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Aspirin 81mg 81 mg Tablet, Chewable — NDC 77333-0049-20 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Aspirin 81mg 81 mg Tablet, Chewable — NDC 77333-049-20 (Billing 77333-0049-20)

by Gendose Pharmaceuticals, LLC · 150 BLISTER PACK in 1 CARTON / 1 TABLET, CHEWABLE in 1 BLISTER PACK

This is a package of Aspirin 81mg 81 mg Tablet, Chewable from Gendose Pharmaceuticals, LLC, marketed since May 2025 and currently FDA-listed. It is this product's only package size.

NDC 77333-0049-20
🏷️ FDA NDC (as labeled) 77333-049-20 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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

NDC database record

One package, one record: these facts belong to NDC 77333-049-20 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
77333 labeler · 049 product · 20 package
Package marketed since
May 1, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 7733304920 5
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 77333-049-20
Product NDC 77333-049
11-digit billing NDC 77333004920
NCPDP billing unit EA — each (per item)
RxCUI 318272
UNII R16CO5Y76E
Application # M013
SPL Set ID 1d6552e8-4f89-411f-a352-8f7835851fc0
Established class (EPC) Nonsteroidal Anti-inflammatory Drug; Platelet Aggregation Inhibitor
Mechanism of action Cyclooxygenase Inhibitors
Physiologic effect Decreased Prostaglandin Production; Decreased Platelet Aggregation
Chemical class Anti-Inflammatory Agents, Non-Steroidal
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-05-01
Route ORAL
Dosage form TABLET, CHEWABLE
Substance ASPIRIN

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 64100010000510
GCN Seq No 004380
GCN 16713
HICL code 001820
Ingredient (HICL) Aspirin
HIC1 code M
Therapeutic class — broad (HIC1) Blood
HIC2 code M9
Therapeutic class — intermediate (HIC2) Drugs Given To Alter Blood Coagulation
HIC3 code M9P
Therapeutic class — specific (HIC3) Platelet Aggregation Inhibitors
AHFS code 20:12.18.00
AHFS class Platelet-Aggregation Inhibitors
FDB label name ASPIRIN 81 MG CHEWABLE TABLET
FDB brand name Aspirin
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 004380
  • GCN: 16713
  • GPI-14 (Medi-Span): 64100010000510
  • HICL (First Databank): 001820
  • AHFS class code: 20:12.18.00
  • RxCUI (RxNorm): 318272
Why two NDCs? The FDA registers this code as 77333-049-20 — 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 → 77333-0049-20. 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 Platelet Aggregation Inhibitor class.

Pharmacologic class Platelet Aggregation Inhibitor, Nonsteroidal Anti-inflammatory Drug
Drug family (ATC) Other agents for local oral treatment, Platelet aggregation inhibitors excl. heparin, Salicylic acid and 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.

Clinical

Label name ASPIRIN 81 MG CHEWABLE TABLET Ingredient Aspirin
📗 Our plain-language guide HelloPharmacist
  • Aspirin is used to temporarily relieve common minor pains — things like headaches, backaches, muscle aches, toothaches, menstrual cramps, and discomfort from a cold — and to reduce...
  • Generally, no — aspirin should not be given to children under 12. More importantly, children and teenagers who have or are recovering from chickenpox or a flu-like illness should n...
  • Yes, stomach upset, heartburn, and nausea are real possibilities with aspirin. Taking it with a full glass of water helps. Some people tolerate enteric-coated or delayed-release fo...
  • Does aspirin upset your stomach? What can I do about it?
📖 Read our full Aspirin guide →
3
Nutrient depletion considerations

Aspirin may be associated with lower levels of 3 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Aspirin 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.

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
77333-0049-20 You're viewing this Main listing 150 BLISTER PACK in 1 CARTON / 1 TABLET, CHEWABLE in 1 BLISTER PACK 2025-05-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Good Sense aspirin 81 mg 00113-0274-68 L. 36 tablets $0.026 — Availability likely —
good sense aspirin 81 mg 00113-0467-08 L. 36 tablets $0.026 — Availability likely —
Rugby Aspirin 81 mg 00536-1008-36 Rugby 36 tablets $0.026 — Availability likely —
aspirin 81 mg 00904-4040-73 Major 36 tablets $0.026 — Availability likely —
Aspirin Low Dose Chewable Orange 81 mg 00904-6794-80 MAJOR 1000 tablets $0.026 — Availability likely —
Aspirin Low Dose Chewable Orange 81 mg 00904-7509-30 Major 1 tablet $0.026 — Availability likely —
Good Neighbor Pharmacy Aspirin 81 mg 24385-0028-68 Amerisource 36 tablets $0.026 — Availability likely —
good neighbor pharmacy aspirin 81 mg 24385-0278-68 Amerisource 36 tablets $0.026 — Availability likely —
Sunmark Aspirin 81 mg 49348-0757-07 Strategic 36 tablets $0.026 — Availability likely —
leader aspirin 81 mg 70000-0419-01 Cardinal 36 tablets $0.026 — Availability likely —
leader aspirin 81 mg 70000-0420-01 Cardinal 36 tablets $0.026 — Availability likely —
foster and thrive aspirin 81 mg 70677-1134-01 Strategic 36 tablets $0.026 — Availability likely —
Chewable Aspirin 81 mg 83324-0075-36 Chain 36 tablets $0.026 — Availability likely —
Bayer Aspirin Regimen Chewable Low Dose Aspirin Orange 81 mg 00280-2080-18 Bayer 18 tablets — — FDA listed —
Bayer Chewable - Aspirin Regimen Low Dose Aspirin Cherry Flavored 81 mg 00280-2090-36 Bayer 36 tablets — — FDA listed —
Aspirin Low Dose 81 mg 00363-0218-79 Walgreen 36 tablets — — FDA listed —
Aspirin Low Dose Chewable Orange 81 mg 00615-8257-05 NCS 15 tablets — — FDA listed —
Chewable Low Dose Aspirin 81 mg 11673-0493-19 TARGET 36 tablets — — FDA listed —
up and up chewable aspirin 81 mg 11673-0702-08 Target 36 tablets — — Discontinued —
Pain Relief Aspirin Chewable, Low Dose 81 mg 11822-0397-07 Rite 36 tablets — — FDA listed —
Low Dose Aspirin 81 mg 16103-0366-05 Pharbest 36 tablets — — FDA listed —
Aspirin 81 mg 17714-0009-36 Advance 1 tablet — — FDA listed —
Aspirin Low Dose Chewable Orange 81 mg 17856-6794-01 ATLANTIC 1 tablet — — FDA listed —
Aspirin Low Dose 81 mg 21130-0051-36 Better 36 tablets — — FDA listed —
Aspirin Low Dose Chewable 81 mg 21130-0397-07 Better 36 tablets — — FDA listed —
Aspirin 81 mg 30142-0467-08 Kroger 36 tablets — — FDA listed —
Topcare Aspirin 81 mg 36800-0274-68 Topco 36 tablets — — FDA listed —
Topcare Aspirin 81 mg 36800-0467-08 Topco 36 tablets — — FDA listed —
Low Dose Chewable Aspirin 81 mg 37835-0573-36 Bi-Mart 36 tablets — — FDA listed —
aspirin chewable, low dose 81 mg 41163-0797-07 United 36 tablets — — FDA listed —
Aspirin Low Dose 81 mg 41163-0918-07 United 36 tablets — — FDA listed —
aspirin 81 mg 41250-0274-08 Meijer 36 tablets — — FDA listed —
aspirin 81 mg 41250-0467-08 Meijer 36 tablets — — FDA listed —
Aspirin 81 mg 42507-0274-68 HyVee 36 tablets — — FDA listed —
Aspirin 81 mg 42507-0467-68 HyVee 36 tablets — — FDA listed —
Chewable Aspirin 81 mg 42507-0605-03 HYVEE 36 tablets — — FDA listed —
First Aid Direct Chewable Aspirin 81 mg 42961-0104-02 Cintas 1 tablet — — FDA listed —
Xpect Chewable Aspirin 81 mg 42961-0258-01 Cintas 1 tablet — — FDA listed —
Medique Products Chewable Low Dose Aspirin 81 mg 47682-0038-46 Unifirst 1 tablet — — FDA listed —
Green Guard Chewable Aspirin 81 mg 47682-0039-46 Unifirst 1 tablet — — FDA listed —
Aspirin Chewable 81 mg 48433-0129-01 Safecor 100 tablets — — FDA listed —
equate aspirin chewable 81 mg 49035-0274-08 Wal-Mart 36 tablets — — FDA listed —
equate aspirin 81 mg 49035-0467-08 Wal-Mart 36 tablets — — FDA listed —
aspirin low dose chewable 81 mg 49483-0334-00 Time-Cap 100000 tablets — — FDA listed —
aspirin 81 mg 50090-2940-00 A-S 36 tablets — — FDA listed —
Aspirin Low Dose 81 mg 50844-0218-07 L.N.K. 36 tablets — — FDA listed —
Aspirin 81 mg 51316-0467-68 CVS 36 tablets — — FDA listed —
Aspirin Low Dose Chewable Orange Pain Reliever 81 mg 51662-1356-01 HF 90 tablets — — FDA listed —
CAREALL Aspirin 81 mg 51824-0057-36 New 36 tablets — — FDA listed —
Adult Chewable Aspirin 81 mg 53943-0152-01 DISCOUNT 36 tablets — — FDA listed —
Chewable Aspirin 81 mg 53943-0205-01 DISCOUNT 36 tablets — — FDA listed —
Aspirin 81 mg 54738-0128-36 Richmond 36 tablets — — FDA listed —
Aspirin Low Dose Chewable Orange 81 mg 55154-0191-00 Cardinal 1 tablet — — FDA listed —
Aspirin Low Dose Chewable Orange 81 mg 55154-2635-00 Cardinal 1 tablet — — Discontinued —
Childrens Aspirin 81 mg 55154-6752-00 Cardinal 1 tablet — — FDA listed —
dg health aspirin 81 mg 55910-0467-68 Dolgencorp, 36 tablets — — FDA listed —
aspirin 81 mg 56062-0274-68 Publix 36 tablets — — FDA listed —
aspirin 81 mg 56062-0467-68 Publix 36 tablets — — FDA listed —
Low Strength Chewable Aspirin 81 mg 57896-0911-36 Geri-Care 36 tablets — — FDA listed —
aspirin 81 mg 59779-0274-08 CVS 36 tablets — — FDA listed —
Aspirin 81 mg 59779-0467-08 CVS 36 tablets — — FDA listed —
Low Dose Aspiriun 81 mg 61504-0105-03 AMERIFOODS 36 tablets — — FDA listed —
aspirin 81 mg 63187-0717-36 Proficient 36 tablets — — FDA listed —
Low Dose Aspirin 81 mg 63868-0332-36 CHAIN 36 tablets — — FDA listed —
Low Dose Chewable Aspirin 81 mg 63941-0105-01 VALU 36 tablets — — FDA listed —
Aspirin Low Dose 81 mg 63941-0397-07 Valu 36 tablets — — FDA listed —
Low Dose Aspirin 81 mg 67091-0389-36 WinCo 36 tablets — — FDA listed —
Chewable Aspirin 81 mg 68998-0205-01 MARC 36 tablets — — FDA listed —
Aspirin Chewable 81 mg 69168-0288-36 Allegiant 36 tablets — — FDA listed —
St. Joseph Chewable Low Dose Aspirin 81 mg 69536-0281-10 Foundation 108 tablets — — FDA listed —
good sense aspirin 81 mg 71205-0442-36 Proficient 36 tablets — — FDA listed —
Chewable Aspirin 81 mg 72036-0205-01 HARRIS 36 tablets — — FDA listed —
Adult Chewable Aspirin 81 mg 72036-0252-01 HARRIS 36 tablets — — FDA listed —
basic care aspirin 81 mg 72288-0467-68 Amazon.com 36 tablets — — FDA listed —
Chewable Aspirin 81 mg 72476-0205-01 RETAIL 36 tablets — — FDA listed —
Low Dose Aspirin 81 mg 72476-0252-01 RETAIL 36 tablets — — FDA listed —
Aspirin 81mg 81 mgthis 77333-0049-20 Gendose 1 tablet — — FDA listed —
Low dose Chewable Aspirin 81 mg 81522-0105-03 FSA 36 tablets — — FDA listed —
Aspirin Low Dose Chewable Orange 81 mg 82804-0156-00 Proficient 100 tablets — — FDA listed —
Aspirin 81mg 81 mg 83139-0288-36 Lodaat 36 tablets — — FDA listed —
Aspirin 81mg 81 mg 83139-0316-36 Lodaat 36 tablets — — FDA listed —
Aspirin Low Dose 81 mg 83324-0069-36 Chain 36 tablets — — FDA listed —
Pain Reliever / Low Dose Aspirin 81 mg 84289-0366-36 PHARMAMED 36 tablets — — FDA listed —
Chewable Aspirin Low Dose 81 mg 85828-0288-36 Grocery 36 tablets — — FDA listed —
Aspirin 81 mg 72288-0740-00 Amazon.com 36 tablets — — FDA listed —
Adult Low Dose Chewable Aspirin 81 mg 85786-0110-36 Farmacias 36 tablets — — FDA listed —
Medline 81 mg 53329-0601-09 Medline 36 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

🏛️
2025
On the market since
May 2025
📍
2026
Currently FDA-listed
1 year 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 orange
ShapeRound
ImprintAZ013
Size8 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.

🧪 Avoiding an ingredient? See Aspirin inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII G263MI44RU
    Dextrates are a carbohydrate mixture made from corn or potato starch. They work as fillers and binders in tablets and capsules to add bulk and help hold the medicine together.
  • UNII GYP6Z2JR6Q
    FD&C Yellow No. 6 Aluminum Lake is a yellow colorant made by combining FD&C Yellow No. 6 dye with aluminum salts. It's used to color tablets, capsules, and other medicines so they're easier to identify.
  • UNII SB8ZUX40TY
    Saccharin sodium is an artificial sweetener made from saccharin salt. It's added to medicines to improve taste, especially in liquid formulations for children or bitter drugs.
  • 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.

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

The official label also statesdextrates, FD&C yellow #6 aluminum lake, orange flavor, saccharin sodium, corn starch

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

LabelerGendose Pharmaceuticals, LLC
FDA applicationM013 (OTC MONOGRAPH DRUG)
Labeler code77333
First marketedMay 2025
Product typeHuman Otc Drug
Portfolio15 products on file

More NDCs from Gendose Pharmaceuticals, LLC labeler code 77333

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 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 24 words ▾

Uses for temporary relief of minor aches and pains or as recommended by your doctor. ask your doctor for other uses of this product.

⏱️ Dosage and Administration 48 words ▾

Directions • drink a full glass of water with each dose • adults and children 12 years and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor • children under 12 years: consult a doctor

⚠️ Warnings ~2 min read ▾

Warnings Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness. Allergy alert: Aspirin may cause a severe allergic reaction which may include: hives facial swelling asthma (wheezing) shock Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding.

The chance is higher if you are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Do not use if you are allergic to aspirin or any other pain reliever/fever reducer. this product for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor. if you have ever had an allergic reaction to this product or any of its ingredients.

Ask a doctor before use if the stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic you have asthma Ask a doctor or pharmacist before use if you are taking a prescription drug for •gout •diabetes •arthritis Stop use and ask a doctor if • an allergic reaction occurs. Seek medical help right away. • you experience any of the following signs of stomach bleeding: • feel faint • vomit blood • have bloody or black stools • have stomach pain that does not get better • pain gets worse or lasts more than 10 days • fever gets worse or lasts more than 3 days • redness or swelling is present • new symptoms occur • ringing in the ears or a loss of hearing occurs If pregnant or breast-feeding, ask a health professional before use.

It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. 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.

📦 Storage and Handling 18 words ▾

Other information • store at 25 ° C (77 ° F); excursions permitted between 15°-30°C (59° - 86°F)

🧪 Active Ingredient 12 words ▾

Active ingredient (in each tablet) Aspirin 81 mg (NSAID**) **nonsteroidal anti-inflammatory drug

🧪 Inactive Ingredients 14 words ▾

Inactive ingredients dextrates, FD&C yellow #6 aluminum lake, orange flavor, saccharin sodium, corn starch

🎯 Purpose 3 words ▾

Purpose Pain Reliever

📄 Do Not Use 48 words ▾

Do not use if you are allergic to aspirin or any other pain reliever/fever reducer. this product for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor. if you have ever had an allergic reaction to this product or any of its ingredients.

📄 Ask a Doctor Before Use If 43 words ▾

Ask a doctor before use if the stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic you have asthma

📄 Ask a Doctor or Pharmacist Before Use If 18 words ▾

Ask a doctor or pharmacist before use if you are taking a prescription drug for •gout •diabetes •arthritis

📄 Stop Use and Ask a Doctor If 90 words ▾

Stop use and ask a doctor if • an allergic reaction occurs. Seek medical help right away. • you experience any of the following signs of stomach bleeding: • feel faint • vomit blood • have bloody or black stools • have stomach pain that does not get better • pain gets worse or lasts more than 10 days • fever gets worse or lasts more than 3 days • redness or swelling is present • new symptoms occur • ringing in the ears or a loss of hearing occurs

🤰 If Pregnant or Breast-Feeding 47 words ▾

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

📄 Keep Out of Reach of Children 22 words ▾

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.

📄 Package Label / Principal Display Panel 4 words ▾

Principal Display Panel label

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

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 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 Gendose Pharmaceuticals, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Gendose Pharmaceuticals, 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.
← 77333-0035-20 · Gendose 77333-0050-20 · Gendose →
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.