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Family Wellness Original Redness Relief Eye Drops Tetrahydrozoline HCl .05 g/100mL Solution/ Drops — NDC 55319-907-01 (Billing 55319-0907-01)

by Family Dollar Services, Inc. · 1 BOTTLE, DROPPER in 1 BOX / 15 mL in 1 BOTTLE, DROPPER

This is a package of Family Wellness Original Redness Relief Eye Drops Tetrahydrozoline HCl .05 g/100mL Solution/ Drops from Family Dollar Services, Inc., marketed since Aug 2023 and currently FDA-listed. It is this product's only package size.

NDC 55319-0907-01
🏷️ FDA NDC (as labeled) 55319-907-01 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 55319-907-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
55319 labeler · 907 product · 01 package
Package marketed since
Aug 12, 2023
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0032251912696
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Tetrahydrozoline Hcl (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Mar 3, 2026 — Lack of Assurance of Sterility (K.C. Pharmaceuticals, Inc) · FDA recall D-0413-2026
Class II · Jun 13, 2023 — CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line. (K.C. Pharmaceuticals, Inc) · FDA recall D-0897-2023
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) 55319-907-01
Product NDC 55319-907
11-digit billing NDC 55319090701
RxCUI 1052943
UNII 0YZT43HS7D
UPC 0032251912696
Application # M018
SPL Set ID fabf540a-8d5c-bb1c-e053-6394a90a75c2
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-08-12
Route OPHTHALMIC
Dosage form SOLUTION/ DROPS
Substance TETRAHYDROZOLINE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 1052943
Why two NDCs? The FDA registers this code as 55319-907-01 — 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 → 55319-0907-01. 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 Sympathomimetics, plain class.

Drug family (ATC) Sympathomimetics, plain, Sympathomimetics used as decongestants
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

📗 Our plain-language guide HelloPharmacist
  • It relieves the redness you see, but it doesn't treat the underlying cause of the irritation. Think of it as a short-term fix to take the red out. If something is genuinely botheri...
  • What exactly does this eye drop do — does it actually fix what's irritating my eye?
  • No — you should remove your contact lenses before putting in the drops. The solution can be absorbed by soft contacts, which can affect the lens and potentially irritate your eye....
  • Can I wear my contact lenses while using these drops?
📖 Read our full Tetrahydrozoline Ophthalmic guide →

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
55319-0907-01 You're viewing this Main listing 1 BOTTLE, DROPPER in 1 BOX / 15 mL in 1 BOTTLE, DROPPER 2023-08-12 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Good Neighbor Pharmacy Eye Drops Original Formula .05 g/100mL 24385-0075-05 AmerisourceBergen 1 bottle $0.097 — Discontinued —
Foster and Thrive Original Formula Eye Drops .05 g/100mL 70677-1159-01 Strategic 1 bottle $0.097 — Availability likely —
Quality Choice Eye Drops Redness Relief .05 g/100mL 83324-0340-15 Chain 1 bottle $0.097 — Availability likely —
Sunmark Eye Drops Original Formula .05 g/100mL 49348-0037-29 Strategic 1 bottle $0.115 — FDA listed —
Walgreens Eye Drops Original 15mL and twin pack .05 g/100mL 00363-4550-01 Walgreens 1 bottle — — FDA listed —
Kroger Eye Drops Original .05 g/100mL 30142-0574-01 The 1 bottle — — FDA listed —
TopCare Health Original Eye Drops .05 g/100mL 36800-0858-01 Topco 1 bottle — — FDA listed —
HEB Original Eye Drops .05 g/100mL 37808-0577-01 HEB 1 bottle — — FDA listed —
Meijer Redness Relief .05 g/100mL 41250-0814-01 Meijer 1 bottle — — FDA listed —
GoodSense Eye Drops Original Formula .05 g/100mL 50804-0141-01 Geiss, 1 bottle — — FDA listed —
CAREALL Eyedrops Original .5 mg/mL 51824-0039-05 New 15 ml — — FDA listed —
Discount Drug Mart Eye Drops Original .05 g/100mL 53943-0073-01 Discount 1 bottle — — FDA listed —
Family Wellness Original Redness Relief Eye Drops .05 g/100mLthis 55319-0907-01 Family 1 bottle — — FDA listed —
Medics Choice Eye Drops Original Redness Reliever .5 mg/mL 55651-0005-01 KC 1 bottle — — FDA listed —
Original Redness Reliever .05 g/100mL 55651-0063-01 KC 1 bottle — — FDA listed —
DG Original Eye Drops .05 g/100mL 55910-0363-01 Dolgencorp 1 bottle — — FDA listed —
CVP Sterile Eye Drops .05 g/100mL 57243-0068-01 Salado 1 bottle — — FDA listed —
Preferred Plus Pharmacy Redness Relief Eye Drops .05 g/100mL 61715-0212-01 Kinray 1 bottle — — FDA listed —
Best Choice Eye Drops Original .05 g/100mL 63941-0139-01 Valu 1 bottle — — FDA listed —
Redness Reliever, Circle K .5 mg/mL 66715-5429-04 Lil' 1 bottle — — FDA listed —
Lil Drug Store Eye Drops Redness Reliever .5 mg/mL 66715-6832-04 Lil 1 bottle — — FDA listed —
CIRCLE K sterile eye drops .05 g/100mL 66715-8882-01 Lil' 1 bottle — — FDA listed —
Lil Drug Store Sterile Eye Drops Redness Reliever .05 g/100mL 66715-8883-01 Lil' 1 bottle — — FDA listed —
Winco Original Formula Eye Drops .05 g/100mL 67091-0310-15 WinCo 1 bottle — — FDA listed —
Equate Eye Drops .5 mg/mL 67172-0281-01 Prestige 1 bottle — — Discontinued —
Equate Eye Drops .5 mg/mL 67172-0282-01 Prestige 1 bottle — — Discontinued —
Harris Teeter Eye Drops Original .05 g/100mL 69256-0977-01 Harris 1 bottle — — FDA listed —
Visine Red Eye Comfort .5 mg/mL 69968-0355-01 Kenvue 1 bottle — — FDA listed —
Equate Original Eye Drops .05 g/100mL 79903-0158-05 Walmart, 1 bottle — — FDA listed —
Original Redness Reliever .05 g/100mL 79903-0363-01 Walmart 1 bottle — — FDA listed —
Equaline Sterile Eye Drops .05 g/100mL 83455-0210-01 United 1 bottle — — 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
Aug 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 Services, Inc.
FDA applicationM018 (OTC MONOGRAPH DRUG)
Labeler code55319
First marketedAug 2023
Product typeHuman Otc Drug
Portfolio19 products on file

More NDCs from Family Dollar Services, Inc. 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
🎯 Indications and Usage 11 words ▾

Use relieves redness of the eye due to minor eye irritations

⏱️ Dosage and Administration 15 words ▾

Directions instill 1 to 2 drops in the affected eye(s) up to 4 times daily

⚠️ Warnings 127 words ▾

Warnings For external use only Ask a doctor before use if you have narrow angle glaucoma When using this product pupils may become enlarged temporarily to avoid contamination, do not touch tip of container to any surface. Replace cap after using. if solution changes color or becomes cloudy, do not use overuse may produce increased redness of the eye remove contact lens before using Stop use and ask a doctor if you experience eye pain changes in vision continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

🧪 Active Ingredient 5 words ▾

Active ingredient Tetrahydrozoline HCl 0.05%

🧪 Inactive Ingredients 14 words ▾

Inactive ingredients benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, sodium chloride

🎯 Purpose 3 words ▾

Purpose Redness reliever

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 Family Wellness Original Redness Relief Eye Drops (this brand).

Top reported reactions

Fatigue3
Alanine Aminotransferase Increased2
Aspartate Aminotransferase Increased2
Asthenia2
Blood Alkaline Phosphatase Increased2
Dysgeusia2
Fall2

Age at onset

Elderly1

Reporter sex

13 reports
Male · 54%
Female · 46%

Serious outcomes

Hospitalization7
Death2
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 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 — 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 Services, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Family Dollar Services, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 55319-0906-01 · Family 55319-0908-01 · 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.