Ibuprofen PM Diphenhydramine Citrate, 200 mg; 38 mg Tablet, Coated, 120-count — NDC 69607-1970-01 package photo

Ibuprofen PM Diphenhydramine Citrate, 200 mg; 38 mg Tablet, Coated, 120-count

by WR Group, Inc. · 1 BOTTLE, PLASTIC in 1 BOX (69607-1970-1) / 120 TABLET, COATED in 1 BOTTLE, PLASTIC
NDC 69607-1970-01
🏷️ FDA NDC (as labeled) 69607-1970-1 billing pads the package segment with a zero
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) 69607-1970-1
Product NDC 69607-1970
11-digit billing NDC 69607197001
RxCUI 895664
UNII WK2XYI10QM, 4OD433S209
UPC 0811079036964
Application # ANDA211404
SPL Set ID 1e2feaf0-7fff-43d5-bcfe-9f2851bdc805
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 2025-02-28
Route ORAL
Dosage form TABLET, COATED
Substance IBUPROFEN; DIPHENHYDRAMINE CITRATE
Why two NDCs? The FDA registers this code as 69607-1970-1 — a 5-4-1 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 package segment → 69607-1970-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the 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

LabelerWR Group, Inc.
Application holderPLD ACQUISITIONS LLC
FDA applicationANDA211404 (ANDA)
Labeler code69607
First marketedFeb 2025
Product typeHuman Otc Drug
Portfolio6 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

📖 What it is MedlinePlus · NLM

Diphenhydramine is used to treat allergy and cold symptoms: sneezing runny nose red, itchy, watery eyes itching of the nose or throat Diphenhydramine is also used to treat insomnia (difficulty falling asleep or staying asleep) in adults, but should not be used to make a child sleepy. Diphenhydramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms. Diphenhydramine is also available in combination with other medications. This monograph only includes information about the use of diphenh...

Read the full MedlinePlus article ↗
📗 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
ShapeOval
ImprintPL72
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.

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

  • UNII R12CBM0EIZ
    A natural wax derived from a Brazilian palm tree, used as a coating and polish on tablets and capsules. It creates a smooth, shiny finish that protects the medicine and improves appearance.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • 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 L06K8R7DQK
    A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
  • 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 VH2XOU12IE
    Polydextrose is a synthetic polymer made from dextrose (sugar) that acts as a bulking agent and filler in medicines. It helps give tablets and capsules proper volume and texture while often adding slight sweetness.
  • UNII B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • 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 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • 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.

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

The official label also statescarnauba wax, corn starch, croscarmellose sodium, FD&C blue #2, hypromellose, microcrystalline cellulose, polydestrose,  polyethylene glycol 400, silicon dioxide, stearic acid, 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 DailyMedingredient 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 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 Availability likely
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 mg 58602-0867-09 Aurohealth 30 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 mgthis 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

🏛️
2025
On the market since
Feb 2025
📍
2026
Currently FDA-listed
1 year 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.

🔬 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 ibuprofen pm (this brand).

Top reported reactions

Underdose46
Product Name Confusion44
Somnolence35
Expired Product Administered32
Dizziness23
Accidental Overdose21
Fatigue21

Age at onset

Child2
Adult51
Elderly5

Reporter sex

416 reports
Male · 38%
Female · 62%
Unknown · 0%
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 41 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
69607-1970-01 You're viewing this 1 BOTTLE, PLASTIC in 1 BOX (69607-1970-1) / 120 TABLET, COATED in 1 BOTTLE, PLASTIC 2025-02-28 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 ✓ 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

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 69607-1970-1, 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: 69607-1970-01, written without dashes as 69607197001. 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 69607-1970-01, the first segment (69607) is the labeler code FDA assigned to WR Group, Inc.; the middle segment (1970) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 WR Group, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
WR Group, 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.

📄 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 29 words

Directions do not take more than directed adults and childlren 12 years and over: take 2 caplets at bedtime do not take more than 2 caplets in 24 hours

⚠️ Warnings ~2 min read

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 Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer unless you have time for a full night’s sleep in children under 12 years of age right before or after heart surgery with any other product containing diphenhydramine, even one used on skin if you have sleeplessness without pain Ask a doctor before use if the stomach bleeding warning applies to you you have problem or serious side effects from taking pain relievers or fever reducers you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma or had a stroke you are taking a diuretic you have a breathing problem such as emphysema or chronic bronchitis you have glaucoma you have trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers, or any other sleep-aid under a doctor's care for any continuing medical illness taking any other antihistamines taking aspirin for heart attack or stroke, because ibuprofen may decease this benefit of aspirin taking any other drug When using this product drowsiness will occur avoid alcoholic drinks do not drive a motor vehicle or operate machinery take with food or milk if stomach upset occurs Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better you have symptoms of heart problem or stroke: chest pain trouble breathing weakness in one part or side of body slurred speech leg swelling pain gets worse or last more than 10 days sleeplessness persists continuously for more than 2 weeks.

Insomnia may be a symptom of a serious underlying medical illness redness or swelling is present in the painful area any new symptoms appear If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

📦 Storage and Handling 21 words

Other information read all warnings and directions before use. Keep carton. store between 20-25°C (68-77°F) avoid excessive heat above 40°C (104°F)

🧪 Active Ingredient 15 words

Active ingredient (in each caplet) Diphenhydramine citrate 38 mg ibuprofen 200 mg(NSAID)* *nonsteroidal anti-inflammatory drug

🧪 Inactive Ingredients 24 words

Inactive ingredients carnauba wax, corn starch, croscarmellose sodium, FD&C blue #2, hypromellose, microcrystalline cellulose, polydestrose, polyethylene glycol 400, silicon dioxide, stearic acid, titanium dioxide

🎯 Purpose 5 words

Purpose 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.