GOOD REMEDIES Maximum Strength Urinary Pain Relief Caplet Phenazopyridine hydrochloride 99.5 mg Tablet, Film Coated, 8-count — NDC 70692-178-08 (Billing 70692-0178-08)
by Strive Pharmaceuticals Inc. · 1 BLISTER PACK in 1 CARTON / 8 TABLET, FILM COATED in 1 BLISTER PACK
This is a package of 8 tablets of GOOD REMEDIES Maximum Strength Urinary Pain Relief Caplet Phenazopyridine hydrochloride 99.5 mg Tablet, Film Coated from Strive Pharmaceuticals Inc., marketed since Jan 2025 and currently FDA-listed. It is this product's only package size.
NDC 70692-0178-08
🏷️ FDA NDC (as labeled)
70692-178-08
billing pads the product segment with a zero
🗂️ 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 →
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
70692-178-08
Product NDC
70692-178
11-digit billing NDC
70692017808
RxCUI
1094147
UNII
0EWG668W17
UPC
0370692001099
SPL Set ID
269fa921-f4c4-16e7-e063-6394a90a0cbb
DEA schedule
Non-controlled
Marketing category
UNAPPROVED DRUG OTHER
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2025-01-06
Route
ORAL
Dosage form
TABLET, FILM COATED
Substance
PHENAZOPYRIDINE HYDROCHLORIDE
Quick answers
- RxCUI (RxNorm): 1094147
Why two NDCs?
The FDA registers this code as 70692-178-08 — 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 → 70692-0178-08. 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Other urologicals class.
Drug family (ATC)
Other urologicals
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.
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
📗 Our plain-language guide HelloPharmacist
- It only helps with the pain — it doesn't kill the bacteria causing the infection. Think of it as taking the edge off while your antibiotic does the real work. If you have a UTI, yo...
- Does phenazopyridine actually treat my UTI, or does it just help with the pain?
- That's completely expected with phenazopyridine — it's one of the most common things people notice. The drug itself has an orange-red dye, and it passes into your urine, which is w...
- Why is my urine turning orange or red? Should I be worried?
Patient education
Supplement & herbal interactions
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.
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
💬 Questions about Phenazopyridine hydrochloride?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per each | Per 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.
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 2, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 70692-0178-08 You're viewing this Main listing | 1 BLISTER PACK in 1 CARTON / 8 TABLET, FILM COATED in 1 BLISTER PACK | 2025-01-06 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Good Neighbor Maximum Strength Urinary Pain Relief 99.5 mg 46122-0628-53 | AmerisourceBergen | 12 tablets | $0.184 | — | Availability likely | — |
| URO-PAIN Maximum Strength 99.5 mg 57237-0330-21 | Rising | 12 tablets | $0.184 | — | Availability likely | — |
| Leader Maximum Strength Urinary Pain Relief 99.5 mg 70000-0523-01 | Cardinal | 12 tablets | $0.184 | — | Availability likely | — |
| Foster and Thrive Maximum Strength Urinary Pain Relief 99.5 mg 70677-1230-01 | Strategic | 12 tablets | $0.184 | — | Availability likely | — |
| HealthMart Maximum Strength Urinary Pain Relief 99.5 mg 62011-0412-01 | Strategic | 12 tablets | $0.186 | — | FDA listed | — |
| Sunmark Maximum Strength Urinary Pain Relief 99.5 mg 70677-0078-01 | Strategic | 12 tablets | $0.186 | — | FDA listed | — |
| Wallgreens Maximum Strength Urinary Pain Relief 99.5 mg 00363-8455-12 | Walgreens | 12 tablets | — | — | FDA listed | — |
| Preferred Maximum Strength Urinary Pain Relief 99.5 mg 10956-0210-12 | Reese | 12 tablets | — | — | FDA listed | — |
| Vexia Maximum Strength Urinary Pain Relief 99.5 mg 10956-0703-24 | Reese | 24 tablets | — | — | FDA listed | — |
| Maximum Strength Urinary Pain Relief 99.5 mg 11673-0270-24 | TARGET | 24 tablets | — | — | FDA listed | — |
| Rite Aid Maximum Strength Urinary Pain Relief 99.5 mg 11822-3111-02 | Rite | 12 tablets | — | — | FDA listed | — |
| Signature Care Maximum Strength Urinary Pain Relief 99.5 mg 21130-0792-24 | Safeway | 24 tablets | — | — | FDA listed | — |
| Kroger Maximum Strength Urinary Pain Relief 99.5 mg 30142-0221-24 | THE | 24 tablets | — | — | FDA listed | — |
| Maximum Strength Urinary Pain Relief 99.5 mg 30142-0756-24 | KROGER | 24 tablets | — | — | FDA listed | — |
| TopCare Maximum Strength Urinary Pain Relief 99.5 mg 36800-0510-12 | TOPCO | 12 tablets | — | — | FDA listed | — |
| Meijer Maximum Strength Urinary Pain Relief 99.5 mg 41250-0342-12 | Meijer | 12 tablets | — | — | FDA listed | — |
| Walmart Maximum Strength Urinary Pain Relief 99.5 mg 49035-0297-12 | Walmart | 12 tablets | — | — | FDA listed | — |
| AZO Urinary Pain Relief Maximum Strength 99.5 mg 49973-0247-12 | i-Health, | 12 tablets | — | — | FDA listed | — |
| Phenazopyridine Hydrochloride 99.5 mg 50696-0003-01 | GPT | 25000 tablets | — | — | FDA listed | — |
| Uricalm Maximum Strength 99.5 mg 52389-0241-24 | Kobayashi | 24 tablets | — | — | FDA listed | — |
| Discount Drugmart Maximum Strength Urinary Pain Relief 99.5 mg 53943-0336-12 | Discount | 12 tablets | — | — | FDA listed | — |
| Family Dollar Maximum Strength Urinary Pain Relief 99.5 mg 55319-0211-12 | Family | 12 tablets | — | — | FDA listed | — |
| Dollar General Maximum Strength Urinary Pain Relief 99.5 mg 55910-0631-12 | Dolgencorp, | 12 tablets | — | — | FDA listed | — |
| Uristat Ultra 99.5 mg 63029-0105-12 | Medtech | 12 tablets | — | — | FDA listed | — |
| Monistat Maintain 99.5 mg 63736-0020-12 | Insight | 12 tablets | — | — | FDA listed | — |
| Quality Choice Maximum Strength Urinary Pain Relief 99.5 mg 63868-0297-12 | Chain | 12 tablets | — | — | FDA listed | — |
| Premier Value Maximum Strength Urinary Pain Relief 99.5 mg 68016-0129-12 | Chain | 12 tablets | — | — | FDA listed | — |
| Preferred Maximum Strength Urinary Pain Relief 99.5 mg 68788-7778-01 | Preferred | 12 tablets | — | — | Discontinued | — |
| Harris Teeter Maximum Strength Urinary Pain Relief 99.5 mg 69256-0767-12 | Harris | 12 tablets | — | — | FDA listed | — |
| Cystex Max UTI Pain Relief 99.5 mg 69693-0514-24 | Clarion | 24 tablets | — | — | FDA listed | — |
| CVS Maximum Strength Urinary Pain Relief 99.5 mg 69842-0713-12 | CVS | 12 tablets | — | — | FDA listed | — |
| RIGHT REMEDIES Maximum Strength Urinary Pain Relief 99.5 mg 70692-0163-39 | Strive | 72 tablets | — | — | FDA listed | — |
| GOOD REMEDIES Maximum Strength Urinary Pain Relief Caplet 99.5 mgthis 70692-0178-08 | Strive | 8 tablets | — | — | FDA listed | — |
| Care One Maximum Strength Urinary Pain Relief 99.5 mg 72476-0210-12 | Retail | 12 tablets | — | — | FDA listed | — |
| Uti Pain Relief 99.5 mg 73436-2441-02 | Cadence | 12 tablets | — | — | FDA listed | — |
| Urinary Pain Relief 99.5 mg 73581-0909-72 | YYBA | 72 tablets | — | — | Discontinued | — |
| Urinary Pain Relief 99.5 mg 73581-0919-12 | YYBA | 120 tablets | — | — | FDA listed | — |
| Uqora Maximum UTI Pain Relief 99.5 mg 73712-0114-12 | Bonafide | 12 tablets | — | — | FDA listed | — |
| Maximum Strength Urinary Pain Relief 99.5 mg 80513-0517-72 | Advanced | 72 tablets | — | — | FDA listed | — |
| Stix Maximum Strength Urinary Pain Relief 99.5 mg 80584-0113-24 | Get | 24 tablets | — | — | FDA listed | — |
| Cheeky Bonsai UTI Pain Relief 99.5 mg 81860-0113-24 | IXXA, | 24 tablets | — | — | FDA listed | — |
| Quality Choice Maximum Strength Urinary Pain Relief 99.5 mg 83324-0199-12 | Chain | 12 tablets | — | — | FDA listed | — |
| Gencare-Urinary Pain Relief Maximum Strength 99.5 mg 72090-0072-01 | Pioneer | 72 tablets | — | — | FDA listed | — |
| Nuvicare-Urinary Pain Relief Maximum Strength 99.5 mg 84324-0042-01 | NUVICARE | 24 tablets | — | — | 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file
Availability & generic status
🏛️
2025
On the market since
Jan 2025
📍
2026
Currently FDA-listed
1 year listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found
We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.
- FDA Orange Book · refreshed Sep 3, 2026
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 5C5403N26O
Acacia is a natural gum derived from acacia tree sap. It serves as a binder, thickener, and emulsifier to help hold ingredients together, improve texture, and stabilize the medicine.
-
UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
-
UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
-
UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
-
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 ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
-
UNII H8AV0SQX4D
A modified starch derived from potato or corn starch. It absorbs water quickly and helps tablets or capsules break apart and dissolve in the stomach, acting as a disintegrant to ensure the medicine releases its active ingredients properly.
-
UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
10 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statescolloidal silicone dioxide, gum acacia extra pure, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, maize starch, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, sodium starch glycolate.
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.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
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
LabelerStrive Pharmaceuticals Inc.
Labeler code70692
First marketedJan 2025
Product typeHuman Otc Drug
Portfolio31 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
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
🎯 Indications and Usage ▾
Use Relief from urinary pain, burning, urgency and frequency associated with urinary tract infections. Treatment should not exceed 2 days; see Directions.
⏱️ Dosage and Administration ▾
Directions • Adults and children 12 years and over: Take 2 tablets 3 times daily with or after meals as needed for up to two days. Take with a full glass of water. Do not use for more than 2 days (12 tablets) without consulting a doctor • Children under 12 years: Do not use without consulting a doctor
⚠️ Warnings ▾
Warnings Do not exceed recommended dosage Do not use if you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician. Ask a doctor before use if you have • liver or kidney disease • allergies to foods, preservatives or dyes • had a hypersensitive reaction to Phenazopyridine Hydrochloride When using this product • stomach upset may occur, taking this product with or after meals may reduce stomach upset. • your urine will become reddish-orange in color. This is not harmful, but care should be taken to avoid staining clothing or other items.
Stop use and ask a doctor if • your symptoms last for more than 2 days • you suspect you are having an adverse reaction to the medication. If pregnant or breastfeeding , ask a health professional before use. A pregnancy test and consultation with a health professional if pregnancy is confirmed is recommended prior to use.
Keep out of reach of children. In case of an overdose, get medical help or contact a Poison Control Center right away.
📦 Storage and Handling ▾
Other information Long-term administration of Phenazopyridine HCl has induced neoplasia in rats (large intestine) and mice (liver). Although no association between Phenazopyridine HCl and human neoplasia has been reported, adequate epidemiological studies along these lines have not been conducted. • This product can interfere with laboratory tests including urine, glucose (sugar), and ketones tests. • This product may stain contact lenses and other items if handled after touching tablets. • Store at room temperature between 20°C-25°C (68°F -77°F) in a dry place and protect from light.
🧪 Active Ingredient ▾
Active ingredient (in each tablet) Phenazopyridine Hydrochloride 99.5 mg
🧪 Inactive Ingredients ▾
Inactive ingredients colloidal silicone dioxide, gum acacia extra pure, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, maize starch, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, sodium starch glycolate.
🎯 Purpose ▾
Purpose Urinary tract analgesic
No label section mentions that — try another word, or open the full label on DailyMed below.
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 GOOD REMEDIES Maximum Strength Urinary Pain Relief Caplet (this brand).
Top reported reactions
Reporter sex
Male · 25%
Female · 75%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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
Marketed without an FDA application
Listed without an FDA application
This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.
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) | ✓ 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 "Unapproved Drug Other". 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 Strive Pharmaceuticals Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Strive Pharmaceuticals 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.
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.