IBUPROFEN AND DIPHENHYDRAMINE HCL

Manufacturer
Strides Pharma Science Limited
Effective date
2022-02-08
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 22:08:12

Label at a glance#

ProductIBUPROFEN AND DIPHENHYDRAMINE HCL
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE, IBUPROFEN
Label structure13 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 Other information • 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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each capsule)                                                               Purposes                                                    

Diphenhydramine hydrochloride 25 mg…………………………………...Nighttime sleep-aid

Solubilized ibuprofen equal to ibuprofen 200 mg (NSAID)*……………...Pain reliever

(present as the free acid and potassium salt)

*nonsteroidal anti-inflammatory drug

Uses

USE IN SPECIFIC POPULATIONS 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

  • 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

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 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. 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

• 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

Anidrisorb, D&C red no. 33, FD&C blue no. 1, gelatin, Hydrolyzed gelatin, medium chain triglyceride. Opacode white ink, Polyethylene glycol 600, potassium hydroxide, purified water.

Ingredients of Opacode white ink: shellac glaze in ethanol, titanium dioxide, n-butyl alcohol, lecithin (soya), simethicone and purified water.

Questions or comments?

OTC - QUESTIONS SECTION

Call at 1877 244 9825

Manufactured by:

Strides Pharma Science Limited

Bengaluru - 562106, India

Distributed by:

Strides Pharma Inc.

East Brunswick, NJ 08816

Revised: 01/2022

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

180 s count container label
180 s count container label
20 s count container label
20 s count container label
20 s count carton label
20 s count carton label
180 s carton label
180 s carton label

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD402
IBUPROFENACTIVE INGREDIENTWK2XYI10QM2
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83M2
IBUPROFENACTIVE MOIETYWK2XYI10QM2
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS32
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0L2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD2
GELATININACTIVE INGREDIENT2G86QN327L2
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM622
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7U2
POLYETHYLENE GLYCOL 600INACTIVE INGREDIENTNL4J9F21N92
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4T2
SHELLACINACTIVE INGREDIENT46N107B71O2
SORBITANINACTIVE INGREDIENT6O92ICV9RU2
SORBITOLINACTIVE INGREDIENT506T60A25R2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

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

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

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 5 · 252 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
POTASSIUM HYDROXIDEPOTASSIUM HYDROXIDEWZH3C48M4TCREAM / TOPICAL0.5 %w/wExact identifier — unii candidate
13 equally ranked IID candidates
GELATINGELATIN2G86QN327LWAFER / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, DELAYED RELEASE PELLETS / ORAL24 mgExact identifier — unii candidate
40 equally ranked IID candidates
GELATINGELATIN2G86QN327LSYRUP / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION / OPHTHALMIC6 mgExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSYRUP / ORAL4370 mg/5mlExact identifier — unii candidate
44 equally ranked IID candidates
SHELLACSHELLAC46N107B71OTABLET, EXTENDED RELEASE / ORAL213.24 mgExact identifier — unii candidate
13 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCREAM / TOPICAL80 mgExact identifier — unii candidate
40 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCREAM, AUGMENTED / TOPICAL15 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
BUTYL ALCOHOLBUTYL ALCOHOL8PJ61P6TS3CAPSULE / ORAL0.02 mgExact identifier — unii candidate
10 equally ranked IID candidates
LECITHIN, SOYBEANSOYBEAN LECITHIN1DI56QDM62TABLET, EXTENDED RELEASE / ORAL20 mgExact identifier — unii candidate
7 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE / ORAL10932 mgExact identifier — unii candidate
44 equally ranked IID candidates
SHELLACSHELLAC46N107B71OFILM / SUBLINGUALNAExact identifier — unii candidate
13 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UCAPSULE / ORAL4771 mgExact identifier — unii candidate
18 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UINJECTION, EMULSION / INTRAVENOUS1.1 %w/vExact identifier — unii candidate
18 equally ranked IID candidates
POLYETHYLENE GLYCOL 600POLYETHYLENE GLYCOL 600NL4J9F21N9TABLET, EXTENDED RELEASE / ORAL2.5 mgExact identifier — unii candidate
9 equally ranked IID candidates
POLYETHYLENE GLYCOL 600POLYETHYLENE GLYCOL 600NL4J9F21N9INJECTION, SOLUTION / INTRAVENOUS5 %w/vExact identifier — unii candidate
9 equally ranked IID candidates
POTASSIUM HYDROXIDEPOTASSIUM HYDROXIDEWZH3C48M4TCAPSULE, LIQUID FILLED / ORAL154 mgExact identifier — unii candidate
13 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET / PERIODONTAL3.44 mgExact identifier — unii candidate
44 equally ranked IID candidates
LECITHIN, SOYBEANSOYBEAN LECITHIN1DI56QDM62AEROSOL, METERED / RESPIRATORY (INHALATION)0.1 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, DELAYED RELEASE / ORAL55 mgExact identifier — unii candidate
40 equally ranked IID candidates
SHELLACSHELLAC46N107B71OCAPSULE / ORAL34.48 mgExact identifier — unii candidate
13 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
37 equally ranked IID candidates
LECITHIN, SOYBEANSOYBEAN LECITHIN1DI56QDM62CREAM / VAGINAL1 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
LECITHIN, SOYBEANSOYBEAN LECITHIN1DI56QDM62TABLET, FILM COATED / ORAL0.33 mgExact identifier — unii candidate
7 equally ranked IID candidates
BUTYL ALCOHOLBUTYL ALCOHOL8PJ61P6TS3CAPSULE, EXTENDED RELEASE / ORAL0.01 mgExact identifier — unii candidate
10 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPSUSPENSION / ORAL113 mgExact identifier — unii candidate
40 equally ranked IID candidates
D&C RED NO. 33D&C RED NO. 339DBA0SBB0LSUSPENSION / ORAL0.13 mg/5mlExact identifier — unii candidate
14 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UOINTMENT / TOPICAL20 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UPOWDER / SUBLINGUAL2 mgExact identifier — unii candidate
18 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET, EXTENDED RELEASE / ORAL239 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR1 mgExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RLOTION / TOPICAL10.7 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDPOWDER, FOR SOLUTION / ORAL0.04 mg/5mlExact identifier — unii candidate
37 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, EXTENDED RELEASE / ORAL428 mgExact identifier — unii candidate
44 equally ranked IID candidates
POLYETHYLENE GLYCOL 600POLYETHYLENE GLYCOL 600NL4J9F21N9CAPSULE / ORAL1742 mgExact identifier — unii candidate
9 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RINJECTION / INTRAMUSCULARNAExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, CHEWABLE / ORAL3555 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LDROPS / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, EXTENDED RELEASE / ORAL90 mgExact identifier — unii candidate
40 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, DELAYED RELEASE / ORAL2 mgExact identifier — unii candidate
37 equally ranked IID candidates
POTASSIUM HYDROXIDEPOTASSIUM HYDROXIDEWZH3C48M4TPASTILLE / ORALADJ PHExact identifier — unii candidate
13 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UFILM, EXTENDED RELEASE / TRANSDERMALNAExact identifier — unii candidate
18 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPGEL / TOPICAL0.06 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, LIQUID FILLED / ORAL0.08 mgExact identifier — unii candidate
37 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET / SUBLINGUAL19 mgExact identifier — unii candidate
44 equally ranked IID candidates
SHELLACSHELLAC46N107B71OCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
13 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION / SUBCUTANEOUS16 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPDROPS / ORALNAExact identifier — unii candidate
40 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET, DELAYED RELEASE / ORAL19 mgExact identifier — unii candidate
44 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPPOWDER, FOR SUSPENSION / ORAL297 mgExact identifier — unii candidate
40 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RINJECTION / INTRASYNOVIAL45 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
POLYETHYLENE GLYCOL 600POLYETHYLENE GLYCOL 600NL4J9F21N9INJECTION / INTRAVENOUS5 %w/vExact identifier — unii candidate
9 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDLIQUID / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RLIQUID / TOPICAL1 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET / ORAL232 mgExact identifier — unii candidate
40 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCREAM / TOPICAL36.8 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
D&C RED NO. 33D&C RED NO. 339DBA0SBB0LSOLUTION / DENTALNAExact identifier — unii candidate
14 equally ranked IID candidates
SHELLACSHELLAC46N107B71OTABLET, FILM COATED / ORAL4.4 mgExact identifier — unii candidate
13 equally ranked IID candidates
POLYETHYLENE GLYCOL 600POLYETHYLENE GLYCOL 600NL4J9F21N9TABLET, DELAYED RELEASE / ORAL1 mgExact identifier — unii candidate
9 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
A200888-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2012-03-05

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 22:38:342026-08A200888-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2012-03-0584e616aacf4f…
2026-08-18 06:07:402026-07A200888-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2012-03-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A200888-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2012-03-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200888-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2012-03-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A200888-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2012-03-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200888-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2012-03-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200888-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2012-03-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200888-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2012-03-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200888-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2012-03-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200888-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2012-03-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200888-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2012-03-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200888-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2012-03-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200888-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2012-03-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200888-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2012-03-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200888-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2012-03-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200888-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2012-03-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200888-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2012-03-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A200888-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2012-03-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A200888-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2012-03-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A200888-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2012-03-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A200888-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2012-03-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A200888-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2012-03-05782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A200888-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2012-03-0587673890dc5c…
2021-03-12 10:30 UTC2021-03A200888-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2012-03-055aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A200888-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2012-03-058869cabd3fbd…
2020-11-12 02:37 UTC2020-11A200888-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2012-03-05c0c555d07b60…
2019-12-14 00:12 UTC2019-12A200888-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2012-03-053f01610625f2…
2019-09-15 20:21 UTC2019-09A200888-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2012-03-05b00525d2431f…
2019-07-19 19:46 UTC2019-07A200888-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2012-03-05ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A200888-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2012-03-056a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A200888-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2012-03-051c564ffb4f44…
2023-12-20 04:57 UTC2023-12A200888-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2012-03-05ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A200888-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2012-03-05a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A200888-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2012-03-059b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A200888-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2012-03-05a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A200888-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2012-03-053f0d92c62455…
2023-05-13 08:27 UTC2023-05A200888-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2012-03-05053a50430f4f…
2023-01-26 05:58 UTC2023-01A200888-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2012-03-053bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A200888-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2012-03-053a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A200888-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2012-03-05f41ea6bd6efb…

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
1377e093-27d5-4207-b3ee-92a3e9218f6910d52858-a55f-4053-aa77-da660556a2ad2025-04-04WarningsExact identifier
spl set id: 10d52858-a55f-4053-aa77-da660556a2ad

Reported adverse events (FAERS/openFDA)#

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