FDA.reportPublic FDA data

Childrens Pain Relief

Product NDC
63868-174
11-digit product format
638680174
Labeler code
63868
Product ID
63868-174_79704be8-4c3c-4ad7-9ccb-1890edc4e4cf
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
QUALITY CHOICE (Chain Drug Marketing Association)
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-10-31
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 productproduct63868-174DDiscontinued by firm2026-10-05
excluded packagepackage63868-17463868-174-18DDiscontinued by firm2026-10-05

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 NDCProductDescriptionFormQuantityStrengthSPL version
63868-174-18Childrens Pain Relief118 mL in 1 BOTTLE, PLASTICSUSPENSION1187

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-174-18ML - Milliliter63868-1743a3b8fc5-ce07-4619-b451-d02849b458c512017-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DCHILDRENS PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DCHILDRENS PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLCHILDRENS PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]2
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8CHILDRENS PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]2
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMINACTIVE INGREDIENTK679OBS311CHILDRENS PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCHILDRENS PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]2
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LCHILDRENS PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCHILDRENS PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCHILDRENS PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]2
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SCHILDRENS PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CHILDRENS PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCHILDRENS PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]2
SORBITOLINACTIVE INGREDIENT506T60A25RCHILDRENS PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]2
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4CHILDRENS PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]2
WATERINACTIVE INGREDIENT059QF0KO0RCHILDRENS PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECHILDRENS PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-174CHILDRENS PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]7Legacy NDC, 1 package rows20240423_a218a4cc-8f01-4af1-8b86-69da7fd3e89d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSNa218a4cc-8f01-4af1-8b86-69da7fd3e89d7
307668acetaminophen 32 MG/ML Oral SuspensionSCDa218a4cc-8f01-4af1-8b86-69da7fd3e89d7
307668acetaminophen 160 MG per 5 ML Oral SuspensionSYa218a4cc-8f01-4af1-8b86-69da7fd3e89d7
307668acetaminophen 320 MG per 10 ML Oral SuspensionSYa218a4cc-8f01-4af1-8b86-69da7fd3e89d7
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSYa218a4cc-8f01-4af1-8b86-69da7fd3e89d7
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSYa218a4cc-8f01-4af1-8b86-69da7fd3e89d7
307668APAP 32 MG/ML Oral SuspensionSYa218a4cc-8f01-4af1-8b86-69da7fd3e89d7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-174-1863868017418118 mL in 1 BOTTLE, PLASTIC (63868-174-18) 118 ml2014-10-310000-00-00NoNoCurrent