FDA.reportPublic FDA data

childrens acetaminophen

Product NDC
71205-406
11-digit product format
712050406
Labeler code
71205
Product ID
71205-406_6ed1bf37-7a09-4b1e-8190-043bacf12429
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Proficient Rx LP
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-04-09
Marketing end
0000-00-00
Substance
ACETAMINOPHEN
Active strength
160 mg/5mL
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct71205-406DDiscontinued by firm2026-10-12
excluded packagepackage71205-40671205-406-04DDiscontinued by firm2026-10-12

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-406-04ML - Milliliter71205-4062a6500d5-29d2-4a5f-b776-76f3e4eabea512020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-406CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PROFICIENT RX LP]4Legacy NDC20240223_35ec3a0e-0776-4d04-935f-96ad4fbb6d3a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-406-04712050406041 BOTTLE in 1 CARTON (71205-406-04) > 118 mL in 1 BOTTLE1 bottle2020-02-190000-00-00NoNoCurrent