Infants Ibuprofen 50 mg/1.25mL Suspension
by Aurohealth LLC · 1 BOTTLE in 1 CARTON (58602-227-04) / 15 mL in 1 BOTTLE
NDC 58602-0227-04
🏷️ FDA NDC (as labeled)
58602-227-04
billing pads the product segment with a zero
This package
Contains15 mL in 1 bottle
Pack sizes2 compare ↓
Also comes in:
30 mL 58602-0227-07
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 →
⚠️
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)
58602-227-04
Product NDC
58602-227
11-digit billing NDC
58602022704
RxCUI
204442
UNII
WK2XYI10QM
Application #
ANDA213506
SPL Set ID
2a48af51-23e2-4fec-a76b-eef1611750f5
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
2024-04-08
Route
ORAL
Dosage form
SUSPENSION
Substance
IBUPROFEN
Why two NDCs?
The FDA registers this code as 58602-227-04 — 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 → 58602-0227-04. 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
LabelerAurohealth LLC
Application holderAUROBINDO PHARMA LTD
FDA applicationANDA213506 (ANDA)
Labeler code58602
First marketedApr 2024
Product typeHuman Otc Drug
Portfolio174 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?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Ibuprofen — tap one for details:
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.
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.
💬 Questions about Ibuprofen?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Color
Pink
FlavorBerry
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 39J80LT57T
Hypromellose 2208 is a plant-derived thickening agent used as a binder and film-coating material. It helps hold tablet ingredients together and creates a protective coating on pills to control how quickly medicine dissolves.
-
UNII 9E0S3UM200
A sugar alcohol solution derived from glucose that stays liquid without forming crystals. It functions as a sweetener, humectant (moisture-retaining agent), and solvent in liquid medications and syrups.
-
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 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 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 8I089SAH3T
A carbohydrate powder extracted from potatoes. It serves as a filler to add bulk and volume to the tablet or capsule, and as a disintegrant to help the medicine break apart and release its active ingredient in your body.
-
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.
13 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesacesulfame potassium, art raspberry flavor (contains propylene glycol), citric acid anhydrous, FD&C Red No. 40, glycerin, hypromellose, noncrystallizing sorbitol solution, polysorbate 80, pregelatinized starch (potato), 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 system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size:
30 mL
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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| good neighbor pharmacy ibuprofen 50 mg/1.25mL 24385-0550-10 | Amerisource | 1 bottle | $0.201 | — | Availability likely | — |
| leader infants ibuprofen 50 mg/1.25mL 70000-0298-01 | Cardinal | 1 bottle | $0.201 | — | Availability likely | — |
| Foster and Thrive Ibuprofen 50 mg/1.25mL 70677-1146-01 | Strategic | 1 bottle | $0.201 | — | Availability likely | — |
| Concentrated ibuprofen infants 50 mg/1.25mL 83324-0005-30 | Chain | 1 bottle | $0.201 | — | Availability likely | — |
| Good Sense ibuprofen infants 50 mg/1.25mL 00113-0057-05 | L. | 1 bottle | $0.312 | — | Availability likely | — |
| ibuprofen 50 mg/1.25mL 00904-5463-35 | Major | 1 bottle | $0.312 | — | Availability likely | — |
| Foster and Thrive Infants Ibuprofen 50 mg/1.25mL 70677-1144-01 | Strategic | 1 bottle | $0.312 | — | Availability likely | — |
| Good Sense Infants Ibuprofen 50 mg/1.25mL 00113-0040-10 | L. | 1 bottle | — | — | FDA listed | — |
| Infants Ibuprofen 50 mg/1.25mL 00363-5100-01 | Walgreens | 1 bottle | — | — | FDA listed | — |
| infants ibuprofen 50 mg/1.25mL 00363-8139-10 | Walgreen | 1 bottle | — | — | FDA listed | — |
| Infants Advil 50 mg/1.25mL 00573-0191-20 | Haleon | 1 bottle | — | — | FDA listed | — |
| up and up dye free infants concentrated ibuprofen 50 mg/1.25mL 11673-0255-10 | Target | 1 bottle | — | — | FDA listed | — |
| ibuprofen 50 mg/1.25mL 11822-0255-01 | Rite | 1 bottle | — | — | FDA listed | — |
| signature care infants ibuprofen 50 mg/1.25mL 21130-0363-10 | Safeway | 1 bottle | — | — | Discontinued | — |
| Infants Ibuprofen 50 mg/1.25mL 21130-0513-10 | Safeway | 1 bottle | — | — | FDA listed | — |
| ibuprofen 50 mg/1.25mL 30142-0255-10 | Kroger | 1 bottle | — | — | FDA listed | — |
| infants dye free ibuprofen 50 mg/1.25mL 30142-0497-10 | Kroger | 1 bottle | — | — | FDA listed | — |
| Topcare Infants Ibuprofen 50 mg/1.25mL 36800-0057-05 | Topco | 1 bottle | — | — | FDA listed | — |
| Topcare Ibuprofen 50 mg/1.25mL 36800-0255-10 | Topco | 1 bottle | — | — | FDA listed | — |
| ibuprofen infants 50 mg/1.25mL 37808-0057-05 | H | 1 bottle | — | — | FDA listed | — |
| infants ibuprofen 50 mg/1.25mL 37808-0255-10 | H | 1 bottle | — | — | FDA listed | — |
| Equaline Ibuprofen 50 mg/1.25mL 41163-0057-05 | United | 1 bottle | — | — | FDA listed | — |
| equaline ibuprofen 50 mg/1.25mL 41163-0255-10 | United | 1 bottle | — | — | FDA listed | — |
| ibuprofen 50 mg/1.25mL 41250-0255-10 | Meijer | 1 bottle | — | — | FDA listed | — |
| care one ibuprofen 50 mg/1.25mL 41520-0255-10 | American | 1 bottle | — | — | FDA listed | — |
| ibuprofen infants 50 mg/1.25mL 42507-0057-05 | HyVee | 1 bottle | — | — | FDA listed | — |
| parents choice infants ibuprofen 50 mg/1.25mL 49035-0601-10 | Wal-Mart | 1 bottle | — | — | FDA listed | — |
| Concentrated ibuprofen infants 50 mg/1.25mL 49035-0635-09 | Wal-Mart | 1 bottle | — | — | FDA listed | — |
| Infants Motrin 50 mg/1.25mL 50580-0100-18 | Kenvue | 1 bottle | — | — | FDA listed | — |
| Motrin Infants 50 mg/1.25mL 50580-0198-50 | Kenvue | 1 bottle | — | — | FDA listed | — |
| IBUPROFEN Infants 50 mg/1.25mL 51672-2146-03 | Sun | 1 bottle | — | — | FDA listed | — |
| Concentrated ibuprofen infants 50 mg/1.25mL 53041-0637-09 | Guardian | 1 bottle | — | — | FDA listed | — |
| Ibuprofen infants Drops 50 mg/1.25mL 53943-0637-09 | Discount | 1 bottle | — | — | FDA listed | — |
| Infants Ibuprofen 50 mg/1.25mL 55319-0637-09 | Family | 1 bottle | — | — | FDA listed | — |
| dg health ibuprofen 50 mg/1.25mL 55910-0255-10 | Dolgencorp, | 1 bottle | — | — | FDA listed | — |
| Dg Health Ibuprofen 50 mg/1.25mL 55910-0503-05 | Dolgencorp, | 1 bottle | — | — | FDA listed | — |
| profen ib infants 50 mg/1.25mL 56062-0057-05 | Publix | 1 bottle | — | — | FDA listed | — |
| profen ib 50 mg/1.25mL 56062-0404-10 | Publix | 1 bottle | — | — | FDA listed | — |
| Infants Ibuprofen 50 mg/1.25mLthis 58602-0227-04 | Aurohealth | 1 bottle | — | — | FDA listed | — |
| ibuprofen 50 mg/1.25mL 59779-0313-05 | CVS | 1 bottle | — | — | Discontinued | — |
| Ibuprofen infants Drops 50 mg/1.25mL 69256-0687-09 | Harris | 1 bottle | — | — | FDA listed | — |
| basic care infants ibuprofen 50 mg/1.25mL 72288-0057-10 | Amazon.com | 1 bottle | — | — | FDA listed | — |
| basic care infants ibuprofen 50 mg/1.25mL 72288-0255-10 | Amazon.com | 1 bottle | — | — | FDA listed | — |
| Infants Ibuprofen 50 mg/1.25mL 72288-0770-10 | Amazon.com | 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
🏛️
2024
On the market since
Apr 2024
📍
2026
Currently FDA-listed
2 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.
🔬 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 INFANTS IBUPROFEN (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 35%
Female · 64%
Unknown · 0%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 58602-0227-04 You're viewing this | 1 BOTTLE in 1 CARTON (58602-227-04) / 15 mL in 1 BOTTLE | 2024-04-08 | Active |
| 58602-0227-07 | 1 BOTTLE in 1 CARTON (58602-227-07) / 30 mL in 1 BOTTLE | 2024-04-08 | Active |
Pack size FAQ
What quantity is in NDC 58602-0227-04?
NDC 58602-0227-04 is listed by the FDA — 1 bottle in 1 carton / 15 ml in 1 bottle.
What NDC number is used to bill for this package of Infants Ibuprofen 50 mg/1.25mL Suspension?
Bill NDC 58602-0227-04 — the 11-digit billing format is 58602022704. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
🧭 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 58602-227-04, 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: 58602-0227-04, written without dashes as 58602022704. 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 58602-0227-04, the first segment (58602) is the labeler code FDA assigned to Aurohealth LLC; the middle segment (0227) 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 Aurohealth LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 bottle (58602-0227-07). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Aurohealth 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
⏱️ Dosage and Administration
⚠️ Warnings
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
🎯 Indications and Usage ▾
Uses temporarily: reduces fever relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches
⏱️ Dosage and Administration ▾
Directions this product does not contain directions or complete warnings for adult use do not give more than directed shake well before using find right dose on chart below. If possible, use weight to dose; otherwise use age. mL = milliliter measure with the dosing device provided. Do not use with any other device. dispense liquid slowly into the child's mouth, toward the inner cheek if needed, repeat dose every 6 to 8 hours do not use more than 4 times a day Dosing Chart Weight (lb) Age (mos) Dose (mL) under 6 mos ask a doctor 12 to 17 lbs 6 to 11 mos 1.25 mL 18 to 23 lbs 12 to 23 mos 1.875 mL Other information store between 20° to 25°C (68° to 77°F) do not use if carton is opened or seal under cap is broken or missing
⚠️ Warnings ▾
Warnings Allergy alert Ibuprofen may cause a 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 other drugs 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 doctor.
🧪 Active Ingredient ▾
Drug Facts Active ingredient (in each 1.25 mL) Ibuprofen USP 50 mg (NSAID) * * nonsteroidal anti-inflammatory drug
🧪 Inactive Ingredients ▾
Inactive ingredients acesulfame potassium, art raspberry flavor (contains propylene glycol), citric acid anhydrous, FD&C Red No. 40, glycerin, hypromellose, noncrystallizing sorbitol solution, polysorbate 80, pregelatinized starch (potato), purified water, sodium benzoate, sucrose, xanthan gum
🎯 Purpose ▾
Purpose Pain reliever/fever reducer
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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.