ADVIL PM - Haleon US Holdings LLC

Manufacturer
Haleon US Holdings LLC
Effective date
2026-07-29
Label type
HUMAN OTC DRUG LABEL
Version
22
Source
daily-update
Hydrated at
2026-08-01 05:10:15

Label at a glance#

ProductADVIL PM
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE, IBUPROFEN
Label structure11 sections

Indications and uses

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

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredients (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine hydrochloride 25 mg

Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*

(present as the free acid and potassium salt)

*nonsteroidal anti-inflammatory drug

Purposes

OTC - PURPOSE SECTION

Nighttime sleep-aid

Pain reliever

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Allergy alert:

SPL UNCLASSIFIED SECTION

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:

SPL UNCLASSIFIED SECTION

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:

SPL UNCLASSIFIED SECTION

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

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

  • 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

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

SPL UNCLASSIFIED SECTION

  • each capsule contains: potassium 20 mg
  • read all warnings and directions before use. Keep carton.
  • store at 20-25°C (68-77°F)
  • avoid excessive heat above 40°C (104°F)
  • protect from light

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C red no. 33, FD&C blue no. 1, gelatin, medium-chain triglycerides, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitol sorbitan solution

Questions or Comments?

OTC - QUESTIONS SECTION

Call 1-855-297-3031

Additional Information

SPL UNCLASSIFIED SECTION

Do Not Use if seal under bottle cap imprinted with
“SEALED for YOUR PROTECTION” is broken or missing.

READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION

PRINCIPAL DISPLAY PANEL (Advil PM Liqui-Gels)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Advil ® PM
LIQUI•GELS ®

Solubilized Ibuprofen, 200 mg /
Diphenhydramine HCl, 25 mg
Pain Reliever (NSAID)/
Nighttime Sleep-Aid

Actual Size

20
Liquid Filled
Capsules

Advil PM LiquiGels 20 capsules
Advil PM LiquiGels 20 capsules

Principal Display Panel (Advil PM Liqui-Gels Minis)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Advil ® PM
LIQUI•GELS ® minis

Smaller Capsule
Same Strength*

Solubilized Ibuprofen, 200 mg /
Diphenhydramine HCl, 25 mg
Pain Reliever (NSAID)/
Nighttime Sleep-Aid

*Compared to Advil PM Liqui-Gels

Actual Size

40
Liquid Filled
Capsules

Advil PM LG Minis 40 ct
Advil PM LG Minis 40 ct

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0573-0167-102024-01-31C16284748780-11030e365-2bf0-111a-e063-dadaa90a10e2Drug Facts
0573-0167-102024-01-31C16284748780-11030e365-2bf0-111a-e063-dadaa90a10e2Drug Facts
0573-0167-182024-01-31C16284748780-11030e365-2bf0-111a-e063-dadaa90a10e2Drug Facts
0573-0167-182024-01-31C16284748780-11030e365-2bf0-111a-e063-dadaa90a10e2Drug Facts
0573-0167-192024-01-31C16284748780-11030e365-2bf0-111a-e063-dadaa90a10e2Drug Facts
0573-0167-192024-01-31C16284748780-11030e365-2bf0-111a-e063-dadaa90a10e2Drug Facts
0573-0167-202024-01-31C16284748780-11030e365-2bf0-111a-e063-dadaa90a10e2Drug Facts
0573-0167-202024-01-31C16284748780-11030e365-2bf0-111a-e063-dadaa90a10e2Drug Facts
0573-0167-212024-01-31C16284748780-11030e365-2bf0-111a-e063-dadaa90a10e2Drug Facts
0573-0167-212024-01-31C16284748780-11030e365-2bf0-111a-e063-dadaa90a10e2Drug Facts
0573-0167-252024-01-31C16284748780-11030e365-2bf0-111a-e063-dadaa90a10e2Drug Facts
0573-0167-252024-01-31C16284748780-11030e365-2bf0-111a-e063-dadaa90a10e2Drug Facts
0573-0167-262024-01-31C16284748780-11030e365-2bf0-111a-e063-dadaa90a10e2Drug Facts
0573-0167-262024-01-31C16284748780-11030e365-2bf0-111a-e063-dadaa90a10e2Drug Facts
0573-0167-422024-01-31C16284748780-11030e365-2bf0-111a-e063-dadaa90a10e2Drug Facts
0573-0167-422024-01-31C16284748780-11030e365-2bf0-111a-e063-dadaa90a10e2Drug Facts
0573-0167-432024-01-31C16284748780-11030e365-2bf0-111a-e063-dadaa90a10e2Drug Facts
0573-0167-432024-01-31C16284748780-11030e365-2bf0-111a-e063-dadaa90a10e2Drug Facts
0573-0167-442024-01-31C16284748780-11030e365-2bf0-111a-e063-dadaa90a10e2Drug Facts
0573-0167-442024-01-31C16284748780-11030e365-2bf0-111a-e063-dadaa90a10e2Drug Facts
0573-0167-552024-01-31C16284748780-11030e365-2bf0-111a-e063-dadaa90a10e2Drug Facts
0573-0167-552024-01-31C16284748780-11030e365-2bf0-111a-e063-dadaa90a10e2Drug Facts
0573-0167-562024-01-31C16284748780-11030e365-2bf0-111a-e063-dadaa90a10e2Drug Facts
0573-0167-562024-01-31C16284748780-11030e365-2bf0-111a-e063-dadaa90a10e2Drug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0573-0167-10EA - Each0573-0167215fd11c-a5f8-40b6-8e00-0762da413c3c12014-01-04
0573-0167-20EA - Each0573-016702755d54-e1de-4282-b019-343a7ef4ea1212012-07-24
0573-0167-25EA - Each0573-01675c48509c-cd84-4810-846a-2222b554326612015-04-03
0573-0167-43EA - Each0573-016708c315ed-78d2-495c-9542-7e0676410f6a12015-01-05
0573-0167-55EA - Each0573-0167902635c1-b011-4bd5-a3c3-c40426075af012015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD4010
IBUPROFENACTIVE INGREDIENTWK2XYI10QM10
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83M10
IBUPROFENACTIVE MOIETYWK2XYI10QM10
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0L10
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD10
GELATININACTIVE INGREDIENT2G86QN327L10
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7U10
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1A10
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4T10
SORBITANINACTIVE INGREDIENT6O92ICV9RU10
SORBITOLINACTIVE INGREDIENT506T60A25R10
WATERINACTIVE INGREDIENT059QF0KO0R10

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
212025-01-15full-release2026-06-01 00:52:52

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 8 · 480 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SORBITOLSORBITOL506T60A25RCONCENTRATE / ORAL600 mg/1mlExact identifier — unii+route
288 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UTABLET, EXTENDED RELEASE / ORAL0.37 mgExact identifier — unii+route
112 equally ranked IID candidates
POTASSIUM HYDROXIDEPOTASSIUM HYDROXIDEWZH3C48M4TCAPSULE, LIQUID FILLED / ORAL154 mgExact identifier — unii+route+dosage form
16 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USOLUTION / ORAL5566 mgExact identifier — unii+route
112 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSUSPENSION / ORAL45000 mgExact identifier — unii+route
288 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, ORALLY DISINTEGRATING / ORAL7 mgExact identifier — unii+route
288 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE, LIQUID FILLED / ORAL1042 mgExact identifier — unii+route+dosage form
16 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RGUM, CHEWING / ORAL6168 mgExact identifier — unii+route
288 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, COATED / ORAL12.96 mgExact identifier — unii+route
288 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION / ORAL29268 mgExact identifier — unii+route
288 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USUSPENSION / ORAL10170 mgExact identifier — unii+route
112 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RPOWDER, FOR SUSPENSION / ORAL12000 mgExact identifier — unii+route
288 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UTABLET / ORAL2 mgExact identifier — unii+route
112 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USOLUTION / ORAL5566 mgExact identifier — unii+route
112 equally ranked IID candidates
SORBITANSORBITAN6O92ICV9RUCAPSULE, LIQUID FILLED / ORALNAExact identifier — unii+route+dosage form
16 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UTABLET, EXTENDED RELEASE / ORAL0.37 mgExact identifier — unii+route
112 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSYRUP / ORAL4370 mg/5mlExact identifier — unii+route
288 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RLIQUID / ORAL53460 mgExact identifier — unii+route
288 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RPOWDER / ORAL36000 mgExact identifier — unii+route
288 equally ranked IID candidates
D&C RED NO. 33D&C RED NO. 339DBA0SBB0LCAPSULE, LIQUID FILLED / ORAL0.01 mgExact identifier — unii+route+dosage form
16 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSUSPENSION / ORAL45000 mgExact identifier — unii+route
288 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UCAPSULE / ORAL4771 mgExact identifier — unii+route
112 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USOLUTION / ORAL5566 mgExact identifier — unii+route
112 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UTABLET, ORALLY DISINTEGRATING / ORAL1 mgExact identifier — unii+route
112 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RPOWDER, FOR SUSPENSION / ORAL12000 mgExact identifier — unii+route
288 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE, LIQUID FILLED / ORAL1042 mgExact identifier — unii+route+dosage form
16 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, ORALLY DISINTEGRATING / ORAL7 mgExact identifier — unii+route
288 equally ranked IID candidates
D&C RED NO. 33D&C RED NO. 339DBA0SBB0LCAPSULE, LIQUID FILLED / ORAL0.01 mgExact identifier — unii+route+dosage form
16 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UTABLET, ORALLY DISINTEGRATING / ORAL1 mgExact identifier — unii+route
112 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSUSPENSION / ORAL45000 mgExact identifier — unii+route
288 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, LIQUID FILLED / ORAL0.08 mgExact identifier — unii+route+dosage form
16 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UTABLET / ORAL2 mgExact identifier — unii+route
112 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSYRUP / ORAL4370 mg/5mlExact identifier — unii+route
288 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCONCENTRATE / ORAL600 mg/1mlExact identifier — unii+route
288 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSUSPENSION / ORAL45000 mgExact identifier — unii+route
288 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UPOWDER, FOR SUSPENSION / ORAL3390 mg/5mlExact identifier — unii+route
112 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RPOWDER, FOR SUSPENSION / ORAL12000 mgExact identifier — unii+route
288 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION, CONCENTRATE / ORAL300 mg/1mlExact identifier — unii+route
288 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, CHEWABLE / ORAL3555 mgExact identifier — unii+route
288 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RPOWDER / ORAL36000 mgExact identifier — unii+route
288 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION, CONCENTRATE / ORAL300 mg/1mlExact identifier — unii+route
288 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, ORALLY DISINTEGRATING / ORAL7 mgExact identifier — unii+route
288 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, FILM COATED / ORAL5 mgExact identifier — unii+route
288 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RPOWDER / ORAL36000 mgExact identifier — unii+route
288 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UTABLET, ORALLY DISINTEGRATING / ORAL1 mgExact identifier — unii+route
112 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, DELAYED RELEASE / ORAL0.01 mgExact identifier — unii+route
288 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION / ORAL29268 mgExact identifier — unii+route
288 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, CHEWABLE / ORAL3555 mgExact identifier — unii+route
288 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USOLUTION / ORAL5566 mgExact identifier — unii+route
112 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USUSPENSION / ORAL10170 mgExact identifier — unii+route
112 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UTABLET / ORAL2 mgExact identifier — unii+route
112 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, ORALLY DISINTEGRATING / ORAL7 mgExact identifier — unii+route
288 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, FILM COATED / ORAL5 mgExact identifier — unii+route
288 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION / ORAL29268 mgExact identifier — unii+route
288 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RLIQUID / ORAL53460 mgExact identifier — unii+route
288 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UTABLET, EXTENDED RELEASE / ORAL0.37 mgExact identifier — unii+route
112 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, LIQUID FILLED / ORAL0.08 mgExact identifier — unii+route+dosage form
16 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCONCENTRATE / ORAL600 mg/1mlExact identifier — unii+route
288 equally ranked IID candidates
POTASSIUM HYDROXIDEPOTASSIUM HYDROXIDEWZH3C48M4TCAPSULE, LIQUID FILLED / ORAL154 mgExact identifier — unii+route+dosage form
16 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCAPSULE / ORAL1111 mgExact identifier — unii+route
288 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021393-001ADVIL PMDIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-21

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-2184e616aacf4f…
2026-08-18 06:07:402026-07N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-2187673890dc5c…
2021-03-12 10:30 UTC2021-03N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-213f01610625f2…
2019-09-15 20:21 UTC2019-09N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-21b00525d2431f…
2019-07-19 19:46 UTC2019-07N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-213f0d92c62455…
2023-05-13 08:27 UTC2023-05N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-21053a50430f4f…
2023-01-26 05:58 UTC2023-01N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021393-001ADVIL PM25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORALRLD, RS2005-12-21f41ea6bd6efb…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021393-00188838492022-01-17U-16182014-12-095c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021393-00191557182022-01-17Drug product2015-11-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021393-00188838492022-01-17U-16182014-12-095d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021393-00191557182022-01-17Drug product2015-11-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021393-00188838492022-01-17U-16182014-12-094b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021393-00191557182022-01-17Drug product2015-11-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021393-00188838492022-01-17U-16182014-12-0974a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021393-00191557182022-01-17Drug product2015-11-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021393-00188838492022-01-17U-16182014-12-09bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021393-00191557182022-01-17Drug product2015-11-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021393-00188838492022-01-17U-16182014-12-09782e0a99824c…
2021-12-28 21:50 UTC2021-12N021393-00191557182022-01-17Drug product2015-11-10782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021393-00188838492022-01-17U-16182014-12-0987673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021393-00191557182022-01-17Drug product2015-11-1087673890dc5c…
2021-03-12 10:30 UTC2021-03N021393-00188838492022-01-17U-16182014-12-095aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021393-00191557182022-01-17Drug product2015-11-105aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021393-00188838492022-01-17U-16182014-12-098869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021393-00191557182022-01-17Drug product2015-11-108869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021393-00188838492022-01-17U-16182014-12-09c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021393-00191557182022-01-17Drug product2015-11-10c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021393-00188838492022-01-17U-16182014-12-093f01610625f2…
2019-12-14 00:12 UTC2019-12N021393-00191557182022-01-17Drug product2015-11-103f01610625f2…
2019-09-15 20:21 UTC2019-09N021393-00188838492022-01-17U-16182014-12-09b00525d2431f…
2019-09-15 20:21 UTC2019-09N021393-00191557182022-01-17Drug product2015-11-10b00525d2431f…
2019-07-19 19:46 UTC2019-07N021393-00188838492022-01-17U-16182014-12-09ea99ee380514…
2019-07-19 19:46 UTC2019-07N021393-00191557182022-01-17Drug product2015-11-10ea99ee380514…
2023-01-26 05:58 UTC2023-01N021393-00188838492022-01-17U-16182014-12-093bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01N021393-00191557182022-01-17Drug product2015-11-103bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021393-00188838492022-01-17U-16182014-12-093a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021393-00191557182022-01-17Drug product2015-11-103a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021393-00188838492022-01-17U-16182014-12-09f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N021393-00191557182022-01-17Drug product2015-11-10f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021393-00188838492022-01-17U-16182014-12-09e64feba35796…
2022-09-29 23:25 UTC2022-09N021393-00191557182022-01-17Drug product2015-11-10e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021393-00188838492022-01-17U-16182014-12-09cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021393-00191557182022-01-17Drug product2015-11-10cb3db0bc1861…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ADVIL PMDIPHENHYDRAMINE HCL, IBUPROFENHaleon US Holdings LLC405afdb4-c157-1d88-f232-848063ba47142026-07-29WarningsExact identifier
ndc (package): 0573-0167-25
ndc (package): 0573-0148-06
ndc (package): 0573-0167-42
ndc (package): 0573-0167-20
ndc (package): 0573-0167-26
ndc (package): 0573-0148-07
ndc (package): 0573-0167-56
ndc (package): 0573-0167-43
ndc (package): 0573-0167-21
ndc (package): 0573-0167-18
ndc (package): 0573-0167-44
ndc (package): 0573-0167-55
ndc (package): 0573-0167-10
ndc (package): 0573-0167-19
ndc (product): 0573-0167
ndc (product): 0573-0148
ndc11 (package): 00573016710
ndc11 (package): 00573016718
ndc11 (package): 00573016719
ndc11 (package): 00573016742
ndc11 (package): 00573014806
ndc11 (package): 00573016744
ndc11 (package): 00573016756
ndc11 (package): 00573016743
ndc11 (package): 00573016721
ndc11 (package): 00573014807
ndc11 (package): 00573016720
ndc11 (package): 00573016725
ndc11 (package): 00573016755
ndc11 (package): 00573016726
spl id: 57c5339d-4ab8-ce7f-e063-6394a90a75a5
spl set id: 405afdb4-c157-1d88-f232-848063ba4714

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.