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Acetaminophen and Diphenhydramine hydrochloride 500 mg; 25 mg Tablet, 50-count — NDC 58602-0760-14 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Acetaminophen and Diphenhydramine hydrochloride 500 mg; 25 mg Tablet, 50-count — NDC 58602-760-14 (Billing 58602-0760-14)

by Aurohealth LLC · 1 BOTTLE in 1 CARTON / 50 TABLET in 1 BOTTLE

This is a package of 50 tablets of Acetaminophen and Diphenhydramine hydrochloride 500 mg; 25 mg Tablet from Aurohealth LLC, marketed since Jan 2021 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 58602-0760-14
🏷️ FDA NDC (as labeled) 58602-760-14 billing pads the product segment with a zero
This package
Contains50-count Pack sizes2 compare ↓
Main listing for product 58602-760 · Also comes in: 20 tablets 58602-760-73
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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 58602-760-14
Product NDC 58602-760
11-digit billing NDC 58602076014
UNII 362O9ITL9D, TC2D6JAD40
Application # M013
SPL Set ID 3ba51b52-7ae6-4335-b178-1b7b6ef36227
Established class (EPC) Histamine-1 Receptor Antagonist
Mechanism of action Histamine H1 Receptor Antagonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-01-05
Route ORAL
Dosage form TABLET
Substance ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 58602-760-14 — 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 → 58602-0760-14. 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.

Clinical

🧪 What is this product?

This is an over-the-counter tablet taken by mouth that combines acetaminophen and diphenhydramine hydrochloride. Acetaminophen is typically used to reduce fever and relieve minor aches and pains. Diphenhydramine hydrochloride is a first-generation antihistamine commonly used to relieve allergy symptoms and is also known to cause drowsiness. This product is marketed under the FDA's over-the-counter monograph rules for its drug category.

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.
Try another pack size: 20 tablets
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
58602-0760-14 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 50 TABLET in 1 BOTTLE 2021-01-05 — Active
58602-0760-73 58602-760-73 1 BOTTLE in 1 CARTON / 20 TABLET in 1 BOTTLE 2021-01-05 — Active

Pack size FAQ

What quantity is in this package?
This is a 50-count package — 1 bottle in 1 carton / 50 tablet in 1 bottle.
How does this package differ from NDC 58602-0760-73?
Both are Acetaminophen and Diphenhydramine hydrochloride 500 mg; 25 mg Tablet — the drug itself is identical. This page's package is the 50-count one, while NDC 58602-0760-73 is the 20 tablets package.
What NDC number is used to bill for this package of Acetaminophen and Diphenhydramine hydrochloride 500 mg; 25 mg Tablet?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Pain Relief PM Extra Strength 500 mg/1; 25 mg 83324-0085-01 CHAIN 100 tablets $0.044 — Availability likely —
Pain Relief PM Extra Strength 500 mg/1; 25 mg 63868-0325-50 Chain 50 tablets $0.046 — FDA listed —
Acetaminophen and Diphenhydramine hydrochloride 500 mg/1; 25 mg 21130-0224-18 Better 80 tablets — — FDA listed —
Extra Strength Acetaminophen PM 500 mg/1; 25 mg 30142-0755-01 KROGER 100 tablets — — FDA listed —
Acetaminophen and Diphenhydramine hydrochloride 500 mg/1; 25 mgthis 58602-0760-14 Aurohealth 50 tablets — — FDA listed —
Pain Relief PM 500 mg/1; 25 mg 61504-0095-03 AMERIFOODS 100 tablets — — FDA listed —
Acetaminophen PM Extra Strength 500 mg/1; 25 mg 67091-0137-50 WinCo 50 tablets — — FDA listed —
Acetaminophen PM 500 mg/1; 25 mg 72036-0171-02 Harris 40 tablets — — FDA listed —
Pain Relief PM 500 mg/1; 25 mg 21130-0095-01 Safeway 24 tablets — — FDA listed —
acetaminophen pm extra strength 500 mg/1; 25 mg 41163-0515-01 United 24 tablets — — FDA listed —
Acetaminophen PM 500 mg/1; 25 mg 57344-0095-01 AAA 24 tablets — — FDA listed —
Extra Strength Pain Relief PM 500 mg/1; 25 mg 63941-0095-02 VALU 50 tablets — — FDA listed —
Tylenol PM Extra Strength, CVP HEALTH 500 mg/1; 25 mg 66715-6517-02 Lil' 2 tablets — — FDA listed —
Acetaminophen and Diphenhydramine hydrochloride 500 mg/1; 25 mg 30142-0193-14 KROGER 50 tablets — — FDA listed —
Extra Strength Pain Reliever Pm 500 mg/1; 25 mg 00363-9085-15 WALGREENS 15 tablets — — FDA listed —
pain relief PM 500 mg/1; 25 mg 72036-0095-02 HARRIS 50 tablets — — FDA listed —
Acetaminophen Pm 500 mg/1; 25 mg 72476-0171-01 RETAIL 20 tablets — — FDA listed —
Tylenol PM Extra Strength 500 mg/1; 25 mg 50580-0608-01 Kenvue 24 tablets — — FDA listed —
Tylenol PM Extra Strength 500 mg/1; 25 mg 67751-0241-01 Navajo 2 tablets — — FDA listed —
Pain Relief PM Extra Strength 500 mg/1; 25 mg 68998-0071-03 MARC 80 tablets — — FDA listed —
Acetaminophen PM 500 mg/1; 25 mg 81522-0095-03 FSA 100 tablets — — FDA listed —
Pain Relief PM Extra Strength 500 mg/1; 25 mg 37808-0795-03 HEB 100 tablets — — FDA listed —
pain relief PM 500 mg/1; 25 mg 41250-0195-02 Meijer 50 tablets — — Discontinued —
Pain Relief PM Extra Strength 500 mg/1; 25 mg 50804-0825-02 GoodSense 20 tablets — — FDA listed —
Tylenol PM Extra Strength 500 mg/1; 25 mg 53209-1002-02 Morning 2 tablets — — FDA listed —
Pain Relief PM Extra Strength 500 mg/1; 25 mg 68998-0195-02 MARC 50 tablets — — FDA listed —
Extra Strength Pain Reliever Pm 500 mg/1; 25 mg 79903-0053-10 WALMART 100 tablets — — FDA listed —
Pain Relief PM 500 mg/1; 25 mg 42507-0095-03 HYVEE 100 tablets — — FDA listed —
Acetaminophen and Diphenhydramine hydrochloride 500 mg/1; 25 mg 79903-0267-80 WALMART 80 tablets — — FDA listed —
Acetaminophen PM 500 mg/1; 25 mg 85828-0095-03 Grocery 100 tablets — — FDA listed —
Pain Relief PM Extra Strength 500 mg/1; 25 mg 36800-0095-03 TopCo 100 tablets — — FDA listed —
Tylenol PM Extra Strength 500 mg/1; 25 mg 85237-2945-01 Select 2 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.

Availability & generic status

🏛️
2021
On the market since
Jan 2021
📍
2026
Currently FDA-listed
5 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color blue
ShapeCapsule
ImprintT;6
Size2 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 5138Q19F1X
    Ammonia is a colorless gas made from nitrogen and hydrogen. It's used in medicines as a pH buffer to maintain the correct acidity level and help keep the product stable.
  • UNII M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII PN2ZH5LOQY
    A synthetic red dye approved by the FDA for use in foods, medicines, and cosmetics. It serves as a colorant to make tablets, capsules, and liquids visually distinctive for product identification.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • 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 5Y0974F5PW
    Hydroxypropyl cellulose is a plant-derived thickener and binder made by chemically treating cellulose. In medicines, it helps hold tablets together, thickens liquids, and can form a protective coating on capsules.
  • 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 7T9FYH5QMK
    A plant-derived powder that serves as a binder and filler in tablets and capsules. It helps hold ingredients together, adds bulk, and aids in smooth tablet disintegration when swallowed.
  • UNII PNR0YF693Y
    A plant-based powder made from purified wood cellulose. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in the stomach.
  • UNII 4R4HFI6D95
    Polyethylene glycol 4000 is a synthetic polymer derived from petroleum. It serves as a binder, filler, and lubricant in solid dosage forms, and helps control how quickly the medicine dissolves.
  • UNII RDH86HJV5Z
    Povidone K90 is a synthetic polymer made from a chemical called vinyl pyrrolidone. It acts as a binder to hold pill ingredients together and as a dispersant to help the medicine break down and dissolve properly in your body.
  • 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 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 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.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • 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.

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

The official label also statesammonium hydroxide, black iron oxide, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1, FD&C red #3, gelatin, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch (maize), propylene glycol, shellac glaze, talc, and 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

LabelerAurohealth LLC
FDA applicationM013 (OTC MONOGRAPH DRUG)
Labeler code58602
First marketedJan 2021
Product typeHuman Otc Drug
Portfolio178 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 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 14 words ▾

Uses temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

⏱️ Dosage and Administration 39 words ▾

Directions do not take more than directed adults and children 12 years and over take 2 gelcaps at bedtime do not take more than 2 gelcaps of this product in 24 hours. children under 12 years: do not use

⚠️ Warnings 68 words ▾

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take with other drugs containing acetaminophen more than 4,000 mg of acetaminophen in 24 hours 3 or more alcoholic drinks every day 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.

📦 Storage and Handling 19 words ▾

Other information avoid high humidity store at 20º to 25°C (68º to 77°F) use by expiration date on package

🧪 Active Ingredient 16 words ▾

Drug Facts Active ingredients (in each gelcap) Acetaminophen USP 500 mg Diphenhydramine hydrochloride USP 25 mg

🧪 Inactive Ingredients 39 words ▾

Inactive ingredients ammonium hydroxide, black iron oxide, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1, FD&C red #3, gelatin, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch (maize), propylene glycol, shellac glaze, talc, and titanium dioxide.

🎯 Purpose 6 words ▾

Purpose Pain reliever Nighttime sleep aid

📄 Do Not Use 60 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. with any other product containing diphenhydramine, even one used on skin if you are allergic to acetaminophen or any of the inactive ingredients in this product in children under 12 years of age

📄 Ask a Doctor Before Use If 30 words ▾

Ask a doctor before use if you have liver disease a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland glaucoma

📄 Ask a Doctor or Pharmacist Before Use If 20 words ▾

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

📄 When Using This Product 19 words ▾

When using this product drowsiness will occur avoid alcoholic beverages do not drive a motor vehicle or operate machinery

📄 Stop Use and Ask a Doctor If 59 words ▾

Stop use and ask a doctor if pain gets worse or lasts more than 10 days sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness. new symptoms occur redness or swelling is present fever gets worse or lasts more than 3 days 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 45 words ▾

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

📄 Questions or Comments 21 words ▾

Questions or comments? 1-855-274-4122 Distributed by: AUROHEALTH LLC 279 Princeton- Hightstown Road, East Windsor, NJ 08520 Made in India Code: TS/DRUGS/16/2014

📄 Package Label / Principal Display Panel 99 words ▾

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg/25 mg (20 Gelcaps Bottle) AUROHEALTH NDC 58602-760-73 EXTRA STRENGTH Acetaminophen and Diphenhydramine Hydrochloride Gelcaps 500 mg/25 mg Pain Reliever, Nighttime Sleep Aid Non-Habit Forming Rapid Release 20 GELCAPS PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 100 Caplets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg/25 mg (20 Gelcaps Bottle Carton) AUROHEALTH Compare to the active ingredients in Extra Strength Tylenol ® PM NDC 58602-760-73 EXTRA STRENGTH Acetaminophen and Diphenhydramine Hydrochloride Gelcaps 500 mg/25 mg Pain Reliever, Nighttime sleep aid Non-habit forming Rapid Release 20 GELCAPS PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg / 25 mg (20 Caplets Bottle Carton)

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

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 Aurohealth LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 20 tablets (58602-0760-73). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Aurohealth LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 58602-0755-07 · Aurohealth 58602-0765-76 · Aurohealth →
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.