Headache Relief

Product NDC: 55319-625
Requested package NDC: 55319-625-10
11-digit product format: 553190625
Labeler code: 55319
Product ID: 55319-625_7b90a600-edc6-4772-ae2b-c9db60989a34
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Aspirin, Caffeine
Dosage form: TABLET
Route: ORAL
Labeler: Family Dollar (FAMILY WELLNESS)
Application: part343
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2016-08-31
Marketing end: 0000-00-00
Substance: ACETAMINOPHEN; ASPIRIN; CAFFEINE
Active strength: 250 mg/1; mg/1; mg/1
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	55319-625	55319-625-10	D	Discontinued by firm		2026-10-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2022-08-30 03:57 UTC · source 2022-08-29	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55319-625-10	2023-01-23	C162847	48780-1	d6a99b39-ec31-a426-e053-dadaa90af4c2	Drug Facts
55319-625-10	2022-01-28	C162847	48780-1	d6a99b39-ec31-a426-e053-dadaa90af4c2	Drug Facts

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55319-625	HEADACHE RELIEF EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET [FAMILY DOLLAR (FAMILY WELLNESS)]	6	Legacy NDC	20240328_533eba29-c03c-498b-906f-37f638049029.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
R16CO5Y76E	ASPIRIN	50-78-2	ASPIRIN
3G6A5W338E	CAFFEINE	58-08-2	CAFFEINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
55319-625-10	55319062510	1 BOTTLE, PLASTIC in 1 BOX (55319-625-10) > 100 TABLET in 1 BOTTLE, PLASTIC	2016-08-31	0000-00-00	No	No	Current