FDA.reportPublic FDA data

signature care childrens pain relief

Product NDC
21130-243
Requested package NDC
21130-243-26
11-digit product format
211300243
Labeler code
21130
Product ID
21130-243_0f09f326-b185-4a76-a761-b59c6391fc53
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Safeway
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2015-09-28
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage21130-24321130-243-26DDiscontinued by firm2026-11-03

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
21130-243-26signature care childrens pain relief1 in 1 CARTONSUSPENSION14
21130-243-26signature care childrens pain relief118 mL in 1 BOTTLESUSPENSION1184

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DSIGNATURE CARE CHILDRENS PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [SAFEWAY]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DSIGNATURE CARE CHILDRENS PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [SAFEWAY]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLSIGNATURE CARE CHILDRENS PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [SAFEWAY]1
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8SIGNATURE CARE CHILDRENS PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [SAFEWAY]1
CALCIUM SULFATEINACTIVE INGREDIENTWAT0DDB505SIGNATURE CARE CHILDRENS PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [SAFEWAY]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311SIGNATURE CARE CHILDRENS PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [SAFEWAY]1
CARRAGEENANINACTIVE INGREDIENT5C69YCD2YJSIGNATURE CARE CHILDRENS PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [SAFEWAY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USIGNATURE CARE CHILDRENS PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [SAFEWAY]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOASIGNATURE CARE CHILDRENS PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [SAFEWAY]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSIGNATURE CARE CHILDRENS PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [SAFEWAY]1
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SSIGNATURE CARE CHILDRENS PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [SAFEWAY]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SIGNATURE CARE CHILDRENS PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [SAFEWAY]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUSIGNATURE CARE CHILDRENS PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [SAFEWAY]1
SODIUM PHOSPHATE, TRIBASICINACTIVE INGREDIENTA752Q30A6XSIGNATURE CARE CHILDRENS PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [SAFEWAY]1
SORBITOLINACTIVE INGREDIENT506T60A25RSIGNATURE CARE CHILDRENS PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [SAFEWAY]1
WATERINACTIVE INGREDIENT059QF0KO0RSIGNATURE CARE CHILDRENS PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [SAFEWAY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-243SIGNATURE CARE CHILDRENS PAIN RELIEF (ACETAMINOPHEN) SUSPENSION [SAFEWAY]4Legacy NDC, 2 package rows20240907_fccb5aca-5707-491f-beb4-08f568919169.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
signature care childrens pain reliefACETAMINOPHENSafewayfccb5aca-5707-491f-beb4-08f5689191692024-09-06WarningsExact identifier
ndc (package): 21130-243-26
ndc (product): 21130-243
ndc11 (package): 21130024326

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSNfccb5aca-5707-491f-beb4-08f5689191694
307668acetaminophen 32 MG/ML Oral SuspensionSCDfccb5aca-5707-491f-beb4-08f5689191694
307668acetaminophen 160 MG per 5 ML Oral SuspensionSYfccb5aca-5707-491f-beb4-08f5689191694
307668acetaminophen 320 MG per 10 ML Oral SuspensionSYfccb5aca-5707-491f-beb4-08f5689191694
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSYfccb5aca-5707-491f-beb4-08f5689191694
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSYfccb5aca-5707-491f-beb4-08f5689191694
307668APAP 32 MG/ML Oral SuspensionSYfccb5aca-5707-491f-beb4-08f5689191694

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21130-243-26211300243261 BOTTLE in 1 CARTON (21130-243-26) > 118 mL in 1 BOTTLE1 bottle2015-09-280000-00-00NoNoCurrent