Infants Pain and Fever

Product NDC: 49580-0621
11-digit product format: 495800621
Labeler code: 49580
Product ID: 49580-0621_5ae99a49-0863-4b18-84cd-bd2929e3ec3a
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: SUSPENSION
Route: ORAL
Labeler: P & L Development, LLC
Application: part343
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2018-01-31
Marketing end: 0000-00-00
Substance: ACETAMINOPHEN
Active strength: 160 mg/5mL
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	49580-0621		D	Discontinued by firm		2026-10-16
excluded package	package	49580-0621	49580-0621-2	D	Discontinued by firm		2026-10-16

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, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49580-0621-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49580-0621-2	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
49580-0621-2	2023-05-17	C162847	48780-1	f386c64a-2621-0266-e053-dadaa90a7c1a	Drug Facts
49580-0621-2	2023-01-30	C162847	48780-1	f386c64a-2621-0266-e053-dadaa90a7c1a	Drug Facts

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49580-0621	INFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [P & L DEVELOPMENT, LLC]	4	Legacy NDC	20240417_91510f2e-25ec-4fe2-8895-970ba603c7c5.zip

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
49580-0621-2	49580062102	1 BOTTLE, PLASTIC in 1 BOX (49580-0621-2) > 59 mL in 1 BOTTLE, PLASTIC	2018-01-31	0000-00-00	No	No	Current