VALUMEDS EXTRA STRENGTH PAIN RELIEF

Product NDC: 68210-0130
Requested package NDC: 68210-0130-1
11-digit product format: 682100130
Labeler code: 68210
Product ID: 68210-0130_eea02438-3b59-2899-e053-2995a90a7bdf
Type: HUMAN OTC DRUG
Nonproprietary name: ACETAMINOPHEN
Dosage form: TABLET
Route: ORAL
Labeler: SPIRIT PHARMACEUTICALS LLC
Application: part343
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2017-05-15
Marketing end: 0000-00-00
Substance: ACETAMINOPHEN
Active strength: 500 mg/1
NDC exclude flag: No
Listing certified through: 2023-12-31
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	68210-0130	68210-0130-1	I	Inactivated by FDA		2026-10-05

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	68210-0130	68210-0130-1	E	Excluded after deficient or non-compliant submission was not corrected		excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68210-0130-1	VALUMEDS EXTRA STRENGTH PAIN RELIEF	100 in 1 BOTTLE	TABLET	100		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68210-0130	VALUMEDS EXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET [SPIRIT PHARMACEUTICALS LLC]	7	Legacy NDC, 1 package rows	20241212_72a8bc52-3864-4e3d-8659-eef2d959bdf9.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198440	acetaminophen 500 MG Oral Tablet	PSN	72a8bc52-3864-4e3d-8659-eef2d959bdf9	7
198440	acetaminophen 500 MG Oral Tablet	SCD	72a8bc52-3864-4e3d-8659-eef2d959bdf9	7
198440	APAP 500 MG Oral Tablet	SY	72a8bc52-3864-4e3d-8659-eef2d959bdf9	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68210-0130-1	68210013001	100 TABLET in 1 BOTTLE (68210-0130-1)	100 tablet	2017-05-15	0000-00-00	No	No	Current