Home › NDC Lookup › 55319-0628-16
Maximum Strength Cold and Flu Acetaminophen,Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl 10 mg; 5 mg; 325 mg; 200 mg Capsule, Liquid Filled, 16-count — NDC 55319-0628-16 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Maximum Strength Cold and Flu Acetaminophen,Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl 10 mg; 5 mg; 325 mg; 200 mg Capsule, Liquid Filled, 16-count — NDC 55319-628-16 (Billing 55319-0628-16)

by FAMILY DOLLAR SERVICES · 16 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

This is a package of 16 capsules of Maximum Strength Cold and Flu Acetaminophen,Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl 10 mg; 5 mg; 325 mg; 200 mg Capsule, Liquid Filled from FAMILY DOLLAR SERVICES, marketed since Aug 2020 and currently FDA-listed. It is this product's only package size.

NDC 55319-0628-16
🏷️ FDA NDC (as labeled) 55319-628-16 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 Oct 8, 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 55319-628-16 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
55319 labeler · 628 product · 16 package
Package marketed since
Aug 24, 2020
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 5531962816 3
FDA record last changed
Oct 8, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 55319-628-16
Product NDC 55319-628
11-digit billing NDC 55319062816
RxCUI 1656815
UNII 9D2RTI9KYH, 04JA59TNSJ, 362O9ITL9D, 495W7451VQ
Application # M012
SPL Set ID a7343bea-53cc-4621-e053-2a95a90a2a5f
Established class (EPC) Expectorant
Physiologic effect Decreased Respiratory Secretion Viscosity; Increased Respiratory Secretions
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-08-24
Route ORAL
Dosage form CAPSULE, LIQUID FILLED
Substance DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; GUAIFENESIN
Quick answers
  • RxCUI (RxNorm): 1656815
Why two NDCs? The FDA registers this code as 55319-628-16 — 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 → 55319-0628-16. 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

🧪 What is this product?

This is an oral liquid-filled capsule sold as an over-the-counter cold and flu product under FDA's OTC monograph rules. It contains acetaminophen, typically used to relieve pain and reduce fever; dextromethorphan, commonly used to suppress cough; guaifenesin, an expectorant typically used to help thin mucus; and phenylephrine, a decongestant commonly used to relieve nasal congestion. This combination is intended for people seeking multi-symptom cold and flu relief.

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 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
55319-0628-16 You're viewing this Main listing 16 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 2020-08-24 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Maximum Strength Mucinex Fast-Max Cold and Flu 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 63824-0518-08 Reckitt 8 capsules $0.737 — FDA listed —
Mucinex Fast-Max Cold, Flu and Sore Throat 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 63824-0591-16 Reckitt 8 capsules $0.737 — FDA listed —
Mucinex Sinus-Max Pressure, Pain and Cough 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 63824-0693-08 Reckitt 8 capsules $0.737 — FDA listed —
Mucinex Fast-Max Cold and Flu Maximum Strength 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 72854-0126-08 Reckitt 8 capsules $0.737 — FDA listed —
Mucinex Fast-Max Cold, Flu and Sore Throat Maximum Strength 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 72854-0127-16 Reckitt 8 capsules $0.737 — FDA listed —
Mucinex Sinus-Max Pressure, Pain and Cough Maximum Strength 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 72854-0202-08 Reckitt 8 capsules $0.737 — FDA listed —
Alka-Seltzer Plus Maximum Strength Cough, Mucus and Congestion Powermax 200 mg/1; 325 mg/1; 10 mg/1; 5 mg 00280-0061-01 Bayer 8 capsules — — FDA listed —
Alka Seltzer COLD Cold Mucus Congestion Maximum Strength Fast Gels 200 mg/1; 325 mg/1; 10 mg/1; 5 mg 00280-8294-24 Bayer 8 capsules — — FDA listed —
DAYTIME COLD AND FLU Maximum Strength 325 mg/1; 200 mg/1; 10 mg/1; 5 mg 00363-0109-24 Walgreens 12 capsules — — FDA listed —
SEVERE DAYTIME COLD and FLU DAYTIME MAXIMUM STRENGTH NON-DROWSY SEVERE 200 mg/1; 10 mg/1; 5 mg/1; 325 mg 00363-8996-24 Walgreens 12 capsules — — FDA listed —
COLD, Flu and Sore Throat 325 mg/1; 200 mg/1; 10 mg/1; 5 mg 00363-9016-16 Walgreens 8 capsules — — FDA listed —
Maximum Strength Cold and Flu 325 mg/1; 200 mg/1; 10 mg/1; 5 mg 00363-9017-16 Walgreens 8 capsules — — FDA listed —
Cold And Flu Daytime Severe 5 mg/1; 325 mg/1; 200 mg/1; 10 mg 11673-0972-16 TARGET 16 capsules — — FDA listed —
Maximum Strength Cold And Flu 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 11673-0978-16 TARGET 8 capsules — — FDA listed —
Acetaminophen, Guaifenesin, Phenylephrine Hcl and Dextromethorphan HBr 5 mg/1; 10 mg/1; 325 mg/1; 200 mg 35916-0166-01 Softgel 12 capsules — — FDA listed —
Vicks DayQuil Severe Cold and Flu 5 mg/1; 325 mg/1; 10 mg/1; 200 mg 37000-0517-02 The 2 capsules — — FDA listed —
Daytime Severe Cold And Flu 5 mg/1; 200 mg/1; 325 mg/1; 10 mg 41226-0625-16 KROGER 8 capsules — — FDA listed —
ACETAMINOPHEN, DEXTROMETHORPHAN HBr, GUAILFENESIN,PHENLYEPHRINE HCL 5 mg/1; 325 mg/1; 10 mg/1; 200 mg 41226-0628-16 Kroger 16 capsules — — FDA listed —
COLD FLU and SORE THROAT RELIEF 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 41520-0984-14 FOODHOLD 8 capsules — — FDA listed —
Severe sinus Congestion Relief 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 41520-0985-14 FOODHOLD 8 capsules — — FDA listed —
Daytime Severe Cold and Flu Relief 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 51013-0174-04 PuraCap 12 capsules — — FDA listed —
Daytime Severe Cold And Flu 10 mg/1; 5 mg/1; 200 mg/1; 325 mg 51316-0525-24 CVS 24 capsules — — FDA listed —
Daytime Severe Cold and Flu 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 53345-0021-01 Humanwell 3000 capsules — — FDA listed —
Maximum Strength Cold And Flu 10 mg/1; 5 mg/1; 325 mg/1; 200 mgthis 55319-0628-16 FAMILY 16 capsules — — FDA listed —
Acetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl 325 mg/1; 200 mg/1; 10 mg/1; 5 mg 69729-0782-10 OPMX 10 capsules — — FDA listed —
Severe Cold Daytime 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 69842-0505-16 CVS 16 capsules — — FDA listed —
Maximum Strength Cold, Flu And Sore Throat 200 mg/1; 10 mg/1; 5 mg/1; 325 mg 69842-0616-16 CVS 8 capsules — — FDA listed —
Maximum Strength Cold And Flu 325 mg/1; 10 mg/1; 5 mg/1; 200 mg 69842-0789-16 CVS 8 capsules — — FDA listed —
Mucus Relief Cold Flu Sore Throat Maximum Strength 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 69842-0969-16 CVS 1 capsule — — Discontinued —
RIGHT REMEDIES DAYTIME SEVERE COLD AND FLU softgel 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 70692-0836-84 Strive 48 capsules — — FDA listed —
DayTime SEVERE Cold and Flu Relief SOFTGELS 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 76162-0636-24 Topco 12 capsules — — FDA listed —
TopCare Day Time SEVERE Cold and Flu 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 76162-0811-24 Topco 12 capsules — — FDA listed —
Maximum Strength Non Drowsy Daytime Severe Cold and Flu 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 79903-0162-24 Wal-Mart 12 capsules — — FDA listed —
equate MAXIMUM STRENGTH DAYTIME SEVERE Cold and Flu SOFTGELS 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 79903-0386-24 WALMART 12 capsules — — FDA listed —
QUALITY CHOICE DayTime Severe Cold and Flu 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 83324-0037-24 Chain 12 capsules — — FDA listed —
QUALITY CHOICE Maximum Strength Daytime Cold and Flu 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 83324-0162-24 Chain 12 capsules — — 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

🏛️
2020
On the market since
Aug 2020
📍
2026
Currently FDA-listed
6 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.

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 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 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • 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 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 46N107B71O
    Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
  • UNII 8KW3E207O2
    A liquid sweetener made from sorbitol, a sugar alcohol derived from glucose. It sweetens the medicine and also acts as a humectant to help retain moisture and improve texture in liquid formulations.
  • 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.
  • 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 FD&C yellow#6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide

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

LabelerFAMILY DOLLAR SERVICES
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code55319
First marketedAug 2020
Product typeHuman Otc Drug

More NDCs from FAMILY DOLLAR SERVICES labeler code 55319

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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 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 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 49 words ▾

Uses temporarily relieves these common cold and flu symptoms: nasal congestion headache cough stuffy nose minor aches and pains sore throat sinus congestion and pressure temporarily reduces fever helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

⏱️ Dosage and Administration 45 words ▾

Directions Do not take more than directed (see Overdose warning) do not exceed more than 12 softgels in any 24-hour period adults and children 12 years of age and over: take 2 softgels every 4 hours children under 12 years of age: do not use

⚠️ Warnings 100 words ▾

Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take: more than 12 softgels in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks daily 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.

🧪 Active Ingredient 18 words ▾

Active ingredients (in each softgel) Acetaminophen 325 mg Dextromethorphan HBr 10mg Guaifenesin 200 mg Phenylephrine HCl 5 mg

🧪 Inactive Ingredients 19 words ▾

Inactive ingredients FD&C yellow#6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide

🎯 Purpose 9 words ▾

Purpose Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant

📄 Do Not Use 79 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 now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

📄 Ask a Doctor Before Use If 47 words ▾

Ask a doctor before use if you have liver disease heart disease diabetes high blood pressure thyroid disease trouble urinating due to enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus)

📄 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 10 words ▾

When using this product, do not use more than directed.

📄 Stop Use and Ask a Doctor If 61 words ▾

Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back, or occurs with rash or headache that lasts. These could be signs of a serious condition.

🤰 If Pregnant or Breast-Feeding 10 words ▾

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

📄 Keep Out of Reach of Children 57 words ▾

Keep out of reach of children. 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 for children even if you do not notice any signs or symptoms.

📄 Other Information 9 words ▾

Other information store at 20-25°C (68-77°F) avoid excessive heat

📄 Questions or Comments 5 words ▾

Questions or comments? Call 1-877-290-4008

📄 Package Label / Principal Display Panel 2 words ▾

628T-Family Dollar

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

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 MAXIMUM STRENGTH COLD AND FLU (this brand).

Top reported reactions

Toxicity To Various Agents3
Intentional Product Misuse2
Anaphylactic Reaction1
Choking1
Erythema1
Heart Rate Increased1
Peripheral Swelling1

Age at onset

Adult3

Reporter sex

7 reports
Male · 29%
Female · 71%

Serious outcomes

Hospitalization4
Death3
Reports over time (by year) — tap or hover for the count & year
2024 2025 2026 2 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
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 FAMILY DOLLAR SERVICES. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
FAMILY DOLLAR SERVICES 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.
← 55319-0624-12 · FAMILY 55319-0633-03 · Family →
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.