Ibuprofen and Diphenhydramine Citrate Tablets

Manufacturer: Dr. Reddy's Laboratories Limited
Effective date: 2018-12-05
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 22:58:45

Label at a glance#

ProductIbuprofen and Diphenhydramine Citrate

Active ingredientIbuprofen, Diphenhydramine Citrate

Label structure12 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 caplets at bedtime. do not take more than 2 caplets in 24 hours

Label contents#

Full prescribing information#

SPL PRODUCT DATA ELEMENTS SECTION

SPL UNCLASSIFIED SECTION

ACTIVE INGREDIENTS (IN EACH CAPLET)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine citrate USP, 38 mg

Ibuprofen USP, 200 mg (NSAID)**

* capsule-shaped tablets

**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 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 an NSAID [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

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, 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

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
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
vomit blood
have bloody or black stools
have stomach pain that does not get better
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 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 the 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 caplets at bedtime.
do not take more than 2 caplets in 24 hours

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

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)

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

carnauba wax, corn starch, colloidal silicon dioxide, croscarmellose sodium, FD&C blue no. 2, hypromelllose, microcrystalline cellulose, polydextrose, polyethylene glycol 400, pregelatinized starch, sodium lauryl sulfate, stearic acid, titanium dioxide

QUESTIONS?

OTC - QUESTIONS SECTION

Call 1-888-375-3784

SPL UNCLASSIFIED SECTION

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

Manufactured by:

Dr. Reddy’s Laboratories Limited

Bachepalli – 502 325 INDIA.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Container:

container

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Container carton

carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
895664	ibuprofen 200 MG / diphenhydrAMINE citrate 38 MG Oral Tablet	PSN	3
895664	diphenhydramine citrate 38 MG / ibuprofen 200 MG Oral Tablet	SCD	3

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DIPHENHYDRAMINE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813
IBUPROFEN Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20191108

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1e73f975-1ce7-705e-2bcf-788b1b5e24ba	Product name	5	20251124
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
16cde546-8deb-4df2-a072-dab5566ede95	Product name	1	20231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015	Product name	4	20230808
874f4e63-49d2-5150-5d77-052172814ebd	Product name	6	20230105
557673c2-8256-b351-e863-4ec71a5a64b0	Product name	2	20160714
dbc9a339-6215-4e94-9546-57a3b34902ce	Product name	1	20160517
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
61c18d4e-b552-5478-8fc0-df38b93e3100	Product name	1	20140508
7b2938c9-7eb7-e312-ae90-f54f4240361e	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508
997601aa-bb5f-6971-6b90-a21132c12c7b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
55111-565-05	Ibuprofen and Diphenhydramine Citrate	500 in 1 BOTTLE	TABLET	500	3
55111-565-05	Ibuprofen and Diphenhydramine Citrate	1 in 1 CARTON	TABLET	1	3
55111-565-14	Ibuprofen and Diphenhydramine Citrate	1 in 1 CARTON	TABLET	1	3
55111-565-14	Ibuprofen and Diphenhydramine Citrate	20 in 1 BOTTLE	TABLET	20	3
55111-565-18	Ibuprofen and Diphenhydramine Citrate	180 in 1 BOTTLE	TABLET	180	3
55111-565-18	Ibuprofen and Diphenhydramine Citrate	1 in 1 CARTON	TABLET	1	3
55111-565-30	Ibuprofen and Diphenhydramine Citrate	1 in 1 CARTON	TABLET	1	3
55111-565-30	Ibuprofen and Diphenhydramine Citrate	30 in 1 BOTTLE	TABLET	30	3
55111-565-40	Ibuprofen and Diphenhydramine Citrate	40 in 1 BOTTLE	TABLET	40	3
55111-565-40	Ibuprofen and Diphenhydramine Citrate	1 in 1 CARTON	TABLET	1	3
55111-565-80	Ibuprofen and Diphenhydramine Citrate	1 in 1 CARTON	TABLET	1	3
55111-565-80	Ibuprofen and Diphenhydramine Citrate	80 in 1 BOTTLE	TABLET	80	3
55111-565-90	Ibuprofen and Diphenhydramine Citrate	1 in 1 CARTON	TABLET	1	3
55111-565-90	Ibuprofen and Diphenhydramine Citrate	90 in 1 BOTTLE	TABLET	90	3
55111-565-92	Ibuprofen and Diphenhydramine Citrate	2500 in 1 POUCH	TABLET	2500	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55111-565	IBUPROFEN AND DIPHENHYDRAMINE CITRATE TABLET [DR. REDDY'S LABORATORIES LIMITED]	3	Current NDC, Legacy NDC, 15 package rows	20190312_42c06daf-541a-7721-b875-ea18364501a4.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
diphenhydramine citrate	ACTIVE INGREDIENT	4OD433S209	1
ibuprofen	ACTIVE INGREDIENT	WK2XYI10QM	1
diphenhydramine	ACTIVE MOIETY	8GTS82S83M	1
ibuprofen	ACTIVE MOIETY	WK2XYI10QM	1
carnauba wax	INACTIVE INGREDIENT	R12CBM0EIZ	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	1
colloidal silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	1
FD&C blue no. 2	INACTIVE INGREDIENT	L06K8R7DQK	1
HYPROMELLOSE	INACTIVE INGREDIENT	3NXW29V3WO	1
polydextrose	INACTIVE INGREDIENT	VH2XOU12IE	1
polyethylene glycol 400	INACTIVE INGREDIENT	B697894SGQ	1
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	1
stearic acid	INACTIVE INGREDIENT	4ELV7Z65AP	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	1

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

Ibuprofen and Diphenhydramine Citrate
Ibuprofen
Diphenhydramine Citrate
Diphenhydramine
carnauba wax
STARCH, CORN
Silicon Dioxide
croscarmellose sodium
FD&C blue no. 2
CELLULOSE, MICROCRYSTALLINE
hypromelloses
polydextrose
polyethylene glycol 400
sodium lauryl sulfate
stearic acid
titanium dioxide

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
55111-565	55111-565-14, 55111-565-30, 55111-565-40, 55111-565-80, 55111-565-90, 55111-565-18, 55111-565-05, 55111-565-92

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Ibuprofen	WK2XYI10QM	ACTIB
Diphenhydramine Citrate	4OD433S209	ACTIB
carnauba wax	R12CBM0EIZ	IACT
STARCH, CORN	O8232NY3SJ	IACT
Silicon Dioxide	ETJ7Z6XBU4	IACT
croscarmellose sodium	M28OL1HH48	IACT
FD&C blue no. 2	L06K8R7DQK	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
hypromelloses	3NXW29V3WO	IACT
polydextrose	VH2XOU12IE	IACT
polyethylene glycol 400	B697894SGQ	IACT
sodium lauryl sulfate	368GB5141J	IACT
stearic acid	4ELV7Z65AP	IACT
titanium dioxide	15FIX9V2JP	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 2 · 108 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
stearic acid	STEARIC ACID	4ELV7Z65AP	TABLET / ORAL		336 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
colloidal silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL		750 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
polydextrose	POLYDEXTROSE	VH2XOU12IE	TABLET / ORAL		20 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL		232 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / ORAL		1116 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL		6184 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
polyethylene glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET / ORAL		193 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	TABLET / ORAL		336 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
croscarmellose sodium	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL		736 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
polydextrose	POLYDEXTROSE	VH2XOU12IE	TABLET / ORAL		20 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
FD&C blue no. 2	FD&C BLUE NO. 2	L06K8R7DQK	TABLET / ORAL		25 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / ORAL		1116 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
HYPROMELLOSE	HYPROMELLOSE	3NXW29V3WO	TABLET / ORAL		1127 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL		232 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
carnauba wax	CARNAUBA WAX	R12CBM0EIZ	TABLET / ORAL	167.8 mg		Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	TABLET / ORAL		336 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL		232 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	TABLET / ORAL		336 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
FD&C blue no. 2	FD&C BLUE NO. 2	L06K8R7DQK	TABLET / ORAL		25 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
HYPROMELLOSE	HYPROMELLOSE	3NXW29V3WO	TABLET / ORAL		1127 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
carnauba wax	CARNAUBA WAX	R12CBM0EIZ	TABLET / ORAL	167.8 mg		Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL		6184 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
FD&C blue no. 2	FD&C BLUE NO. 2	L06K8R7DQK	TABLET / ORAL		25 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
carnauba wax	CARNAUBA WAX	R12CBM0EIZ	TABLET / ORAL	167.8 mg		Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL		232 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
HYPROMELLOSE	HYPROMELLOSE	3NXW29V3WO	TABLET / ORAL		1127 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	TABLET / ORAL		233 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / ORAL		1116 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL		6184 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL		232 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
polydextrose	POLYDEXTROSE	VH2XOU12IE	TABLET / ORAL		20 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / ORAL		1116 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
croscarmellose sodium	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL		736 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
HYPROMELLOSE	HYPROMELLOSE	3NXW29V3WO	TABLET / ORAL		1127 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
carnauba wax	CARNAUBA WAX	R12CBM0EIZ	TABLET / ORAL	167.8 mg		Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	TABLET / ORAL		233 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL		232 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
polyethylene glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET / ORAL		193 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
polyethylene glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET / ORAL		193 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
croscarmellose sodium	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL		736 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
HYPROMELLOSE	HYPROMELLOSE	3NXW29V3WO	TABLET / ORAL		1127 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
HYPROMELLOSE	HYPROMELLOSE	3NXW29V3WO	TABLET / ORAL		1127 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
polyethylene glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET / ORAL		193 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
polyethylene glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET / ORAL		193 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
carnauba wax	CARNAUBA WAX	R12CBM0EIZ	TABLET / ORAL	167.8 mg		Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
polydextrose	POLYDEXTROSE	VH2XOU12IE	TABLET / ORAL		20 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL		232 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	TABLET / ORAL		336 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
polydextrose	POLYDEXTROSE	VH2XOU12IE	TABLET / ORAL		20 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
colloidal silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL		750 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
colloidal silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL		750 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
HYPROMELLOSE	HYPROMELLOSE	3NXW29V3WO	TABLET / ORAL		1127 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL		6184 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL		232 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
polyethylene glycol 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET / ORAL		193 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL		6184 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
FD&C blue no. 2	FD&C BLUE NO. 2	L06K8R7DQK	TABLET / ORAL		25 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
croscarmellose sodium	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL		736 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
FD&C blue no. 2	FD&C BLUE NO. 2	L06K8R7DQK	TABLET / ORAL		25 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
colloidal silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL		750 mg	Exact identifier — unii+route+dosage form 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 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
A090619-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	DIPHENHYDRAMINE CITRATE; IBUPROFEN	38MG;200MG	TABLET / ORAL			2009-07-08

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	A090619-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2009-07-08	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A090619-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2009-07-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090619-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2009-07-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090619-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2009-07-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090619-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2009-07-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090619-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2009-07-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090619-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2009-07-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090619-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2009-07-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090619-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2009-07-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090619-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2009-07-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090619-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2009-07-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090619-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2009-07-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090619-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2009-07-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090619-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2009-07-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090619-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2009-07-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090619-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2009-07-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090619-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2009-07-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090619-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2009-07-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090619-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2009-07-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090619-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2009-07-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090619-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2009-07-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090619-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2009-07-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090619-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2009-07-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090619-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2009-07-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090619-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2009-07-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090619-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2009-07-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090619-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2009-07-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090619-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2009-07-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090619-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2009-07-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090619-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2009-07-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090619-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2009-07-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090619-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2009-07-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090619-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2009-07-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090619-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2009-07-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090619-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2009-07-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090619-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2009-07-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090619-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2009-07-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090619-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2009-07-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090619-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2009-07-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090619-001	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	38MG;200MG	TABLET / ORAL	2009-07-08	`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
Ibuprofen and Diphenhydramine Citrate	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	Dr. Reddy's Laboratories Limited	42c06daf-541a-7721-b875-ea18364501a4	2018-12-05	Warnings	Exact identifier ndc (package): 55111-565-18 ndc (package): 55111-565-05 ndc (package): 55111-565-40 ndc (package): 55111-565-14 ndc (package): 55111-565-80 ndc (package): 55111-565-30 ndc (package): 55111-565-90 ndc (package): 55111-565-92 ndc (product): 55111-565 ndc11 (package): 55111056518 ndc11 (package): 55111056580 ndc11 (package): 55111056505 ndc11 (package): 55111056592 ndc11 (package): 55111056590 ndc11 (package): 55111056530 ndc11 (package): 55111056540 ndc11 (package): 55111056514 spl id: d2953b94-9244-2c86-ac0c-7610dd1e7963 spl set id: 42c06daf-541a-7721-b875-ea18364501a4

Reported adverse events (FAERS/openFDA)#

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