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Guaifenesin and Codeine Phosphate 100 mg/5mL; 10 mg/5mL Solution, 237 mL — NDC 00121-0775-08 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Guaifenesin and Codeine Phosphate 100 mg/5mL; 10 mg/5mL Solution, 237 mL — NDC 0121-0775-08 (Billing 00121-0775-08)

by PAI Holdings, LLC · 237 mL in 1 BOTTLE

This is a package of 237 mL of Guaifenesin and Codeine Phosphate 100 mg/5mL; 10 mg/5mL Solution from PAI Holdings, LLC, no longer marketed (first marketed Oct 2006), no longer in the FDA NDC Directory; retail pharmacies pay about $0.0441 per mL (NADAC).

NDC 00121-0775-08
🏷️ FDA NDC (as labeled) 0121-0775-08 billing pads the labeler segment with a zero
This package
Contains237 mL Cost per mL$0.0441 NADAC Per package$10.45 / 237 ml Pack sizes3 compare ↓
Product page 00121-0775-16 Also comes in: 118 ml 0121-0775-04 473 ml 0121-0775-16
OTC Discontinued CV ⚠ Discontinued by firm ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Oct 1, 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 0121-0775-08 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
0121 labeler · 0775 product · 08 package
Listing certified through
Dec 31, 2026
Billing quantity
237 mL per package
Barcode (UPC-A, from the NDC)
3 0121077508 6
FDA record last changed
Oct 1, 2026
Past resolved recalls for this product (1)
Class III · Jan 7, 2025 · Terminated — Superpotent; sodium benzoate preservative (PAI Holdings, LLC. dba Pharmaceutical Associates Inc) · FDA recall D-0222-2025
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0121-0775-08
Product NDC 0121-0775
11-digit billing NDC 00121077508
NCPDP billing unit ML — per mL (volume)
RxCUI 995868
UNII 495W7451VQ, GSL05Y1MN6
Application # M012
SPL Set ID 88d0994c-4270-4408-8837-bd97510b2118
Established class (EPC) Expectorant
Physiologic effect Decreased Respiratory Secretion Viscosity; Increased Respiratory Secretions
DEA schedule CV
Marketing category OTC MONOGRAPH DRUG
Marketing status Discontinued
FDA listing status Discontinued by firm
Marketing start 2006-10-01
Route ORAL
Dosage form SOLUTION
Substance GUAIFENESIN; CODEINE PHOSPHATE

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

GPI-14 43997002282020
GPI class guaiFENesin-Codeine
GCN Seq No 045669
GCN 91713
HICL code 000206
Ingredient (HICL) Codeine Phosphate/Guaifenesin
HIC1 code B
Therapeutic class — broad (HIC1) Respiratory System
HIC2 code B4
Therapeutic class — intermediate (HIC2) Drugs Affecting The Trachea And Bronchi (Contin.1)
HIC3 code B4S
Therapeutic class — specific (HIC3) Opioid Antitussive-Expectorant Combination
AHFS code 28:08.08.00
AHFS class Opioid Agonists (28:08)
FDB label name GUAIFEN-CODEINE 100-10 MG/5 ML
FDB brand name Guaifenesin-Codeine
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 045669
  • GCN: 91713
  • GPI-14 (Medi-Span): 43997002282020
  • HICL (First Databank): 000206
  • AHFS class code: 28:08.08.00
  • RxCUI (RxNorm): 995868
Why two NDCs? The FDA registers this code as 0121-0775-08 — 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 → 00121-0775-08. 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 Opioid Agonist class.

Pharmacologic class Opioid Agonist
Drug family (ATC) Opium alkaloids and derivatives
How it works Full Opioid Agonists
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 GUAIFEN-CODEINE 100-10 MG/5 ML Ingredient Codeine Phosphate/Guaifenesin
🧪 What is this product?

This is an oral liquid cough and cold product sold over the counter under FDA's OTC monograph rules. Guaifenesin is an expectorant typically used to help thin and clear mucus from the airways. Codeine phosphate is a cough suppressant commonly used to reduce cough reflex. Together, these ingredients are formulated to address both mucus buildup and cough symptoms during respiratory illness.

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 mLPer package
Retail pharmacies payNADAC · weekly $0.044 $10.45 / 237 ml
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.
NADAC price history (per mL) — tap or hover for the price & month
Jan 2022 May 2022 Sep 2022 Feb 2023 $0.053 $0.041
▼ Down 17% over the last 10 months.
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 Per unit Per pack Marketing startMarketing endStatus
00121-0775-04 0121-0775-04 118 mL in 1 BOTTLE $0.0645 / mL $7.61 2006-10-01 — Active
00121-0775-08 You're viewing this 237 mL in 1 BOTTLE $0.0441 / mL $10.44 2006-10-01 — Discontinued by firm
00121-0775-16 0121-0775-16 Main listing 473 mL in 1 BOTTLE $0.0327 / mL $15.47 2006-10-01 — Active

You're viewing one of 3 pack sizes for this product.

Per mL, this pack runs about 35% above the cheapest pack (473 mL, $0.0327 vs $0.0441 NADAC).

This pack shows little to no recent Medicaid volume — the 473 ml pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package contains 237 mL — 237 ml in 1 bottle.
How does this package differ from NDC 00121-0775-04?
Both are Guaifenesin and Codeine Phosphate 100 mg/5mL; 10 mg/5mL Solution — the drug itself is identical. This page's package is the 237 mL one, while NDC 00121-0775-04 is the 118 ml package. Per-mL NADAC also differs: $0.0441 here vs $0.0645 for the 118 ml pack.
What NDC number is used to bill for this package of Guaifenesin and Codeine Phosphate 100 mg/5mL; 10 mg/5mL Solution?
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.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Guaifenesin and Codeine Phosphate 100 mg/5mL; 10 mg/5mLthis 00121-0775-08 PAI 237 ml $0.044 — Discontinued —
Codeine-Guaifenesin 10 mg/5mL; 100 mg/5mL 58657-0500-04 Method 120 ml $0.059 — Availability likely +33%
Codeine-Guaifenesin 10 mg/5mL; 100 mg/5mL 69367-0272-04 Westminster 118 ml $0.064 — Availability likely +46%
Guaifenesin and Codeine Phosphate 200 mg/10mL; 20 mg/10mL 00121-1550-00 PAI 10 cups — — FDA listed —
Guaifenesin and Codeine Phosphate 100 mg/5mL; 10 mg/5mL 00121-1775-00 PAI 10 cups — — FDA listed —
Guaifenesin and Codeine Phosphate 100 mg/5mL; 10 mg/5mL 50090-1428-00 A-S 118 ml — — FDA listed —
Codeine-Guaifenesin 10 mg/5mL; 100 mg/5mL 50090-6435-00 A-S 118 ml — — FDA listed —
Guaifenesin and Codeine Phosphate 10 mg/5mL; 100 mg/5mL 55154-5791-05 Cardinal 5 cups — — FDA listed —
Codeine-Guaifenesin 10 mg/5mL; 100 mg/5mL 68071-5173-04 NuCare 120 ml — — FDA listed —
Guaifenesin and Codeine Phosphate 100 mg/5mL; 10 mg/5mL 68788-8361-01 Preferred 118 ml — — FDA listed —
Codeine-Guaifenesin 10 mg/5mL; 100 mg/5mL 71205-0624-04 Proficient 118 ml — — FDA listed —
Codeine-Guaifenesin 10 mg/5mL; 100 mg/5mL 72162-1669-02 Bryant 120 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

🏛️
2006
On the market since
Oct 2006
📍
2026
Currently FDA-listed
20 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 red
FlavorCherry
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 H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • 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 H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • 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 L7T10EIP3A
    A cooling compound from mint plants used as a flavoring agent and to create a fresh sensation in medicines. It helps mask bitter tastes and improve how the product feels in the mouth.
  • 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 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 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 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 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.

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

The official label also statesCitric acid, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin and sorbitol.

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
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code00121
First marketedOct 2006
DEA scheduleCV
Product typeHuman Otc Drug
Portfolio5 products on file

More NDCs from PAI Holdings, LLC labeler code 00121

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 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 34 words ▾

Uses temporarily relieves cough due to minor throat and bronchial irritations as may occur with the common cold or inhaled irritants helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive

⏱️ Dosage and Administration 85 words ▾

Directions take every 4 hours do not exceed 6 doses in 24 hours a special measuring device should be used to give an accurate dose of this product to children under 6 years of age giving a higher dose than recommended by a doctor can result in serious side effects for a child adults and children 12 years and over 10 mL (2 teaspoonfuls) children 6 to under 12 years of age 5 mL (1 teaspoonful) children under 6 years of age Consult a doctor

⚠️ Warnings 180 words ▾

Warnings Do not use in adults and children who have a chronic pulmonary disease or shortness of breath, or children who are taking other drugs, unless directed by a doctor. Ask a doctor before use if you have a cough with too much phlegm (mucus) a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema Ask a doctor or pharmacist before use if you are taking sedatives, tranquilizers and drugs used for depression, especially monoamine oxidase inhibitors (MAOIs). These combinations may cause greater sedation (drowsiness) than is caused by the product used alone.

Stop use and ask a doctor if cough lasts for more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These can be signs of a serious condition. may cause or aggravate constipation If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.

In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. Use of codeine-containing preparation is not recommended for children under 2 years of age.

📦 Storage and Handling 33 words ▾

Other information Sodium Content: 5 mg/5 mL Tamper evident: Do not use if seal under cap is broken or missing Keep container closed and store away from heat Store at 20°- 25°C (68°-77°F)

🧪 Active Ingredient 20 words ▾

Active ingredients in each 5 mL (teaspoonful) Purposes Codeine Phosphate, USP 10 mg Cough Suppressant Guaifenesin, USP 100 mg Expectorant

🧪 Inactive Ingredients 33 words ▾

Inactive ingredients Citric acid, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin and sorbitol.

🎯 Purpose 20 words ▾

Active ingredients in each 5 mL (teaspoonful) Purposes Codeine Phosphate, USP 10 mg Cough Suppressant Guaifenesin, USP 100 mg Expectorant

📄 Do Not Use 29 words ▾

Do not use in adults and children who have a chronic pulmonary disease or shortness of breath, or children who are taking other drugs, unless directed by a doctor.

📄 Ask a Doctor Before Use If 29 words ▾

Ask a doctor before use if you have a cough with too much phlegm (mucus) a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema

📄 Ask a Doctor or Pharmacist Before Use If 38 words ▾

Ask a doctor or pharmacist before use if you are taking sedatives, tranquilizers and drugs used for depression, especially monoamine oxidase inhibitors (MAOIs). These combinations may cause greater sedation (drowsiness) than is caused by the product used alone.

📄 Stop Use and Ask a Doctor If 38 words ▾

Stop use and ask a doctor if cough lasts for more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These can be signs of a serious condition. may cause or aggravate constipation

🤰 If Pregnant or Breast-Feeding 10 words ▾

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

📄 Keep Out of Reach of Children 35 words ▾

Keep out of reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. Use of codeine-containing preparation is not recommended for children under 2 years of age.

📄 Questions or Comments 23 words ▾

Questions or comments? Call 1-800-845-8210 or visit paipharma.com Serious side effects associated with use of this product may be reported to this number.

📄 Package Label / Principal Display Panel 218 words ▾

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label NDC 0121-0775-16 Guaifenesin and Codeine Phosphate Oral Solution USP CV 100 mg/10 mg per 5 mL Expectorant / Cough Suppressant Alcohol Free / Sugar Free Each teaspoonful (5 mL) contains: Guaifenesin, USP 100 mg Codeine Phosphate, USP 10 mg Dispense in a tight, light-resistant container with a child-resistant closure. DO NOT ACCEPT IF SEAL AROUND CAP IS BROKEN OR MISSING 16 fl oz (473 mL) pai Pharmaceutical Associates, Inc. Greenville, SC 29605 Principal Display Panel - 473 mL Bottle Label

PRINCIPAL DISPLAY PANEL - 5 mL Unit Dose Cup Label Delivers 5 mL NDC 0121-1775-05 G UAIFENESIN AND C ODEINE P HOSPHATE O RAL S OLUTION USP CV 100 mg/10 mg per 5 mL Expectorant / Cough Suppressant Alcohol Free / Sugar Free Package Not Child-Resistant PHARMACEUTICAL ASSOCIATES, INC. GREENVILLE, SC 29605 SEE INSERT PRINCIPAL DISPLAY PANEL - 10 mL Unit Dose Cup Label

PRINCIPAL DISPLAY PANEL - 10 mL Unit Dose Cup Label Delivers 10 mL NDC 0121-1550-10 G UAIFENESIN AND C ODEINE P HOSPHATE O RAL S OLUTION USP CV 200 mg/20 mg per 10 mL Expectorant / Cough Suppressant Alcohol Free / Sugar Free Package Not Child-Resistant PHARMACEUTICAL ASSOCIATES, INC. GREENVILLE, SC 29605 SEE INSERT Principal Display Panel - 10 mL Unit Dose Cup Label - 1775

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

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
473 ml00121-0775-16 28,598 Rx · $363,287
118 ml00121-0775-04 3,053 Rx · $46,145
237 ml this page00121-0775-08 No Medicaid data
Drug total (last 4 qtrs): 31,651 Rx · 5,320,396 units · $409,432 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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 Guaifenesin and Codeine Phosphate — the ingredient across all brands.

Top reported reactions

Nausea22
Diarrhoea19
Fatigue19
Pain14
Rash13
Vomiting13
Hypertension12

Age at onset

Adult20
Elderly16

Reporter sex

126 reports
Male · 29%
Female · 70%
Unknown · 1%

Serious outcomes

Hospitalization43
Death17
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 19 0
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.

About this NDC listing & data coverage

Over-the-counter (OTC) product No longer marketed (per FDA listing data)
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) ✓ Available
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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 118 ml (00121-0775-04), 473 ml (00121-0775-16). 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?
PAI Holdings, 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.
← 00121-0773-08 · PAI 00121-0777-08 · 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.