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Advil PM

diphenhydramine citrate and ibuprofen · Tablet, Coated

Over-the-counter NDA RLD Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Advil PM
Generic name
diphenhydramine citrate and ibuprofen
Dosage form
Tablet, Coated
Route
Oral
Marketing category
NDA · NDA
Labeler
Lil' Drug Store Products, Inc.
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
5
Packages
32
Data completeness
83% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Diphenhydramine Citrate 38 mg/1 895664 View
Ibuprofen 200 mg/1 310965 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Coated
Route of administration
Oral
Presentations
37

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Anti-Inflammatory Agents EPC All 251 members
Cyclooxygenase Inhibitors [MoA] MoA All 251 members
Histamine H1 Receptor Antagonists [MoA] MoA All 136 members
Histamine-1 Receptor Antagonist [EPC] EPC All 134 members
Non-Steroidal [CS] CS All 251 members
Nonsteroidal Anti-inflammatory Drug [EPC] EPC All 251 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
021394
Application type
NDA · New Drug Application
Approval date
December 21, 2005
Sponsor
HALEON US HOLDINGS
Products on application
1
Submissions recorded
14
Products approved under application 021394.
Product Trade name Form Strength Ingredient Status TE Flags
021394-001 ADVIL PM TABLET DIPHENHYDRAMINE CITRATE; IBUPROFEN Over-the-counter — RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
—
Reference Listed Drug
Yes
Reference Standard
Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA
Most recent submissions on application 021394.
Type No. Action Status Date Review
Supplement 33 Labeling Approved February 21, 2023 Standard
Supplement 32 Labeling Approved January 10, 2022 Standard
Supplement 26 Labeling Approved October 2, 2018 Standard
Supplement 25 Labeling Approved April 18, 2018 Standard
Supplement 23 Labeling Approved July 21, 2017 Standard
Supplement 21 Labeling Approved March 30, 2017 Standard
Supplement 20 Manufacturing (CMC) Approved March 15, 2016 Standard
Supplement 18 Manufacturing (CMC) Approved April 7, 2015 Standard
Supplement 19 Manufacturing (CMC) Approved January 5, 2015 Standard
Supplement 14 Labeling Approved April 25, 2011 Standard
Supplement 15 Labeling Approved September 1, 2010 Standard
Supplement 12 Labeling Approved May 19, 2009 Standard
Supplement 10 Labeling Approved June 11, 2008 Standard
Original application 1 Type 4 - New Combination Approved December 21, 2005 Standard

Review documents

  • 0 · Supplement · February 22, 2023
  • 0 · Supplement · February 22, 2023
  • 0 · Supplement · January 11, 2022
  • 0 · Supplement · January 11, 2022
  • 0 · Supplement · October 26, 2018
  • 0 · Supplement · October 15, 2018
  • 0 · Supplement · April 23, 2018
  • 0 · Supplement · April 20, 2018
  • 0 · Supplement · July 26, 2017
  • 0 · Supplement · July 25, 2017
  • 0 · Supplement · April 5, 2017
  • 0 · Supplement · April 3, 2017
  • 0 · Supplement · April 28, 2011
  • 0 · Supplement · September 7, 2010
  • 0 · Supplement · May 27, 2009
  • 0 · Supplement · June 13, 2008
  • 0 · Original application · September 7, 2006
  • 0 · Original application · January 19, 2006
  • 0 · Original application · January 5, 2006

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260527). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260527 HUMAN OTC DRUG · 20260408 HUMAN OTC DRUG · 20241127

Indications and Usage

openFDA Drug Labeling

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

Active ingredients (in each caplet) Purposes Diphenhydramine citrate 38 mg Nighttime sleep-aid Ibuprofen 200 mg (NSAID) nonsteroidal anti-inflammatory drug Pain reliever

Dosage and Administration

openFDA Drug Labeling

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

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 stomach bleeding warning applies to you you have problems 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, 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 decrease 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 problems or stroke: chest pain trouble breathing weakness in one part or side of body slurred speech leg swelling pain gets worse or lasts 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 during the last 3 months of 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 right away.

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

openFDA Drug Labeling

Ask a doctor before use if • stomach bleeding warning applies to you • you have problems 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 • 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

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 problems or stroke: chest pain trouble breathing weakness in one part or side of body slurred speech leg swelling pain gets worse or lasts 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

Active Ingredient

openFDA Drug Labeling

Active ingredients (in each caplet) Diphenhydramine citrate 38 mg Ibuprofen 200 mg (NSAID)* *nonsteroidal anti-inflammatory drug Purposes Nighttime sleep-aid Pain reliever

Adverse event reports

Source: openFDA FAERS
283,546
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: IBUPROFEN. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Recalls

Source: FDA Enforcement
Drug recall enforcement reports associated with this product.
Classification Reported Firm Reason Status
Class III March 26, 2014 Pfizer Us Pharmaceutical Group Subpotent Drug: This lot is being recalled because of out-of-specification test results for Diphenhydramine citrate. Terminated

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
0573-0164-04 0573-0164 Haleon US Holdings LLC 4 TABLET, COATED in 1 POUCH (0573-0164-04) December 21, 2005
0573-0164-05 0573-0164 Haleon US Holdings LLC 2 BOTTLE in 1 CARTON (0573-0164-05) / 2 TABLET, COATED in 1 BOTTLE December 21, 2005
0573-0164-08 0573-0164 Haleon US Holdings LLC 1 VIAL in 1 PACKAGE (0573-0164-08) / 8 TABLET, COATED in 1 VIAL March 17, 2017
0573-0164-09 0573-0164 Haleon US Holdings LLC 8 TABLET, COATED in 1 VIAL (0573-0164-09) March 17, 2017
0573-0164-12 0573-0164 Haleon US Holdings LLC 6 POUCH in 1 CARTON (0573-0164-12) / 2 TABLET, COATED in 1 POUCH December 21, 2005
0573-0164-14 0573-0164 Haleon US Holdings LLC 2 POUCH in 1 CARTON (0573-0164-14) / 2 TABLET, COATED in 1 POUCH December 21, 2005
0573-0164-20 0573-0164 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0164-20) / 20 TABLET, COATED in 1 BOTTLE December 21, 2005
0573-0164-21 0573-0164 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0164-21) / 30 TABLET, COATED in 1 BOTTLE December 21, 2005
0573-0164-30 0573-0164 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0164-30) / 40 TABLET, COATED in 1 BOTTLE December 21, 2005
0573-0164-32 0573-0164 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0164-32) / 50 TABLET, COATED in 1 BOTTLE December 21, 2005
0573-0164-33 0573-0164 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0164-33) / 50 TABLET, COATED in 1 BOTTLE December 21, 2005
0573-0164-40 0573-0164 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0164-40) / 80 TABLET, COATED in 1 BOTTLE December 21, 2005
0573-0164-41 0573-0164 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0164-41) / 100 TABLET, COATED in 1 BOTTLE December 21, 2005
0573-0164-43 0573-0164 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0164-43) / 120 TABLET, COATED in 1 BOTTLE December 21, 2005
0573-0164-44 0573-0164 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0164-44) / 140 TABLET, COATED in 1 BOTTLE December 21, 2005
0573-0164-45 0573-0164 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0164-45) / 180 TABLET, COATED in 1 BOTTLE December 21, 2005
0573-0164-46 0573-0164 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0164-46) / 180 TABLET, COATED in 1 BOTTLE December 21, 2005
0573-0164-49 0573-0164 Haleon US Holdings LLC 1 BOTTLE in 1 CARTON (0573-0164-49) / 200 TABLET, COATED in 1 BOTTLE December 21, 2005
0573-0164-55 0573-0164 Haleon US Holdings LLC 50 POUCH in 1 TRAY (0573-0164-55) / 2 TABLET, COATED in 1 POUCH December 21, 2005
0573-0164-65 0573-0164 Haleon US Holdings LLC 120 TABLET, COATED in 1 BOTTLE (0573-0164-65) September 30, 2016
0573-0164-91 0573-0164 Haleon US Holdings LLC 3000 POUCH in 1 BOX (0573-0164-91) / 2 TABLET, COATED in 1 POUCH December 21, 2005
66715-9633-3 66715-9633 Lil' Drug Store Products, Inc. 30 POUCH in 1 BOX, UNIT-DOSE (66715-9633-3) / 2 TABLET, COATED in 1 POUCH April 19, 2022
66715-9733-2 66715-9733 Lil' Drug Store Products, Inc. 2 POUCH in 1 CARTON (66715-9733-2) / 2 TABLET, COATED in 1 POUCH May 11, 2010
66715-9733-3 66715-9733 Lil' Drug Store Products, Inc. 3 POUCH in 1 CARTON (66715-9733-3) / 2 TABLET, COATED in 1 POUCH February 14, 2018
67751-147-01 67751-147 Navajo Manufacturing Company Inc. 1 POUCH in 1 CARTON (67751-147-01) / 2 TABLET, COATED in 1 POUCH September 16, 2016
67751-147-02 67751-147 Navajo Manufacturing Company Inc. 2 POUCH in 1 CARTON (67751-147-02) / 4 TABLET, COATED in 1 POUCH September 16, 2016
67751-147-06 67751-147 Navajo Manufacturing Company Inc. 3 POUCH in 1 CARTON (67751-147-06) / 2 TABLET, COATED in 1 POUCH April 25, 2025
85237-1784-1 85237-1784 Select Consumer Group 1 POUCH in 1 CONTAINER (85237-1784-1) / 2 TABLET, COATED in 1 POUCH (85237-1784-0) June 4, 2025
85237-1784-2 85237-1784 Select Consumer Group 2 POUCH in 1 CONTAINER (85237-1784-2) / 2 TABLET, COATED in 1 POUCH (85237-1784-0) June 4, 2025
85237-1784-4 85237-1784 Select Consumer Group 25 POUCH in 1 CARTON (85237-1784-4) / 2 TABLET, COATED in 1 POUCH (85237-1784-0) June 4, 2025
85237-1784-5 85237-1784 Select Consumer Group 30 POUCH in 1 CARTON (85237-1784-5) / 2 TABLET, COATED in 1 POUCH (85237-1784-0) June 4, 2025
85237-1784-7 85237-1784 Select Consumer Group 3 POUCH in 1 CONTAINER (85237-1784-7) / 2 TABLET, COATED in 1 POUCH (85237-1784-0) June 4, 2025
0573-0164 0573-0164 Haleon US Holdings LLC — December 21, 2005
66715-9633 66715-9633 Lil' Drug Store Products, Inc. — April 19, 2022
66715-9733 66715-9733 Lil' Drug Store Products, Inc. — May 11, 2010
67751-147 67751-147 Navajo Manufacturing Company Inc. — September 16, 2016
85237-1784 85237-1784 Select Consumer Group — December 21, 2005

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Drug Labeling FDA / NLM Prescribing information reproduced above
FAERS FDA Adverse event report counts
Enforcement FDA Recall records

Generated September 25, 2026 · 13 sections on this page.