Ibuprofen PM

Manufacturer: TOP CARE (Topco Associates LLC)
Effective date: 2018-12-27
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: legacy-cache
Hydrated at: 2026-08-02 00:38:49

Label at a glance#

ProductIbuprofen PM

Active ingredientIBUPROFEN, DIPHENHYDRAMINE HYDROCHLORIDE

Label structure10 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 each capsule contains : potassium 20 mg read all warnings and directions before use. Keep carton. store at 20°-25°C (68°-77° F) avoid high humidity and excessively heat above 40 o C (104 o F) protect from light.

Contacts and useful links#

PhoneLabel contact1-888-423-0139

Websitewww.topcarebrand.com

www.topcarebrand.com

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)
*non-steroidal anti-inflammatory drug

Purpose

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: 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:

have had stomach ulcers or bleeding problems
take a blood thinning (anticoagulant) or steroid drug
are age 60 or older
take other drugs containing prescription or nonprescription NSAIDS [aspirin, ibuprofen, naproxen, or others]
take more or for a longer time than directed.
have 3 or more alcoholic drinks every day while using this product

Do not use

OTC - DO NOT USE SECTION

in children under 12 years of age
if you have ever had an allergic reaction to any other pain reliever/fever reducer
right before or after heart surgery
unless you have time for a full night’s sleep
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

the stomach bleeding warning applies to you
you have a history of stomach problems, such as heartburn
you have glaucoma
you have high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma
you are taking a diuretic
you have problems or serious side effects from taking pain relievers or fever reducers.
you have a breathing problem such as emphysema or chronic bronchitis
you have trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

OTC - STOP USE SECTION

taking sedatives or tranquilizers, or any other sleep-aid
taking any other drug
taking any other antihistamines
taking aspirin for heart attack or stroke, because ibuprofen may decease this benefit of aspirin
under a doctor's care for any continuing medical illness

When using this product

OTC - KEEP OUT OF REACH OF CHILDREN 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
the risk of heart attack or stroke may increase if you use more than directed or for longer than directed.

Stop use and ask a doctor if

OTC - STOP USE SECTION

you experience any of the following signs of stomach bleeding:
- feel faint
- have bloody or black stools
- vomit blood
- have stomach pain that does not get better
- pain gets worse or last more than 10 days
- sleepnessness 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 of breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

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

STORAGE AND HANDLING 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 high humidity and excessively heat above 40^oC (104^o F)
protect from light.

Other information

OTHER SAFETY INFORMATION

each capsule contains: potassium 20 mg
read all warnings and directions before use. Keep carton.
store at 20º to 25ºC (68º to 77ºF)
avoid high humidity and excessive heat above 40ºC (104ºF)
protect fron light

Inactive Ingredients

INACTIVE INGREDIENT SECTION

FD&C Blue #1, FD&C Red #40, gelatin, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitan,sorbitol

Questions or comments?

OTC - QUESTIONS SECTION

call toll free 1-888-423-0139

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SOFTGELS

Ibuprofen PM

IBUPROFEN, 200 mg

Pain Reliever (NSAID)

Diphenhydramine HCl, 25 mg

Nighttime Sleep-Aid

SOFTGELS**

(**LIQUID FILLED CAPSULES)

COMPARE TO ADVIL® PM LIQUI-GELS® active ingredients†

†This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Advil® PM LIQUI-GELS®

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

topcare@topco.com www.topcarebrand.com

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	1
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	1
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	1
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	1
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	1
SORBITAN	INACTIVE INGREDIENT	6O92ICV9RU	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

Ibuprofen PM
Ibuprofen and Diphenhydramine HCl
IBUPROFEN
DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENHYDRAMINE
FD&C BLUE NO. 1
FD&C RED NO. 40
GELATIN
POLYETHYLENE GLYCOL, UNSPECIFIED
POTASSIUM HYDROXIDE
WATER
SORBITAN
SORBITOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
36800-165	36800-165-32, 36800-165-40

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
IBUPROFEN	WK2XYI10QM	ACTIB
DIPHENHYDRAMINE HYDROCHLORIDE	TC2D6JAD40	ACTIB
FD&C BLUE NO. 1	H3R47K3TBD	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
GELATIN	2G86QN327L	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
POTASSIUM HYDROXIDE	WZH3C48M4T	IACT
WATER	059QF0KO0R	IACT
SORBITAN	6O92ICV9RU	IACT
SORBITOL	506T60A25R	IACT

Source Document#

Source XML

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 3 · 169 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SORBITOL	SORBITOL	506T60A25R	SOLUTION/ DROPS / OPHTHALMIC	0.25 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, COATED / ORAL	0.52 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	GUM, CHEWING / BUCCAL		48 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	LOTION / TOPICAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, COATED / ORAL	12.96 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOLUTION / RECTAL	0.01 %w/v		Exact identifier — unii candidate 37 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SYRUP / ORAL	4370 mg/5ml		Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET / ORAL	27.53 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	CAPSULE, DELAYED RELEASE / ORAL		1791 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	POWDER / RESPIRATORY (INHALATION)	100 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
POTASSIUM HYDROXIDE	POTASSIUM HYDROXIDE	WZH3C48M4T	CAPSULE, EXTENDED RELEASE / ORAL	0.07 mg		Exact identifier — unii candidate 13 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	PASTE, DENTIFRICE / DENTAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SUSPENSION/ DROPS / ORAL		1 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION / NASAL	25 mg/1ml		Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	POWDER, FOR SOLUTION / ORAL	0.33 mg/5ml		Exact identifier — unii candidate 28 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	INJECTION / INTRAVENOUS	20 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	ELIXIR / ORAL	833.3 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	ELIXIR / ORAL	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR		1 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET, DELAYED RELEASE / ORAL	19 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	GUM, CHEWING / BUCCAL		102 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION / INTRAMUSCULAR	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET, CHEWABLE / ORAL		3555 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	CAPSULE / ORAL		10932 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	FILM / SUBLINGUAL	0.07 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	CAPSULE, COATED PELLETS / ORAL	65 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	ELIXIR / ORAL	12.5 mg/5ml		Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, CHEWABLE / ORAL	40 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET / SUBLINGUAL		19 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, COATED PELLETS / ORAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, LIQUID FILLED / ORAL		1 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	INJECTION, SUSPENSION / INTRAMUSCULAR	1.3 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	1.04 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	AEROSOL, FOAM / TOPICAL	4.95 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	POWDER / ORAL		36000 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET, FILM COATED / ORAL		57 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SYRUP / ORAL	0.05 mg/5ml		Exact identifier — unii candidate 37 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET, EXTENDED RELEASE / ORAL		239 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET / ORAL		46 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SOLUTION / ORAL		38 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SUSPENSION / ORAL		1 mg	Exact identifier — unii candidate 37 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SOLUTION / DENTAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	GUM, CHEWING / ORAL		6168 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	MOUTHWASH / BUCCAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SYRUP / ORAL		3 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION / OPHTHALMIC		6 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, COATED PELLETS / ORAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET, CHEWABLE / ORAL		24 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	14 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION / INTRASYNOVIAL	45 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOLUTION / DENTAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
POTASSIUM HYDROXIDE	POTASSIUM HYDROXIDE	WZH3C48M4T	INJECTION / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 13 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	POWDER, FOR SUSPENSION / ORAL	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
POTASSIUM HYDROXIDE	POTASSIUM HYDROXIDE	WZH3C48M4T	SOLUTION / ORAL	ADJ PH		Exact identifier — unii candidate 13 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SYSTEM / TOPICAL		6300 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
POTASSIUM HYDROXIDE	POTASSIUM HYDROXIDE	WZH3C48M4T	SOLUTION / TOPICAL	14.02 %w/w		Exact identifier — unii candidate 13 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 44.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL			2010-11-22

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 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090397-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2010-11-22	`3a93d1ddd44b…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
da90a140-5f31-4a43-866f-cad7ffcffdd6			3d2916b6-b17c-4cc8-8f10-717cce92a32b	2018-12-27	Warnings	Exact identifier spl id: da90a140-5f31-4a43-866f-cad7ffcffdd6 spl set id: 3d2916b6-b17c-4cc8-8f10-717cce92a32b

Reported adverse events (FAERS/openFDA)#

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