Acetaminophen 250 mg and Ibuprofen 125 mg

Product NDC: 70264-040
11-digit product format: 702640040
Labeler code: 70264
Product ID: 70264-040_43c8f4e2-0cd4-448f-e063-6394a90a3a88
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen 250 mg and Ibuprofen 125 mg
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: R J General Corporation
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-10-30
Substance: ACETAMINOPHEN; IBUPROFEN
Active strength: 250; 125 mg/1; mg/1
Pharmacologic classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Acetaminophen 250 mg and Ibuprofen 125 mg
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	250 mg/1
IBUPROFEN	125 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
362O9ITL9D	Internal UNII lookup
WK2XYI10QM	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2387532	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
68d3be55-9340-4cc9-a05a-12b9338ddc56	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1e73f975-1ce7-705e-2bcf-788b1b5e24ba	Product name	5	20251124
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
61c18d4e-b552-5478-8fc0-df38b93e3100	Product name	1	20140508
7b2938c9-7eb7-e312-ae90-f54f4240361e	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	Strength	SPL version
70264-040-12	Acetaminophen 250 mg and Ibuprofen 125 mg	50 in 1 CARTON	TABLET, FILM COATED	50		2
70264-040-12	Acetaminophen 250 mg and Ibuprofen 125 mg	2 in 1 POUCH	TABLET, FILM COATED	2		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70264-040	ACETAMINOPHEN 250 MG AND IBUPROFEN 125 MG TABLET, FILM COATED [R J GENERAL CORPORATION]	1	Current NDC, 2 package rows	20241116_68d3be55-9340-4cc9-a05a-12b9338ddc56.zip

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 61 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Chewable Aspirin	ASPIRIN	RETAIL BUSINESS SERVICES , LLC.	c94d68ea-7f25-881f-e053-2995a90aa47f	2024-10-15	Warnings	Exact identifier application number: M013
LOW DOSE ASPIRIN	ASPIRIN	RETAIL BUSINESS SERVICES , LLC.	c94d750e-5a85-77f5-e053-2995a90a6915	2024-10-15	Warnings	Exact identifier application number: M013
Infants Pain and Fever	ACETAMINOPHEN	Walgreen Company	9e08eb38-7538-4fa0-a0e1-047ab6cb1680	2024-10-15	Warnings	Exact identifier application number: M013
pain relief	ACETAMINOPHEN	PUBLIX SUPER MARKETS INC	9e779cc6-4641-6132-e053-2a95a90a3493	2024-10-11	Warnings	Exact identifier application number: M013
Pain Reliever	ACETAMINOPHEN	CHAIN DRUG CONSORTIUM	5c1a3081-ae25-4895-bf76-ebcbb9fc8072	2024-10-11	Warnings	Exact identifier application number: M013
Aspirin 81 MG	ASPIRIN	Meijer	b3e5711c-9529-4eec-871d-de8efa858b86	2024-10-11	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	MEIJER DISTRIBUTION INC	9586e830-a285-4a07-8b34-969875442348	2024-10-11	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN	Chain Drug Marketing Association	68a52858-35c5-402a-8ceb-8d8a7c1e5f6c	2024-10-11	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN	Chain Drug Marketing Association	5de40821-3218-4320-bf11-9493bf01d489	2024-10-11	Warnings	Exact identifier application number: M013
Pain Relief PM Extra Strength	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	Chain Drug Marketing Association	475becec-1a56-4cfa-a0c5-562f8772adfb	2024-10-11	Warnings	Exact identifier application number: M013
Topcare Pain Relief	ACETAMINOPHEN	Topco Associates LLC	6036c15b-1168-4103-9471-6a74a2140e53	2024-10-10	Warnings	Exact identifier application number: M013
Childrens Acetaminophen	ACETAMINOPHEN	PAI Holdings, LLC dba PAI Pharma	46d9d8cd-e3db-492c-9386-7e8255beff64	2024-10-08	Warnings	Exact identifier application number: M013
dg health aspirin	ASPIRIN	Dolgencorp, LLC	0ab34dc7-0110-4fc3-ae53-234e7d7bca3c	2024-10-07	Warnings	Exact identifier application number: M013
ValuMeds Pain Relief PM Pain Reliever and Nighttime Sleep Aid Acetaminophen, Extra Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE	Cabinet Health P.B.C.	19ba1fb6-22ea-488e-9e52-94c14ceb80d1	2024-10-07	Warnings	Exact identifier application number: M013
foster and thrive aspirin	ASPIRIN	Strategic Sourcing Services LLC	4d66a8a8-a1c1-4430-8845-21ae67700c39	2024-10-07	Warnings	Exact identifier application number: M013
leader aspirin	ASPIRIN	Cardinal Health 110, LLC. dba Leader	ca603b12-e0f7-4d79-8e0d-4651a788ba9b	2024-10-07	Warnings	Exact identifier application number: M013
foster and thrive aspirin	ASPIRIN	McKesson Medical-Surgical, Inc.	e9342478-93d6-45de-948f-f4162ee675b2	2024-10-07	Warnings	Exact identifier application number: M013
Maximum Strength Backache Relief	MAGNESIUM SALICYLATE	JHK DBA American Safety & First Aid	f8cbcd4e-cfad-4592-8774-52e681494c45	2024-10-07	Warnings	Exact identifier application number: M013
Alka-Seltzer Original Flavor	ALKA-SELTZER ORIGINAL FLAVOR	Navajo Manufacturing Company Inc.	f70875ab-241c-4876-e053-6294a90a8092	2024-10-03	Warnings	Exact identifier application number: M013
Tylenol Extra Strength	ACETAMINOPHEN	Navajo Manufacturing Company Inc.	86b6ac01-3866-4cd8-a1be-9babb6ff311b	2024-10-02	Warnings	Exact identifier application number: M013

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
WK2XYI10QM	IBUPROFEN	15687-27-1	IBUPROFEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2387532	acetaminophen 250 MG / ibuprofen 125 MG Oral Tablet	PSN	68d3be55-9340-4cc9-a05a-12b9338ddc56	2
2387532	acetaminophen 250 MG / ibuprofen 125 MG Oral Tablet	SCD	68d3be55-9340-4cc9-a05a-12b9338ddc56	2
2387532	APAP 250 MG / ibuprofen 125 MG Oral Tablet	SY	68d3be55-9340-4cc9-a05a-12b9338ddc56	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70264-040-12	70264004012	50 POUCH in 1 CARTON (70264-040-12) / 2 TABLET, FILM COATED in 1 POUCH	50 pouch	2024-10-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Advil Dual Action with Acetaminophen Acetaminophen 250 mg and Ibuprofen (NSAID) 125 mg Tablets Pain Reliever	R J General Corporation	2025-11-17	HUMAN OTC DRUG LABEL	2