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Advil PM
diphenhydramine citrate and ibuprofen · Tablet, Coated
Overview
Active ingredients
Source: NDC DirectoryForms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| 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| 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 BookCodes 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| 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 LabelingReproduced 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.
Indications and Usage
openFDA Drug LabelingUses • for relief of occasional sleeplessness when associated with minor aches and pains • helps you fall asleep and stay asleep
Purpose
openFDA Drug LabelingActive 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 LabelingDirections • 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
openFDA Drug LabelingWarnings 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
openFDA Drug LabelingDo 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 LabelingAsk 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
openFDA Drug LabelingStop 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 LabelingActive 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 FAERSAttributed 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| 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| 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
| 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.