FDA.reportPublic FDA data

childrens fever reducer and pain reliever

Product NDC
11822-0107
11-digit product format
118220107
Labeler code
11822
Product ID
11822-0107_e203b743-5416-471e-aa0d-4543ea976975
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Rite Aid Corporation
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1997-02-26
Substance
ACETAMINOPHEN
Active strength
160 mg/5mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
childrens fever reducer and pain reliever
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN160 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D
Rxcui307668

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11822-0107-12023-10-30C16284748780-1f386c649-c0d2-0266-e053-dadaa90a7c1aRite Aid Corporation Children’s Fever Reducer and Pain Reliever Drug Facts
11822-0107-22023-10-30C16284748780-1f386c649-c0d2-0266-e053-dadaa90a7c1aRite Aid Corporation Children’s Fever Reducer and Pain Reliever Drug Facts
11822-0107-12023-01-30C16284748780-1f386c649-c0d2-0266-e053-dadaa90a7c1aRite Aid Corporation Children’s Fever Reducer and Pain Reliever Drug Facts
11822-0107-22023-01-30C16284748780-1f386c649-c0d2-0266-e053-dadaa90a7c1aRite Aid Corporation Children’s Fever Reducer and Pain Reliever Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-0107-1childrens fever reducer and pain reliever1 in 1 CARTONSUSPENSION18
11822-0107-1childrens fever reducer and pain reliever118 mL in 1 BOTTLESUSPENSION1188
11822-0107-2childrens fever reducer and pain reliever1 in 1 CARTONSUSPENSION18
11822-0107-2childrens fever reducer and pain reliever148 mL in 1 BOTTLESUSPENSION1488

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DCHILDRENS FEVER REDUCER AND PAIN RELIEVER (ACETAMINOPHEN) SUSPENSION [RITE AID CORPORATION]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DCHILDRENS FEVER REDUCER AND PAIN RELIEVER (ACETAMINOPHEN) SUSPENSION [RITE AID CORPORATION]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLCHILDRENS FEVER REDUCER AND PAIN RELIEVER (ACETAMINOPHEN) SUSPENSION [RITE AID CORPORATION]3
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8CHILDRENS FEVER REDUCER AND PAIN RELIEVER (ACETAMINOPHEN) SUSPENSION [RITE AID CORPORATION]3
CALCIUM SULFATEINACTIVE INGREDIENTWAT0DDB505CHILDRENS FEVER REDUCER AND PAIN RELIEVER (ACETAMINOPHEN) SUSPENSION [RITE AID CORPORATION]3
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311CHILDRENS FEVER REDUCER AND PAIN RELIEVER (ACETAMINOPHEN) SUSPENSION [RITE AID CORPORATION]3
CARRAGEENANINACTIVE INGREDIENT5C69YCD2YJCHILDRENS FEVER REDUCER AND PAIN RELIEVER (ACETAMINOPHEN) SUSPENSION [RITE AID CORPORATION]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCHILDRENS FEVER REDUCER AND PAIN RELIEVER (ACETAMINOPHEN) SUSPENSION [RITE AID CORPORATION]3
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LCHILDRENS FEVER REDUCER AND PAIN RELIEVER (ACETAMINOPHEN) SUSPENSION [RITE AID CORPORATION]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACHILDRENS FEVER REDUCER AND PAIN RELIEVER (ACETAMINOPHEN) SUSPENSION [RITE AID CORPORATION]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCHILDRENS FEVER REDUCER AND PAIN RELIEVER (ACETAMINOPHEN) SUSPENSION [RITE AID CORPORATION]3
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SCHILDRENS FEVER REDUCER AND PAIN RELIEVER (ACETAMINOPHEN) SUSPENSION [RITE AID CORPORATION]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CHILDRENS FEVER REDUCER AND PAIN RELIEVER (ACETAMINOPHEN) SUSPENSION [RITE AID CORPORATION]3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCHILDRENS FEVER REDUCER AND PAIN RELIEVER (ACETAMINOPHEN) SUSPENSION [RITE AID CORPORATION]3
SODIUM PHOSPHATE, TRIBASICINACTIVE INGREDIENTA752Q30A6XCHILDRENS FEVER REDUCER AND PAIN RELIEVER (ACETAMINOPHEN) SUSPENSION [RITE AID CORPORATION]3
SORBITOLINACTIVE INGREDIENT506T60A25RCHILDRENS FEVER REDUCER AND PAIN RELIEVER (ACETAMINOPHEN) SUSPENSION [RITE AID CORPORATION]3
WATERINACTIVE INGREDIENT059QF0KO0RCHILDRENS FEVER REDUCER AND PAIN RELIEVER (ACETAMINOPHEN) SUSPENSION [RITE AID CORPORATION]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-0107CHILDRENS FEVER REDUCER AND PAIN RELIEVER (ACETAMINOPHEN) SUSPENSION [RITE AID CORPORATION]8Current NDC, Legacy NDC, 4 package rows20240920_a63727c3-64d8-4ae9-8da3-974cae6beed2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSNa63727c3-64d8-4ae9-8da3-974cae6beed28
307668acetaminophen 32 MG/ML Oral SuspensionSCDa63727c3-64d8-4ae9-8da3-974cae6beed28
307668acetaminophen 160 MG per 5 ML Oral SuspensionSYa63727c3-64d8-4ae9-8da3-974cae6beed28
307668acetaminophen 320 MG per 10 ML Oral SuspensionSYa63727c3-64d8-4ae9-8da3-974cae6beed28
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSYa63727c3-64d8-4ae9-8da3-974cae6beed28
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSYa63727c3-64d8-4ae9-8da3-974cae6beed28
307668APAP 32 MG/ML Oral SuspensionSYa63727c3-64d8-4ae9-8da3-974cae6beed28

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-0107-1118220107011 BOTTLE in 1 CARTON (11822-0107-1) / 118 mL in 1 BOTTLE1 bottle1997-02-260000-00-00NoNoCurrent
11822-0107-2118220107021 in 1 CARTONHistorical