Ibuprofen and Diphenhydramine Citrate 200 mg; 38 mg Tablet, Coated, 80-count — NDC 58602-0867-72 package photo

Ibuprofen and Diphenhydramine Citrate 200 mg; 38 mg Tablet, Coated, 80-count

by Aurohealth LLC · 1 BOTTLE, PLASTIC in 1 CARTON (58602-867-72) / 80 TABLET, COATED in 1 BOTTLE, PLASTIC
NDC 58602-0867-72
🏷️ FDA NDC (as labeled) 58602-867-72 billing pads the product segment with a zero
This package
Contains80-count Pack sizes17 compare ↓
OTC Generic On market Non-controlled
🗂️ Data synced Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 58602-867-72
Product NDC 58602-867
11-digit billing NDC 58602086772
RxCUI 895664
UNII WK2XYI10QM, 4OD433S209
Application # ANDA216204
SPL Set ID 21c1f5c5-19fa-4a59-bad3-ea85fd37471b
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 2022-05-31
Route ORAL
Dosage form TABLET, COATED
Substance IBUPROFEN; DIPHENHYDRAMINE CITRATE
Why two NDCs? The FDA registers this code as 58602-867-72 — 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 → 58602-0867-72. 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 applicationANDA216204 (ANDA)
Labeler code58602
First marketedMay 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 →
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.

💊 What it looks like

Color Blue
ShapeCapsule
ImprintDI;200
Size15 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.

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.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
good neighbor pharmacy ibuprofen pm 38 mg/1; 200 mg 46122-0708-41 Amerisource 80 tablets $0.122 — Discontinued —
Leader Ibuprofen PM 38 mg/1; 200 mg 70000-0157-01 Cardinal 40 tablets $0.125 — FDA listed —
good sense ibuprofen pm 38 mg/1; 200 mg 00113-0050-58 L. 40 tablets $0.131 — Availability likely —
foster and thrive ibuprofen pm 38 mg/1; 200 mg 70677-1131-01 Strategic 40 tablets $0.131 — Availability likely —
Ibuprofen PM 38 mg/1; 200 mg 00363-0050-27 Walgreen 80 tablets — — FDA listed —
Advil Pm 38 mg/1; 200 mg 00573-0164-04 Haleon 4 tablets — — FDA listed —
up and up ibuprofen pm 38 mg/1; 200 mg 11673-0050-58 Target 40 tablets — — FDA listed —
ibuprofen pm 38 mg/1; 200 mg 11822-0050-01 Rite 80 tablets — — Discontinued —
Ibuprofen PM 200 mg/1; 38 mg 21130-0056-40 Safeway, 40 tablets — — FDA listed —
Ibuprofen and Diphenhydramine Citrate 200 mg/1; 38 mg 21130-0228-12 Better 40 tablets — — FDA listed —
Signature Care Ibuprofen PM 38 mg/1; 200 mg 21130-0283-27 Safeway 80 tablets — — Discontinued —
Ibuprofen Pm 38 mg/1; 200 mg 21130-0623-76 Safeway 120 tablets — — FDA listed —
ADVIL PM- diphenhydramine citrate and ibuprofen tablet, coated 38 mg/1; 200 mg 29485-6533-04 Lil 2 tablets — — FDA listed —
ADVIL PM- diphenhydramine citrate and ibuprofen tablet, coated 38 mg/1; 200 mg 29485-7008-03 Lil 2 tablets — — FDA listed —
ibuprofen pm 38 mg/1; 200 mg 30142-0050-27 Kroger 80 tablets — — FDA listed —
Ibuprofen PM 200 mg/1; 38 mg 30142-0278-80 KROGER 80 tablets — — FDA listed —
Topcare Ibuprofen PM 38 mg/1; 200 mg 36800-0050-27 Topco 80 tablets — — FDA listed —
ibuprofen pm 38 mg/1; 200 mg 37808-0703-60 H 20 tablets — — FDA listed —
equaline ibuprofen pm 38 mg/1; 200 mg 41163-0050-27 United 80 tablets — — FDA listed —
Ibuprofen PM 38 mg/1; 200 mg 41250-0050-27 Meijer 80 tablets — — Discontinued —
Care One Ibuprofen PM 38 mg/1; 200 mg 41520-0050-27 American 80 tablets — — FDA listed —
ibuprofen pm 38 mg/1; 200 mg 42507-0050-27 HyVee 80 tablets — — FDA listed —
equate ibuprofen pm 38 mg/1; 200 mg 49035-0699-27 Wal-Mart 80 tablets — — FDA listed —
Motrin PM 200 mg/1; 38 mg 50580-0563-20 Kenvue 20 tablets — — FDA listed —
Ibuprofen and Diphenhydramine Citrate 200 mg/1; 38 mg 55111-0565-05 Dr. 500 tablets — — FDA listed —
Exchange Select Ibuprofen PM 38 mg/1; 200 mg 55301-0050-60 Army 20 tablets — — FDA listed —
Ibuprofen PM 200 mg/1; 38 mg 55319-0197-20 Family 20 tablets — — FDA listed —
dg health Ibuprofen pm 38 mg/1; 200 mg 55910-0050-27 Dolgencorp 80 tablets — — FDA listed —
Ibuprofen and Diphenhydramine Citrate 200 mg/1; 38 mgthis 58602-0867-72 Aurohealth 80 tablets — — FDA listed —
ibuprofen pm 38 mg/1; 200 mg 59779-0050-27 CVS 80 tablets — — FDA listed —
Ibuprofen 200 mg and Diphenhydramine Citrate 38 mg 200 mg/1; 38 mg 63548-0197-02 PLD 20 tablets — — FDA listed —
Advil PM, TRAVEL BASIX 200 mg/1; 38 mg 66715-6433-02 Lil' 2 tablets — — FDA listed —
Advil PM, CVP HEALTH 200 mg/1; 38 mg 66715-6533-02 Lil' 2 tablets — — FDA listed —
Advil PM 200 mg/1; 38 mg 66715-9633-03 Lil' 2 tablets — — FDA listed —
Advil PM 200 mg/1; 38 mg 66715-9733-02 Lil' 2 tablets — — FDA listed —
Advil PM 38 mg/1; 200 mg 67751-0147-01 Navajo 2 tablets — — FDA listed —
Ibuprofen PM 200 mg/1; 38 mg 69607-1970-01 WR 120 tablets — — FDA listed —
basic care ibuprofen pm 38 mg/1; 200 mg 72288-0050-60 Amazon.com 20 tablets — — FDA listed —
Amazon Basic Care Ibuprofen Pm 200 mg/1; 38 mg 72288-0061-77 Amazon.com 120 tablets — — FDA listed —
Ibuprofen PM 200 mg/1; 38 mg 79903-0186-20 WALMART 20 tablets — — 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
May 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
58602-0867-09 1 BOTTLE in 1 CARTON (58602-867-09) / 30 TABLET, COATED in 1 BOTTLE 2022-05-31 Active
58602-0867-12 1 BOTTLE in 1 CARTON (58602-867-12) / 40 TABLET, COATED in 1 BOTTLE 2022-05-31 Active
58602-0867-14 1 BOTTLE in 1 CARTON (58602-867-14) / 50 TABLET, COATED in 1 BOTTLE 2022-05-31 Active
58602-0867-18 1 BOTTLE in 1 CARTON (58602-867-18) / 80 TABLET, COATED in 1 BOTTLE 2022-05-31 Active
58602-0867-21 1 BOTTLE in 1 CARTON (58602-867-21) / 100 TABLET, COATED in 1 BOTTLE 2022-05-31 Active
58602-0867-23 1 BOTTLE in 1 CARTON (58602-867-23) / 120 TABLET, COATED in 1 BOTTLE 2022-05-31 Active
58602-0867-27 140 TABLET, COATED in 1 BOTTLE (58602-867-27) 2022-05-31 Active
58602-0867-32 180 TABLET, COATED in 1 BOTTLE (58602-867-32) 2022-05-31 Active
58602-0867-34 200 TABLET, COATED in 1 BOTTLE (58602-867-34) 2022-05-31 Active
58602-0867-46 140 TABLET, COATED in 1 BOTTLE, PLASTIC (58602-867-46) 2022-05-31 Active
58602-0867-70 1 BOTTLE, PLASTIC in 1 CARTON (58602-867-70) / 40 TABLET, COATED in 1 BOTTLE, PLASTIC 2022-05-31 Active
58602-0867-72 You're viewing this 1 BOTTLE, PLASTIC in 1 CARTON (58602-867-72) / 80 TABLET, COATED in 1 BOTTLE, PLASTIC 2022-05-31 Active
58602-0867-73 1 BOTTLE in 1 CARTON (58602-867-73) / 20 TABLET, COATED in 1 BOTTLE 2022-05-31 Active
58602-0867-78 1 BOTTLE, PLASTIC in 1 CARTON (58602-867-78) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC 2022-05-31 Active
58602-0867-80 200 TABLET, COATED in 1 BOTTLE, PLASTIC (58602-867-80) 2022-05-31 Active
58602-0867-92 180 TABLET, COATED in 1 BOTTLE, PLASTIC (58602-867-92) 2022-05-31 Active
58602-0867-97 120 TABLET, COATED in 1 BOTTLE, PLASTIC (58602-867-97) 2022-05-31 Active

Pack size FAQ

What quantity is in NDC 58602-0867-72?
NDC 58602-0867-72 is a 80-count package — 1 bottle, plastic in 1 carton / 80 tablet, coated in 1 bottle, plastic.
What is the difference between NDC 58602-0867-72 and NDC 58602-0867-73?
Both are Ibuprofen and Diphenhydramine Citrate 200 mg; 38 mg Tablet, Coated — the drug itself is identical. NDC 58602-0867-72 is the 80-count package, while NDC 58602-0867-73 is the 20 tablets package.
What NDC number is used to bill for this package of Ibuprofen and Diphenhydramine Citrate 200 mg; 38 mg Tablet, Coated?
Bill NDC 58602-0867-72 — the 11-digit billing format is 58602086772. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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) — 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

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 58602-867-72, 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: 58602-0867-72, written without dashes as 58602086772. 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 58602-0867-72, the first segment (58602) is the labeler code FDA assigned to Aurohealth LLC; the middle segment (0867) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (72) 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.
Does this product come in other package sizes?
Yes — the FDA directory lists 16 other package presentations of this same product, including 20 tablets (58602-0867-73), 30 tablets (58602-0867-09), 40 tablets (58602-0867-12). 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.

📄 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 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 54 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 read all warnings and directions before use. Keep carton. store at 20° to 25°C (68° to 77°F) avoid excessive heat above 40°C (104°F)

⚠️ 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 20 words ▾

Drug Facts Active ingredients (in each caplet) Diphenhydramine citrate USP 38 mg Ibuprofen USP 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug

🧪 Inactive Ingredients 72 words ▾

Inactive ingredients carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C blue # 2, glyceryl dibehenate, hypromellose, lactose monohydrate, microcrystalline cellulose, palmitic acid, polydextrose, polyethylene glycol, pregelatinized starch (maize), sodium lauryl sulfate, sodium starch glycolate, stearic acid, and 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 No.: 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 ↗
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.