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Acetaminophen 650 mg/20.3mL Solution — NDC 00121-3141-00 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Acetaminophen 650 mg/20.3mL Solution — NDC 0121-3141-00 (Billing 00121-3141-00)

by PAI Holdings, LLC dba PAI Pharma · 10 TRAY in 1 CASE / 10 CUP, UNIT-DOSE in 1 TRAY / 20.3 mL in 1 CUP, UNIT-DOSE

This is a package of Acetaminophen 650 mg/20.3mL Solution from PAI Holdings, LLC dba PAI Pharma, marketed since Dec 2025 and currently FDA-listed. It is this product's only package size.

NDC 00121-3141-00
🏷️ FDA NDC (as labeled) 0121-3141-00 billing pads the labeler segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Acetaminophen (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Oct 21, 2025 — Defective Container (Kenvue Brands LLC) · FDA recall D-0121-2026
Class II · Aug 20, 2025 — Discoloration (Baxter Healthcare Corporation) · FDA recall D-0596-2025
Class II · May 22, 2025 — cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets). (Aurobindo Pharma USA Inc) · FDA recall D-0471-2025
Class I · Jul 8, 2024 — Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL) (Hikma Pharmaceuticals USA Inc.) · FDA recall D-0635-2024
Class II · May 20, 2024 — Discoloration: Brownish tablets (Contract Pharmacal Corporation) · FDA recall D-0566-2024
Class II · Nov 13, 2023 — Failed Impurities/Degradation Specifications (KINDER FARMS LLC) · FDA recall D-0143-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0121-3141-00
Product NDC 0121-3141
11-digit billing NDC 00121314100
NCPDP billing unit ML — per mL (volume)
RxCUI 307675
UNII 362O9ITL9D
Application # M013
SPL Set ID 33599f18-5f49-4f22-8a77-a072115763ef
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-12-09
Route ORAL
Dosage form SOLUTION
Substance ACETAMINOPHEN

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

GPI-14 64200010002010
GCN Seq No 065758
GCN 27802
HICL code 001866
Ingredient (HICL) Acetaminophen
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H3
Therapeutic class — intermediate (HIC2) Analgesics
HIC3 code H3E
Therapeutic class — specific (HIC3) Analgesic/Antipyretics,Non-Salicylate
AHFS code 28:08.16.00
AHFS class Non-Opioid Analgesics
FDB label name ACETAMINOPHEN 650MG/20.3ML CUP
FDB brand name Acetaminophen
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 065758
  • GCN: 27802
  • GPI-14 (Medi-Span): 64200010002010
  • HICL (First Databank): 001866
  • AHFS class code: 28:08.16.00
  • RxCUI (RxNorm): 307675
Why two NDCs? The FDA registers this code as 0121-3141-00 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00121-3141-00. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Anilides class.

Drug family (ATC) Anilides
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name ACETAMINOPHEN 650MG/20.3ML CUP Ingredient Acetaminophen
📖 What it is MedlinePlus · NLM

Acetaminophen is used to relieve mild to moderate pain and to reduce fever. Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It temporarily relieves minor aches and pains, like headache, backache, toothache, muscle aches, cold aches, minor arthritis pain and menstrual cramps. It also reduces fever.
  • Follow your product label or prescriber exactly and never exceed the maximum daily amount. Remember that the limit counts every product with acetaminophen. Too much can seriously d...
  • Check the label first. Many combination products also contain acetaminophen, and you shouldn't use two together. If you aren't sure, ask me or your pharmacist.
  • Having 3 or more alcoholic drinks every day while using it raises the risk of liver damage. If you take warfarin, talk with your doctor or pharmacist first, since regular high dail...
📖 Read our full Acetaminophen guide →
1
Nutrient depletion considerations

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

🧪 Full Acetaminophen 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 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00121-3141-00 You're viewing this Main listing 10 TRAY in 1 CASE / 10 CUP, UNIT-DOSE in 1 TRAY / 20.3 mL in 1 CUP, UNIT-DOSE 2025-12-09 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Children Acetaminophen Oral Solution 160 mg/5mL 00904-7014-16 MAJOR 473 ml $0.011 — Availability likely —
Liquid Acetaminophen 160 mg/5mL 54859-0809-16 LLORENS 473 ml $0.011 — Availability likely —
Acetaminophen 160 mg/5mL 57237-0304-12 Rising 118 ml $0.024 — Availability likely —
M-Pap 160 mg/5mL 58657-0524-04 Method 120 ml $0.024 — Availability likely —
Acetaminophen 160 mg/5mL 69367-0323-04 Westminster 118 ml $0.024 — Availability likely —
M-Pap 160 mg/5mL 58657-0525-04 Method 120 ml $0.040 — FDA listed —
Acetaminophen 160 mg/5mL 00121-0657-00 PAI 10 cups — — FDA listed —
Acetaminophen 160 mg/5mL 00121-1047-00 PAI 10 cups — — FDA listed —
Acetaminophen 325 mg/10.15mL 00121-1314-00 PAI 10 cups — — FDA listed —
Acetaminophen 650 mg/20.3mL 00121-1971-00 PAI 10 cups — — FDA listed —
Acetaminophen 325 mg/10.15mL 00121-2094-00 PAI 10 cups — — FDA listed —
Acetaminophen 650 mg/20.3mLthis 00121-3141-00 PAI 10 cups — — FDA listed —
Ed Apap 160 mg/5mL 00485-0057-08 EDWARDS 236 ml — — FDA listed —
Acetaminophen 160 mg/5mL 00904-7319-70 Major 10 cups — — FDA listed —
Acetaminophen 325 mg/10.15mL 00904-7320-71 Major 10 cups — — FDA listed —
Acetaminophen 650 mg/20.3mL 00904-7321-76 Major 10 cups — — FDA listed —
MAX relief junior 160 mg/5mL 17856-0025-01 ATLANTIC 50 cups — — FDA listed —
MAX relief junior 160 mg/5mL 17856-0045-01 ATLANTIC 48 syringes — — FDA listed —
MAX relief junior 160 mg/5mL 17856-0046-01 ATLANTIC 120 syringes — — FDA listed —
MAX relief junior Grape 160 mg/5mL 17856-1122-01 ATLANTIC 50 cups — — FDA listed —
Bactimicina Childrens Pain and Fever 160 mg/5mL 24286-1550-04 DLC 1 bottle — — FDA listed —
Acetaminophen Solution 160 mg/5mL 39328-0031-50 Patrin 10 cups — — FDA listed —
Acetaminophen Solution 325 mg/10.15mL 39328-0032-50 Patrin 10 cups — — FDA listed —
Acetaminophen Solution 650 mg/20.3mL 39328-0034-50 Patrin 10 cups — — FDA listed —
Acetaminophen 160 mg/5mL 50090-6059-00 A-S 118 ml — — FDA listed —
Acetaminophen 160 mg/5mL 52343-0555-12 Acetris 118 ml — — FDA listed —
DR. SANA PAIN AND FEVER FOR Children 160 mg/5mL 53113-0516-06 GADAL 1 bottle — — FDA listed —
Acetaminophen 650 mg/20.3mL 55154-9449-05 Cardinal 5 cups — — FDA listed —
GeriCare Liquid Pain Relief 160 mg/5mL 57896-0160-16 Geri-Care 473 ml — — FDA listed —
Acetaminophen 650 mg/20.3mL 60687-0740-37 American 10 cups — — FDA listed —
Acetaminophen 325 mg/10.15mL 60687-0751-56 American 10 cups — — FDA listed —
Little Remedies Infant Fever/Pain Reliever 160 mg/5mL 63029-0610-01 Medtech 1 bottle — — FDA listed —
M-Pap 160 mg/5mL 63629-1157-01 Bryant 120 ml — — FDA listed —
M-Pap 160 mg/5mL 63629-1158-01 Bryant 473 ml — — FDA listed —
Acetaminophen 160 mg/5mL 71205-0730-04 Proficient 118 ml — — FDA listed —
M-Pap 160 mg/5mL 71335-2755-01 Bryant 118 ml — — FDA listed —
M-Pap 160 mg/5mL 72162-1673-02 Bryant 120 ml — — FDA listed —
M-Pap 160 mg/5mL 72162-2404-02 Bryant 473 ml — — FDA listed —
Dr Kids Pain and Fever 160 mg/5mL 73282-2522-01 CalmCo 30 vials — — FDA listed —
Acetaminophen Oral Solution 160 mg/5mL 73564-0816-16 Aldama 1 bottle — — Discontinued —
Childrens Acetaminophen Oral Liquid Grape Flavor 160 mg/5mL 82568-0009-04 AARNA 1 bottle — — FDA listed —
Acetaminophen 160 mg/5mL 83720-0500-04 Oncor 118 ml — — FDA listed —
Children Acetaminophen Oral Solution 160 mg/5mL 83939-0010-01 VERITYRX. 1 ml — — FDA listed —
M-Pap 160 mg/5mL 83939-0011-01 VERITYRX, 5 ml — — 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
Dec 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

FlavorGrape
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 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 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • 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 B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • 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 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • UNII 4VON5FNS3C
    Sodium metabisulfite is a preservative derived from sulfur compounds. It prevents microbial growth and oxidation in medicines, helping extend shelf life and maintain product stability.
  • UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • UNII 96K6UQ3ZD4
    Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
  • 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.

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

The official label also statesInactive ingredients  anhydrous citric acid, edetate disodium, flavor, glycerin, polyethylene glycol 400, purified water, sodium benzoate, sodium metabisulfite, sorbitol, sucralose, trisodium citrate dihydrate

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

LabelerPAI Holdings, LLC dba PAI Pharma
FDA applicationM013 (OTC MONOGRAPH DRUG)
Labeler code00121
First marketedDec 2025
Product typeHuman Otc Drug
Portfolio142 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🆘 Overdosage 📦 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 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 40 words ▾

Uses • for the temporary relief of minor aches and pains due to headache muscular aches backache sore throat flu the common cold toothache premenstrual and menstrual cramps • for the minor pain from arthritis • and to reduce fever

⏱️ Dosage and Administration 62 words ▾

Directions do not take more than directed (see overdose warning ) dose product from the single dose cup the product is packaged in mL=milliliter age dose adults and children 12 years of age and over 20.3 mL (650 mg) every 4 to 6 hours not to exceed 6 doses in a 24-hour period children under 12 years of age consult a doctor

⚠️ Warnings 102 words ▾

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if, you take more than 6 doses in 24 hours, which is the maximum daily amount taken 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.

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

🆘 Overdosage 50 words ▾

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

📦 Storage and Handling 19 words ▾

Other information ■ Each 20.3 mL contains: sodium 24 mg ■ store at 20° to 25°C (68° to 77°F)

🧪 Active Ingredient 9 words ▾

Active ingredient (in each 20.3 mL) Acetaminophen 650 mg

🧪 Inactive Ingredients 23 words ▾

Inactive ingredients anhydrous citric acid, edetate disodium, flavor, glycerin, polyethylene glycol 400, purified water, sodium benzoate, sodium metabisulfite, sorbitol, sucralose, trisodium citrate dihydrate

🎯 Purpose 4 words ▾

Purposes Pain reliever/fever reducer

📄 Do Not Use 42 words ▾

Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist if you are allergic to aetaminophen or any of the inactive ingredients of this product

📄 Ask a Doctor Before Use If 46 words ▾

Ask a doctor before use if the user • has liver disease

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

📄 Ask a Doctor or Pharmacist Before Use If 17 words ▾

Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin

🤰 If Pregnant or Breast-Feeding 10 words ▾

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

📄 Keep Out of Reach of Children 6 words ▾

Keep out of reach of children.

📄 Questions or Comments 16 words ▾

Questions or comments? Call 1-800-845-8210. You may also report serious side effects to this phone number.

📄 Package Label / Principal Display Panel 49 words ▾

PRINCIPAL DISPLAY PANEL - 20.3 mL Cup Delivers 20.3 mL NDC 0121-3141-21 Acetaminophen Oral Solution USP 650 mg/20.3 mL Pain Reliever/Fever Reducer Alcohol Free/Dye Free/Sugar Free Grape Flavored Package Not Child-Resistant Dist. by: PAI Pharma GREENVILLE, SC 29605 See insert for drug facts lidding for

20.3 Acetaminophen FN1047 lidding

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

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

Medicare Part D (outpatient prescription) spending for Acetaminophen — the program that covers self-administered drugs. 5 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 Acetaminophen. 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
$34K
Claims incl. refills
277
Beneficiaries
145
Spend / beneficiary
$234.25
Spend / claim
$122.62
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.

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 PAI Holdings, LLC dba PAI Pharma. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
PAI Holdings, LLC dba PAI Pharma 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.
← 00121-3036-95 · PAI 00121-4027-94 · PAI →
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.