NDC 68084-710-11 - Oxycodone and Acetaminophen

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 68084-710
Requested NDC: 68084-710-11
Package NDCs from labels: 68084-710-11, 68084-710-01
Manufacturer: American Health Packaging
Effective date: 2024-07-11
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Oxycodone and Acetaminophen - American Health Packaging	American Health Packaging	2024-07-11	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68084-710-01	Oxycodone and Acetaminophen	100 in 1 BOX, UNIT-DOSE	TABLET	100		8
68084-710-11	Oxycodone and Acetaminophen	1 in 1 BLISTER PACK	TABLET	1		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68084-710	OXYCODONE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]	8	Current NDC, Legacy NDC, 2 package rows	20240713_03c9ff0d-46e8-448c-944a-7ad59d1afd6d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68084-710-01	EA - Each	68084-710	7daaf6ea-55f1-4da3-a7a2-803a3f42d399	1	2014-08-01
68084-710-11	EA - Each	68084-710	f911a0ad-37bf-414e-9ff4-9db1fd8d9003	1	2014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	OXYCODONE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]	1
OXYCODONE HYDROCHLORIDE	ACTIVE INGREDIENT	C1ENJ2TE6C	OXYCODONE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	OXYCODONE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]	1
OXYCODONE	ACTIVE MOIETY	CD35PMG570	OXYCODONE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	OXYCODONE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	OXYCODONE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	OXYCODONE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	OXYCODONE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	OXYCODONE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	OXYCODONE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	OXYCODONE AND ACETAMINOPHEN TABLET [AMERICAN HEALTH PACKAGING]	1

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 108 of 158 · 3,158 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Severe Sinus Congestion Allergy and Cough Formula	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	PuraCap Pharmaceutical LLC	36a4ec1f-50c3-4d61-ada9-987ccad3563c	2024-11-26	Warnings	Exact identifier unii: 362O9ITL9D
First Aid Only Extra-Strength Non-Aspirin	ACETAMINOPHEN	Acme United Corporation	6891d57a-10a6-53de-e053-2a91aa0ac7c2	2024-11-26	Warnings	Exact identifier unii: 362O9ITL9D
BRONCOCHEM COLD AND FLU CAPLETS	ACETAMINOPHEN-DEXTROMETHORPHAN HBR-PHENYLEPHRINE HCL-CHLORPHENIRAMINE MALEATE	LABORATORIO MAGNACHEM INTERNATIONAL SRL	ac4f6a39-e455-4d33-8bb8-ae8dc6ebc2f6	2024-11-26	Warnings	Exact identifier unii: 362O9ITL9D
Alka-Seltzer Plus Cold and Flu, CVP	CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE TABLET	Lil' Drug Store Products, Inc.	e7a27773-69d6-9e07-e053-2a95a90af8ea	2024-11-25	Warnings	Exact identifier unii: 362O9ITL9D
ACETAMINOPHEN (RED)	ACETAMINOPHEN	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	06eabf4b-f8c0-439a-acf1-aa6e3075c717	2024-11-25	Warnings	Exact identifier unii: 362O9ITL9D
ACETAMINOPHEN (RED)	ACETAMINOPHEN	Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd	a352f588-4a70-42b2-8f9c-a73a0629517d	2024-11-25	Warnings	Exact identifier unii: 362O9ITL9D
DayTime Sinus Relief	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	4361912e-4b56-4743-b11d-acfb94482a2e	2024-11-25	Warnings	Exact identifier unii: 362O9ITL9D
NightTime Sinus Relief	ACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	413d82d3-a896-4f15-9fca-c1b7b9a1ee63	2024-11-25	Warnings	Exact identifier unii: 362O9ITL9D
Pain Relief Extra Strength	ACETAMINOPHEN	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	5c42dd28-820c-4cc5-9016-11ad5e580616	2024-11-25	Warnings	Exact identifier unii: 362O9ITL9D
Night Cold Flu Cough and Allergy	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	590f4f0d-c8b0-412d-be1e-3eb2ccb29ac0	2024-11-25	Warnings	Exact identifier unii: 362O9ITL9D
Daytime Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	cbd3a905-1c41-4cb0-8df6-36784430d627	2024-11-25	Warnings	Exact identifier unii: 362O9ITL9D
Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	7a28d0fe-0e0a-453a-b604-1cc784dd153c	2024-11-25	Warnings	Exact identifier unii: 362O9ITL9D
Cough and Cold plus	ACETAMINOPHEN, PHENYLEPHRINE HCL, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd	c483d88f-cb0a-4dd6-b3ae-559521782ba6	2024-11-25	Warnings	Exact identifier unii: 362O9ITL9D
DayTime Sinus	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE	Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.	a0b01aef-4248-4d41-862c-0c8884dfca5e	2024-11-25	Warnings	Exact identifier unii: 362O9ITL9D
DayTime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	3af20739-6794-42e0-b404-3f0401d10a6d	2024-11-25	Warnings	Exact identifier unii: 362O9ITL9D
NightTime Sinus	ACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.	0f3b1404-9252-470a-aa8c-b360c85731f3	2024-11-25	Warnings	Exact identifier unii: 362O9ITL9D
ASP Daytime PE	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	b84f2392-0b24-4af0-80f7-c45454093f51	2024-11-25	Warnings	Exact identifier unii: 362O9ITL9D
ASP Nighttime Max	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	d8756d1f-baf5-412d-a493-a1c051eae302	2024-11-25	Warnings	Exact identifier unii: 362O9ITL9D
COMBOGESIC IV	ACETAMINOPHEN AND IBUPROFEN INJECTION	Hikma Pharmaceuticals USA Inc.	be408a5a-48e4-43c0-9cb1-bbf830b54f5b	2024-11-25	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 362O9ITL9D
Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	a01abac3-c13e-40f2-ae98-34bd6c9b7504	2024-11-21	Warnings	Exact identifier unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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