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Diphenhydramine HCl and Ibuprofen 25 mg; 200 mg Capsule, Liquid Filled, 160-count

by Aurohealth LLC · 160 CAPSULE, LIQUID FILLED in 1 BOTTLE (58602-717-30)
NDC 58602-0717-30
🏷️ FDA NDC (as labeled) 58602-717-30 billing pads the product segment with a zero
OTC Generic On market Non-controlled
🗂️ Data synced 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

FDA NDC (as labeled) 58602-717-30
Product NDC 58602-717
11-digit billing NDC 58602071730
RxCUI 901814
UNII TC2D6JAD40, WK2XYI10QM
Application # ANDA210676
SPL Set ID 39af6dfa-e822-43a5-bd1a-338cf5da89ce
Established class (EPC) Nonsteroidal Anti-inflammatory Drug
Mechanism of action Cyclooxygenase Inhibitors
Chemical class Anti-Inflammatory Agents, Non-Steroidal
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-12-09
Route ORAL
Dosage form CAPSULE, LIQUID FILLED
Substance DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN
Why two NDCs? The FDA registers this code as 58602-717-30 — 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 → 58602-0717-30. 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 Histamine-1 Receptor Antagonist class.

Pharmacologic class Histamine-1 Receptor Antagonist
Drug family (ATC) Propionic acid derivatives, Antihistamines for topical use, Aminoalkyl ethers
How it works Histamine H1 Receptor Antagonists
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.

🏭 Manufacturer & labeler

LabelerAurohealth LLC
Application holderAUROBINDO PHARMA LTD
FDA applicationANDA210676 (ANDA)
Labeler code58602
First marketedDec 2022
Product typeHuman Otc Drug
Portfolio175 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.

🩺 Clinical

📗 Our plain-language guide HelloPharmacist
  • No — this product is specifically for nights when you have both minor pain AND trouble sleeping at the same time. It's not meant to be used as a plain sleep aid. If you're struggli...
  • What exactly is this medicine for — can I just take it to help me sleep?
  • Take 2 capsules or caplets at bedtime — whichever form your product comes in. Don't take more than that in 24 hours. If it bothers your stomach, go ahead and take it with food or a...
  • How do I take it, and is it okay to take with food?
📖 Read our full Diphenhydramine / Ibuprofen 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.

🧪 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 AV0YTZ4E6J
    A chemical compound derived from sorbitol, a natural sugar alcohol. It acts as an emulsifier and surfactant to help blend oil and water-based ingredients in medicines, ensuring uniform texture and stability.
  • UNII 9DBA0SBB0L
    A synthetic red dye derived from coal tar used as a colorant in medicines and cosmetics. It gives tablets, capsules, and liquids their red or pink appearance for identification and visual appeal.
  • 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 1T8387508X
    Gelatin Type B is a protein derived from cattle bones and skin, processed to specific strength standards. In medicines, it forms capsule shells that hold and protect the drug contents until they dissolve in the digestive system.
  • UNII 0VUT3PMY82
    Hypromellose 2910 is a plant-derived thickening agent made from cellulose. In medicines, it forms protective coatings on tablets or capsules, controls how fast the drug releases, and thickens liquid formulations.
  • UNII ND2M416302
    Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
  • UNII 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • UNII NL4J9F21N9
    Polyethylene glycol 600 is a synthetic liquid polymer used as a solvent and humectant in medicines. It helps dissolve active ingredients and keeps products from drying out.
  • UNII WZH3C48M4T
    Potassium hydroxide is a strong alkaline chemical used in medicines to adjust and maintain the pH level of liquid formulations, helping keep the product stable and the active ingredients effective.
  • UNII U725QWY32X
    Povidone K30 is a synthetic polymer made from petroleum. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the 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 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

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

The official label also statesD&C Red No.33, gelatin, hypromellose, isopropyl alcohol, Neelicert FD&C Blue No.1, polyethylene glycol, propylene glycol, potassium hydroxide, povidone, purified water, sorbitol sorbitan solution, titanium dioxide. Questions or comments? Call 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST) Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India Code: TS/DRUGS/16/2014

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.

💲 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ibuprofen PM 200 mg/1; 25 mg 00363-0207-11 WALGREEN 20 capsules — — FDA listed —
Advil Pm 25 mg/1; 200 mg 00573-0148-06 Haleon 40 capsules — — FDA listed —
Advil Pm 25 mg/1; 200 mg 00573-0167-25 Haleon 20 capsules — — FDA listed —
Ibuprofen, Diphenhydramine Hcl 200 mg/1; 25 mg 11673-0225-15 TARGET 40 capsules — — FDA listed —
Ibuprofen, Diphenhydramine Hcl 200 mg/1; 25 mg 11822-0789-04 Rite 40 capsules — — FDA listed —
Ibuprofen PM 200 mg/1; 25 mg 30142-0232-15 KROGER 40 capsules — — FDA listed —
Ibuprofen PM 200 mg/1; 25 mg 36800-0237-15 TOP 40 capsules — — FDA listed —
Ibuprofen PM 200 mg/1; 25 mg 36800-0756-40 TOP 40 capsules — — FDA listed —
Ibuprofen PM 200 mg/1; 25 mg 41250-0285-15 MEIJER 40 capsules — — FDA listed —
Ibuprofen PM 200 mg/1; 25 mg 42681-0061-01 Whole 40 capsules — — FDA listed —
Ibuprofen PM 200 mg/1; 25 mg 49035-0670-15 Wal-Mart 40 capsules — — FDA listed —
Diphenhydramine HCl and Ibuprofen 25 mg/1; 200 mgthis 58602-0717-30 Aurohealth 160 capsules — — FDA listed —
Diphenhydramine HCl and Ibuprofen 25 mg/1; 200 mg 58602-0814-10 Aurohealth 32 capsules — — FDA listed —
Diphenhydramine HCl and Ibuprofen 25 mg/1; 200 mg 58602-0887-10 Aurohealth 32 capsules — — FDA listed —
Ibuprofen PM 200 mg/1; 25 mg 59640-0020-15 HEB 40 capsules — — FDA listed —
Ibuprofen PM 200 mg/1; 25 mg 63868-0829-40 CHAIN 40 capsules — — FDA listed —
Ibuprofen and Diphenhydramine HCl 200 mg/1; 25 mg 63941-0682-15 VALU 40 capsules — — FDA listed —
Ibuprofen PM 200 mg/1; 25 mg 68016-0057-40 Premier 40 capsules — — FDA listed —
Ibuprofen, Diphenhydramine Hcl 200 mg/1; 25 mg 69452-0205-04 Bionpharma 6 capsules — — FDA listed —
pain relief pm 200 mg/1; 25 mg 69452-0264-22 Bionpharma 120 capsules — — FDA listed —
pain relief pm 200 mg/1; 25 mg 69452-0507-78 Bionpharma 80 capsules — — FDA listed —
Ibuprofen PM 200 mg/1; 25 mg 69842-0870-15 CVS 40 capsules — — FDA listed —
Ibuprofen PM 200 mg/1; 25 mg 69842-0913-40 CVS 40 capsules — — FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2022
On the market since
Dec 2022
📍
2026
Currently FDA-listed
4 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
58602-0717-30 You're viewing this 160 CAPSULE, LIQUID FILLED in 1 BOTTLE (58602-717-30) 2022-12-09 Active

🧭 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) ✓ 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

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 FDA registers it as 58602-717-30, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 58602-0717-30, written without dashes as 58602071730. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 58602-0717-30, the first segment (58602) is the labeler code FDA assigned to Aurohealth LLC; the middle segment (0717) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (30) identifies this exact package size and type. Together they name one specific package of one specific product.
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.
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.

📄 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 20 words ▾

Uses for relief of occasional sleeplessness when associated with minor aches and pains helps you fall asleep and stay asleep

⏱️ Dosage and Administration 71 words ▾

Directions do not take more than directed adults and children 12 years and over: take 2 capsules at bedtime do not take more than 2 capsules in 24 hours Other information each capsule contains: potassium 20 mg read all warnings and directions before use. store at 20° to 25°C (68° to 77°F) avoid excessive heat above 40°C (104°F) protect from light Organic Impurities Test is Pending Meets USP dissolution test 2

⚠️ Warnings 153 words ▾

Warnings Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding.

The chance is higher if you are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed. Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal.

The risk is higher if you use more than directed or for longer than directed.

🧪 Active Ingredient 32 words ▾

Drug Facts Active ingredients (in each capsule) Diphenhydramine hydrochloride USP 25 mg Solubilized ibuprofen equal to 200 mg ibuprofen USP (NSAID)* (present as the free acid and potassium salt) *nonsteroidal anti-inflammatory drug

🧪 Inactive Ingredients 57 words ▾

Inactive ingredients D&C Red No.33, gelatin, hypromellose, isopropyl alcohol, Neelicert FD&C Blue No.1, polyethylene glycol, propylene glycol, potassium hydroxide, povidone, purified water, sorbitol sorbitan solution, titanium dioxide. Questions or comments? Call 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST) Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India Code: TS/DRUGS/16/2014

🎯 Purpose 5 words ▾

Purposes Nighttime sleep-aid Pain reliever

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 58602-0716-16 · Aurohealth 58602-0721-57 · 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.