FDA.reportPublic FDA data

Childrens Pain Relief

Product NDC
49580-0288
11-digit product format
495800288
Labeler code
49580
Product ID
49580-0288_48130f80-89fd-464f-a849-252060ceb5a1
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
2014-11-30
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct49580-0288DDiscontinued by firm2026-10-05
excluded packagepackage49580-028849580-0288-4DDiscontinued by firm2026-10-05

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct49580-0288DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage49580-028849580-0288-4DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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
NDCEffectiveActionDocumentIndexing SPLRelated label
49580-0288-42023-02-24C16284748780-1f386c649-af7f-0266-e053-dadaa90a7c1aDrug Facts
49580-0288-42023-01-30C16284748780-1f386c649-af7f-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DCHILDRENS PAIN RELIEF READYINCASE (ACETAMINOPHEN) SUSPENSION [AARON INDUSTRIES INC.]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DCHILDRENS PAIN RELIEF READYINCASE (ACETAMINOPHEN) SUSPENSION [AARON INDUSTRIES INC.]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLCHILDRENS PAIN RELIEF READYINCASE (ACETAMINOPHEN) SUSPENSION [AARON INDUSTRIES INC.]1
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8CHILDRENS PAIN RELIEF READYINCASE (ACETAMINOPHEN) SUSPENSION [AARON INDUSTRIES INC.]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311CHILDRENS PAIN RELIEF READYINCASE (ACETAMINOPHEN) SUSPENSION [AARON INDUSTRIES INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCHILDRENS PAIN RELIEF READYINCASE (ACETAMINOPHEN) SUSPENSION [AARON INDUSTRIES INC.]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LCHILDRENS PAIN RELIEF READYINCASE (ACETAMINOPHEN) SUSPENSION [AARON INDUSTRIES INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCHILDRENS PAIN RELIEF READYINCASE (ACETAMINOPHEN) SUSPENSION [AARON INDUSTRIES INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCHILDRENS PAIN RELIEF READYINCASE (ACETAMINOPHEN) SUSPENSION [AARON INDUSTRIES INC.]1
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SCHILDRENS PAIN RELIEF READYINCASE (ACETAMINOPHEN) SUSPENSION [AARON INDUSTRIES INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CHILDRENS PAIN RELIEF READYINCASE (ACETAMINOPHEN) SUSPENSION [AARON INDUSTRIES INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCHILDRENS PAIN RELIEF READYINCASE (ACETAMINOPHEN) SUSPENSION [AARON INDUSTRIES INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RCHILDRENS PAIN RELIEF READYINCASE (ACETAMINOPHEN) SUSPENSION [AARON INDUSTRIES INC.]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4CHILDRENS PAIN RELIEF READYINCASE (ACETAMINOPHEN) SUSPENSION [AARON INDUSTRIES INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RCHILDRENS PAIN RELIEF READYINCASE (ACETAMINOPHEN) SUSPENSION [AARON INDUSTRIES INC.]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECHILDRENS PAIN RELIEF READYINCASE (ACETAMINOPHEN) SUSPENSION [AARON INDUSTRIES INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49580-0288CHILDRENS PAIN RELIEF READYINCASE (ACETAMINOPHEN) SUSPENSION [P & L DEVELOPMENT, LLC]6Legacy NDC20230225_e9fc5bd3-0557-4e7b-a048-84332930c8e5.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49580-0288-4495800288041 BOTTLE, PLASTIC in 1 BOX (49580-0288-4) > 118 mL in 1 BOTTLE, PLASTIC2014-11-300000-00-00NoNoCurrent