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Daytime Nighttime Cold Flu Relief Acetaminophen, Dextromethorphan HBR, Doxylamine succinate, Phenylephrine HCl Kit — NDC 55319-566-24 (Billing 55319-0566-24)

by Family Dollar (FAMILY WELLNESS) · 1 KIT in 1 KIT * 8 BLISTER PACK in 1 CARTON / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 16 BLISTER PACK in 1 CARTON / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

This is a package of Daytime Nighttime Cold Flu Relief Acetaminophen, Dextromethorphan HBR, Doxylamine succinate, Phenylephrine HCl Kit from Family Dollar (FAMILY WELLNESS), marketed since Jul 2023 and currently FDA-listed. It is this product's only package size.

NDC 55319-0566-24
🏷️ FDA NDC (as labeled) 55319-566-24 billing pads the product 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

NDC database record

One package, one record: these facts belong to NDC 55319-566-24 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
55319 labeler · 566 product · 24 package
Package marketed since
Jul 1, 2023
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 5531956624 3
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 55319-566-24
Product NDC 55319-566
11-digit billing NDC 55319056624
RxCUI 1086997, 1094549, 2634564
Application # M012
SPL Set ID 150e5c3a-7c86-4b66-af30-a376df697401
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-07-01
Dosage form KIT
Quick answers
  • RxCUI (RxNorm): 1086997
Why two NDCs? The FDA registers this code as 55319-566-24 — 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 → 55319-0566-24. 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 over-the-counter kit containing two separate products for managing cold and flu symptoms. The daytime formulation includes acetaminophen (a pain reliever and fever reducer), dextromethorphan (a cough suppressant), and phenylephrine (a decongestant). The nighttime formulation contains acetaminophen, dextromethorphan, and doxylamine succinate (an antihistamine used to promote drowsiness). These products are marketed under federal guidelines for nonprescription cold and flu relief combinations.

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.
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
55319-0566-24 You're viewing this Main listing 1 KIT in 1 KIT * 8 BLISTER PACK in 1 CARTON / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 16 BLISTER PACK in 1 CARTON / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 2023-07-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
foster and thrive daytime cold and flu relief nighttime cold and flu relief 70677-1028-01 Strategic 2 capsules $0.151 — FDA listed —
Goodnow cold flu day relief cold flu night relief 82501-1211-01 Gobrands, 2 capsules — — FDA listed —
Daytime Nighttime Cold Flu Relief 41163-0901-48 United 1 capsule — — FDA listed —
NiteTime DayTime Cold and Flu 41250-0597-02 Meijer 1 kit — — FDA listed —
Daytime Nighttime Cold and Flu Relief Multi-Symptom 67091-0336-48 WinCo 16 capsules — — FDA listed —
Cold and Flu Day, Night 00363-1213-02 Walgreen 1 kit — — FDA listed —
daytime nighttime cold and flu 00363-1733-02 Walgreen 1 kit — — FDA listed —
Daytime Nighttime Cold Flu Relief 72476-0850-48 Care 16 capsules — — FDA listed —
Daytime Nighttime Cold Flu Relief 11822-0851-04 Rite 8 capsules — — FDA listed —
Daytime Nighttime Cold Flu Relief 21130-0058-48 Safeway, 16 capsules — — FDA listed —
equaline daytime and nighttime cold and flu relief 41163-0567-02 United 1 kit — — FDA listed —
equate daytime cold and flu nighttime cold and flu 49035-0718-02 Wal-Mart 1 kit — — FDA listed —
Cold and Flu Daytime, Nighttime, Multi-Symptom 00363-9012-48 Walgreens 8 capsules — — FDA listed —
Vicks DayQuil NyQuil ULTRA CONCENTRATED COLD and FLU 69423-0802-96 The 1 kit — — FDA listed —
Topcare Nite Time Day Time Cold and Flu 36800-0580-72 Topco 2 capsules — — FDA listed —
Daytime Nighttime Cold Flu Relief 68016-0799-48 Chain 1 capsule — — Discontinued —
Cold And Flu Daytime-Nighttime 11673-0984-24 TARGET 8 capsules — — FDA listed —
Daytime Nighttime Cold Flu Relief 49035-0192-48 EQUATE 16 capsules — — FDA listed —
Daytime Nighttime Cold Flu Relief 69256-0901-48 Harris 1 capsule — — FDA listed —
basic care daytime nighttime cold and flu 72288-0733-02 Amazon.com 1 kit — — FDA listed —
Daytime Nighttime Cold Flu Relief 72476-0901-48 Care 32 capsules — — FDA listed —
Daytime Nighttime Cold Flu Reliefthis 55319-0566-24 Family 1 capsule — — FDA listed —
Daytime Nighttime Cold Flu Relief 67091-0393-48 WinCo 1 capsule — — FDA listed —
Severe Cold and Flu 00363-1597-02 Walgreen 1 kit — — FDA listed —
Cold and Flu Daytime, Nighttime, Multi-Symptom 00363-9011-24 Walgreens 8 capsules — — FDA listed —
Daytime Nighttime Cold Flu Relief 69842-0852-24 CVS 1 capsule — — FDA listed —
Daytime Nighttime Cold Flu Relief 81522-0901-48 FSA 1 capsule — — FDA listed —
Daytime Nighttime Cold Flu Relief 21130-0901-48 Safeway, 16 capsules — — FDA listed —
TopCare Day Time Nite Time Cold and Flu Relief 36800-0301-02 Topco 1 kit — — FDA listed —
Daytime Nighttime Cold and Flu Relief Multi-Symptom 59726-0901-24 P 8 capsules — — FDA listed —
daytime nighttime cold and flu 00363-0567-02 Walgreen 1 kit — — FDA listed —
Daytime Nighttime Cold Flu Relief 69842-0896-24 CVS 1 capsule — — FDA listed —
basic care daytime cold and flu nighttime cold and flu 72288-0580-72 Amazon.com 2 capsules — — FDA listed —
Cold and Flu Daytime Nighttime 51316-0123-02 CVS 1 kit — — FDA listed —
Topcare Day Time Nite Time Cold and Flu 36800-0597-02 Topco 1 kit — — FDA listed —
Daytime Nighttime Cold Flu Relief 41163-0850-48 United 16 capsules — — FDA listed —
Daytime-Nighttime Severe Cold And Flu 41226-0627-24 KROGER 4 capsules — — FDA listed —
daytime nitetime cold and flu 41250-0733-02 Meijer 1 kit — — FDA listed —
dg health cold and flu relief 55910-0811-72 Dolgencorp 2 capsules — — FDA listed —
Severe Nighttime Severe Daytime 59779-0597-02 CVS 1 kit — — FDA listed —
Severe Cold and Flu Nighttime Daytime 42507-0597-02 HyVee 1 kit — — FDA listed —
Daytime Nighttime Cold And Flu 72288-0791-02 Amazon.com 1 kit — — FDA listed —
Good Sense Daytime Nighttime Cold And Flu 00113-5800-72 L. 2 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

🏛️
2023
On the market since
Jul 2023
📍
2026
Currently FDA-listed
3 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 (FAMILY WELLNESS)
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code55319
First marketedJul 2023
Product typeHuman Otc Drug
Portfolio63 products on file

More NDCs from Family Dollar (FAMILY WELLNESS) 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 📦 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 📄 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 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 58 words ▾

Uses DAYTIME temporarily relieves common cold and flu symptoms: cough due to minor throat and bronchial irritation fever sore throat nasal congestion and sinus pressure headache minor aches and pains NIGHTTIME temporarily relieves common cold and flu symptoms: cough due to minor throat and bronchial irritation sore throat headache minor aches and pains fever runny nose & sneezing

⏱️ Dosage and Administration 101 words ▾

Directions DAYTIME do not take more than directed (see Overdose warning) do not take more than 4 doses in 24 hours swallow whole; do not crush, chew, or dissolve adults and children 12 years and over: take 2 softgels with water every 4 hours children under 12 years: do not use NIGHTTIME do not take more than directed (see Overdose warning) do not take more than 4 doses in 24 hours swallow whole; do not crush, chew, or dissolve adults and children 12 years and over: take 2 softgels with water every 6 hours children under 12 years: do not use

⚠️ Warnings ~2 min read ▾

Warnings Liver warning: These products contain acetaminophen. Severe liver damage may occur if you take: more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using these products 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. 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 you have DAYTIME liver disease heart disease diabetes thyroid disease high blood pressure cough that occurs with too much phlegm (mucus) trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema NIGHTTIME liver disease glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are DAYTIME taking the blood thinning drug warfarin NIGHTTIME taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product, DAYTIME do not exceed recommended dosage.

NIGHTTIME do not exceed recommended dosage excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if DAYTIME nervousness, dizziness or sleeplessness occur pain, cough, and nasal congestion gets worse or lasts more than 7 days redness or swelling is present new symptoms occur fever gets worse or lasts more than 3 days cough comes back or occurs with rash or headache that lasts.

These could be signs of a serious condition. NIGHTTIME pain 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 headache that lasts. These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning : Taking more than the recommended dose can cause liver damage.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

📦 Storage and Handling 9 words ▾

Other information store between 15-30°C (59-86°F) avoid excessive heat

🧪 Active Ingredient 36 words ▾

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

Active ingredients for Nighttime (in each softgel) Acetaminophen 325 mg Dextromethorphan HBr 15 mg Doxylamine succinate 6.25 mg

🧪 Inactive Ingredients 52 words ▾

Inactive ingredients DAYTIME FD&C red #40, FD&C yellow #6, gelatin, glycerin, lecithin, light mineral oil, mannitol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol, white ink NIGHTTIME D&C yellow #10, FD&C blue #1, gelatin, glycerin, lecithin, light mineral oil, mannitol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol, white ink

🎯 Purpose 19 words ▾

Purpose for Daytime Pain reliever/fever reducer Cough suppressant Nasal decongestant

Purpose for Nighttime Pain reliever/fever reducer Cough suppressant Antihistamine

📄 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 85 words ▾

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

📄 Ask a Doctor or Pharmacist Before Use If 28 words ▾

Ask a doctor or pharmacist before use if you are DAYTIME taking the blood thinning drug warfarin NIGHTTIME taking the blood thinning drug warfarin taking sedatives or tranquilizers

📄 When Using This Product 46 words ▾

When using this product, DAYTIME do not exceed recommended dosage. NIGHTTIME do not exceed recommended dosage excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery

📄 Stop Use and Ask a Doctor If 109 words ▾

Stop use and ask a doctor if DAYTIME nervousness, dizziness or sleeplessness occur pain, cough, and nasal congestion gets worse or lasts more than 7 days redness or swelling is present new symptoms occur fever gets worse or lasts more than 3 days cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. NIGHTTIME pain 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 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 can cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

📄 Questions or Comments 8 words ▾

Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

📄 Package Label / Principal Display Panel 209 words ▾

Principal Display Panel COMPARE TO THE ACTIVE INGREDIENTS IN VICKS ® DAYQUIL™ AND NYQUIL™ COLD & FLU LIQUICAPS™† DAYTIME COLD & FLU RELIEF Acetaminophen 325 mg Pain Reliever/Fever Reducer Dextromethorphan HBr 10 mg Cough Suppressant Phenylephrine HCI 5 mg Nasal Decongestant RELIEVES Aches, Fever, Sore Throat Cough Nasal Congestion & Sinus Pressure Alcohol-Free Antihistamine-Free SOFTGELS** (** LIQUID-FILLED CAPSULES) NIGHTTIME COLD & FLU RELIEF Acetaminophen 325 mg Pain Reliever/Fever Reducer Dextromethorphan HBr 15 mg Cough Suppressant Doxylamine succinate 6.25 mg Antihistamine Relieves Aches, Fever, Sore Throat Cough Runny Nose, Sneezing Alcohol-Free SOFTGELS** (**LIQUID-FILLED CAPSULES) When using Daytime and Nighttime products, carefully read the labeling to ensure correct dosing. †This product is not manufactured or distributed by The Procter & Gamble Company.

Vicks ® , DayQuil™, NyQuil™, and LiquiCaps™ are registered trademarks of The Procter and Gamble Company. TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS SIGNS OF TAMPERING. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY MIDWOOD BRANDS LLC, 510 VOLVO PKWY, CHESAPEAKE, VA 23320

Product Label FAMILY WELLNESS Daytime Nighttime Cold & Flu Relief Acetaminophen 325 mg Dextromethorphan HBr 15 mg Doxylamine Succinate 6.25 mg Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg

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 Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl — the ingredient across all brands.

Top reported reactions

Dyspnoea3
Vomiting3
Chills2
Dizziness2
Headache2
Hypersensitivity2
Nasopharyngitis2

Age at onset

Adult1
Elderly1

Reporter sex

23 reports
Male · 25%
Female · 75%

Serious outcomes

Hospitalization5
Life-threatening1
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 5 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 Kit / multi-component package

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 (FAMILY WELLNESS). Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Family Dollar (FAMILY WELLNESS) 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.
← 55319-0565-10 · Family 55319-0567-16 · 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.