Advil PM, CVP HEALTH

Manufacturer: Lil' Drug Store Products, Inc.
Effective date: 2024-11-27
Label type: HUMAN OTC DRUG LABEL
Version: 12
Source: full-release
Hydrated at: 2026-06-01 00:44:18

Label at a glance#

ProductAdvil PM

Active ingredientIBUPROFEN, DIPHENHYDRAMINE CITRATE

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

Storage and handling

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)

Contacts and useful links#

PhoneLabel contact1-800-88-ADVIL

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each caplet)	Purposes
Diphenhydramine citrate 38 mg	Nighttime sleep-aid
Ibuprofen 200 mg (NSAID) ^*	Pain reliever

* nonsteroidal anti-inflammatory drug

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Other information

STORAGE AND HANDLING 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

calcium stearate, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C blue no. 2 aluminum lake, glyceryl behenate, hypromellose, lactose monohydrate, microcrystalline cellulose, pharmaceutical ink, polydextrose, polyethylene glycol, pregelatinized starch, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

Call weekdays 9 AM to 5 PM EST at 1-800-88-ADVIL

SPL UNCLASSIFIED SECTION

Repackaged and distributed with permission of Pfizer Consumer Healthcare by:
Lil' Drug Store Products, Inc., 1201 Continental Place NE, Cedar Rapids, IA 52402

Advil PM, 6ct, Lil' Drug Store ® - PDP/Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Advil ^® PM

Ibuprofen, 200 mg/
Diphenhydramine citrate, 38 mg
Pain Reliever (NSAID)/
Nighttime Sleep-Aid

[caplet image]

6
Coated Caplets*

*Capsule-Shaped Tablets

[ Lil' Drug Store ^® logo]

PDP/Package

Advil PM, 4ct TRAVEL BASIX - PDP/Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Advil PM

Ibuprofen, 200 mg/

Diphenhydramine Citrate, 38 mg

Pain Reliever (NSAID)/

Nighttime Sleep-Aid

[caplet image]

Coated Caplets*

*Capsule-Shaped Tablets

[TRAVEL BASIX logo]

PDP/Package

Advil PM 4ct, CVP ® HEALTH - PDP/Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDP/PackageAdvil PM

Ibuprofen, 200 mg/

Diphenhydramine Citrate, 38 mg

Pain Reliever (NSAID)/

Nighttime Sleep-Aid

[caplet image]

Coated Caplets*

*Capsule-Shaped Tablets

[CVP® HEALTH logo]

AdvilPM 30pc Dispens-It Box, Lil' Drug Store ®

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AdvilPM

Ibuprofen, 200 mg/
Diphenhydramine citrate, 38 mg
Pain Reliever (NSAID)/
Nighttime Sleep-Aid

[caplet image]

For relief of occasional

sleeplessness when

associated with minor aches and pains

Helps you fall asleep

and stay asleep

See full Drug Facts information

on the back of this dispenser

30 PACKETS OF 2 COATED CAPLETS EACH*
*Capsule-Shaped Tablets

[Lil' Drug Store® logo]

PDP/Package

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	12
895664	diphenhydramine citrate 38 MG / ibuprofen 200 MG Oral Tablet	SCD	12

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
66715-6433-2	2024-01-30	C162847	48780-1	1030e365-636a-111a-e063-dadaa90a10e2	Advil ® PM Lil' Drug Store ® , TRAVEL BASIX, CVP ® HEALTH
66715-6533-2	2024-01-30	C162847	48780-1	1030e365-636a-111a-e063-dadaa90a10e2	Advil ® PM Lil' Drug Store ® , TRAVEL BASIX, CVP ® HEALTH
66715-9733-2	2024-01-30	C162847	48780-1	1030e365-636a-111a-e063-dadaa90a10e2	Advil ® PM Lil' Drug Store ® , TRAVEL BASIX, CVP ® HEALTH
66715-9733-3	2024-01-30	C162847	48780-1	1030e365-636a-111a-e063-dadaa90a10e2	Advil ® PM Lil' Drug Store ® , TRAVEL BASIX, CVP ® HEALTH
66715-9733-8	2024-01-30	C162847	48780-1	1030e365-636a-111a-e063-dadaa90a10e2	Advil ® PM Lil' Drug Store ® , TRAVEL BASIX, CVP ® HEALTH

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
66715-6433-2	Advil PM, TRAVEL BASIX	2 in 1 POUCH	TABLET, COATED	2	12
66715-6433-2	Advil PM, TRAVEL BASIX	2 in 1 CARTON	TABLET, COATED	2	12
66715-6533-2	Advil PM, CVP HEALTH	2 in 1 POUCH	TABLET, COATED	2	12
66715-6533-2	Advil PM, CVP HEALTH	2 in 1 CARTON	TABLET, COATED	2	12
66715-9633-3	Advil PM	30 in 1 BOX, UNIT-DOSE	TABLET, COATED	30	12
66715-9633-3	Advil PM	2 in 1 POUCH	TABLET, COATED	2	12
66715-9733-2	Advil PM	2 in 1 CARTON	TABLET, COATED	2	12
66715-9733-2	Advil PM	2 in 1 POUCH	TABLET, COATED	2	12
66715-9733-3	Advil PM	3 in 1 CARTON	TABLET, COATED	3	12
66715-9733-3	Advil PM	2 in 1 POUCH	TABLET, COATED	2	12
66715-9733-8	Advil PM	2 in 1 POUCH	TABLET, COATED	2	12
66715-9733-8	Advil PM	5 in 1 CARTON	TABLET, COATED	5	12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66715-6433	ADVIL PM (IBUPROFEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED ADVIL PM, TRAVEL BASIX (IBUPROFEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED ADVIL PM, CVP HEALTH (IBUPROFEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]	12	Current NDC, 2 package rows	20241219_b876bb40-a38b-445a-bc8a-466b3bfe166d.zip
66715-6533	ADVIL PM (IBUPROFEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED ADVIL PM, TRAVEL BASIX (IBUPROFEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED ADVIL PM, CVP HEALTH (IBUPROFEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]	12	Current NDC, 2 package rows	20241219_b876bb40-a38b-445a-bc8a-466b3bfe166d.zip
66715-9633	ADVIL PM (IBUPROFEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED ADVIL PM, TRAVEL BASIX (IBUPROFEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED ADVIL PM, CVP HEALTH (IBUPROFEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]	12	Current NDC, 2 package rows	20241219_b876bb40-a38b-445a-bc8a-466b3bfe166d.zip
66715-9733	ADVIL PM (IBUPROFEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED ADVIL PM, TRAVEL BASIX (IBUPROFEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED ADVIL PM, CVP HEALTH (IBUPROFEN AND DIPHENHYDRAMINE CITRATE) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]	12	Current NDC, Legacy NDC, 6 package rows	20241219_b876bb40-a38b-445a-bc8a-466b3bfe166d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Diphenhydramine citrate	ACTIVE INGREDIENT	4OD433S209	2
Ibuprofen	ACTIVE INGREDIENT	WK2XYI10QM	2
Diphenhydramine	ACTIVE MOIETY	8GTS82S83M	2
Ibuprofen	ACTIVE MOIETY	WK2XYI10QM	2
aluminum oxide	INACTIVE INGREDIENT	LMI26O6933	2
calcium stearate	INACTIVE INGREDIENT	776XM7047L	2
carnauba wax	INACTIVE INGREDIENT	R12CBM0EIZ	2
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	2
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	2
FD&C blue no. 2	INACTIVE INGREDIENT	L06K8R7DQK	2
glyceryl dibehenate	INACTIVE INGREDIENT	R8WTH25YS2	2
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	2
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	2
polydextrose	INACTIVE INGREDIENT	VH2XOU12IE	2
polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	2
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	2
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	2
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	2
stearic acid	INACTIVE INGREDIENT	4ELV7Z65AP	2
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	2

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

Advil PM
Ibuprofen and Diphenhydramine citrate
CALCIUM STEARATE
CARNAUBA WAX
SILICON DIOXIDE
STARCH, CORN
CROSCARMELLOSE SODIUM
FD&C BLUE NO. 2
ALUMINUM OXIDE
GLYCERYL DIBEHENATE
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MICROCRYSTALLINE CELLULOSE
POLYDEXTROSE
POLYETHYLENE GLYCOL, UNSPECIFIED
SODIUM LAURYL SULFATE
STEARIC ACID
TITANIUM DIOXIDE
IBUPROFEN
DIPHENHYDRAMINE CITRATE
DIPHENHYDRAMINE
Advil PM, TRAVEL BASIX
Advil PM, CVP HEALTH

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
66715-9633	66715-9633-3
66715-9733	66715-9733-2, 66715-9733-8, 66715-9733-3
66715-6433	66715-6433-2
66715-6533	66715-6533-2

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 72 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CALCIUM STEARATE	776XM7047L	IACT
CARNAUBA WAX	R12CBM0EIZ	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
STARCH, CORN	O8232NY3SJ	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
FD&C BLUE NO. 2	L06K8R7DQK	IACT
ALUMINUM OXIDE	LMI26O6933	IACT
GLYCERYL DIBEHENATE	R8WTH25YS2	IACT
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
POLYDEXTROSE	VH2XOU12IE	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
STEARIC ACID	4ELV7Z65AP	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
IBUPROFEN	WK2XYI10QM	ACTIB
DIPHENHYDRAMINE CITRATE	4OD433S209	ACTIB
CALCIUM STEARATE	776XM7047L	IACT
CARNAUBA WAX	R12CBM0EIZ	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
STARCH, CORN	O8232NY3SJ	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
FD&C BLUE NO. 2	L06K8R7DQK	IACT
ALUMINUM OXIDE	LMI26O6933	IACT
GLYCERYL DIBEHENATE	R8WTH25YS2	IACT
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
POLYDEXTROSE	VH2XOU12IE	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
STEARIC ACID	4ELV7Z65AP	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
IBUPROFEN	WK2XYI10QM	ACTIB
DIPHENHYDRAMINE CITRATE	4OD433S209	ACTIB
CARNAUBA WAX	R12CBM0EIZ	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
STARCH, CORN	O8232NY3SJ	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	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 · 170 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
lactose monohydrate	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET, COATED / ORAL		1301 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
aluminum oxide	ALUMINUM OXIDE	LMI26O6933	TABLET / ORAL	NA		Exact identifier — unii+route 10 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, COATED / ORAL		58 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
FD&C blue no. 2	FD&C BLUE NO. 2	L06K8R7DQK	TABLET, COATED / ORAL	24.12 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
FD&C blue no. 2	FD&C BLUE NO. 2	L06K8R7DQK	TABLET, COATED / ORAL	24.12 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
lactose monohydrate	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET, COATED / ORAL		1301 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
polydextrose	POLYDEXTROSE	VH2XOU12IE	TABLET, EXTENDED RELEASE / ORAL		22 mg	Exact identifier — unii+route 30 equally ranked IID candidates
polydextrose	POLYDEXTROSE	VH2XOU12IE	TABLET, FILM COATED / ORAL		18 mg	Exact identifier — unii+route 30 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, COATED / ORAL		920 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
glyceryl dibehenate	GLYCERYL DIBEHENATE	R8WTH25YS2	TABLET, COATED / ORAL		19 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, COATED / ORAL		58 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
polydextrose	POLYDEXTROSE	VH2XOU12IE	TABLET, EXTENDED RELEASE / ORAL		22 mg	Exact identifier — unii+route 30 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	TABLET, COATED / ORAL	42.4 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
calcium stearate	CALCIUM STEARATE	776XM7047L	TABLET, COATED / ORAL	12.2 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
carnauba wax	CARNAUBA WAX	R12CBM0EIZ	TABLET, COATED / ORAL	207.5 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	TABLET, COATED / ORAL	42.4 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, COATED / ORAL		920 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, COATED / ORAL		176 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
carnauba wax	CARNAUBA WAX	R12CBM0EIZ	TABLET, COATED / ORAL	207.5 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	TABLET, COATED / ORAL	42.4 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
polydextrose	POLYDEXTROSE	VH2XOU12IE	TABLET, FILM COATED / ORAL		18 mg	Exact identifier — unii+route 30 equally ranked IID candidates
starch, corn	STARCH, CORN	O8232NY3SJ	TABLET, COATED / ORAL		256 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	TABLET, COATED / ORAL		123 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, COATED / ORAL		58 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, COATED / ORAL		49 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
calcium stearate	CALCIUM STEARATE	776XM7047L	TABLET, COATED / ORAL	12.2 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, COATED / ORAL		920 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, COATED / ORAL		920 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
aluminum oxide	ALUMINUM OXIDE	LMI26O6933	TABLET / ORAL	NA		Exact identifier — unii+route 10 equally ranked IID candidates
polydextrose	POLYDEXTROSE	VH2XOU12IE	TABLET / ORAL		20 mg	Exact identifier — unii+route 30 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, COATED / ORAL		49 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
FD&C blue no. 2	FD&C BLUE NO. 2	L06K8R7DQK	TABLET, COATED / ORAL	24.12 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
polydextrose	POLYDEXTROSE	VH2XOU12IE	TABLET, FILM COATED / ORAL		18 mg	Exact identifier — unii+route 30 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, COATED / ORAL		176 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
calcium stearate	CALCIUM STEARATE	776XM7047L	TABLET, COATED / ORAL	12.2 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
polydextrose	POLYDEXTROSE	VH2XOU12IE	TABLET, EXTENDED RELEASE / ORAL		22 mg	Exact identifier — unii+route 30 equally ranked IID candidates
lactose monohydrate	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET, COATED / ORAL		1301 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
FD&C blue no. 2	FD&C BLUE NO. 2	L06K8R7DQK	TABLET, COATED / ORAL	24.12 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
polydextrose	POLYDEXTROSE	VH2XOU12IE	TABLET / ORAL		20 mg	Exact identifier — unii+route 30 equally ranked IID candidates
carnauba wax	CARNAUBA WAX	R12CBM0EIZ	TABLET, COATED / ORAL	207.5 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
polydextrose	POLYDEXTROSE	VH2XOU12IE	TABLET / ORAL		20 mg	Exact identifier — unii+route 30 equally ranked IID candidates
aluminum oxide	ALUMINUM OXIDE	LMI26O6933	TABLET / ORAL	NA		Exact identifier — unii+route 10 equally ranked IID candidates
FD&C blue no. 2	FD&C BLUE NO. 2	L06K8R7DQK	TABLET, COATED / ORAL	24.12 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, COATED / ORAL		58 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
calcium stearate	CALCIUM STEARATE	776XM7047L	TABLET, COATED / ORAL	12.2 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
polydextrose	POLYDEXTROSE	VH2XOU12IE	TABLET, EXTENDED RELEASE / ORAL		22 mg	Exact identifier — unii+route 30 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, COATED / ORAL		176 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
croscarmellose sodium	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, COATED / ORAL		224 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
glyceryl dibehenate	GLYCERYL DIBEHENATE	R8WTH25YS2	TABLET, COATED / ORAL		19 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
lactose monohydrate	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET, COATED / ORAL		1301 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, COATED / ORAL		49 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
glyceryl dibehenate	GLYCERYL DIBEHENATE	R8WTH25YS2	TABLET, COATED / ORAL		19 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, COATED / ORAL		176 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
glyceryl dibehenate	GLYCERYL DIBEHENATE	R8WTH25YS2	TABLET, COATED / ORAL		19 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
calcium stearate	CALCIUM STEARATE	776XM7047L	TABLET, COATED / ORAL	12.2 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	TABLET, COATED / ORAL		123 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
polydextrose	POLYDEXTROSE	VH2XOU12IE	TABLET / ORAL		20 mg	Exact identifier — unii+route 30 equally ranked IID candidates
sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	TABLET, COATED / ORAL		123 mg	Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
carnauba wax	CARNAUBA WAX	R12CBM0EIZ	TABLET, COATED / ORAL	207.5 mg		Exact identifier — unii+route+dosage form 10 equally ranked IID candidates
polydextrose	POLYDEXTROSE	VH2XOU12IE	TABLET, FILM COATED / ORAL		18 mg	Exact identifier — unii+route 30 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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021394-001	ADVIL PM	DIPHENHYDRAMINE CITRATE; IBUPROFEN	38MG;200MG	TABLET / ORAL		RLD, RS	2005-12-21

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021394-001	ADVIL PM	38MG;200MG	TABLET / ORAL	RLD, RS	2005-12-21	`f41ea6bd6efb…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021394-001	8263647	2022-05-30	Drug product	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021394-001	8263647	2022-05-30	Drug product	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021394-001	8263647	2022-05-30	Drug product	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021394-001	8263647	2022-05-30	Drug product	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021394-001	8263647	2022-05-30	Drug product	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021394-001	8263647	2022-05-30	Drug product	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021394-001	8263647	2022-05-30	Drug product	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021394-001	8263647	2022-05-30	Drug product	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021394-001	8263647	2022-05-30	Drug product	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021394-001	8263647	2022-05-30	Drug product	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021394-001	8263647	2022-05-30	Drug product	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021394-001	8263647	2022-05-30	Drug product	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021394-001	8263647	2022-05-30	Drug product	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N021394-001	8263647	2022-05-30	Drug product	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021394-001	8263647	2022-05-30	Drug product	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021394-001	8263647	2022-05-30	Drug product	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021394-001	8263647	2022-05-30	Drug product	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021394-001	8263647	2022-05-30	Drug product	`cb3db0bc1861…`

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
Advil PM, TRAVEL BASIX	IBUPROFEN AND DIPHENHYDRAMINE CITRATE	Lil' Drug Store Products, Inc.	b876bb40-a38b-445a-bc8a-466b3bfe166d	2024-11-27	Warnings	Exact identifier ndc (package): 66715-9733-8 ndc (package): 66715-9633-3 ndc (package): 66715-6433-2 ndc (package): 66715-9733-2 ndc (package): 66715-9733-3 ndc (package): 66715-6533-2 ndc (product): 66715-6533 ndc (product): 66715-9633 ndc (product): 66715-9733 ndc (product): 66715-6433 ndc11 (package): 66715653302 ndc11 (package): 66715973303 ndc11 (package): 66715973302 ndc11 (package): 66715973308 ndc11 (package): 66715963303 ndc11 (package): 66715643302 spl id: 27e68e85-e284-30b9-e063-6394a90aba9b spl set id: b876bb40-a38b-445a-bc8a-466b3bfe166d

Reported adverse events (FAERS/openFDA)#

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