 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 it is MedlinePlus · NLM

Prescription ibuprofen is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints) and rheumatoid arthritis (arthritis caused by swelling of the lining of the joints). It is also used to relieve mild to moderate pain, including menstrual pain (pain that happens before or during a menstrual period). Nonprescription ibuprofen is used to reduce fever and to relieve minor aches and pain from headaches, muscle aches, arthritis, menstrual periods, the common cold, toothaches, and backaches. Ibuprofen is in a clas...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It does a lot more than just kill pain. Ibuprofen is an anti-inflammatory drug, so it relieves pain, reduces swelling and inflammation, and brings down fever. Over-the-counter prod...
  • What's ibuprofen actually used for — is it just a painkiller?
  • Yes, it really does help. Ibuprofen can irritate the stomach lining, so taking it with food or a glass of milk significantly reduces the chance of nausea or stomach upset. You don'...
  • Should I take ibuprofen with food? Does it really matter?
📖 Read our full Ibuprofen guide →
1
Nutrient depletion considerations

Ibuprofen may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Ibuprofen nutrient depletion report →
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.

💊 What it looks like

Color pink
FlavorBubble Gum
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 23OV73Q5G9
    Acesulfame potassium is an artificial sweetener that tastes about 200 times sweeter than sugar. It's added to medicines to improve taste without adding calories or affecting blood sugar.
  • UNII XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • 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 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
  • 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.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

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

The official label also statesacesulfame potassium, artificial bubble gum flavor, citric acid anhydrous, FD&C red #40, glycerin, polysorbate 80, pregelatinized corn starch, purified water, sodium benzoate, sucrose, xanthan gum

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 mLPer 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
Ibuprofen 100 mg/5mL 51672-2130-01 Sun 1 bottle $0.024 — FDA listed —
Ibuprofen 100 mg/5mL 00904-5309-09 Major 1 bottle $0.024 — Availability likely —
Ibuprofen 100 mg/5mL 00472-2002-16 Actavis 473 ml $0.024 AB Availability likely —
good sense ibuprofen childrens 100 mg/5mL 00113-0166-26 L. 1 bottle $0.030 — Availability likely —
Good Sense Ibuprofen Childrens 100 mg/5mL 00113-0660-26 L. 1 bottle $0.030 — Availability likely —
Good Sense Ibuprofen 100 mg/5mL 00113-0685-26 L. 1 bottle $0.030 — Availability likely —
good sense ibuprofen childrens 100 mg/5mL 00113-0897-26 L. 1 bottle $0.030 — Availability likely —
Ibuprofen Childrens 100 mg/5mL 00904-5577-20 Major 1 bottle $0.030 — Availability likely —
Good Neighbor Pharmacy ibuprofen childrens 100 mg/5mL 24385-0009-26 Amerisource 1 bottle $0.030 — Availability likely —
Good Neighbor Pharmacy Childrens Ibuprofen 100 mg/5mL 24385-0372-26 Amerisource 1 bottle $0.030 — Availability likely —
good neighbor pharmacy ibuprofen 100 mg/5mL 24385-0905-26 Amerisource 1 bottle $0.030 — Availability likely —
Childrens Ibuprofen 100 mg/5mL 68001-0521-92 BluePoint 1 bottle $0.030 — Availability likely —
Leader Childrens Ibuprofen 100 mg/5mL 70000-0181-01 Cardinal 1 bottle $0.030 — Availability likely —
Leader Ibuprofen 100 mg/5mL 70000-0262-01 Cardinal 1 bottle $0.030 — Availability likely —
Leader Childrens Ibuprofen 100 mg/5mL 70000-0263-01 Cardinal 1 bottle $0.030 — Availability likely —
leader Ibuprofen 100 mg/5mL 70000-0264-01 Cardinal 1 bottle $0.030 — Availability likely —
Childrens Ibuprofen 100 mg/5mL 83324-0012-04 Chain 1 bottle $0.030 — Availability likely —
Childrens Ibuprofen 100 mg/5mL 83324-0013-04 Chain 1 bottle $0.030 — Availability likely —
Childrens Ibuprofen 100 mg/5mL 83324-0014-04 Chain 1 bottle $0.030 — Availability likely —
Ibuprofen 100 mg/5mL 51672-1385-08 Sun 1 bottle $0.032 AB Availability likely —
Ibuprofen 100 mg/5mL 64380-0997-03 Strides 1 bottle $0.032 AB Availability likely —
Childrens Ibuprofen 100 mg/5mL 45802-0133-26 Padagis 1 bottle $0.034 — Availability likely —
Childrens Ibuprofen 100 mg/5mL 45802-0140-26 Padagis 1 bottle $0.034 — Availability likely —
ibuprofen 100 mg/5mL 45802-0897-26 Padagis 1 bottle $0.034 — Availability likely —
Ibuprofen Oral 100 mg/5mL 69230-0308-11 Camber 1 bottle $0.034 — Availability likely —
Ibuprofen Oral 100 mg/5mL 69230-0309-11 Camber 1 bottle $0.034 — Availability likely —
Ibuprofen Oral 100 mg/5mL 69230-0310-11 Camber 1 bottle $0.034 — Availability likely —
Ibuprofen Oral 100 mg/5mL 69230-0311-11 Camber 1 bottle $0.034 — Availability likely —
Ibuprofen Oral 100 mg/5mL 70677-0153-01 Strategic 1 bottle $0.034 — Availability likely —
Ibuprofen Oral 100 mg/5mL 70677-1115-01 Strategic 1 bottle $0.034 — Availability likely —
Ibuprofen Oral 100 mg/5mL 70677-1116-01 Strategic 1 bottle $0.034 — Availability likely —
Ibuprofen Oral 100 mg/5mL 70677-1117-01 Strategic 1 bottle $0.034 — Availability likely —
Ibuprofen Oral 100 mg/5mL 70677-1118-01 Strategic 1 bottle $0.034 — Availability likely —
Childrens Ibuprofen Oral Suspension Original Berry Flavor 100 mg/5mL 83474-0002-04 Puro 1 bottle $0.034 — Availability likely —
Ibuprofen Oral 100 mg/5mL 70677-0150-01 Strategic 1 bottle $0.035 — Availability likely —
Ibuprofen Oral 100 mg/5mL 70677-0152-01 Strategic 1 bottle $0.035 — Availability likely —
Ibuprofen Oral 100 mg/5mL 70677-0151-01 Strategic 1 bottle $0.035 — Availability likely —
Ibuprofen 100 mg/5mL 51672-1409-08 Sun 1 bottle $0.039 AB FDA listed —
Ibuprofen 100 mg/5mL 45802-0952-26 Padagis 1 bottle $0.045 AB Availability likely —
Ibuprofen 100 mg/5mL 59651-0032-12 Aurobindo 1 bottle $0.045 AB Availability likely —
Childrens Ibuprofen Oral Suspension 100 mg/5mL 00121-0833-00 PAI 10 cups — — FDA listed —
Childrens Ibuprofen Oral Suspension 100 mg/5mL 00121-0914-00 Pharmaceutical 10 cups — — FDA listed —
Dye Free Childrens Ibuprofen 100 mg/5mL 00121-1022-05 PAI 10 cups — — FDA listed —
Childrens Ibuprofen Oral Suspension 200 mg/10mL 00121-1666-00 PAI 10 cups — — FDA listed —
Childrens Ibuprofen Oral Suspension 100 mg/10mL 00121-1828-00 Pharmaceutical 10 cups — — FDA listed —
Dye Free Childrens Ibuprofen 200 mg/10mL 00121-2044-00 PAI 10 cups — — FDA listed —
ibuprofen childrens 100 mg/5mL 00363-0166-26 Walgreen 1 bottle — — FDA listed —
Ibuprofen Childrens 100 mg/5mL 00363-0660-26 Walgreen 1 bottle — — FDA listed —
Childrens Ibuprofen 100 Dye Free 100 mg/5mL 00363-0806-26 Walgreen 1 bottle — — FDA listed —
ibuprofen childrens 100 mg/5mL 00363-0897-26 Walgreen 1 bottle — — FDA listed —
Childrens Ibuprofen 100 mg/5mL 00363-8901-24 WALGREEN 1 bottle — — FDA listed —
Childrens Advil 100 mg/5mL 00573-0170-01 Haleon 1 bottle — — FDA listed —
Childrens Advil 100 mg/5mL 00573-0171-03 Haleon 1 bottle — — FDA listed —
Childrens Advil 100 mg/5mL 00573-0207-30 Haleon 1 bottle — — FDA listed —
Childrens Advil 100 mg/5mL 00573-0232-30 Haleon 1 bottle — — FDA listed —
Childrens Advil 100 mg/5mL 00573-0290-01 Haleon 1 bottle — — FDA listed —
Childrens Advil 100 mg/5mL 00573-1174-12 Haleon 1 bottle — — FDA listed —
Childrens Ibuprofen 100 mg/5mL 10202-0150-24 7-Eleven 1 bottle — — FDA listed —
Childrens Ibuprofen 100 mg/5mL 10202-0711-24 7-Eleven 1 bottle — — FDA listed —
Up and Up childrens ibuprofen 100 mg/5mL 11673-0166-26 Target 1 bottle — — Discontinued —
up and up childrens ibuprofen 100 mg/5mL 11673-0660-26 Target 1 bottle — — FDA listed —
up and up ibuprofen 100 mg/5mL 11673-0685-26 Target 1 bottle — — FDA listed —
Childrens Ibuprofen 100 mg/5mL 11822-0166-01 Rite 1 bottle — — Discontinued —
ibuprofen 100 mg/5mL 11822-0660-01 Rite 1 bottle — — Discontinued —
ibuprofen childrens 100 mg/5mL 11822-0897-01 Rite 1 bottle — — Discontinued —
childrens ibuprofen 100 mg/5mL 11822-1685-00 Rite 1 bottle — — FDA listed —
Childrens Ibuprofen 100 mg/5mL 11822-9998-08 Rite 1 bottle — — FDA listed —
Ibuprofen 100 mg/5mL 17856-5309-01 ATLANTIC 5 ml — — FDA listed —
Ibuprofen 100 mg/5mL 17856-5310-01 ATLANTIC 50 cups — — FDA listed —
signature care childrens ibuprofen 100 mg/5mL 21130-0011-26 Safeway 1 bottle — — Discontinued —
Signature Care Childrens Ibuprofen 100 mg/5mL 21130-0035-26 Safeway 1 bottle — — Discontinued —
Childrens Ibuprofen 100 mg/5mL 21130-0216-20 Better 1 bottle — — FDA listed —
Childrens Ibuprofen 100 mg/5mL 21130-0506-26 Safeway 1 bottle — — FDA listed —
Childrens Ibuprofen 100 mg/5mL 21130-0510-26 Safeway 1 bottle — — FDA listed —
signature care childrens ibuprofen 100 mg/5mL 21130-0911-26 Safeway 1 bottle — — Discontinued —
Good Neighbor Pharmacy Childrens Ibuprofen 100 mg/5mL 24385-0361-25 Amerisource 1 bottle — — Discontinued —
Childrens FLANAX ORAL 100 mg/5mL 27854-0777-99 Belmora 1 bottle — — FDA listed —
Childrens Ibuprofen 100 mg/5mL 30142-0281-08 KROGER 1 bottle — — FDA listed —
Ibuprofen Childrens 100 mg/5mL 30142-0660-26 Kroger 1 bottle — — FDA listed —
ibuprofen childrens 100 mg/5mL 30142-0897-34 Kroger 1 bottle — — Discontinued —
Childrens Ibuprofen 100 mg/5mL 30142-0965-08 Kroger 1 bottle — — FDA listed —
topcare childrens ibuprofen 100 mg/5mL 36800-0166-26 Topco 1 bottle — — FDA listed —
Topcare Childrens Ibuprofen 100 mg/5mL 36800-0660-00 Topco 1 bottle — — FDA listed —
ibuprofen 100 mg/5mL 37808-0023-26 H 1 bottle — — FDA listed —
childrens ibuprofen 100 mg/5mL 37808-0200-26 H 1 bottle — — FDA listed —
Ibuprofen Childrens 100 mg/5mL 37808-0363-26 H 1 bottle — — FDA listed —
Equaline ibuprofen childrens 100 mg/5mL 41163-0166-26 United 1 bottle — — FDA listed —
Equaline Ibuprofen 100 mg/5mL 41163-0685-26 United 1 bottle — — FDA listed —
equaline ibuprofen childrens 100 mg/5mL 41163-0897-26 United 1 bottle — — FDA listed —
Childrens Ibuprofen 100 mg/5mL 41250-0419-26 Meijer 1 bottle — — FDA listed —
ibuprofen childrens 100 mg/5mL 41250-0660-26 Meijer 1 bottle — — FDA listed —
childrens ibuprofen 100 mg/5mL 41250-0685-26 Meijer 1 bottle — — FDA listed —
ibuprofen childrens 100 mg/5mL 41250-0897-26 Meijer 1 bottle — — FDA listed —
care one ibuprofen childrens 100 mg/5mL 41520-0166-26 American 1 bottle — — FDA listed —
Care One ibuprofen childrens 100 mg/5mL 41520-0685-26 American 1 bottle — — FDA listed —
care one ibuprofen 100 mg/5mL 41520-0897-26 American 1 bottle — — FDA listed —
ibuprofen childrens 100 mg/5mL 42507-0166-18 HyVee 1 bottle — — FDA listed —
Ibuprofen childrens 100 mg/5mL 42507-0660-26 HyVee 1 bottle — — FDA listed —
childrens ibuprofen 100 mg/5mL 42507-0685-26 HyVee 1 bottle — — FDA listed —
ibuprofen 100 mg/5mL 42507-0897-26 HyVee 1 bottle — — FDA listed —
equate ibuprofen childrens 100 mg/5mL 49035-0166-26 Wal-Mart 1 bottle — — FDA listed —
equate ibuprofen childrens 100 mg/5mL 49035-0660-26 Wal-Mart 1 bottle — — FDA listed —
Ibuprofen 100 mg/5mL 49035-0693-08 EQUATE 1 bottle — — FDA listed —
equate ibuprofen 100 mg/5mL 49035-0897-26 Wal-Mart 1 bottle — — FDA listed —
Ibuprofen Oral 100 mg/5mL 50090-4129-00 A-S 1 bottle — — FDA listed —
Ibuprofen 100 mg/5mL 50090-7274-00 A-S 1 bottle — — FDA listed —
ibuprofen 100 mg/5mL 50090-7653-00 A-S 1 bottle — — FDA listed —
Childrens Motrin 100 mg/5mL 50580-0184-01 Kenvue 1 bottle — — FDA listed —
Childrens MOTRIN 100 mg/5mL 50580-0601-08 Kenvue 1 bottle — — FDA listed —
Childrens Motrin 100 mg/5mL 50580-0603-04 Kenvue 1 bottle — — FDA listed —
Childrens Motrin 100 mg/5mL 50580-0604-04 Kenvue 1 bottle — — FDA listed —
Dye Free Childrens Ibuprofen 100 mg/5mL 51316-0914-03 CVS 1 bottle — — FDA listed —
Childrens Ibuprofen Bubblegum Dye Free 100 mg/5mL 51316-0932-04 CVS 1 bottle — — FDA listed —
Ibuprofen 100 mg/5mL 51672-2144-01 Sun 1 bottle — — FDA listed —
ibuprofen 100 mg/5mL 51672-5321-01 Sun 1 bottle — — FDA listed —
Pediacare Childrens Ibuprofen Berry 100 mg/5mL 52412-0910-04 RANDOB 1 bottle — — FDA listed —
Childrens Ibuprofen 100 mg/5mL 52412-0911-04 Randob 1 bottle — — FDA listed —
Childrens Ibuprofen bubblegum 100 mg/5mL 53041-0572-03 Guardian 1 bottle — — FDA listed —
Childrens Ibuprofen fruit 100 mg/5mL 53041-0632-03 Guardian 1 bottle — — FDA listed —
Childrens Ibuprofen 100 mg/5mL 53041-0634-03 Guardian 1 bottle — — FDA listed —
Childrens Ibuprofen blue raspberry 100 mg/5mL 53041-0638-03 Guardian 1 bottle — — FDA listed —
Childrens Ibuprofen grape 100 mg/5mL 53041-0639-03 Guardian 1 bottle — — FDA listed —
Childrens Ibuprofen Oral Suspension 100 mg/5mL 53942-0119-24 DEMOULAS 1 bottle — — FDA listed —
Childrens Ibuprofen Oral Suspension 100 mg/5mL 53943-0119-24 Discount 1 bottle — — FDA listed —
Childrens Ibuprofen 100 mg/5mL 53943-0682-03 Discount 1 bottle — — FDA listed —
Childrens Ibuprofen 100 mg/5mL 55154-1577-05 Cardinal 5 cups — — FDA listed —
Childrens Ibuprofen 100 mg/5mL 55319-0114-03 Family 1 bottle — — FDA listed —
Childrens Ibuprofen 572 100 mg/5mL 55319-0929-03 Family 1 bottle — — FDA listed —
dg health childrens ibuprofen 100 mg/5mL 55910-0102-26 Dolgencorp, 1 bottle — — FDA listed —
DG Health childrens ibuprofen 100 mg/5mL 55910-0166-26 Dolgencorp, 1 bottle — — FDA listed —
Rexall Ibuprofen 100 mg/5mL 55910-0685-26 Dolgencorp, 1 bottle — — FDA listed —
DG Health Ibuprofen 100 mg/5mL 55910-0897-26 Dolgencorp 1 bottle — — FDA listed —
profen ib 100 mg/5mL 56062-0166-26 Publix 1 bottle — — FDA listed —
profen IB childrens 100 mg/5mL 56062-0897-26 Publix 1 bottle — — FDA listed —
Childrens Ibuprofen 100 mg/5mL 58602-0002-20 Aurohealth 1 bottle — — FDA listed —
Childrens Ibuprofen 100 mg/5mL 58602-0003-20 Aurohealth 1 bottle — — FDA listed —
Childrens Ibuprofen 100 mg/5mL 58602-0008-24 Aurohealth 1 bottle — — FDA listed —
Ibuprofen 100 mg/5mL 59779-0166-26 CVS 1 bottle — — FDA listed —
ibuprofen childrens 100 mg/5mL 59779-0660-26 CVS 1 bottle — — FDA listed —
Ibuprofen 100 mg/5mL 59779-0685-26 CVS 1 bottle — — FDA listed —
ibuprofen childrens 100 mg/5mL 59779-0897-26 CVS 1 bottle — — FDA listed —
Childrens Ibuprofen 100 mg/5mL 59779-0971-26 CVS 1 bottle — — FDA listed —
Childrens Ibuprofen 100 mg/5mL 60687-0743-17 American 10 cups — — FDA listed —
Ibuprofen Oral 100 mg/5mL 63629-8540-01 Bryant 1 bottle — — FDA listed —
Ibuprofen Oral 100 mg/5mL 63629-8851-01 Bryant 1 bottle — — FDA listed —
Ibuprofen Oral 100 mg/5mL 63629-8852-01 Bryant 1 bottle — — FDA listed —
Ibuprofen Oral 100 mg/5mL 63629-8853-01 Bryant 1 bottle — — FDA listed —
Childrens Ibuprofen Oral Suspension 100 mg/5mL 63868-0796-04 Chain 1 bottle — — FDA listed —
Childrens Ibuprofen Oral Suspension, Bubble Gum 100 mg/5mL 63941-0127-24 Best 1 bottle — — FDA listed —
Childrens Ibuprofen Oral Suspension, Dye Free 100 mg/5mL 63941-0128-24 Best 1 bottle — — FDA listed —
Ibuprofen Oral 100 mg/5mL 68071-1628-04 NuCare 118 ml — — FDA listed —
Ibuprofen 100 mg/5mL 68071-3589-04 NuCare 1 bottle — AB FDA listed —
Childrens Ibuprofen 100 mg/5mL 68071-5290-04 NuCare 1 bottle — — FDA listed —
Childrens Ibuprofen 100 mg/5mL 68094-0494-61 Precision 10 cups — — FDA listed —
Childrens Ibuprofen 100 mg/5mL 68094-0503-61 Precision 10 cups — — Discontinued —
Dye Free Childrens Ibuprofen 100 mg/5mL 68094-0600-61 Precision 10 cups — — FDA listed —
Childrens Ibuprofen 100 mg/5mL 68788-4031-01 Preferred 1 bottle — — FDA listed —
good sense ibuprofen childrens 100 mg/5mL 68788-4036-01 Preferred 1 bottle — — FDA listed —
Ibuprofen 100 mg/5mL 68788-8288-01 Preferred 1 bottle — — FDA listed —
Childrens Ibuprofen Oral Suspension 100 mg/5mL 68998-0320-24 Marc 1 bottle — — FDA listed —
Childrens Ibuprofen 100 mg/5mL 69256-0634-03 Harris 1 bottle — — FDA listed —
Childrens Ibuprofen Oral Suspension 100 mg/5mL 69618-0078-54 Reliable 1 bottle — — FDA listed —
Ibuprofen 100 mg/5mL 70518-4595-00 REMEDYREPACK 1 bottle — AB FDA listed —
Ibuprofen 100 mg/5mL 71205-0213-72 Proficient 1 bottle — — FDA listed —
Ibuprofen 100 mg/5mL 71205-0367-72 Proficient 1 bottle — AB FDA listed —
ibuprofen 100 mg/5mL 71205-0395-72 Proficient 1 bottle — — FDA listed —
Ibuprofen 100 mg/5mL 71205-0716-72 Proficient 1 bottle — AB FDA listed —
Ibuprofen Oral 100 mg/5mL 72162-1909-02 Bryant 1 bottle — — FDA listed —
Ibuprofen Oral 100 mg/5mL 72162-1910-02 Bryant 1 bottle — — FDA listed —
Ibuprofen Oral 100 mg/5mL 72162-1911-02 Bryant 1 bottle — — FDA listed —
Ibuprofen Oral 100 mg/5mL 72162-1912-02 Bryant 1 bottle — — FDA listed —
Childrens Ibuprofen 100 mg/5mL 72162-2285-02 Bryant 1 bottle — — FDA listed —
Childrens Ibuprofen 100 mg/5mL 72162-2286-02 Bryant 1 bottle — — FDA listed —
ibuprofen 100 mg/5mL 72162-2341-02 Bryant 1 bottle — — FDA listed —
basic care childrens ibuprofen 100 mg/5mL 72288-0166-26 Amazon.com 1 bottle — — FDA listed —
basic care childrens ibuprofen 100 mg/5mL 72288-0660-26 Amazon.com 1 bottle — — FDA listed —
basic care childrens ibuprofen 100 mg/5mL 72288-0685-26 Amazon.com 1 bottle — — FDA listed —
basic care childrens ibuprofen 100 mg/5mL 72288-0897-26 Amazon.com 1 bottle — — FDA listed —
Childrens Ibuprofen 100 mg/5mL 72888-0479-01 Advagen 1 bottle — — FDA listed —
Childrens Ibuprofen Oral Suspension 100 mg/5mL 76281-0119-24 AptaPharma 1 bottle — — FDA listed —
Childrens Ibuprofen Grape 100 mg/5mL 76281-0126-24 AptaPharma 1 bottle — — FDA listed —
Childrens Ibuprofen Oral Suspension Dye free 100 mg/5mL 76281-0128-24 AptaPharma 1 bottle — — FDA listed —
Childrens Ibuprofen 100 mg/5mL 79395-0003-92 Chalkboard 1 bottle — — FDA listed —
CHILDRENS Ibuprofen 100 mg/5mL 81033-0019-01 Kesin 100 cups — — FDA listed —
Childrens Ibuprofen Oral Suspension Dye Free 100 mg/5mL 81522-0311-11 FSA 1 bottle — — FDA listed —
Ibuprofen Childrens 100 mg/5mLthis 81522-0700-04 FSA 1 bottle — — FDA listed —
Ibuprofen Childrens 100 mg/5mL 81522-0938-04 FSA 1 bottle — — Discontinued —
Kosher Meds 100 mg/5mL 82179-0001-04 Mollec 1 bottle — — FDA listed —
Kosher Meds Dye-Free Ibuprofen 100 mg/5mL 82179-0006-04 Mollec 1 bottle — — FDA listed —
Ibuprofen Childrens 100 mg/5mL 63941-0761-94 Best 1 bottle — — Discontinued —
Ibuprofen Childrens 100 mg/5mL 63941-0762-94 Best 1 bottle — — Discontinued —
Ibuprofen Childrens 100 mg/5mL 63941-0760-94 Best 1 bottle — — Discontinued —
Ibuprofen 100 mg/5mL 51662-1582-01 HF 120 ml — — FDA listed —
Childrens Ibuprofen 100 mg/5mL 72288-0392-34 Amazon.com 1 bottle — — FDA listed —
ibuprofen 100 mg/5mL 68071-5315-04 NuCare 1 bottle — — FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2022
On the market since
Apr 2022
📍
2026
Currently FDA-listed
4 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Ibuprofen (matched by generic name) — the program that covers self-administered drugs. 19 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Ibuprofen. CMS lists 3 products for this generic; we show the highest-spend one. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$12.28M
Claims incl. refills
1.8M
Beneficiaries
1.4M
Spend / beneficiary
$8.95
Spend / claim
$6.72
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
81522-0700-04 You're viewing this 1 BOTTLE in 1 CARTON (81522-700-04) / 118 mL in 1 BOTTLE 2022-04-21 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

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 81522-700-04, 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: 81522-0700-04, written without dashes as 81522070004. 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 81522-0700-04, the first segment (81522) is the labeler code FDA assigned to FSA Store Inc. (Caring Mills); the middle segment (0700) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) 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 FSA Store Inc. (Caring Mills). Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
FSA Store Inc. (Caring Mills) 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 ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 20 words ▾

Uses temporarily: relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache reduces fever

⏱️ Dosage and Administration 128 words ▾

Directions this product does not contain directions or complete warnings for adult use do not give more than directed shake well before using mL = milliliter find right dose on chart. if possible, use weight to dose; otherwise use age. use only enclosed dosing cup. Do not use any other dosing device. if needed, repeat dose ever 6-8 hours do not use more than 4 times a day replace original bottle cap to maintain child resistance Dosing Chart Weight (lb) Age (yr) Dose (mL)* under 24 under 2 years ask a doctor 24-35 lbs 2-3 years 5 mL 36-47 lbs 4-5 years 7.5 mL 48-59 lbs 6-8 years 10 mL 60-71 lbs 9-10 years 12.5 mL 72-95 lbs 11 years 15 mL *or as directed by a doctor

⚠️ Warnings ~2 min read ▾

Warnings Allergy alert : Ibuprofen may cause severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters. If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning : This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if your child : has had stomach ulcers or bleeding problems takes a blood thinning (anticoagulant) or steroid drug takes others drug containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) takes more or for a longer time than directed Heart attack and stroke warning : NSAIDs except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal.

The risk is higher if you use more than directed or for longer than directed. Sore throat warning : Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly.

Do not use more than 2 days or administer to children under 3 years of age unless directed by a doctor. Do not use if the child has ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer right before or after heart surgery Ask a doctor before use if stomach bleeding warning applies to your child child has a history of stomach problems, such as heartburn child has problems or serious side effects from taking pain relievers or fever reducers child has not been drinking fluids child has lost a lot of fluid due to vomiting or diarrhea child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or had a stroke child has asthma child is taking a diuretic Ask a doctor or pharmacist before use if the child is under a doctor's care for any serious condition taking any other drug When using this product take with food or milk if stomach upset occurs Stop use and ask a doctor if child experiences any of the following signs of stomach bleeding: feels faint vomit blood has bloody or black stool has stomach pain that does not get better child has symptoms of heart problems or stroke: chest pain trouble breathing weakness in one part or side of body slurred speech leg swelling the child does not get any relief within first day (24 hours) of treatment fever or pain gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

🧪 Active Ingredient 14 words ▾

Active ingredient (in each 5 mL) Ibuprofen, USP 100 mg (NSAID)** **nonsteroidal anti-inflammatory drug

🧪 Inactive Ingredients 27 words ▾

Inactive ingredients acesulfame potassium, artificial bubble gum flavor, citric acid anhydrous, FD&C red #40, glycerin, polysorbate 80, pregelatinized corn starch, purified water, sodium benzoate, sucrose, xanthan gum

🎯 Purpose 4 words ▾

Purpose Pain reliever/fever reducer

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 81522-0666-01 · FSA 81522-0725-01 · FSA →
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.