Advil PM

Manufacturer: WYETH CONSUMER HEALTHCARE LLC | Exel Inc. dba DHL Supply Chain (USA)
Effective date: 2018-11-20
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: legacy-cache
Hydrated at: 2026-08-02 00:45:56

Label at a glance#

ProductAdvil PM

Active ingredientDIPHENHYDRAMINE CITRATE, IBUPROFEN

Label structure8 sections

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)

Label contents#

Full prescribing information#

(IN EACH CAPLET)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine citrate 38 mg

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

OTC - PURPOSE SECTION

Nighttime sleep-aid

Pain reliever

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

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

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)

INDICATIONS & USAGE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

50
Coated Caplets*
*Capsule-Shaped Tablets

PAA043838

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0573-0164-05	EA - Each	0573-0164	29ee0873-ce1d-488b-945e-8060bb4ccb4a	1	2012-07-24
0573-0164-08	EA - Each	0573-0164	61da8eca-12fa-4e21-ad47-a371b3e87f99	1	2022-06-06
0573-0164-12	EA - Each	0573-0164	17b84eac-a74d-4ffe-8ac8-3de75c13d8e0	1	2019-06-19
0573-0164-14	EA - Each	0573-0164	f1a6b8ef-c28d-4a6d-9a89-98d4e5372015	1	2019-06-19
0573-0164-20	EA - Each	0573-0164	e0975540-d483-4aa3-9a5f-a647f2986fcc	1	2012-07-24
0573-0164-30	EA - Each	0573-0164	da7bb72a-9d06-4eb0-b919-d87393627420	1	2012-07-24
0573-0164-40	EA - Each	0573-0164	ad944255-4b0d-4ec7-9f86-47f47e6b9d91	1	2012-07-24
0573-0164-43	EA - Each	0573-0164	40258c9f-9173-4c4c-95de-258d67f51a5f	1	2013-08-02
0573-0164-55	EA - Each	0573-0164	88938333-f8b2-4a98-8627-645de71706b2	1	2014-02-04

Products#

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

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

Advil PM
Diphenhydramine Citrate And Ibuprofen
CALCIUM STEARATE
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
CROSCARMELLOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
TITANIUM DIOXIDE
DIPHENHYDRAMINE CITRATE
DIPHENHYDRAMINE
CARNAUBA WAX
STARCH, CORN
FD&C BLUE NO. 2
GLYCERYL DIBEHENATE
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
ANHYDROUS LACTOSE
MICROCRYSTALLINE CELLULOSE
POLYDEXTROSE
SODIUM LAURYL SULFATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
IBUPROFEN
STEARIC ACID

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0573-0164	0573-0164-34

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CALCIUM STEARATE	776XM7047L	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
DIPHENHYDRAMINE CITRATE	4OD433S209	ACTIB
CARNAUBA WAX	R12CBM0EIZ	IACT
STARCH, CORN	O8232NY3SJ	IACT
FD&C BLUE NO. 2	L06K8R7DQK	IACT
GLYCERYL DIBEHENATE	R8WTH25YS2	IACT
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
POLYDEXTROSE	VH2XOU12IE	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
IBUPROFEN	WK2XYI10QM	ACTIB
STEARIC ACID	4ELV7Z65AP	IACT

Source Document#

Source XML

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ADVIL PM	DIPHENHYDRAMINE CITRATE AND IBUPROFEN	Haleon US Holdings LLC	658fc201-47c9-6a6d-8af9-6208298d43b4	2024-04-08	Warnings	Exact identifier ndc (product): 0573-0164
9223efcf-fbba-423a-8778-48a266aee684			7586892a-32c2-a43f-e053-2991aa0a4680	2021-01-18	Warnings	Exact identifier spl set id: 7586892a-32c2-a43f-e053-2991aa0a4680

Reported adverse events (FAERS/openFDA)#

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