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BackAid acetaminophen, caffeine 75 mg; 500 mg Tablet, Film Coated, 14-count — NDC 52389-0253-14 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

BackAid acetaminophen, caffeine 75 mg; 500 mg Tablet, Film Coated, 14-count — NDC 52389-253-14 (Billing 52389-0253-14)

by Kobayashi Healthcare International, Inc. · 1 BLISTER PACK in 1 CARTON / 14 TABLET, FILM COATED in 1 BLISTER PACK

This is a package of 14 tablets of BackAid acetaminophen, caffeine 75 mg; 500 mg Tablet, Film Coated from Kobayashi Healthcare International, Inc., marketed since Oct 2024 and currently FDA-listed. It is the main listing for this product, which comes in 3 package sizes.

NDC 52389-0253-14
🏷️ FDA NDC (as labeled) 52389-253-14 billing pads the product segment with a zero
This package
Contains14-count Pack sizes3 compare ↓
Main listing for product 52389-253 · Also comes in: 14 tablets 52389-253-28 38 tablets 52389-253-38
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 27, 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 52389-253-14 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
52389 labeler · 253 product · 14 package
Package marketed since
Dec 11, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0072959530280
FDA record last changed
Aug 27, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 52389-253-14
Product NDC 52389-253
11-digit billing NDC 52389025314
UNII 3G6A5W338E, 362O9ITL9D
UPC 0072959530280
Application # M013
SPL Set ID 25db6bb5-96b6-4be1-e063-6294a90a2300
Established class (EPC) Central Nervous System Stimulant; Methylxanthine
Physiologic effect Central Nervous System Stimulation
Chemical class Xanthines
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-10-31
Route ORAL
Dosage form TABLET, FILM COATED
Substance CAFFEINE; ACETAMINOPHEN
Why two NDCs? The FDA registers this code as 52389-253-14 — 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 → 52389-0253-14. 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.

Clinical

🧪 What is this product?

BackAid is an over-the-counter oral tablet that combines acetaminophen and caffeine. Acetaminophen is commonly used to help reduce pain and fever, while caffeine is a central nervous system stimulant typically included to enhance the pain-relieving effect. This product is marketed as an OTC monograph drug, meaning it follows FDA's established rules for combination pain relievers in this category.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 14 tablets 38 tablets
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
52389-0253-14 You're viewing this Main listing 1 BLISTER PACK in 1 CARTON / 14 TABLET, FILM COATED in 1 BLISTER PACK 2024-12-11 — Active
52389-0253-28 52389-253-28 2 BLISTER PACK in 1 CARTON / 14 TABLET, FILM COATED in 1 BLISTER PACK 2024-12-11 — Active
52389-0253-38 52389-253-38 1 BOTTLE, PLASTIC in 1 CARTON / 38 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 2024-12-11 — Active

Pack size FAQ

What quantity is in this package?
This is a 14-count package — 1 blister pack in 1 carton / 14 tablet, film coated in 1 blister pack.
How does this package differ from NDC 52389-0253-38?
Both are BackAid acetaminophen, caffeine 75 mg; 500 mg Tablet, Film Coated — the drug itself is identical. This page's package is the 14-count one, while NDC 52389-0253-38 is the 38 tablets package.
What NDC number is used to bill for this package of BackAid acetaminophen, caffeine 75 mg; 500 mg Tablet, Film Coated?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
BackAid 75 mg/1; 500 mgthis 52389-0253-14 Kobayashi 14 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

🏛️
2024
On the market since
Oct 2024
📍
2026
Currently FDA-listed
2 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color white
ShapeOval
ImprintALVA
Size15 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

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

  • UNII 43AGM4PHPI
    A mixture of plant or animal oils and fats with 10 to 18 carbon chains. Used as a solvent and carrier to dissolve or suspend active ingredients, helping deliver the medicine effectively.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII 7CVR7L4A2D
    A starch-derived carbohydrate produced by breaking down corn, potato, or tapioca starch. It functions as a filler and binder to give the medicine bulk and texture, and sometimes as a mild sweetener or texture enhancer in powders and tablets.
  • UNII VH2XOU12IE
    Polydextrose is a synthetic polymer made from dextrose (sugar) that acts as a bulking agent and filler in medicines. It helps give tablets and capsules proper volume and texture while often adding slight sweetness.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • 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 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

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

The official label also statesCorn starch, croscarmellose sodium, hypromellose, maltodextrin, microcrystalline cellulose, polydextrose, povidone, silicon dioxide, stearic acid, talc, titanium dioxide, triglycerides.

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

LabelerKobayashi Healthcare International, Inc.
FDA applicationM013 (OTC MONOGRAPH DRUG)
Labeler code52389
First marketedOct 2024
Product typeHuman Otc Drug
Portfolio26 products on file

More NDCs from Kobayashi Healthcare International, Inc. labeler code 52389

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. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 💬 Information for Patients 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 16 words ▾

Uses For the temporary relief of minor aches and pains associated with backache muscular aches headache

⏱️ Dosage and Administration 71 words ▾

Directions Read all package directions and warnings before use. Use only as directed. Adults: Two (2) caplets with a full glass of water every 6 hours while symptoms persist, not to exceed 3 doses (6 caplets) in 24 hours, or as directed by a doctor. Do not exceed recommended dosage. For use by normally healthy adults only. Persons under 18 years of age should use only as directed by a doctor.

⚠️ Warnings 72 words ▾

Warnings Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 6 caplets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product. Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away.

🧪 Active Ingredient 11 words ▾

Active ingredients (in each caplet) Acetaminophen, 500 mg Caffeine, 75 mg

🧪 Inactive Ingredients 20 words ▾

Inactive ingredients Corn starch, croscarmellose sodium, hypromellose, maltodextrin, microcrystalline cellulose, polydextrose, povidone, silicon dioxide, stearic acid, talc, titanium dioxide, triglycerides.

🎯 Purpose 6 words ▾

Purpose Analgesic (pain reliever) Analgesic aid

💬 Information for Patients 58 words ▾

Other information **CONTENTS SEALED: Each BACKAID white­ colored, oval shaped caplet bears the identifying mark "ALVA" and is sealed in a clear plastic blister with a paper/foil backing. Do not use if seal appears broken or if product contents do not match product description. You may report serious side effects to the phone number provided under Questions? below.

📄 Do Not Use 27 words ▾

Do not use with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

📄 Ask a Doctor Before Use If 10 words ▾

Ask a doctor before use if you have liver disease.

📄 Ask a Doctor or Pharmacist Before Use If 16 words ▾

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

📄 When Using This Product 43 words ▾

When using this product, limit the use of caffeine-containing medications, foods or beverages because too mush caffeine may cause nervousness irritability sleeplessness occasional rapid heartbeat The recommended dose of this product contains about as much caffeine as one and one-half cups of coffee.

📄 Stop Use and Ask a Doctor If 34 words ▾

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

🤰 If Pregnant or Breast-Feeding 10 words ▾

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

📄 Keep Out of Reach of Children 43 words ▾

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

📄 Questions or Comments 2 words ▾

Questions? 1-800-792-2582.

📄 Patient Package Insert ~3 min read ▾

Package insert New & Improved Formula Maximum Strength BACKAID 6 Hour Formula Acetaminophen + Caffeine Eases Pain of Inflammation Relieves Backache and Sciatica Pain Active ingredients: Each caplet contains: acetaminophen 500 mg (analgesic/pain reliever) and caffeine anhydrous 75 mg (analgesic aid). Uses: For the temporary relief of minor aches and pains associated with • backache • muscular aches • headache Warnings Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 6 caplets in 24 hours, which is the maximum dally amount • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using this product.

Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include • skin reddening • blisters • rash. If a skin reaction occurs, stop use and seek medical help right away.

Do not use • with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask a doctor before use if you have liver disease.

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. When using this product, limit the use of caffeine-containing medications, foods or beverages because too much cafeine may cause nervousness irritability sleeplessness occassional rapid heatbeat The recommended dose of this product contains about as much caffeine as one and one-half cups of coffee. Stop use and ask a doctor if pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or welling is present any new symptoms appear If pregnant or breast feeding, ask a health professional before use.

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

Directions: Read all package directions and warnings before use. Use only as directed. Adults: Two (2) caplets with a full glass of water every 6 hours while symptoms persist, not to exceed 3 doses (6 caplets) in 24 hours, or as directed by a doctor.

Do not exceed recommended dosage. For use by normally healthy adults only. Persons under 18 years of age should use only as directed by a doctor.

Other information: **CONTENTS SEALED: Each BACKAID white colored, oval shaped caplet bears the identifying mark "ALVA" and is sealed in a clear plastic blister with a paper/foil backing or in a bottle with a safety seal under the cap. Do not use if seal appears broken or if product contents do not match product description. • You may report serious side effects to the phone number provided under Questions? below. Inactive ingredients Corn starch, croscarmellose sodium, hypromellose, maltodextrin, microcrystalline cellulose, polydextrose, povidone, silicon dioxide, stearic acid, talc, titanium dioxide, triglycerides.

Questions? 1-800-792-2582 Fórmula nueva y mejorada Maxima concentración BACKAID Fórmula de 6 horas Acetaminofeno + cafeina Alivia el dolor de la inflamación Alivia el dolor de espalda y el dolor ciático Ingredientes activos: Cada comprimido oblongo contiene: 500 mg de acetaminofeno (un analgésico, alivia el dolor) y 75 mg de cafeína anhidra (ayuda analgésica). Usos: Para el alivio temporal de dolores menores asociados con dolor de espalda dolores musculares dolor de cabeza Advertencias: Advertencia hepática: Este producto contiene acetaminofeno.

Puede producirse un daño hepático grave si usted toma: más de 6 comprimidos oblongos en 24 horas, que es la cantidad diaria máxima otros fármacos que contienen acetaminofeno al mismo tiempo 3 o más bebidas alcohólicas cada día mientras usa este producto. Alerta de alergias: El acetaminofeno puede causar reacciones graves en la piel. Los síntomas pueden incluir: enrojecimiento de la piel ampollas sarpullido Si se produce una reacción en la piel,… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 1 words ▾

PDP

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 Kobayashi Healthcare International, Inc.. 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 2 other package presentations of this same product, including 14 tablets (52389-0253-28), 38 tablets (52389-0253-38). 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?
Kobayashi Healthcare International, Inc. 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.
← 52389-0249-10 · Kobayashi 52389-0298-30 · Kobayashi →
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.