Acetaminophen and Ibuprofen

Product NDC: 58602-893
11-digit product format: 586020893
Labeler code: 58602
Product ID: 58602-893_4c479545-4af0-49b7-8a62-632a97c5c637
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen and Ibuprofen
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aurohealth LLC
Application: ANDA218359
Marketing category: ANDA
Marketing start: 2024-03-26
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

Related Records

Related UNII Ingredients

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

Packages

Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
58602-893-01	58602089301	1 BOTTLE, PLASTIC in 1 CARTON (58602-893-01) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC		2024-03-26	No	No	Historical
58602-893-02	58602089302	1 BOTTLE in 1 CARTON (58602-893-02) / 144 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2024-12-17	No	No	Historical
58602-893-03	58602089303	1 BOTTLE in 1 CARTON (58602-893-03) / 10 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2024-03-26	No	No	Historical
58602-893-07	58602089307	1 BOTTLE in 1 CARTON (58602-893-07) / 24 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2024-03-26	No	No	Historical
58602-893-11	58602089311	1 BOTTLE in 1 CARTON (58602-893-11) / 36 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2024-03-26	No	No	Historical
58602-893-14	58602089314	1 BOTTLE in 1 CARTON (58602-893-14) / 50 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2024-03-26	No	No	Historical
58602-893-21	58602089321	1 BOTTLE in 1 CARTON (58602-893-21) / 100 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2024-03-26	No	No	Historical
58602-893-29	58602089329	1 BOTTLE in 1 CARTON (58602-893-29) / 150 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2024-03-26	No	No	Historical
58602-893-35	58602089335	225 TABLET, FILM COATED in 1 BOTTLE (58602-893-35)		2024-03-26	No	No	Historical
58602-893-40	58602089340	500 TABLET, FILM COATED in 1 BOTTLE (58602-893-40)		2024-03-26	No	No	Historical
58602-893-41	58602089341	1000 TABLET, FILM COATED in 1 BOTTLE (58602-893-41)		2024-03-26	No	No	Historical
58602-893-44	58602089344	400 TABLET, FILM COATED in 1 BOTTLE (58602-893-44)		2024-03-26	No	No	Historical
58602-893-46	58602089346	1 BOTTLE, PLASTIC in 1 CARTON (58602-893-46) / 18 TABLET, FILM COATED in 1 BOTTLE, PLASTIC		2024-03-26	No	No	Historical
58602-893-49	58602089349	1 BOTTLE, PLASTIC in 1 CARTON (58602-893-49) / 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC		2024-03-26	No	No	Historical
58602-893-51	58602089351	216 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (58602-893-51)		2024-03-26	No	No	Historical
58602-893-61	58602089361	1 BLISTER PACK in 1 CARTON (58602-893-61) / 2 TABLET, FILM COATED in 1 BLISTER PACK	1 blister pack	2024-03-26	No	No	Historical
58602-893-62	58602089362	216 TABLET, FILM COATED in 1 BOTTLE (58602-893-62)		2024-03-26	No	No	Historical
58602-893-65	58602089365	1 BOTTLE in 1 CARTON (58602-893-65) / 72 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2024-03-26	No	No	Historical
58602-893-73	58602089373	1 BOTTLE in 1 CARTON (58602-893-73) / 20 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2024-03-26	No	No	Historical
58602-893-78	58602089378	1 BOTTLE, PLASTIC in 1 CARTON (58602-893-78) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC		2024-03-26	No	No	Historical
58602-893-79	58602089379	500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (58602-893-79)		2024-03-26	No	No	Historical
58602-893-80	58602089380	1 BOTTLE, PLASTIC in 1 CARTON (58602-893-80) / 72 TABLET, FILM COATED in 1 BOTTLE, PLASTIC		2024-03-26	No	No	Historical
58602-893-82	58602089382	1 BOTTLE in 1 CARTON (58602-893-82) / 18 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2024-03-26	No	No	Historical
58602-893-84	58602089384	225 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (58602-893-84)		2024-03-26	No	No	Historical
58602-893-85	58602089385	1 BOTTLE, PLASTIC in 1 CARTON (58602-893-85) / 36 TABLET, FILM COATED in 1 BOTTLE, PLASTIC		2024-03-26	No	No	Historical
58602-893-88	58602089388	750 TABLET, FILM COATED in 1 BOTTLE (58602-893-88)		2024-03-26	No	No	Historical
58602-893-94	58602089394	1 BOTTLE, PLASTIC in 1 CARTON (58602-893-94) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC		2024-03-26	No	No	Historical
58602-893-95	58602089395	750 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (58602-893-95)		2024-03-26	No	No	Historical
58602-893-96	58602089396	1 BOTTLE, PLASTIC in 1 CARTON (58602-893-96) / 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC		2024-03-26	No	No	Historical
58602-893-99	58602089399	400 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (58602-893-99)		2024-03-26	No	No	Historical

Related DailyMed Labels

Title	Manufacturer	Effective date	Type	Version
Acetaminophen and Ibuprofen - Aurohealth LLC \| APL HEALTHCARE LIMITED	Aurohealth LLC \| APL HEALTHCARE LIMITED	2025-07-03	Human OTC Drug Label	3