ADVIL PM- diphenhydramine citrate and ibuprofen tablet, coated

Product NDC: 29485-6644
11-digit product format: 294856644
Labeler code: 29485
Product ID: 29485-6644_e41b69e1-b680-565d-e053-2a95a90aeee0
Type: HUMAN OTC DRUG
Nonproprietary name: Advil PM
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Mechanical Servants LLC
Application: NDA021394
Marketing category: NDA
Marketing start: 2010-03-11
Marketing end: 0000-00-00
Substance: DIPHENHYDRAMINE CITRATE; IBUPROFEN
Active strength: 38 mg/1; mg/1
Pharmacologic classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

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

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
29485-6644-2	ADVIL PM- diphenhydramine citrate and ibuprofen tablet, coated	1 in 1 BLISTER PACK	TABLET, COATED	1		5
29485-6644-2	ADVIL PM- diphenhydramine citrate and ibuprofen tablet, coated	2 in 1 POUCH	TABLET, COATED	2		5

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
29485-6644	ADVIL PM- DIPHENHYDRAMINE CITRATE AND IBUPROFEN TABLET, COATED (ADVIL PM) TABLET, COATED [LIL DRUG STORE PRODUCTS, INC]	5	Legacy NDC, 2 package rows	20250101_d1138e15-8ae4-7b49-e053-2995a90a9607.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4OD433S209	DIPHENHYDRAMINE CITRATE	88637-37-0	DIPHENHYDRAMINE CITRATE
WK2XYI10QM	IBUPROFEN	15687-27-1	IBUPROFEN

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
895664	ibuprofen 200 MG / diphenhydrAMINE citrate 38 MG Oral Tablet	PSN	d1138e15-8ae4-7b49-e053-2995a90a9607	5
895664	diphenhydramine citrate 38 MG / ibuprofen 200 MG Oral Tablet	SCD	d1138e15-8ae4-7b49-e053-2995a90a9607	5

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
29485-6644-2	29485664402	1 POUCH in 1 BLISTER PACK (29485-6644-2) > 2 TABLET, COATED in 1 POUCH	1 pouch	2010-03-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ADVIL PM- diphenhydramine citrate and ibuprofen tablet, coated	Lil Drug Store Products, Inc	2024-12-30	HUMAN OTC DRUG LABEL	5